A nutrition education tool for practical application of the food based dietary guidelines for primary school teachers in Nelson Mandela Bay
- Authors: Joubert, Tayla Kate
- Date: 2019
- Subjects: Nutrition -- Education
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/44616 , vital:38152
- Description: Background: The South Africa Food-Based Dietary Guidelines (SAFBDG) was developed to promote better food choices for a healthy lifestyle and are included in the school syllabus. Schools remain viable platforms for nutrition education with teachers playing significant roles, but research has shown that teachers do not necessarily know about the SAFBDG and how to incorporate these into the teaching programme. Aim: The aim of this study was to develop a tool in the form of a nutrition education guide for primary school teachers, aimed at the practical application of the SAFBDG, in order to enhance the nutrition knowledge, attitudes and dietary practices of the teachers. Research design and methodology: A quasi-experimental, one group, quantitative design was employed. Forty-six teachers were conveniently chosen from schools in previously disadvantaged areas of Nelson Mandela Bay. The study design consisted of four phases. Phase one consisted of a pre-test where the teachers’ nutrition knowledge, nutrition attitudes, dietary practices, staff wellness and physical activity were determined by means of a standardised questionnaire. A nutritional assessment was also conducted in phase one. In phase two, the nutrition guide, which was Curriculum Assessment Policy Statement compliant for grades four to seven, was developed. In phase three, the guide was used in a workshop to train the teachers that attended phase one of the study, on how to use the nutrition education guide. In phase four, a post-test was conducted after the training to evaluate the effectiveness of the training and to determine whether there has been an increase in the teachers’ nutrition knowledge. Data from the questionnaires were analysed on Microsoft Excel 2016 MSO (16.0.4639.1000). Ethical approval for this study was obtained from the Faculty Postgraduate Studies Committee (FPGSC) of the Faculty of Health Sciences, Nelson Mandela University (Ethics clearance reference number: H18-HEA-DIET-005) and all ethical principles were upheld according to the Belmont report and the Declaration of Helsinki. Results: Of the 46 teachers who participated 36 (78 %) were obese. The mean waist circumference and waist-to-hip ratio was 109.99 and 0.887 respectively (± 17.32 and ± 0.089). The teachers obtained a relatively high mean overall score in the pre-test of 69 % (± 10.78). Only 42 % of the teachers had heard of the SAFBDG before the study. There was an overall statistical significant increase in knowledge of 6 % (p = 0.03) from the pre-test to the post-test. The dietary practice was obtained through a food frequency questionnaire (FFQ), which showed under-reporting. The most neglected food groups were legumes, dairy and vegetables/ fruit. Hypertension was the highest self-reported condition, with just under a quarter of the teachers having hypertension (high blood pressure). There was no statistical significance between the teachers’ BMI and their nutrition knowledge as well as no statistical significance between their BMI and their physical activity level. Conclusion and recommendations: Even though the teachers obtained a relatively high mean overall score in their pre-test, there were still gaps in their nutrition knowledge. These gaps in the teachers’ knowledge results in insufficient nutrition knowledge being provided to the learners, leading to poor dietary practices and misconceptions regarding different foods among the learners as well as the teachers. By providing training for the teachers, it will not only improve their nutrition knowledge but potentially also help to improve their lifestyle. With enhanced nutrition knowledge, the teachers can communicate sufficient information to their learners. The DoBE need to advocate for a healthier school environment in which the SAFBDG are implemented more extensively in the curriculum as well as part of school food policies.
- Full Text:
- Date Issued: 2019
- Authors: Joubert, Tayla Kate
- Date: 2019
- Subjects: Nutrition -- Education
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/44616 , vital:38152
- Description: Background: The South Africa Food-Based Dietary Guidelines (SAFBDG) was developed to promote better food choices for a healthy lifestyle and are included in the school syllabus. Schools remain viable platforms for nutrition education with teachers playing significant roles, but research has shown that teachers do not necessarily know about the SAFBDG and how to incorporate these into the teaching programme. Aim: The aim of this study was to develop a tool in the form of a nutrition education guide for primary school teachers, aimed at the practical application of the SAFBDG, in order to enhance the nutrition knowledge, attitudes and dietary practices of the teachers. Research design and methodology: A quasi-experimental, one group, quantitative design was employed. Forty-six teachers were conveniently chosen from schools in previously disadvantaged areas of Nelson Mandela Bay. The study design consisted of four phases. Phase one consisted of a pre-test where the teachers’ nutrition knowledge, nutrition attitudes, dietary practices, staff wellness and physical activity were determined by means of a standardised questionnaire. A nutritional assessment was also conducted in phase one. In phase two, the nutrition guide, which was Curriculum Assessment Policy Statement compliant for grades four to seven, was developed. In phase three, the guide was used in a workshop to train the teachers that attended phase one of the study, on how to use the nutrition education guide. In phase four, a post-test was conducted after the training to evaluate the effectiveness of the training and to determine whether there has been an increase in the teachers’ nutrition knowledge. Data from the questionnaires were analysed on Microsoft Excel 2016 MSO (16.0.4639.1000). Ethical approval for this study was obtained from the Faculty Postgraduate Studies Committee (FPGSC) of the Faculty of Health Sciences, Nelson Mandela University (Ethics clearance reference number: H18-HEA-DIET-005) and all ethical principles were upheld according to the Belmont report and the Declaration of Helsinki. Results: Of the 46 teachers who participated 36 (78 %) were obese. The mean waist circumference and waist-to-hip ratio was 109.99 and 0.887 respectively (± 17.32 and ± 0.089). The teachers obtained a relatively high mean overall score in the pre-test of 69 % (± 10.78). Only 42 % of the teachers had heard of the SAFBDG before the study. There was an overall statistical significant increase in knowledge of 6 % (p = 0.03) from the pre-test to the post-test. The dietary practice was obtained through a food frequency questionnaire (FFQ), which showed under-reporting. The most neglected food groups were legumes, dairy and vegetables/ fruit. Hypertension was the highest self-reported condition, with just under a quarter of the teachers having hypertension (high blood pressure). There was no statistical significance between the teachers’ BMI and their nutrition knowledge as well as no statistical significance between their BMI and their physical activity level. Conclusion and recommendations: Even though the teachers obtained a relatively high mean overall score in their pre-test, there were still gaps in their nutrition knowledge. These gaps in the teachers’ knowledge results in insufficient nutrition knowledge being provided to the learners, leading to poor dietary practices and misconceptions regarding different foods among the learners as well as the teachers. By providing training for the teachers, it will not only improve their nutrition knowledge but potentially also help to improve their lifestyle. With enhanced nutrition knowledge, the teachers can communicate sufficient information to their learners. The DoBE need to advocate for a healthier school environment in which the SAFBDG are implemented more extensively in the curriculum as well as part of school food policies.
- Full Text:
- Date Issued: 2019
A nutrition education tool for practical application of the food based dietary guidelines for primary school teachers in Nelson Mandela Bay
- Authors: Joubert, Tayla Kate
- Date: 2019
- Subjects: Malnutrition -- South Africa -- Port Elizabeth , Nutrition—Evaluation Nutrition -- Evaluation Nutrition -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/45019 , vital:38226
- Description: The South Africa Food-Based Dietary Guidelines (SAFBDG) was developed to promote better food choices for a healthy lifestyle and are included in the school syllabus. Schools remain viable platforms for nutrition education with teachers playing significant roles, but research has shown that teachers do not necessarily know about the SAFBDG and how to incorporate these into the teaching programme. The aim of this study was to develop a tool in the form of a nutrition education guide for primary school teachers, aimed at the practical application of the SAFBDG, in order to enhance the nutrition knowledge, attitudes and dietary practices of the teachers. A quasi-experimental, one group, quantitative design was employed. Forty-six teachers were conveniently chosen from schools in previously disadvantaged areas of Nelson Mandela Bay. The study design consisted of four phases. Phase one consisted of a pre-test where the teachers’ nutrition knowledge, nutrition attitudes, dietary practices, staff wellness and physical activity were determined by means of a standardised questionnaire. A nutritional assessment was also conducted in phase one. In phase two, the nutrition guide, which was Curriculum Assessment Policy Statement compliant for grades four to seven, was developed. In phase three, the guide was used in a workshop to train the teachers that attended phase one of the study, on how to use the nutrition education guide. In phase four, a post-test was conducted after the training to evaluate the effectiveness of the training and to determine whether there has been an increase in the teachers’ nutrition knowledge. Data from the questionnaires were analysed on Microsoft Excel 2016 MSO (16.0.4639.1000). Ethical approval for this study was obtained from the Faculty Postgraduate Studies Committee (FPGSC) of the Faculty of Health Sciences, Nelson Mandela University (Ethics clearance reference number: H18-HEA-DIET-005) and all ethical principles were upheld according to the Belmont report and the Declaration of Helsinki. Results of the research 46 teachers who participated 36 (78 %) were obese. The mean waist circumference and waist-to-hip ratio was 109.99 and 0.887 respectively (± 17.32 and ± 0.089). The teachers obtained a relatively high mean overall score in the pre-test of 69 % (± 10.78). Only 42 % of the teachers had heard of the SAFBDG before the study. There was an overall statistical significant increase in knowledge of 6 % (p = 0.03) from the pre-test to the post-test. The dietary practice was obtained through a food frequency questionnaire (FFQ), which showed under-reporting. The most neglected food groups were legumes, dairy and vegetables/ fruit. Hypertension was the highest self-reported condition, with just under a quarter of the teachers having hypertension (high blood pressure). There was no statistical significance between the teachers’ BMI and their nutrition knowledge as well as no statistical significance between their BMI and their physical activity level. Even though the teachers obtained a relatively high mean overall score in their pre-test, there were still gaps in their nutrition knowledge. These gaps in the teachers’ knowledge results in insufficient nutrition knowledge being provided to the learners, leading to poor dietary practices and misconceptions regarding different foods among the learners as well as the teachers. By providing training for the teachers, it will not only improve their nutrition knowledge but potentially also help to improve their lifestyle. With enhanced nutrition knowledge, the teachers can communicate sufficient information to their learners. The DoBE need to advocate for a healthier school environment in which the SAFBDG are implemented more extensively in the curriculum as well as part of school food policies.
- Full Text:
- Date Issued: 2019
- Authors: Joubert, Tayla Kate
- Date: 2019
- Subjects: Malnutrition -- South Africa -- Port Elizabeth , Nutrition—Evaluation Nutrition -- Evaluation Nutrition -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/45019 , vital:38226
- Description: The South Africa Food-Based Dietary Guidelines (SAFBDG) was developed to promote better food choices for a healthy lifestyle and are included in the school syllabus. Schools remain viable platforms for nutrition education with teachers playing significant roles, but research has shown that teachers do not necessarily know about the SAFBDG and how to incorporate these into the teaching programme. The aim of this study was to develop a tool in the form of a nutrition education guide for primary school teachers, aimed at the practical application of the SAFBDG, in order to enhance the nutrition knowledge, attitudes and dietary practices of the teachers. A quasi-experimental, one group, quantitative design was employed. Forty-six teachers were conveniently chosen from schools in previously disadvantaged areas of Nelson Mandela Bay. The study design consisted of four phases. Phase one consisted of a pre-test where the teachers’ nutrition knowledge, nutrition attitudes, dietary practices, staff wellness and physical activity were determined by means of a standardised questionnaire. A nutritional assessment was also conducted in phase one. In phase two, the nutrition guide, which was Curriculum Assessment Policy Statement compliant for grades four to seven, was developed. In phase three, the guide was used in a workshop to train the teachers that attended phase one of the study, on how to use the nutrition education guide. In phase four, a post-test was conducted after the training to evaluate the effectiveness of the training and to determine whether there has been an increase in the teachers’ nutrition knowledge. Data from the questionnaires were analysed on Microsoft Excel 2016 MSO (16.0.4639.1000). Ethical approval for this study was obtained from the Faculty Postgraduate Studies Committee (FPGSC) of the Faculty of Health Sciences, Nelson Mandela University (Ethics clearance reference number: H18-HEA-DIET-005) and all ethical principles were upheld according to the Belmont report and the Declaration of Helsinki. Results of the research 46 teachers who participated 36 (78 %) were obese. The mean waist circumference and waist-to-hip ratio was 109.99 and 0.887 respectively (± 17.32 and ± 0.089). The teachers obtained a relatively high mean overall score in the pre-test of 69 % (± 10.78). Only 42 % of the teachers had heard of the SAFBDG before the study. There was an overall statistical significant increase in knowledge of 6 % (p = 0.03) from the pre-test to the post-test. The dietary practice was obtained through a food frequency questionnaire (FFQ), which showed under-reporting. The most neglected food groups were legumes, dairy and vegetables/ fruit. Hypertension was the highest self-reported condition, with just under a quarter of the teachers having hypertension (high blood pressure). There was no statistical significance between the teachers’ BMI and their nutrition knowledge as well as no statistical significance between their BMI and their physical activity level. Even though the teachers obtained a relatively high mean overall score in their pre-test, there were still gaps in their nutrition knowledge. These gaps in the teachers’ knowledge results in insufficient nutrition knowledge being provided to the learners, leading to poor dietary practices and misconceptions regarding different foods among the learners as well as the teachers. By providing training for the teachers, it will not only improve their nutrition knowledge but potentially also help to improve their lifestyle. With enhanced nutrition knowledge, the teachers can communicate sufficient information to their learners. The DoBE need to advocate for a healthier school environment in which the SAFBDG are implemented more extensively in the curriculum as well as part of school food policies.
- Full Text:
- Date Issued: 2019
A stunting profile of children under the age of five visiting Bhisho hospital clinic, part of the umbrella project: a profile of stunting in children under the age of five in food insecure villages in Mqanduli, Ngqushwa and Bhisho hospital, Eastern Cape, South Africa
- Authors: Beyleveld, Janine
- Date: 2020
- Subjects: Children -- growth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/50201 , vital:42066
- Description: Introduction and Background: Stunting is the most prevalent form of childhood malnutrition where about 149 million children under the age of five can be classified as stunted globally. South Africa has one of the highest stunting rates in the world at 27%, causing devastating effects on economic productivity as well as on an individual’s nutritional status. The presence of stunted growth in children is a strong indicator of chronic undernutrition and highlights injustices experienced within communities. Aims and Objectives: The aim of this study is to develop a stunning profile of children under the age of five, visiting BhishoHospital’s gateway clinic in the Eastern Cape, South Africa. The objectives were to determine the prevalence of stunting of the children visiting Bhisho Hospital’s clinic and to identify the drivers of stunting in the area. Methodology: A quantitative study with a descriptive, cross-sectional design was used. The study population included all children under the age of five visiting Bhisho Hospital’s clinic. Data was collected by means of an interview-administered questionnaire. Results: The prevalence of stunting in the area was 47.5%. A significant association was found between the participants' main form of sanitation and stunting category in the group of infants younger than six months (p = 0.007) and the group older than six months(p = 0.040). Discussion: The prevalence of stunting in the area was far higher than the national average of 27%, although the majority of the sample had a normal weight. The use of non-flush toilets was found to be a risk factor for childhood stunting. Recommendation: Financial and political investment in child health needs to be placed as a top priority in South Africa to reduce stunting rates.
- Full Text:
- Date Issued: 2020
- Authors: Beyleveld, Janine
- Date: 2020
- Subjects: Children -- growth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/50201 , vital:42066
- Description: Introduction and Background: Stunting is the most prevalent form of childhood malnutrition where about 149 million children under the age of five can be classified as stunted globally. South Africa has one of the highest stunting rates in the world at 27%, causing devastating effects on economic productivity as well as on an individual’s nutritional status. The presence of stunted growth in children is a strong indicator of chronic undernutrition and highlights injustices experienced within communities. Aims and Objectives: The aim of this study is to develop a stunning profile of children under the age of five, visiting BhishoHospital’s gateway clinic in the Eastern Cape, South Africa. The objectives were to determine the prevalence of stunting of the children visiting Bhisho Hospital’s clinic and to identify the drivers of stunting in the area. Methodology: A quantitative study with a descriptive, cross-sectional design was used. The study population included all children under the age of five visiting Bhisho Hospital’s clinic. Data was collected by means of an interview-administered questionnaire. Results: The prevalence of stunting in the area was 47.5%. A significant association was found between the participants' main form of sanitation and stunting category in the group of infants younger than six months (p = 0.007) and the group older than six months(p = 0.040). Discussion: The prevalence of stunting in the area was far higher than the national average of 27%, although the majority of the sample had a normal weight. The use of non-flush toilets was found to be a risk factor for childhood stunting. Recommendation: Financial and political investment in child health needs to be placed as a top priority in South Africa to reduce stunting rates.
- Full Text:
- Date Issued: 2020
Adolescent mothers’ breastfeeding experiences in Nelson Mandela Bay health district
- Authors: Fordjour Afriyie, Vera
- Date: 2017
- Subjects: Breastfeeding -- South Africa -- Eastern Cape , Children -- Nutrition -- South Africa -- Port Elizabeth , Teenage mothers -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/13879 , vital:27316
- Description: Rationale: There is limited research available in South Africa that explores the breastfeeding experience among adolescent mothers; most of the studies were conducted in developed countries. One such study relating to the above mentioned developed countries stated that social and commitment factors influence the decision to breastfeed by adolescents. Furthermore, while adolescent mothers appreciate the benefits of breastfeeding, pain, public exposure and perceived complexities related to breastfeeding create barriers for them. The researcher was unable to ascertain if similar ambiguities exist among adolescent mothers in South Africa, and in the Eastern Cape (EC) in particular with its high rates of adolescent pregnancy. In order to attempt to develop age appropriate recommendations to assist adolescent mothers with their breastfeeding journey, the researcher undertook this research study to answer the following question: What are the breastfeeding experiences of adolescent mothers in the Nelson Mandela Bay Heath District (NMBHD)? Aim: The research aim was to determine the experiences of adolescent mothers regarding breastfeeding in NMBHD. Methods: The study implemented a qualitative research approach. To enhance the design, the researcher utilised an explorative, descriptive and contextual research design. The ethical principles that guided this study were autonomy, nonmaleficence, beneficence and justice. Fourteen adolescent mothers, attending PHC facilities in the NMBHD participated in the study. Participants were chosen from a purposive sampling technique and data were collected from semi-structured interviews, compromising of individual interviews. The researcher analysed the data using the using the eight steps of the Tesch analysis technique. Data was also analysed by an independent coder. Results obtained from the Tesch approach were compared to that of the independent coder results. Thereafter, the major themes and sub-themes that related to the study objectives were identified. Results: Three themes and 10 sub-themes were identified. Lack of knowledge and poor adherence to EBF, perceived breastmilk insufficiency, as well as incorrect infant feeding advice given by maternal mothers and grandmothers were associated with early introduction of complementary feeding. Most participants were motivated to breastfeed due to its economic and bonding benefits, as well as seeing their infant‟s progress in growth. Challenges of breastfeeding mentioned by the participants include: lack of support from the fathers of their infants and from health care providers, breast milk leakage, and the foul smell associated with the leaking of breast milk. The participants of the study also had suggestions to help improve the support given to adolescent mothers by health care providers in PHC facilities. Conclusions and recommendations: In conclusion, this study‟s findings revealed that adolescent mothers may need extra age appropriate education and support to assist them in breastfeeding successfully at PHC facilities, the community and schools. Maternal mothers and grandmothers were found to be the primary source of a support network for most adolescent mothers as opposed to health care providers who were categorised as being the secondary source of support. Thus, breastfeeding promotion tailored at maternal mothers and grandmothers would be beneficial in improving their knowledge about the recommended infant feeding practices and consequently aid in providing appropriate support and advice to adolescent mothers. Additionally, training and attitude modification of health care providers is needed to provide adolescent mothers with age-appropriate, effective and sensitive care and counselling.
- Full Text:
- Date Issued: 2017
- Authors: Fordjour Afriyie, Vera
- Date: 2017
- Subjects: Breastfeeding -- South Africa -- Eastern Cape , Children -- Nutrition -- South Africa -- Port Elizabeth , Teenage mothers -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/13879 , vital:27316
- Description: Rationale: There is limited research available in South Africa that explores the breastfeeding experience among adolescent mothers; most of the studies were conducted in developed countries. One such study relating to the above mentioned developed countries stated that social and commitment factors influence the decision to breastfeed by adolescents. Furthermore, while adolescent mothers appreciate the benefits of breastfeeding, pain, public exposure and perceived complexities related to breastfeeding create barriers for them. The researcher was unable to ascertain if similar ambiguities exist among adolescent mothers in South Africa, and in the Eastern Cape (EC) in particular with its high rates of adolescent pregnancy. In order to attempt to develop age appropriate recommendations to assist adolescent mothers with their breastfeeding journey, the researcher undertook this research study to answer the following question: What are the breastfeeding experiences of adolescent mothers in the Nelson Mandela Bay Heath District (NMBHD)? Aim: The research aim was to determine the experiences of adolescent mothers regarding breastfeeding in NMBHD. Methods: The study implemented a qualitative research approach. To enhance the design, the researcher utilised an explorative, descriptive and contextual research design. The ethical principles that guided this study were autonomy, nonmaleficence, beneficence and justice. Fourteen adolescent mothers, attending PHC facilities in the NMBHD participated in the study. Participants were chosen from a purposive sampling technique and data were collected from semi-structured interviews, compromising of individual interviews. The researcher analysed the data using the using the eight steps of the Tesch analysis technique. Data was also analysed by an independent coder. Results obtained from the Tesch approach were compared to that of the independent coder results. Thereafter, the major themes and sub-themes that related to the study objectives were identified. Results: Three themes and 10 sub-themes were identified. Lack of knowledge and poor adherence to EBF, perceived breastmilk insufficiency, as well as incorrect infant feeding advice given by maternal mothers and grandmothers were associated with early introduction of complementary feeding. Most participants were motivated to breastfeed due to its economic and bonding benefits, as well as seeing their infant‟s progress in growth. Challenges of breastfeeding mentioned by the participants include: lack of support from the fathers of their infants and from health care providers, breast milk leakage, and the foul smell associated with the leaking of breast milk. The participants of the study also had suggestions to help improve the support given to adolescent mothers by health care providers in PHC facilities. Conclusions and recommendations: In conclusion, this study‟s findings revealed that adolescent mothers may need extra age appropriate education and support to assist them in breastfeeding successfully at PHC facilities, the community and schools. Maternal mothers and grandmothers were found to be the primary source of a support network for most adolescent mothers as opposed to health care providers who were categorised as being the secondary source of support. Thus, breastfeeding promotion tailored at maternal mothers and grandmothers would be beneficial in improving their knowledge about the recommended infant feeding practices and consequently aid in providing appropriate support and advice to adolescent mothers. Additionally, training and attitude modification of health care providers is needed to provide adolescent mothers with age-appropriate, effective and sensitive care and counselling.
- Full Text:
- Date Issued: 2017
An investigation into development of a stable aqeous suspension of Metronidazole Benzoate for oral use
- Authors: Zietsman, Sharon Lynne
- Date: 2005
- Subjects: Metronidazole -- Testing , Excipients -- South Africa -- Testing , Rheology -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10158 , http://hdl.handle.net/10948/456 , Metronidazole -- Testing , Excipients -- South Africa -- Testing , Rheology -- South Africa
- Description: Metronidazole is a synthetic, nitroimidazole-derivative antibacterial and antiprotozoal agent (ed. McEvoy, 2001). It has been reported that crystallization occurs in aqueous suspensions of metronidazole benzoate, a bland-tasting prodrug of metronidazole, as a result of conversion from the anhydrous to the monohydrate form, thereby compromising the stability and clinical efficacy of the substance due to the particle size growth (Hoelgaard & Moller, 1983). A generic South African based pharmaceutical company commenced formulation of an aqueous metronidazole benzoate suspension and experienced problems with crystallization that occurred in products stored at 2 to 8 °C. This study aimed to continue development of the product in order to identify a formulation that prevents formation of the hydrate form of metronidazole benzoate and the accompanying crystal growth. A variety of metronidazole benzoate suspensions were manufactured on a laboratory scale using a number of natural and synthetic suspending agents, including magnesium aluminium silicate, povidone K90, xanthan gum and Avicel® RC-591 (microcrystalline cellulose and carboxymethylcellulose sodium), over a range of concentrations. Analytical quantification methods were developed and validated, and the physicochemical properties of the raw material and finished products were fully characterized. Rheological tests were performed in order to characterize the suspension flow properties. Real-time and accelerated stability studies and a temperature cycle study were conducted in accordance with the International Conference on Harmonization (ICH) guidelines. Conversion of metronidazole benzoate to the monohydrate form took place in suspensions containing xanthan gum 0.65 percent m/v under real-time and accelerated storage conditions. The suspensions containing Avicel® RC-591 were found to be physically and chemically stable after the temperature cycle and over the 12-week period whilst stored at 25 ºC / 60 percent RH and 5 ºC. The suspensions were chemically stable whilst stored at 40 ºC / 75 percent RH but showed sedimentation at this accelerated condition. The metronidazole benzoate contained in these products remained in the anhydrous state under all storage conditions and were consequently concluded to be the most stable formulations out of all the products analyzed in the current study. The suspending agent system consisting of microcrystalline cellulose and carboxymethylcellulose sodium thus shows promise in preventing the conversion of metronidazole benzoate from the anhydrate to the monohydrate form, thereby inhibited the subsequent increase in particle size due to crystal growth.
- Full Text:
- Date Issued: 2005
- Authors: Zietsman, Sharon Lynne
- Date: 2005
- Subjects: Metronidazole -- Testing , Excipients -- South Africa -- Testing , Rheology -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10158 , http://hdl.handle.net/10948/456 , Metronidazole -- Testing , Excipients -- South Africa -- Testing , Rheology -- South Africa
- Description: Metronidazole is a synthetic, nitroimidazole-derivative antibacterial and antiprotozoal agent (ed. McEvoy, 2001). It has been reported that crystallization occurs in aqueous suspensions of metronidazole benzoate, a bland-tasting prodrug of metronidazole, as a result of conversion from the anhydrous to the monohydrate form, thereby compromising the stability and clinical efficacy of the substance due to the particle size growth (Hoelgaard & Moller, 1983). A generic South African based pharmaceutical company commenced formulation of an aqueous metronidazole benzoate suspension and experienced problems with crystallization that occurred in products stored at 2 to 8 °C. This study aimed to continue development of the product in order to identify a formulation that prevents formation of the hydrate form of metronidazole benzoate and the accompanying crystal growth. A variety of metronidazole benzoate suspensions were manufactured on a laboratory scale using a number of natural and synthetic suspending agents, including magnesium aluminium silicate, povidone K90, xanthan gum and Avicel® RC-591 (microcrystalline cellulose and carboxymethylcellulose sodium), over a range of concentrations. Analytical quantification methods were developed and validated, and the physicochemical properties of the raw material and finished products were fully characterized. Rheological tests were performed in order to characterize the suspension flow properties. Real-time and accelerated stability studies and a temperature cycle study were conducted in accordance with the International Conference on Harmonization (ICH) guidelines. Conversion of metronidazole benzoate to the monohydrate form took place in suspensions containing xanthan gum 0.65 percent m/v under real-time and accelerated storage conditions. The suspensions containing Avicel® RC-591 were found to be physically and chemically stable after the temperature cycle and over the 12-week period whilst stored at 25 ºC / 60 percent RH and 5 ºC. The suspensions were chemically stable whilst stored at 40 ºC / 75 percent RH but showed sedimentation at this accelerated condition. The metronidazole benzoate contained in these products remained in the anhydrous state under all storage conditions and were consequently concluded to be the most stable formulations out of all the products analyzed in the current study. The suspending agent system consisting of microcrystalline cellulose and carboxymethylcellulose sodium thus shows promise in preventing the conversion of metronidazole benzoate from the anhydrate to the monohydrate form, thereby inhibited the subsequent increase in particle size due to crystal growth.
- Full Text:
- Date Issued: 2005
An investigation into the introduction of process analytical technology, using near infrared analysis, to selected pharmaceutical processes
- Authors: Naicker, Krishnaveni
- Date: 2007
- Subjects: Near infrared spectroscopy , Pharmaceutical chemistry
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10153 , http://hdl.handle.net/10948/577 , http://hdl.handle.net/10948/d1011710 , Near infrared spectroscopy , Pharmaceutical chemistry
- Description: Introduction: Process analytical technologies are systems for the analysis and control of manufacturing processes to assure acceptable end-product quality. This is achieved by timely measurements of critical parameters and performance attributes of raw material and in-process material and processes. The introduction of process analytical technology using near infrared analysis was investigated in three areas, namely incoming raw material analysis, blend uniformity analysis and moisture determination in the fluid bed dryer. Methodology: Incoming raw material identification - The FOSS XDS rapid content analyzer was used for the development of a NIR method for the identification and material qualification of starch maize and lactose monohydrate. Blend uniformity analysis – The SP15 Laboratory Blender fitted with near infrared probe was utilized for the study. Two types of blend experiments were designed to monitor the distribution of magnesium stearate (lubricant) in the blend, namely, a powder blend utilizing lactose monohydrate and a granule blend utilizing Ridaq® granule. Software methods were developed to monitor the standard deviation of the absorbance at the wavelengths that were specific for lactose monohydrate, Ridaq® granule and magnesium stearate. To confirm the prediction of end-point using near infrared, results were verified using an atomic absorption method for magnesium stearate. The blends were sampled at the selected time intervals corresponding to three states of the blend, namely, before end-point, at end-point and after end-point using a sampling plan. An additional six blends were conducted for the granule blend and sampled when the standard deviation had reached a value below 3 x 10-6 at the magnesium stearate wavelength at four consecutive data points (standard deviation value extrapolated from blends carried out to predetermined time intervals). Moisture determination in the fluid bed dryer – Moisture values for two products (Product A and Product B) were retrospectively collected from past production batches. A process capability study was conducted on the moisture values to determine if the current process was in a state of control. Results and Discussion: Incoming raw material identification – The algorithms used for the spectral library were able to distinguish between the raw materials selected. The spectral library positively identified the starch maize and lactose monohydrate samples that were not present in the library. The negative challenge with pregelatinised starch and tablettose demonstrated that the spectral library was able to differentiate between closely related compounds. Blend uniformity analysis – Blends sampled at the predetermined time intervals demonstrated a homogeneous state when the standard deviation of the absorbance was low and a non-homogeneous state when the standard deviation of the absorbance was high, thus near infrared prediction on the state of the blend was confirmed by the standard analytical methods. The series of Ridaq® granule and magnesium stearate blends sampled when the standard deviation was below 3 x 10-6 were homogeneous with the exception of one blend that was marginally out of specification. Blend durations were significantly lower than the standard blend durations used in the facility and ranged from 112 to 198 seconds. Moisture determination in the fluid bed dryer – From the process capability study of the two products it was noted that Product A is stable but can still be optimized while Product B is at a desirable state. The statistical evaluation of the moisture values for Product A and Product B demonstrated that the use of the product temperature to monitor the moisture gave consistent results. The current process is stable and capable of producing repeatable results although near infrared provides a means for continuously monitoring the product moisture and allows one to take action to prevent over-drying or under-drying. Conclusion: From the investigations conducted, it can be seen that there is definitely a niche for process analytical technology at this pharmaceutical company. The implementation is a gradual process of change, which may take time, probably several years (Heinze & Hansen 2005).
- Full Text:
- Date Issued: 2007
- Authors: Naicker, Krishnaveni
- Date: 2007
- Subjects: Near infrared spectroscopy , Pharmaceutical chemistry
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10153 , http://hdl.handle.net/10948/577 , http://hdl.handle.net/10948/d1011710 , Near infrared spectroscopy , Pharmaceutical chemistry
- Description: Introduction: Process analytical technologies are systems for the analysis and control of manufacturing processes to assure acceptable end-product quality. This is achieved by timely measurements of critical parameters and performance attributes of raw material and in-process material and processes. The introduction of process analytical technology using near infrared analysis was investigated in three areas, namely incoming raw material analysis, blend uniformity analysis and moisture determination in the fluid bed dryer. Methodology: Incoming raw material identification - The FOSS XDS rapid content analyzer was used for the development of a NIR method for the identification and material qualification of starch maize and lactose monohydrate. Blend uniformity analysis – The SP15 Laboratory Blender fitted with near infrared probe was utilized for the study. Two types of blend experiments were designed to monitor the distribution of magnesium stearate (lubricant) in the blend, namely, a powder blend utilizing lactose monohydrate and a granule blend utilizing Ridaq® granule. Software methods were developed to monitor the standard deviation of the absorbance at the wavelengths that were specific for lactose monohydrate, Ridaq® granule and magnesium stearate. To confirm the prediction of end-point using near infrared, results were verified using an atomic absorption method for magnesium stearate. The blends were sampled at the selected time intervals corresponding to three states of the blend, namely, before end-point, at end-point and after end-point using a sampling plan. An additional six blends were conducted for the granule blend and sampled when the standard deviation had reached a value below 3 x 10-6 at the magnesium stearate wavelength at four consecutive data points (standard deviation value extrapolated from blends carried out to predetermined time intervals). Moisture determination in the fluid bed dryer – Moisture values for two products (Product A and Product B) were retrospectively collected from past production batches. A process capability study was conducted on the moisture values to determine if the current process was in a state of control. Results and Discussion: Incoming raw material identification – The algorithms used for the spectral library were able to distinguish between the raw materials selected. The spectral library positively identified the starch maize and lactose monohydrate samples that were not present in the library. The negative challenge with pregelatinised starch and tablettose demonstrated that the spectral library was able to differentiate between closely related compounds. Blend uniformity analysis – Blends sampled at the predetermined time intervals demonstrated a homogeneous state when the standard deviation of the absorbance was low and a non-homogeneous state when the standard deviation of the absorbance was high, thus near infrared prediction on the state of the blend was confirmed by the standard analytical methods. The series of Ridaq® granule and magnesium stearate blends sampled when the standard deviation was below 3 x 10-6 were homogeneous with the exception of one blend that was marginally out of specification. Blend durations were significantly lower than the standard blend durations used in the facility and ranged from 112 to 198 seconds. Moisture determination in the fluid bed dryer – From the process capability study of the two products it was noted that Product A is stable but can still be optimized while Product B is at a desirable state. The statistical evaluation of the moisture values for Product A and Product B demonstrated that the use of the product temperature to monitor the moisture gave consistent results. The current process is stable and capable of producing repeatable results although near infrared provides a means for continuously monitoring the product moisture and allows one to take action to prevent over-drying or under-drying. Conclusion: From the investigations conducted, it can be seen that there is definitely a niche for process analytical technology at this pharmaceutical company. The implementation is a gradual process of change, which may take time, probably several years (Heinze & Hansen 2005).
- Full Text:
- Date Issued: 2007
Anthropometric indicators in identifying malnutrition risk among children younger than two years in Motherwell, Nelson Mandela Metropolitan Municipality
- Authors: McLaren, Shawn William
- Date: 2017
- Subjects: Nutrition disorders in children -- South Africa -- Nelson Mandela Bay Municipality , Malnutrition in children -- South Africa -- Nelson Mandela Bay Municipality
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/19256 , vital:28811
- Description: Introduction: South Africa is burdened with a high prevalence of childhood malnutrition. The World Health Organisation (WHO) endorses weight for length (WFL) Z-scores and mid-upper arm circumference (MUAC) as tools for identifying children who are malnourished. The MUAC measurement offers many advantages for its use in community nutrition, and may aid in the early identification of malnourished children. More accurate and comprehensive data on child anthropometric status are needed in the Nelson Mandela Bay Health District (NMBHD), as well as assessment of the efficacy of using a simplified tool such as MUAC to screen for malnutrition. Aim: This study aimed to synthesise a profile of the nutritional status of children younger than two years old in Motherwell, Nelson Mandela Metropolitan Municipality (NMMM) to assess the value of MUAC as a predictor of malnutrition risk and develop malnutrition screening recommendations relevant to this population. Methods: This study followed a cross-sectional design using a quantitative approach. A convenience sample (n=419) of children below 24 months of age was selected from clinics and creches in Motherwell between October 2015 and February 2016 (Ethics approval: H15-HEA-DIET-002). Primary caregivers provided informed written consent for study participation. Trained fieldworkers performed anthropometric measurements according to standardised methods and completed a structured questionnaire. Data was described using means and standard deviations. Linear regression was used to assess relationships within the data. The MUAC’s ability to identify malnutrition was described using sensitivity and specificity probabilities. Results: Only 6% of the sample of children (n=23) were classified as stunted and 3% of the children (n=12) were severely stunted. The WHZ Z-score identified 0% (n=1) child with severe acute malnutrition (SAM), and 1% (n=3) children as MAM. The MUAC identified more children as SAM (2%) and MAM (3%). It was found that 16% of the children (n=65) were overweight or obese according to WHZ. It was found that there is a strong linear relationship between WHZ and MUAC (r=0.739). Using the least squares regression equation, a MUAC cut off value of 13,80cm for males and 13,5cm for females between six and 24 months old was projected. The male cut-off value has a 100% sensitivity and 94,5% specificity for MAM and SAM while the female MUAC cut off had a specificity of 96,4%. Low birth weight children had significantly (p<0.0005) lower mean WAZ and HAZ scores than normal birth weight children. Conclusions and recommendations The prevalence of overweight and obesity among children younger than two years was high in Motherwell, while stunting and wasting prevalence were lower than expected for the population. Raising the MUAC cut-off values from 12,5cm for MAM to 13,80cm for males and 13,47cm for females may increase the number of children younger than two years who are included in nutrition interventions. It is recommended that healthcare workers focus on breastfeeding and appropriate complementary feeding practices to reduce the risk of overweight in infants and young children.
- Full Text:
- Authors: McLaren, Shawn William
- Date: 2017
- Subjects: Nutrition disorders in children -- South Africa -- Nelson Mandela Bay Municipality , Malnutrition in children -- South Africa -- Nelson Mandela Bay Municipality
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/19256 , vital:28811
- Description: Introduction: South Africa is burdened with a high prevalence of childhood malnutrition. The World Health Organisation (WHO) endorses weight for length (WFL) Z-scores and mid-upper arm circumference (MUAC) as tools for identifying children who are malnourished. The MUAC measurement offers many advantages for its use in community nutrition, and may aid in the early identification of malnourished children. More accurate and comprehensive data on child anthropometric status are needed in the Nelson Mandela Bay Health District (NMBHD), as well as assessment of the efficacy of using a simplified tool such as MUAC to screen for malnutrition. Aim: This study aimed to synthesise a profile of the nutritional status of children younger than two years old in Motherwell, Nelson Mandela Metropolitan Municipality (NMMM) to assess the value of MUAC as a predictor of malnutrition risk and develop malnutrition screening recommendations relevant to this population. Methods: This study followed a cross-sectional design using a quantitative approach. A convenience sample (n=419) of children below 24 months of age was selected from clinics and creches in Motherwell between October 2015 and February 2016 (Ethics approval: H15-HEA-DIET-002). Primary caregivers provided informed written consent for study participation. Trained fieldworkers performed anthropometric measurements according to standardised methods and completed a structured questionnaire. Data was described using means and standard deviations. Linear regression was used to assess relationships within the data. The MUAC’s ability to identify malnutrition was described using sensitivity and specificity probabilities. Results: Only 6% of the sample of children (n=23) were classified as stunted and 3% of the children (n=12) were severely stunted. The WHZ Z-score identified 0% (n=1) child with severe acute malnutrition (SAM), and 1% (n=3) children as MAM. The MUAC identified more children as SAM (2%) and MAM (3%). It was found that 16% of the children (n=65) were overweight or obese according to WHZ. It was found that there is a strong linear relationship between WHZ and MUAC (r=0.739). Using the least squares regression equation, a MUAC cut off value of 13,80cm for males and 13,5cm for females between six and 24 months old was projected. The male cut-off value has a 100% sensitivity and 94,5% specificity for MAM and SAM while the female MUAC cut off had a specificity of 96,4%. Low birth weight children had significantly (p<0.0005) lower mean WAZ and HAZ scores than normal birth weight children. Conclusions and recommendations The prevalence of overweight and obesity among children younger than two years was high in Motherwell, while stunting and wasting prevalence were lower than expected for the population. Raising the MUAC cut-off values from 12,5cm for MAM to 13,80cm for males and 13,47cm for females may increase the number of children younger than two years who are included in nutrition interventions. It is recommended that healthcare workers focus on breastfeeding and appropriate complementary feeding practices to reduce the risk of overweight in infants and young children.
- Full Text:
Antibacterial activity of liposome encapsulated cyclo(TYR-PRO)
- Authors: Tshanga, Siphokazi Sisanda
- Date: 2011
- Subjects: Peptide antibiotics , Antibacterial agents -- Therapeutic use -- Testing
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10132 , http://hdl.handle.net/10948/1450 , Peptide antibiotics , Antibacterial agents -- Therapeutic use -- Testing
- Description: Cyclic dipeptides (CDPs) are amino acid-based compounds, some of which possess antibacterial activity. The encapsulation of certain drugs into liposomes has been found to improve their activity in terms of bioavailability and duration of action. Liposomes are small vesicles that are under investigation as drug carriers for the delivery of therapeutic agents. A number of liposome formulations are currently under clinical trial review, whilst some have already been approved for clinical use. The aim of this study was to optimize a liposomal cyclo(Tyr-Pro) formulation and to assess its antibacterial activity against various Gram-positive and Gram-negative bacteria. Response surface methodology (RSM) using the central composite design (CCD) model was used to optimize liposomal formulations of cyclo(Tyr-Pro) for each of the four bacteria, namely Bacillus cereus, Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. Percent drug encapsulated and bacterial inhibition were investigated with respect to two independent variables, i.e. lipid composition and cholesterol content. Design Expert 8 was used for the purpose of finding the combination of independent variables that would yield an optimal formulation for each bacterium. The model selected by the software failed to adequately correlate the predicted models to the experimental data. The in vitro experiments showed that the antibacterial activity of liposome-encapsulated cyclo(Tyr-Pro) was superior to that of its free counterpart. Binding maximum or Bmax for the encapsulated compound at concentrations as low as 0.412 mg/ml, was significantly higher than that obtained for free cyclo(Tyr-Pro) which was tested at a concentration of 20 mg/ml. Furthermore, encapsulation of cyclo(Tyr-Pro) into a liposome formulation enhanced its potency. This was evident in the lower IC50 values for the liposomal compound when compared to free cyclo(Tyr-Pro).
- Full Text:
- Date Issued: 2011
- Authors: Tshanga, Siphokazi Sisanda
- Date: 2011
- Subjects: Peptide antibiotics , Antibacterial agents -- Therapeutic use -- Testing
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10132 , http://hdl.handle.net/10948/1450 , Peptide antibiotics , Antibacterial agents -- Therapeutic use -- Testing
- Description: Cyclic dipeptides (CDPs) are amino acid-based compounds, some of which possess antibacterial activity. The encapsulation of certain drugs into liposomes has been found to improve their activity in terms of bioavailability and duration of action. Liposomes are small vesicles that are under investigation as drug carriers for the delivery of therapeutic agents. A number of liposome formulations are currently under clinical trial review, whilst some have already been approved for clinical use. The aim of this study was to optimize a liposomal cyclo(Tyr-Pro) formulation and to assess its antibacterial activity against various Gram-positive and Gram-negative bacteria. Response surface methodology (RSM) using the central composite design (CCD) model was used to optimize liposomal formulations of cyclo(Tyr-Pro) for each of the four bacteria, namely Bacillus cereus, Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. Percent drug encapsulated and bacterial inhibition were investigated with respect to two independent variables, i.e. lipid composition and cholesterol content. Design Expert 8 was used for the purpose of finding the combination of independent variables that would yield an optimal formulation for each bacterium. The model selected by the software failed to adequately correlate the predicted models to the experimental data. The in vitro experiments showed that the antibacterial activity of liposome-encapsulated cyclo(Tyr-Pro) was superior to that of its free counterpart. Binding maximum or Bmax for the encapsulated compound at concentrations as low as 0.412 mg/ml, was significantly higher than that obtained for free cyclo(Tyr-Pro) which was tested at a concentration of 20 mg/ml. Furthermore, encapsulation of cyclo(Tyr-Pro) into a liposome formulation enhanced its potency. This was evident in the lower IC50 values for the liposomal compound when compared to free cyclo(Tyr-Pro).
- Full Text:
- Date Issued: 2011
Associations between family history of diseases of lifestyle, lifestyle behaviour and anthropometric nutritional status of pre-school children in ECD centres in the Nelson Mandela Bay Municipality
- Authors: Wilson, Teresa Margaret
- Date: 2020
- Subjects: Nutrition--Evaluation
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/46344 , vital:39602
- Description: Introduction: Childhood overweight and obesity is an escalating global health issue. In Africa, overweight and obesity prevalence in children has nearly doubled since 2000(World Health Organisation, 2018).TheSANHANES-1 study (2013) identified that overweight and obesity in were most prevalent in urban informal areas of South Africa, with approximately a quarter of the children classified as overweight or obese (Shisana et al., 2013).In the Nelson Mandela Bay Municipality(NMBM), a double burden of disease was identified in the lower socio-economic population (Phekana et al., 2016). This study and others recommended further study into the contributing factors and behaviours which play a role in the development of overweight and obesity in children. These include household dietary intake, family history of lifestyle diseases, as well as the children’s and parental physical activity and sedentary time (Zhang et al.,2016).Aim: The aim of the study was to determine the associations between family history of diseases of lifestyle, lifestyle behaviour and anthropometric nutritional status of pre-school children in NMBM to describe underlying causes of childhood overweight and obesity.Methods: A cross-sectional design, using a quantitative approach, was used for this study(Ethics approval: H18-HEA-DIET-004). The study population included adult parents and/or caregivers of children from urban areas of Nelson Mandela Bay Municipality attending crèches and schools in these areas, in the age group from birth to 96 months (8 years). Randomised cluster sampling of crèches and schools from an existing database of anthropometrical data of children attending these crèches and schools in the area was done and a final sample of n=155obtained. With the assistance of a trained fieldworker, respondents completed a questionnaire detailing the family history of lifestyle diseases, physical activity levels and sedentary screen time behaviours, and a graphical adjusted version of a household dietary diversity questionnaire. Data about children’s activity levels in the preschool/creche environment was collected by the fieldworker by assessing the ECD centres’daily activity schedules. The anthropometric data of the children of the respondents was accessed from an existing database of these measurements. The data was described using means and standard deviations. Inferential statistics determined any existing associations between these underlying influences of childhood obesity.Results: Only 2% (n=3) of the children were underweight and 12% (n=9) were at risk of becoming underweight as classified by WAZ. HAZ scores identified26% (n=40) of the children at risk of becoming stunted, and 6% (n=9) of the children were already stunted. WHZ classified5% (n=8)of the children as overweight and 5% (n=8)as obese. A further 22% (n=34) of the children were at risk of becoming overweight.BMI/age classificationidentified25% (n=38) of the children as overweight and a further 12% (n=19) as obese. Out of the sample, 12%(n=17) of mothers and 8% (n=7) of fathers were categorised as overweight-to-obese according to the SA specific waist circumference(WC)cut-offs. Out of the children, 15% (n=22) have at least one parent who was overweight-to-obese. Traditional WC categories were classified48% (n=67) of the mothers as overweight-to-obese and at high risk for metabolic syndrome. Of all the lifestyle diseases, hypertension was the most prevalent with 29% (n=41) of households having at least one parent with hypertension. Parental physical activity was grossly overestimated, and the results found to be invalid. The Diet Variety and Frequency score resulted in a mean of 65.00 (n=154, SD=27.37) out of a possible 100 for the households in this sample, and junk food was consumed on three to four occasions per day in 32% (n=49) of households. There were no significant associations found between the parents’ variables and underweight children. Statistically small to medium effect associations were found between parental weight (both SA specific and traditional categories) and overweight children (classified by WHZ and BMI/age). Conclusions and recommendations: The prevalence of overweight and obesity among children in the NMBM was high. The only possible underlying cause of childhood overweight and obesity in pre-school children in the NMBM that could be determined by this study was parents’ weight classified by WC. However, it must be reiterated that due to the cross-sectional nature of the study, an association does not immediately mean causation, and the results are not adequate to rule out other underlying factors influencing childhood obesity. It is recommended that the results of the study are used to incentivise the final implementation of all the intervention targets laid out in the Strategic Plan for the Prevention and Control of Obesity in South Africa 2015-2020 in NMB, and for the development of the future obesity strategy after 2020. The results have shown the necessity for future health interventions to be targeted at the family as a unit.
- Full Text:
- Date Issued: 2020
- Authors: Wilson, Teresa Margaret
- Date: 2020
- Subjects: Nutrition--Evaluation
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/46344 , vital:39602
- Description: Introduction: Childhood overweight and obesity is an escalating global health issue. In Africa, overweight and obesity prevalence in children has nearly doubled since 2000(World Health Organisation, 2018).TheSANHANES-1 study (2013) identified that overweight and obesity in were most prevalent in urban informal areas of South Africa, with approximately a quarter of the children classified as overweight or obese (Shisana et al., 2013).In the Nelson Mandela Bay Municipality(NMBM), a double burden of disease was identified in the lower socio-economic population (Phekana et al., 2016). This study and others recommended further study into the contributing factors and behaviours which play a role in the development of overweight and obesity in children. These include household dietary intake, family history of lifestyle diseases, as well as the children’s and parental physical activity and sedentary time (Zhang et al.,2016).Aim: The aim of the study was to determine the associations between family history of diseases of lifestyle, lifestyle behaviour and anthropometric nutritional status of pre-school children in NMBM to describe underlying causes of childhood overweight and obesity.Methods: A cross-sectional design, using a quantitative approach, was used for this study(Ethics approval: H18-HEA-DIET-004). The study population included adult parents and/or caregivers of children from urban areas of Nelson Mandela Bay Municipality attending crèches and schools in these areas, in the age group from birth to 96 months (8 years). Randomised cluster sampling of crèches and schools from an existing database of anthropometrical data of children attending these crèches and schools in the area was done and a final sample of n=155obtained. With the assistance of a trained fieldworker, respondents completed a questionnaire detailing the family history of lifestyle diseases, physical activity levels and sedentary screen time behaviours, and a graphical adjusted version of a household dietary diversity questionnaire. Data about children’s activity levels in the preschool/creche environment was collected by the fieldworker by assessing the ECD centres’daily activity schedules. The anthropometric data of the children of the respondents was accessed from an existing database of these measurements. The data was described using means and standard deviations. Inferential statistics determined any existing associations between these underlying influences of childhood obesity.Results: Only 2% (n=3) of the children were underweight and 12% (n=9) were at risk of becoming underweight as classified by WAZ. HAZ scores identified26% (n=40) of the children at risk of becoming stunted, and 6% (n=9) of the children were already stunted. WHZ classified5% (n=8)of the children as overweight and 5% (n=8)as obese. A further 22% (n=34) of the children were at risk of becoming overweight.BMI/age classificationidentified25% (n=38) of the children as overweight and a further 12% (n=19) as obese. Out of the sample, 12%(n=17) of mothers and 8% (n=7) of fathers were categorised as overweight-to-obese according to the SA specific waist circumference(WC)cut-offs. Out of the children, 15% (n=22) have at least one parent who was overweight-to-obese. Traditional WC categories were classified48% (n=67) of the mothers as overweight-to-obese and at high risk for metabolic syndrome. Of all the lifestyle diseases, hypertension was the most prevalent with 29% (n=41) of households having at least one parent with hypertension. Parental physical activity was grossly overestimated, and the results found to be invalid. The Diet Variety and Frequency score resulted in a mean of 65.00 (n=154, SD=27.37) out of a possible 100 for the households in this sample, and junk food was consumed on three to four occasions per day in 32% (n=49) of households. There were no significant associations found between the parents’ variables and underweight children. Statistically small to medium effect associations were found between parental weight (both SA specific and traditional categories) and overweight children (classified by WHZ and BMI/age). Conclusions and recommendations: The prevalence of overweight and obesity among children in the NMBM was high. The only possible underlying cause of childhood overweight and obesity in pre-school children in the NMBM that could be determined by this study was parents’ weight classified by WC. However, it must be reiterated that due to the cross-sectional nature of the study, an association does not immediately mean causation, and the results are not adequate to rule out other underlying factors influencing childhood obesity. It is recommended that the results of the study are used to incentivise the final implementation of all the intervention targets laid out in the Strategic Plan for the Prevention and Control of Obesity in South Africa 2015-2020 in NMB, and for the development of the future obesity strategy after 2020. The results have shown the necessity for future health interventions to be targeted at the family as a unit.
- Full Text:
- Date Issued: 2020
Change of perspectives and behaviour regarding lifestyle, with emphasis on dietary habits, in a rural community
- Authors: Barnard, Mariska
- Date: 2020
- Subjects: Food habits
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/46384 , vital:39565
- Description: Background: The steady increase in deaths due to non-communicable diseases (NCDs) in South Africa is raising concern, as 63% of all deaths worldwide are attributed to NCDs and these diseases cause 36 million deaths each year, with 80 % of incidences occurring in low-and middle-income countries. In rural communities where income is increasing, the prevalence of NCDs are increasing as well. Due to the lack of NCD prevention and treatment in rural communities, it is expected that, if health promotion strategies are not implemented and socio-economic development in South Africa continues, there will soon be an uncontrollable NCD epidemic. It has been found that dietary risks affected people’s healthirrespective of their age, gender or residential sociodemographic development and that dietary improvement might prevent one in every five deaths worldwide.Aim:The aim of this study was to determine the factors that influence the perceptions and behaviour in a rural community with a low socio-economic status regarding dietary habits and to use the knowledge to formulate an effective dietary modification strategy.Designand methodology:For this study,action research with a quantitative and qualitative component was followed.The quantitative component focuses on measureable aspects, and the qualitative component focuses on meaning. Data was collected following the standard operating procedure for anthropometry, blood pressure and blood glucose. Further methods used were questionnaires, 24-hour dietary recalls and focus group discussions. Data were analysed using Microsoft Excel, FoodFinder3 and other calculations.Sample and setting:A convenience sample (n = 16) wasused and this study was undertaken on request of the non-governmental organization, Karoo Angels and included all participants who earn an income and who do not work for themselves, that were willing to participate and living in Rietbron and Vondeling, in the Sarah BaartmanDistrict in the Eastern Cape. Results:Weight changes took place, both the crafters in the mild thinness category gained weight, one gained 3.9 kg and the other 0.5 kg. The three crafters in the normal category did not have to gain or lose weight, but all three ofthem gained an average of 3.6 kg. For the group who had to lose weight, no statistically significant weight change took place from before the intervention (76.08 ±17.67 kg) to after the intervention (75.81 ± 17.81 kg, t(10) = 0.692, p = 0.505). The maximum weight lost ivwas 3.1 kg and the maximum weight gained was 3.2 kg. Changes took place regarding BMI, waist circumference, waist-to-hip ratio and neck circumference. Some positively changed their BMI status.After the implementation of the intervention, there was a slight decrease in frequency of alcohol consumption, but smoking and physical activity remained mostly the same. Hypertension was the most prevalent NCD and is linked to smoking and alcohol consumption which is prevalent in this study. Fruit and vegetable consumption is low, and a slight increase in consumption was evident. A maximum dietary diversityscore of seven and minimum of two, where the mean was 3.81was found. The crafters’ diet did not meet the DASH diet recommendation,the mean energy distribution is of all macronutrients differ with ±4% and none of the participants’ mean micronutrients intake met the recommendations of the DASH diet or RDA. Factors that prevent them from reaching their goals included low income, low availability of fruit, vegetables and transport and no storage for food.Conclusion:It is important to consider the individuals’ living conditions, resources, knowledge, motivation and social group. The environment and resources available have a significant impact on the lifestyle of the individuals. Directing efforts of behaviour change to increase dietary diversity as the main objective, might be a more efficient way to change behaviour.Recommendations:Future studies should consider doing this study over a longer time period. The involvement of a psychologist would also be beneficial to assist the process of behaviour change.
- Full Text:
- Date Issued: 2020
- Authors: Barnard, Mariska
- Date: 2020
- Subjects: Food habits
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/46384 , vital:39565
- Description: Background: The steady increase in deaths due to non-communicable diseases (NCDs) in South Africa is raising concern, as 63% of all deaths worldwide are attributed to NCDs and these diseases cause 36 million deaths each year, with 80 % of incidences occurring in low-and middle-income countries. In rural communities where income is increasing, the prevalence of NCDs are increasing as well. Due to the lack of NCD prevention and treatment in rural communities, it is expected that, if health promotion strategies are not implemented and socio-economic development in South Africa continues, there will soon be an uncontrollable NCD epidemic. It has been found that dietary risks affected people’s healthirrespective of their age, gender or residential sociodemographic development and that dietary improvement might prevent one in every five deaths worldwide.Aim:The aim of this study was to determine the factors that influence the perceptions and behaviour in a rural community with a low socio-economic status regarding dietary habits and to use the knowledge to formulate an effective dietary modification strategy.Designand methodology:For this study,action research with a quantitative and qualitative component was followed.The quantitative component focuses on measureable aspects, and the qualitative component focuses on meaning. Data was collected following the standard operating procedure for anthropometry, blood pressure and blood glucose. Further methods used were questionnaires, 24-hour dietary recalls and focus group discussions. Data were analysed using Microsoft Excel, FoodFinder3 and other calculations.Sample and setting:A convenience sample (n = 16) wasused and this study was undertaken on request of the non-governmental organization, Karoo Angels and included all participants who earn an income and who do not work for themselves, that were willing to participate and living in Rietbron and Vondeling, in the Sarah BaartmanDistrict in the Eastern Cape. Results:Weight changes took place, both the crafters in the mild thinness category gained weight, one gained 3.9 kg and the other 0.5 kg. The three crafters in the normal category did not have to gain or lose weight, but all three ofthem gained an average of 3.6 kg. For the group who had to lose weight, no statistically significant weight change took place from before the intervention (76.08 ±17.67 kg) to after the intervention (75.81 ± 17.81 kg, t(10) = 0.692, p = 0.505). The maximum weight lost ivwas 3.1 kg and the maximum weight gained was 3.2 kg. Changes took place regarding BMI, waist circumference, waist-to-hip ratio and neck circumference. Some positively changed their BMI status.After the implementation of the intervention, there was a slight decrease in frequency of alcohol consumption, but smoking and physical activity remained mostly the same. Hypertension was the most prevalent NCD and is linked to smoking and alcohol consumption which is prevalent in this study. Fruit and vegetable consumption is low, and a slight increase in consumption was evident. A maximum dietary diversityscore of seven and minimum of two, where the mean was 3.81was found. The crafters’ diet did not meet the DASH diet recommendation,the mean energy distribution is of all macronutrients differ with ±4% and none of the participants’ mean micronutrients intake met the recommendations of the DASH diet or RDA. Factors that prevent them from reaching their goals included low income, low availability of fruit, vegetables and transport and no storage for food.Conclusion:It is important to consider the individuals’ living conditions, resources, knowledge, motivation and social group. The environment and resources available have a significant impact on the lifestyle of the individuals. Directing efforts of behaviour change to increase dietary diversity as the main objective, might be a more efficient way to change behaviour.Recommendations:Future studies should consider doing this study over a longer time period. The involvement of a psychologist would also be beneficial to assist the process of behaviour change.
- Full Text:
- Date Issued: 2020
Compound distribution models for athletics records
- Authors: Hanly, Erin
- Date: 2013
- Subjects: Athletics , Statistics -- Sports , Forecasting -- Sports
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10105 , http://hdl.handle.net/10948/d1018609
- Description: World records in athletics capture the attention of both the general public and the academic community. Athletics records provide a wealth of quantifiable data, which represent the pinnacle of human ability at the time of the record. This research discusses modelling the progression of athletics world records using a compound distribution model which is found in actuarial statistics. Compound distributions allow for the simultaneous modelling of the frequency of record breaking and of the amount by which the record is improved at each record-breaking performance. A number of assumptions accompany the use of the compound distribution model. This research evaluates the athletics data for adherence to these assumptions, before carrying out distribution-fitting and goodnessof-fit testing. Forecasts of future performance are obtained by means of a simulation method. The forecasts obtained from the compound model are compared to forecasts obtained from non-linear models which have been proposed in literature. This research focuses on short-term forecasts, however, a modification to the compound model which allows for longer-term forecasts is also illustrated.
- Full Text:
- Date Issued: 2013
- Authors: Hanly, Erin
- Date: 2013
- Subjects: Athletics , Statistics -- Sports , Forecasting -- Sports
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10105 , http://hdl.handle.net/10948/d1018609
- Description: World records in athletics capture the attention of both the general public and the academic community. Athletics records provide a wealth of quantifiable data, which represent the pinnacle of human ability at the time of the record. This research discusses modelling the progression of athletics world records using a compound distribution model which is found in actuarial statistics. Compound distributions allow for the simultaneous modelling of the frequency of record breaking and of the amount by which the record is improved at each record-breaking performance. A number of assumptions accompany the use of the compound distribution model. This research evaluates the athletics data for adherence to these assumptions, before carrying out distribution-fitting and goodnessof-fit testing. Forecasts of future performance are obtained by means of a simulation method. The forecasts obtained from the compound model are compared to forecasts obtained from non-linear models which have been proposed in literature. This research focuses on short-term forecasts, however, a modification to the compound model which allows for longer-term forecasts is also illustrated.
- Full Text:
- Date Issued: 2013
Depressive disorders and chronic comorbid disease states: a pharmacoepidemiological evaluation
- Authors: Kritiotis, Lia Costas
- Date: 2007
- Subjects: Depression, Mental , Child psychopathology , Adolescent psychopathology
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10151 , http://hdl.handle.net/10948/653 , Depression, Mental , Child psychopathology , Adolescent psychopathology
- Description: The treatment of Depressive Disorders in patients with chronic comorbid disease states warrants careful consideration of the risk-benefit ratio pertaining to the pharmacokinetic and pharmacodynamic characteristics of the antidepressant being considered, against the physiological susceptibilities of the patient; potential drug-drug interactions and depressive symptoms. The primary aim of this study was to investigate the relationship between Depressive Disorders and the most frequently diagnosed chronic comorbid disease states in a depressed South African study population; and to comment on the appropriateness of antidepressants prescribed to these patients. This retrospective drug utilisation study consisted of two parts: the first part focused on the prevalence of the most frequently diagnosed chronic comorbidities in a depressed South African population (N = 21 171). The three most prevalent chronic comorbid disease states were Hypertension (52.87 percent), Lipid Disorders (20.40 percent) and Arthritis (16.70 percent). The second part of the study included an assessment of the antidepressants prescribed to depressed patients in 2004 (N = 6 150). Emphasis was placed on the suitability of antidepressants selected for depressed adult patients (18 years of age and older) with comorbid Hypertension, Lipid Disorders or Arthritis. SSRIs were prescribed most frequently to the depressed patients during 2004 (59.67 percent). SSRIs are the suggested first-line treatments for depressed patients with multiple chronic comorbid disease states. However, of the SSRIs, fluoxetine has the least favourable pharmacokinetic profile and was found to be the antidepressant prescribed most often. Amitriptyline, which was the TCA prescribed most frequently, produces the greatest degree of anticholinergic, sedative and hypotensive effects, relative to other agents in the same antidepressant class. Thus, it is not recommended as a first-line antidepressant, especially in depressed patients with comorbidities. This study identifies potential areas of intervention regarding antidepressant prescribing in depressed individuals with chronic comorbid disease states and offers recommendations to promote the selection of optimal, individualised drug treatment strategies for these patients.
- Full Text:
- Date Issued: 2007
- Authors: Kritiotis, Lia Costas
- Date: 2007
- Subjects: Depression, Mental , Child psychopathology , Adolescent psychopathology
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10151 , http://hdl.handle.net/10948/653 , Depression, Mental , Child psychopathology , Adolescent psychopathology
- Description: The treatment of Depressive Disorders in patients with chronic comorbid disease states warrants careful consideration of the risk-benefit ratio pertaining to the pharmacokinetic and pharmacodynamic characteristics of the antidepressant being considered, against the physiological susceptibilities of the patient; potential drug-drug interactions and depressive symptoms. The primary aim of this study was to investigate the relationship between Depressive Disorders and the most frequently diagnosed chronic comorbid disease states in a depressed South African study population; and to comment on the appropriateness of antidepressants prescribed to these patients. This retrospective drug utilisation study consisted of two parts: the first part focused on the prevalence of the most frequently diagnosed chronic comorbidities in a depressed South African population (N = 21 171). The three most prevalent chronic comorbid disease states were Hypertension (52.87 percent), Lipid Disorders (20.40 percent) and Arthritis (16.70 percent). The second part of the study included an assessment of the antidepressants prescribed to depressed patients in 2004 (N = 6 150). Emphasis was placed on the suitability of antidepressants selected for depressed adult patients (18 years of age and older) with comorbid Hypertension, Lipid Disorders or Arthritis. SSRIs were prescribed most frequently to the depressed patients during 2004 (59.67 percent). SSRIs are the suggested first-line treatments for depressed patients with multiple chronic comorbid disease states. However, of the SSRIs, fluoxetine has the least favourable pharmacokinetic profile and was found to be the antidepressant prescribed most often. Amitriptyline, which was the TCA prescribed most frequently, produces the greatest degree of anticholinergic, sedative and hypotensive effects, relative to other agents in the same antidepressant class. Thus, it is not recommended as a first-line antidepressant, especially in depressed patients with comorbidities. This study identifies potential areas of intervention regarding antidepressant prescribing in depressed individuals with chronic comorbid disease states and offers recommendations to promote the selection of optimal, individualised drug treatment strategies for these patients.
- Full Text:
- Date Issued: 2007
Development and characterisation of miconazole nitrate loaded solid lipid nanoparticles for incorporation into a vaginal mucoadhesive system
- Authors: Gwimo, Wimana Alexis
- Date: 2019
- Subjects: Vaginitis , Vagina -- Diseases Sexually transmitted diseases -- Diagnosis Sexually transmitted diseases -- Treatment
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/39632 , vital:35335
- Description: Vulvovaginal candidiasis (VVC) is the second most common cause of vaginitis, affecting 75% of women of sexual maturity. The prescribed first line treatment involves the use of locally-acting imidazole creams. These conventional dosage forms possess limitations, such as leakage, messiness and low residence time at the site of application; all which promote poor patient adherence to pharmacotherapy. Poor adherence is then attributed to increased incidence of VVC reoccurrence and the emergence of Candida strains. It was, therefore, speculated that through the use of novel drug delivery systems (NDDS), the pharmacokinetic and antimicrobial characteristics of a model antifungal drug (miconazole nitrate [MNZ]) could be improved. Primary aim: To develop, optimise and characterise a mucoadhesive hydrogel incorporated with MNZ loaded solid lipid nanoparticles (MNZ-SLNs) for the intended treatment of VVC. This study was conducted in three phases, viz. pre-formulation studies, development, optimisation and characterisation of MNZ-SLNs, and the development and characterisation of MNZ-SLN-loaded thermoresponsive hydrogel. An alternative method for the quantification of MNZ was developed through the use of an octyl stationary phase. The method was deemed suitable for its intended use with a linear equation of y = 811214x + 67958 and a respective limit of quantitation (LoQ) and detection of 0.015 mg/ml and 0.052 mg/ml. Differential scanning calorimetry (DSC) studies suggested that cholesterol showed great promise of facilitating high drug entrapment efficiency (EE). MNZ-SLNs were prepared by means of a novel melt- emulsification sonication and low temperature solidification method and optimised statistically by a 13-run-two-factor central composite rotatable design (CCRD). The predicted optimisation parameters were 4% m/v lipid concentration and 260.94 sonication time. Optimal MNZ-SLN formulations were prepared and characterised by means of photon correlation spectroscopy (PCS), transmission electron microscopy (TEM) and centrifugation. PCS revealed uniform particles with a narrow polydispersity index (PDI) and a mean hydrodynamic diameter (z-avg.) of 73.03 nm and zeta potential (ZP) of 38.43 mV. Percent EE was calculated via an indirect method as 75.24%. Furthermore, the MNZ -SLNs were incorporated into a mucoadhesive thermo-responsive hydrogel with a sol-gel transition temperature of 33.33 ± 2.82 °C. In vitro drug release testing (IVDRT) was undertaken with the aid of a Franz diffusion vertical cell (FDVC) apparatus. A % cumulative drug release of 27.94% and 15.87% was obtained for MNZ- SLNs and MNZ-SLN hydrogels, respectively, after eight hours. The resultant data was fitted into various kinetic models with the aid of DDSolverTM (Microsoft Excel® add-ins, 2016) to evaluate which model attained the highest correlation co-efficient (r2). Both formulations attained high r2 of 0.9941 and 0.9945, respectively, with the Korsmeyer- Peppas mathematical model. A high diffusional exponent (n) of >1 was observed, suggesting a super case II drug release mechanism. Finally, a modified Kirby-Bauer disc diffusion assay was used for ascertaining Candida albicans susceptibility to the developed formulations. Controls in the form of unloaded preparations and a commercially available cream were used. MNZ-SLNs and MNZ-hydrogel demonstrated superior antifungal activity to the commercially available cream. These results indicate that the developed MNZ-SLNloaded hydrogel formulation with localised thermo-responsive effect may be a promising carrier for intravaginal delivery of MNZ in the treatment of VVC.
- Full Text:
- Date Issued: 2019
- Authors: Gwimo, Wimana Alexis
- Date: 2019
- Subjects: Vaginitis , Vagina -- Diseases Sexually transmitted diseases -- Diagnosis Sexually transmitted diseases -- Treatment
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/39632 , vital:35335
- Description: Vulvovaginal candidiasis (VVC) is the second most common cause of vaginitis, affecting 75% of women of sexual maturity. The prescribed first line treatment involves the use of locally-acting imidazole creams. These conventional dosage forms possess limitations, such as leakage, messiness and low residence time at the site of application; all which promote poor patient adherence to pharmacotherapy. Poor adherence is then attributed to increased incidence of VVC reoccurrence and the emergence of Candida strains. It was, therefore, speculated that through the use of novel drug delivery systems (NDDS), the pharmacokinetic and antimicrobial characteristics of a model antifungal drug (miconazole nitrate [MNZ]) could be improved. Primary aim: To develop, optimise and characterise a mucoadhesive hydrogel incorporated with MNZ loaded solid lipid nanoparticles (MNZ-SLNs) for the intended treatment of VVC. This study was conducted in three phases, viz. pre-formulation studies, development, optimisation and characterisation of MNZ-SLNs, and the development and characterisation of MNZ-SLN-loaded thermoresponsive hydrogel. An alternative method for the quantification of MNZ was developed through the use of an octyl stationary phase. The method was deemed suitable for its intended use with a linear equation of y = 811214x + 67958 and a respective limit of quantitation (LoQ) and detection of 0.015 mg/ml and 0.052 mg/ml. Differential scanning calorimetry (DSC) studies suggested that cholesterol showed great promise of facilitating high drug entrapment efficiency (EE). MNZ-SLNs were prepared by means of a novel melt- emulsification sonication and low temperature solidification method and optimised statistically by a 13-run-two-factor central composite rotatable design (CCRD). The predicted optimisation parameters were 4% m/v lipid concentration and 260.94 sonication time. Optimal MNZ-SLN formulations were prepared and characterised by means of photon correlation spectroscopy (PCS), transmission electron microscopy (TEM) and centrifugation. PCS revealed uniform particles with a narrow polydispersity index (PDI) and a mean hydrodynamic diameter (z-avg.) of 73.03 nm and zeta potential (ZP) of 38.43 mV. Percent EE was calculated via an indirect method as 75.24%. Furthermore, the MNZ -SLNs were incorporated into a mucoadhesive thermo-responsive hydrogel with a sol-gel transition temperature of 33.33 ± 2.82 °C. In vitro drug release testing (IVDRT) was undertaken with the aid of a Franz diffusion vertical cell (FDVC) apparatus. A % cumulative drug release of 27.94% and 15.87% was obtained for MNZ- SLNs and MNZ-SLN hydrogels, respectively, after eight hours. The resultant data was fitted into various kinetic models with the aid of DDSolverTM (Microsoft Excel® add-ins, 2016) to evaluate which model attained the highest correlation co-efficient (r2). Both formulations attained high r2 of 0.9941 and 0.9945, respectively, with the Korsmeyer- Peppas mathematical model. A high diffusional exponent (n) of >1 was observed, suggesting a super case II drug release mechanism. Finally, a modified Kirby-Bauer disc diffusion assay was used for ascertaining Candida albicans susceptibility to the developed formulations. Controls in the form of unloaded preparations and a commercially available cream were used. MNZ-SLNs and MNZ-hydrogel demonstrated superior antifungal activity to the commercially available cream. These results indicate that the developed MNZ-SLNloaded hydrogel formulation with localised thermo-responsive effect may be a promising carrier for intravaginal delivery of MNZ in the treatment of VVC.
- Full Text:
- Date Issued: 2019
Development of a paediatric-friendly formulation intended for the treatment of multi-drug resistant tuberculosis
- Authors: Nkomo, Jethro
- Date: 2018
- Subjects: Drugs -- Dosage , Pediatrics -- Formulae, receipts, prescriptions Multidrug-resistant tuberculosis -- South Africa Primary health care -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/33660 , vital:32962
- Description: Children suffering from multidrug-resistant tuberculosis (MDR-TB) are treated with at least four drugs a day for at least twenty-four months. Approximately 25 000 - 32 000 children worldwide become infected with MDR-TB each year, yet there is a lack of adequate paediatric MDR-TB options for child-friendly dosage forms for the treatment of the condition. The available options are limited to manipulating different dosage forms intended for adults by means of breaking the tablets or otherwise, to deliver the drugs to children. This challenge that is faced by both health care professionals and caregivers subsequently poses drug quality, efficacy, and safety concerns to children being treated for MDR-TB. The objective of this study was to formulate a paediatric-friendly dosage form for the treatment of MDR-TB in children below the age of eight years. A fixed-dose combination (FDC) in form of a dispersible-tablet that contains two core drugs used in treatment of MDR-TB; levofloxacin and pyrazinamide, was developed. Quality by design principles was employed in developing the product. The systematic procedure ensures that quality is built into the product throughout the manufacturing process. It allows for identification of the critical quality attributes and modification of critical process parameters to lie within desired ranges. Preformulation studies were conducted on the active ingredients to investigate potential interactions and compatibility. Some of the analytical techniques employed in the process included an HPLC assay method that was developed to simultaneously separate levofloxacin and pyrazinamide, differential scanning calorimetry (DSC), infrared spectroscopy (IR), thermogravimetric analysis (TGA), and powder density studies. A direct compression tableting process was selected as the method of choice for product formulation. Active ingredients were blended with the excipients and compressed using tableting equipment to successfully produce FDC fast-disintegrating tablets containing 150 mg of levofloxacin and 300 mg pyrazinamide. The product quality was analysed and optimised using mathematical and statistical techniques such as response surface methodology (RSM) and ANOVA, to meet the required standards recommended by the United States Pharmacopoeia. The FDC dispersible tablet containing levofloxacin and pyrazinamide in the potential treatment of MDR-TB in children was successfully formulated, manufactured and evaluated. The tablet dosage form passed all the relevant quality criteria that governed the scope of this study and disintegrate in approximately 37 seconds when placed in water. It is generally a sizeable challenge to manufacture fixed-dose combination drug products due to physicochemical differences of various drugs, however, with adequate resources researchers may still find a way to formulate more child-friendly dosage forms for MDR-TB. This may lead to improved drug efficacy, reduced safety risks and decreased burden on caregivers and healthcare workers who must administer the treatment.
- Full Text:
- Date Issued: 2018
- Authors: Nkomo, Jethro
- Date: 2018
- Subjects: Drugs -- Dosage , Pediatrics -- Formulae, receipts, prescriptions Multidrug-resistant tuberculosis -- South Africa Primary health care -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/33660 , vital:32962
- Description: Children suffering from multidrug-resistant tuberculosis (MDR-TB) are treated with at least four drugs a day for at least twenty-four months. Approximately 25 000 - 32 000 children worldwide become infected with MDR-TB each year, yet there is a lack of adequate paediatric MDR-TB options for child-friendly dosage forms for the treatment of the condition. The available options are limited to manipulating different dosage forms intended for adults by means of breaking the tablets or otherwise, to deliver the drugs to children. This challenge that is faced by both health care professionals and caregivers subsequently poses drug quality, efficacy, and safety concerns to children being treated for MDR-TB. The objective of this study was to formulate a paediatric-friendly dosage form for the treatment of MDR-TB in children below the age of eight years. A fixed-dose combination (FDC) in form of a dispersible-tablet that contains two core drugs used in treatment of MDR-TB; levofloxacin and pyrazinamide, was developed. Quality by design principles was employed in developing the product. The systematic procedure ensures that quality is built into the product throughout the manufacturing process. It allows for identification of the critical quality attributes and modification of critical process parameters to lie within desired ranges. Preformulation studies were conducted on the active ingredients to investigate potential interactions and compatibility. Some of the analytical techniques employed in the process included an HPLC assay method that was developed to simultaneously separate levofloxacin and pyrazinamide, differential scanning calorimetry (DSC), infrared spectroscopy (IR), thermogravimetric analysis (TGA), and powder density studies. A direct compression tableting process was selected as the method of choice for product formulation. Active ingredients were blended with the excipients and compressed using tableting equipment to successfully produce FDC fast-disintegrating tablets containing 150 mg of levofloxacin and 300 mg pyrazinamide. The product quality was analysed and optimised using mathematical and statistical techniques such as response surface methodology (RSM) and ANOVA, to meet the required standards recommended by the United States Pharmacopoeia. The FDC dispersible tablet containing levofloxacin and pyrazinamide in the potential treatment of MDR-TB in children was successfully formulated, manufactured and evaluated. The tablet dosage form passed all the relevant quality criteria that governed the scope of this study and disintegrate in approximately 37 seconds when placed in water. It is generally a sizeable challenge to manufacture fixed-dose combination drug products due to physicochemical differences of various drugs, however, with adequate resources researchers may still find a way to formulate more child-friendly dosage forms for MDR-TB. This may lead to improved drug efficacy, reduced safety risks and decreased burden on caregivers and healthcare workers who must administer the treatment.
- Full Text:
- Date Issued: 2018
Development of an antiretroviral solid dosage form using multivariate analysis
- Authors: Nqabeni, Luxolo
- Date: 2007
- Subjects: Analysis of variance , Experimental design , Multivariate analysis , Antiretroviral agents -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10145 , http://hdl.handle.net/10948/705 , Analysis of variance , Experimental design , Multivariate analysis , Antiretroviral agents -- South Africa
- Description: The aim of pharmaceutical development is to design a quality product and the manufacturing process to deliver the product in a reproducible manner. The development of a new and generic formulation is based on a large number of experiments. Statistics provides many tools for studying the conditions of formulations and processes and enables us to optimize the same while being able to minimize our experimentation. The purpose of this study was to apply experimental design methodology (DOE) and multivariate analysis to the development and optimization of tablet formulations containing 150 mg lamivudine manufactured by direct compression.
- Full Text:
- Date Issued: 2007
- Authors: Nqabeni, Luxolo
- Date: 2007
- Subjects: Analysis of variance , Experimental design , Multivariate analysis , Antiretroviral agents -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10145 , http://hdl.handle.net/10948/705 , Analysis of variance , Experimental design , Multivariate analysis , Antiretroviral agents -- South Africa
- Description: The aim of pharmaceutical development is to design a quality product and the manufacturing process to deliver the product in a reproducible manner. The development of a new and generic formulation is based on a large number of experiments. Statistics provides many tools for studying the conditions of formulations and processes and enables us to optimize the same while being able to minimize our experimentation. The purpose of this study was to apply experimental design methodology (DOE) and multivariate analysis to the development and optimization of tablet formulations containing 150 mg lamivudine manufactured by direct compression.
- Full Text:
- Date Issued: 2007
Development of antibiotic loaded liposomal hydrocolloid dressings for application in wound healing
- Authors: Ntsalu, Vuyiseka
- Date: 2017
- Subjects: Wound healing -- South Africa Liposomes Hydrocolloid surgical dressings -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/13957 , vital:27361
- Description: Wound healing, as a normal biological process in the human body, is achieved through four precise and highly programmed phases: hemostasis, inflammation, proliferation, and remodeling. For a wound to heal successfully, all four phases must occur in the proper sequence and time frame. However, many factors can interfere with one or more of these phases, thus causing improper or impaired wound healing. Maintaining a moist wound environment is crucial in facilitating the wound-healing process. The beneficial effects of a moist versus a dry wound environment include re-epithelization, tissue granulation, and repair. The use of hydrocolloid occlusive dressings in maintaining a moist wound environment has proven to be a useful adjunct in facilitating wound healing. Although hydrocolloid dressings have been widely used clinically in wound management, bacterial resistance, poor solubility and sustained drug release remain to be a problem for many of the drugs used in wound therapy. In chronic wound management, where patients normally undergo long treatments and frequent dressing changes, a system that delivers drugs into a wound site in a controlled fashion can improve patient compliance and therapeutic outcomes. Liposomes are small phospholipid vesicles that have been widely investigated as drug carriers for the delivery of therapeutic agents. They are spherical lipid vesicles consisting of phospholipid bilayers that improve the efficacy of the drugs by fusing with biological membranes, and eventually releasing their entrapped content into the cells or bacteria. The aim of this study therefore, is to develop a new bacitracin-based controlled release hydrocolloid dressing, with good absorptive properties for improving the efficacy of antibiotics in wound healing. HPLC (high-pressure liquid chromatography) assay of bacitracin was performed for quantification of the drug. Liposomes were prepared using thin film hydration and extrusion methods. Liposomes were also characterized based on their ideal particle size and encapsulation efficiency, and then incorporated into the different ratios of chitosan/gelatin hydrocolloid films. The films were prepared with increase in gelatin concentration and were evaluated for folding endurance, tensile strength, water absorption capacity, morphology, drug release kinetics, antimicrobial activity and stability. The morphology of these films was found to be very smooth and homogeneous proving a good compatibility between the two polymers. With increase in gelatin concentration, folding endurance, water absorption capacity, tensile strength, drug release kinetics and antimicrobial activity were increased. The antibacterial activity against various bacterial species was improved in the bacitracin loaded hydrocolloid films as compared to the blank films. Based on the findings above, it can be concluded that chitosan/gelatin films at 1:3 proportion is a successful wound dressing for wound management with improved wound healing properties than other formulations. This formulation is a potential candidate for the development of alternative pharmaceutical dosage forms, for the treatment of bacterial infected wounds, based on the activity of the eco-friendly chitosan matrix added to the bacitracin activity. In this work, chitosan also demonstrated a great potential as a dressing for advanced wound therapy and confirmed its good biocompatibility and potential to provide, in combination with liposomes, sustained drug release which is highly beneficial for wound treatment. The addition of gelatin improved the water affinity of the films and facilitated water mediated cross-linking process.
- Full Text:
- Date Issued: 2017
- Authors: Ntsalu, Vuyiseka
- Date: 2017
- Subjects: Wound healing -- South Africa Liposomes Hydrocolloid surgical dressings -- South Africa
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/13957 , vital:27361
- Description: Wound healing, as a normal biological process in the human body, is achieved through four precise and highly programmed phases: hemostasis, inflammation, proliferation, and remodeling. For a wound to heal successfully, all four phases must occur in the proper sequence and time frame. However, many factors can interfere with one or more of these phases, thus causing improper or impaired wound healing. Maintaining a moist wound environment is crucial in facilitating the wound-healing process. The beneficial effects of a moist versus a dry wound environment include re-epithelization, tissue granulation, and repair. The use of hydrocolloid occlusive dressings in maintaining a moist wound environment has proven to be a useful adjunct in facilitating wound healing. Although hydrocolloid dressings have been widely used clinically in wound management, bacterial resistance, poor solubility and sustained drug release remain to be a problem for many of the drugs used in wound therapy. In chronic wound management, where patients normally undergo long treatments and frequent dressing changes, a system that delivers drugs into a wound site in a controlled fashion can improve patient compliance and therapeutic outcomes. Liposomes are small phospholipid vesicles that have been widely investigated as drug carriers for the delivery of therapeutic agents. They are spherical lipid vesicles consisting of phospholipid bilayers that improve the efficacy of the drugs by fusing with biological membranes, and eventually releasing their entrapped content into the cells or bacteria. The aim of this study therefore, is to develop a new bacitracin-based controlled release hydrocolloid dressing, with good absorptive properties for improving the efficacy of antibiotics in wound healing. HPLC (high-pressure liquid chromatography) assay of bacitracin was performed for quantification of the drug. Liposomes were prepared using thin film hydration and extrusion methods. Liposomes were also characterized based on their ideal particle size and encapsulation efficiency, and then incorporated into the different ratios of chitosan/gelatin hydrocolloid films. The films were prepared with increase in gelatin concentration and were evaluated for folding endurance, tensile strength, water absorption capacity, morphology, drug release kinetics, antimicrobial activity and stability. The morphology of these films was found to be very smooth and homogeneous proving a good compatibility between the two polymers. With increase in gelatin concentration, folding endurance, water absorption capacity, tensile strength, drug release kinetics and antimicrobial activity were increased. The antibacterial activity against various bacterial species was improved in the bacitracin loaded hydrocolloid films as compared to the blank films. Based on the findings above, it can be concluded that chitosan/gelatin films at 1:3 proportion is a successful wound dressing for wound management with improved wound healing properties than other formulations. This formulation is a potential candidate for the development of alternative pharmaceutical dosage forms, for the treatment of bacterial infected wounds, based on the activity of the eco-friendly chitosan matrix added to the bacitracin activity. In this work, chitosan also demonstrated a great potential as a dressing for advanced wound therapy and confirmed its good biocompatibility and potential to provide, in combination with liposomes, sustained drug release which is highly beneficial for wound treatment. The addition of gelatin improved the water affinity of the films and facilitated water mediated cross-linking process.
- Full Text:
- Date Issued: 2017
Dietary diversity amongst adults who buy at shopping malls in the Nelson Mandela Bay area
- Authors: De Bruin, Eunice Mari
- Date: 2017
- Subjects: Nutrition -- South Africa -- Port Elizabeth , Older people -- Nutrition Diet Food security -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/15027 , vital:28114
- Description: Background: Assessing the level of dietary diversity and contributing factors that influence the level of dietary diversity amongst adults can highlight gaps in nutrition interventions, policies and programmes, which aim at combating the double burden of malnutrition. Aim: The aim of this study was to determine which factors and relationships affect the level of dietary diversity of adults in the Nelson Mandela Bay area. Design: An exploratory comparative, cross-sectional, quantitative study design with a qualitative component that was utilised. Both interviewer- and participantadministered questionnaire sections were applied. Data were analysed using IBM SPSS Statistics, Statistica Version 12, Microsoft Office Excel 2007, Spearman rho correlation co-efficient and Pearson’s chi-square test (p-value <0.05). Participants and setting: A convenience-stratified sample (n=480) was used, consisting of adults who reside and shop at shopping centres in the Nelson Mandela area, after obtaining informed consent. Results: The findings indicated that adults in the Nelson Mandela Bay area who shopped at shopping malls had a medium level of dietary diversity. The dietary patterns found were not in line with the South African Food Based Dietary Guidelines. The most consumed food items were ‘cereals' (95%), 'sweetening agents and sweets' (89%) and ‘spices, condiments and beverages’ (87%). Fruit (45,2%) and vegetables (64,8%) were generally poorly consumed. Significance was shown as having an effect on the level of dietary diversity for factors such as ethnicity, level of education, amount of money spent on food purchase per month, distance travelled to purchase food, and nutrition knowledge. Conclusion: The study suggests that adults living in the Nelson Mandela Bay area have a medium level of dietary diversity, with practices that are not in line with the recommended South African Food Based Dietary Guidelines. Strategies, including nutrition education promotion and the implementation of current policies, programmes and interventions, should be implemented and/or strengthened to encourage behaviour change.
- Full Text:
- Date Issued: 2017
- Authors: De Bruin, Eunice Mari
- Date: 2017
- Subjects: Nutrition -- South Africa -- Port Elizabeth , Older people -- Nutrition Diet Food security -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/15027 , vital:28114
- Description: Background: Assessing the level of dietary diversity and contributing factors that influence the level of dietary diversity amongst adults can highlight gaps in nutrition interventions, policies and programmes, which aim at combating the double burden of malnutrition. Aim: The aim of this study was to determine which factors and relationships affect the level of dietary diversity of adults in the Nelson Mandela Bay area. Design: An exploratory comparative, cross-sectional, quantitative study design with a qualitative component that was utilised. Both interviewer- and participantadministered questionnaire sections were applied. Data were analysed using IBM SPSS Statistics, Statistica Version 12, Microsoft Office Excel 2007, Spearman rho correlation co-efficient and Pearson’s chi-square test (p-value <0.05). Participants and setting: A convenience-stratified sample (n=480) was used, consisting of adults who reside and shop at shopping centres in the Nelson Mandela area, after obtaining informed consent. Results: The findings indicated that adults in the Nelson Mandela Bay area who shopped at shopping malls had a medium level of dietary diversity. The dietary patterns found were not in line with the South African Food Based Dietary Guidelines. The most consumed food items were ‘cereals' (95%), 'sweetening agents and sweets' (89%) and ‘spices, condiments and beverages’ (87%). Fruit (45,2%) and vegetables (64,8%) were generally poorly consumed. Significance was shown as having an effect on the level of dietary diversity for factors such as ethnicity, level of education, amount of money spent on food purchase per month, distance travelled to purchase food, and nutrition knowledge. Conclusion: The study suggests that adults living in the Nelson Mandela Bay area have a medium level of dietary diversity, with practices that are not in line with the recommended South African Food Based Dietary Guidelines. Strategies, including nutrition education promotion and the implementation of current policies, programmes and interventions, should be implemented and/or strengthened to encourage behaviour change.
- Full Text:
- Date Issued: 2017
Food choices of tactile defensive children
- Authors: Smith, Anna Magdalena
- Date: 2003
- Subjects: Children -- Nutrition -- Psychological aspects
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:11034 , http://hdl.handle.net/10948/d1020371
- Description: This research explores a different view of the picky or fussy eater. Although occupational therapists and speech therapists are aware that children with sensory defensiveness and specific tactile defensiveness have different eating habits, this has not been described before.
- Full Text:
- Date Issued: 2003
- Authors: Smith, Anna Magdalena
- Date: 2003
- Subjects: Children -- Nutrition -- Psychological aspects
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:11034 , http://hdl.handle.net/10948/d1020371
- Description: This research explores a different view of the picky or fussy eater. Although occupational therapists and speech therapists are aware that children with sensory defensiveness and specific tactile defensiveness have different eating habits, this has not been described before.
- Full Text:
- Date Issued: 2003
Formulation and process optimisation of ethionamide 250 MGtablets using quality by design principles
- Authors: Isaacs, Nasreen
- Date: 2015
- Subjects: Pharmaceutical chemistry , Drugs -- Design , Pharmaceutical technology
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/3979 , vital:20497
- Description: The traditional approach of Quality by Testing (QbT) limits the assurance of product quality to in-process and post-production testing. To overcome these limitations, a more proactive and systematic means to product development and optimisation is required. Quality by Design (QbD) is an example of such an approach which focuses on understanding the product and its manufacturing process and emphasises that quality should be built into the product and not merely tested. The study aims to optimise ethionamide tablets, an immediate release oral solid dosage form using QbD.
- Full Text:
- Date Issued: 2015
Formulation and process optimisation of ethionamide 250 MGtablets using quality by design principles
- Authors: Isaacs, Nasreen
- Date: 2015
- Subjects: Pharmaceutical chemistry , Drugs -- Design , Pharmaceutical technology
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: http://hdl.handle.net/10948/3979 , vital:20497
- Description: The traditional approach of Quality by Testing (QbT) limits the assurance of product quality to in-process and post-production testing. To overcome these limitations, a more proactive and systematic means to product development and optimisation is required. Quality by Design (QbD) is an example of such an approach which focuses on understanding the product and its manufacturing process and emphasises that quality should be built into the product and not merely tested. The study aims to optimise ethionamide tablets, an immediate release oral solid dosage form using QbD.
- Full Text:
- Date Issued: 2015
Formulation and stability testing of eye drop preparations containing phenylephrine hydrochloride
- Authors: Okafor, Chinedum Oluchukwu
- Date: 2012
- Subjects: Phenylpropanolamine , Viscosity , Glycerin
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10164 , http://hdl.handle.net/10948/d1020985
- Description: Phenylephrine hydrochloride is a potent adrenergic agent and β-receptor sympathomimetic drug, used in its optically active form (Pandey et al., 2003; Pandey et al., 2006). As an α1-adrenergic receptor agonist, phenylephrine hydrochloride is used ocularly as a decongestant for uveitis and as an agent to dilate the pupil (Lang, 1995). High intraocular doses have been reported to cause tachycardia, hypertension, and headache. These side effects are caused by large amounts of the drop draining into the nasal cavity. Eye drops that contain phenylephrine hydrochloride have proven to have low intra-ocular bioavailability because of a short contact time with the eyes which reduces the amount of drug reaching the site of action. Formulations of phenylephrine hydrochloride eye drops have varying shelf-lives of approximately two to four years. The aim of this study was to formulate and manufacture an eye drop product containing phenylephrine hydrochloride. Important characteristics that were targeted were increased ocular absorption by increasing the viscosity of the product and reduced degradation of phenylephrine hydrochloride. A variety of phenylephrine hydrochloride formulations were manufactured on a laboratory scale using hydroxypropyl methylcellulose (HPMC), glycerol, and sodium carboxy methylcellulose as viscosity modifying agents (VMA). The concentration of phenylephrine hydrochloride was ten percent. Ten millimeters of each formulation was made in triplicate. The quantity in each was evaluated using a previously validated high performance (pressure) liquid chromatography method. Physicochemical properties including pH and colour were also evaluated. Stability was assessed using real time and accelerated stability conditions in accordance with the International Conference on Harmonization (ICH) guidelines. Formulations containing hydroxypropyl methylcellulose (HPMC) as the viscosity modifying agents proved to be stable under all storage conditions when compared with formulations containing other viscosity modifying agents (VMA). However, sodium citrate dihydrate; sodium metabisulphite and EDTA also stabilized the formulations to a certain extent Changes in the appearance and colour of products containing glycerol under accelerated storage conditions were observed. The sodium carboxy methylcellulose (SCMC) containing formulation was found to be physically and chemically stable in two conditions, namely 30 °C/65 percent RH and 25 °C/60 percent RH. The formulations containing hydroxypropyl methylcellulose along with an antioxidant showed to be most stable as it remained aesthetically pleasing did not change colour and did not have a reduction in phenylephrine hydrochloride concentrations. This meant that phenylephrine hydrochloride did not degrade while the viscosity modifying agents remained stable. Rheological tests showed differences in the viscosities of the formulations as glycerol had increased in viscosity over time while HMPC and SCMC displayed relative similarities. The formulations were compared to a marketed eye drop containing polyvinyl alcohol as a VMA. After rheological analysis the formulation containing HPMC displayed better viscosity than the product with polyvinyl alcohol. The preservatives in the formulations were active against the microbial organisms use to challenged them.
- Full Text:
- Date Issued: 2012
- Authors: Okafor, Chinedum Oluchukwu
- Date: 2012
- Subjects: Phenylpropanolamine , Viscosity , Glycerin
- Language: English
- Type: Thesis , Masters , MSc
- Identifier: vital:10164 , http://hdl.handle.net/10948/d1020985
- Description: Phenylephrine hydrochloride is a potent adrenergic agent and β-receptor sympathomimetic drug, used in its optically active form (Pandey et al., 2003; Pandey et al., 2006). As an α1-adrenergic receptor agonist, phenylephrine hydrochloride is used ocularly as a decongestant for uveitis and as an agent to dilate the pupil (Lang, 1995). High intraocular doses have been reported to cause tachycardia, hypertension, and headache. These side effects are caused by large amounts of the drop draining into the nasal cavity. Eye drops that contain phenylephrine hydrochloride have proven to have low intra-ocular bioavailability because of a short contact time with the eyes which reduces the amount of drug reaching the site of action. Formulations of phenylephrine hydrochloride eye drops have varying shelf-lives of approximately two to four years. The aim of this study was to formulate and manufacture an eye drop product containing phenylephrine hydrochloride. Important characteristics that were targeted were increased ocular absorption by increasing the viscosity of the product and reduced degradation of phenylephrine hydrochloride. A variety of phenylephrine hydrochloride formulations were manufactured on a laboratory scale using hydroxypropyl methylcellulose (HPMC), glycerol, and sodium carboxy methylcellulose as viscosity modifying agents (VMA). The concentration of phenylephrine hydrochloride was ten percent. Ten millimeters of each formulation was made in triplicate. The quantity in each was evaluated using a previously validated high performance (pressure) liquid chromatography method. Physicochemical properties including pH and colour were also evaluated. Stability was assessed using real time and accelerated stability conditions in accordance with the International Conference on Harmonization (ICH) guidelines. Formulations containing hydroxypropyl methylcellulose (HPMC) as the viscosity modifying agents proved to be stable under all storage conditions when compared with formulations containing other viscosity modifying agents (VMA). However, sodium citrate dihydrate; sodium metabisulphite and EDTA also stabilized the formulations to a certain extent Changes in the appearance and colour of products containing glycerol under accelerated storage conditions were observed. The sodium carboxy methylcellulose (SCMC) containing formulation was found to be physically and chemically stable in two conditions, namely 30 °C/65 percent RH and 25 °C/60 percent RH. The formulations containing hydroxypropyl methylcellulose along with an antioxidant showed to be most stable as it remained aesthetically pleasing did not change colour and did not have a reduction in phenylephrine hydrochloride concentrations. This meant that phenylephrine hydrochloride did not degrade while the viscosity modifying agents remained stable. Rheological tests showed differences in the viscosities of the formulations as glycerol had increased in viscosity over time while HMPC and SCMC displayed relative similarities. The formulations were compared to a marketed eye drop containing polyvinyl alcohol as a VMA. After rheological analysis the formulation containing HPMC displayed better viscosity than the product with polyvinyl alcohol. The preservatives in the formulations were active against the microbial organisms use to challenged them.
- Full Text:
- Date Issued: 2012