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A novel o/w microemulsion fixed dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate: development and characterisation

  • Authors: Mabvira, Samantha
  • Date: 2022-04-06
  • Subjects: Uncatalogued
  • Language: English
  • Type: Master's theses , text
  • Identifier: http://hdl.handle.net/10962/232925 , vital:50038
  • Description: Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2022
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  • Date Issued: 2022-04-06

A retrospective study of antimicrobial prescribing practices in paediatric patients at the Mahalapye District Hospital, Central Botswana

  • Authors: Nyawera, Angella
  • Date: 2022-04-06
  • Subjects: Anti-infective agents Botswana Mahalapye , Drug resistance , Pediatrics Botswana Mahalapye , Pediatrics Formulae, receipts, prescriptions , Drugs Prescribing Moral and ethical aspects
  • Language: English
  • Type: Academic theses , Master's theses , text
  • Identifier: http://hdl.handle.net/10962/290682 , vital:56774
  • Description: Background: The development of antimicrobial resistance (AMR) has been linked to the increased and irrational use of antimicrobial medicines. The aim of this study was to investigate the antimicrobial prescribing practices in the paediatric medical ward at Mahalapye District Hospital (MDH) in Botswana and to determine whether antimicrobial stewardship (AMS) measures were being implemented at the hospital. Methods A cross-sectional, descriptive, mixed methods, observational approach was taken in this study. The study site was the paediatric medical ward (PMW) at MDH. Information about the antimicrobials prescribed for paediatric patients from January 2018 to December 2018 was collected from patients’ information files and compared to national antimicrobial prescribing guidelines to determine prescribers’ adherence. Qualitative semi-structured interviews were conducted with members of staff at MDH to determine whether antimicrobial stewardship (AMS) measures were adopted at the hospital. Results A total of 278 patients were included in this study, 12 of these were admitted twice during the study period. In total 290 admissions were analysed, with 659 antimicrobial medicines prescribed. The most common diagnoses were pneumonia (36.9%), acute gastroenteritis (20.7%), upper respiratory tract infections (3.4%), and bronchiolitis (3.1%). The most prescribed antimicrobials were ampicillin (21.4%), gentamicin (21.2%), and cefotaxime (8.3%). Adherence to guidelines was relatively good, with 82.7% of antimicrobials prescribed for the patients in the study having been prescribed in compliance with the national prescribing guidelines. The semi-structured interviews highlighted the fact that staff knew about AMS and AMR in general, however awareness of an AMS committee at MDH varied. The AMS committee was a multidisciplinary committee, which was a subcommittee of the Drugs and Therapeutics Committee (DTC). Discussion and Conclusion The results suggest that adherence to prescribing guidelines was relatively high compared to other paediatric antimicrobial utilisation studies in African countries. Prescribing of antimicrobial medicines was consistent with other African countries. The long period of time that it takes for microbiological test results to become available means that most prescribers rely on empirical prescribing. The antimicrobial committee is a multidisciplinary committee with defined roles for its members, consistent with international guidelines for implementing an AMS committee at a hospital. , Thesis (MPharm) -- Faculty of Pharmacy, Pharmacy, 2022
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  • Date Issued: 2022-04-06

Comparison of a novel HPLC method and conventional protein assays for the quantitation of insulin aspart in Novorapid®

  • Authors: Dickson, Courtney Rae
  • Date: 2022-04-06
  • Subjects: Uncatalogued
  • Language: English
  • Type: Master's theses , text
  • Identifier: http://hdl.handle.net/10962/290704 , vital:56776
  • Description: Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2022
  • Full Text:
  • Date Issued: 2022-04-06

Fabrication and characterization of ciprofloxacin loaded niosomes for transtympanic delivery

  • Authors: Mhlanga, Asavela
  • Date: 2022-04-06
  • Subjects: Drug delivery systems , Liposomes , Ciprofloxacin , Quinolone antibacterial agents , Drug carriers (Pharmacy) , Drug stability , Lamellarity‎ , Niosomes‎
  • Language: English
  • Type: Academic theses , Master's theses , text
  • Identifier: http://hdl.handle.net/10962/290715 , vital:56777
  • Description: Ciprofloxacin (CPH) is a broad-spectrum antibiotic used to treat bone, joint, and skin infections. It is commercially available as an extended-release tablet and as a cream dosage form. CPH is a bactericidal active pharmaceutical ingredient (API) of the fluoroquinolone drug class. It inhibits deoxyribonucleic acid (DNA) replication by inhibiting bacterial DNA topoisomerase and DNA gyrase enzymes. Common adverse effects include nausea, vomiting, unusual fatigue, pale skin, and may increase the risk of tendinitis, which could be a major concern. CPH is, according to the Biopharmaceutics Classification System (BCS), classified as a BCS class IV drug exhibiting low oral bioavailability, low solubility, and intestinal permeability. CPH was chosen as a good candidate for the study because of its stability in solutions, its low molecular weight (331.4 g/mol), and its moderate lipophilicity (log P = 0.28) [16]. The use of conventional ear drops in the ear is effective, avoids hepatic first metabolism and extensive protein binding and may reduce adverse effects as a low dose may be used to achieve a therapeutic effect. However, conventional ear drops and oral antibiotics have a long onset of action and have to be taken/applied in short intervals. For convenience and assurance of a long residence time in the ear, CPH may be delivered by using a niosomal formulation, a liquid at room temperature, to allow administration into the ear without the need to constantly apply the ear drops for long periods of time. A simple, rapid, precise, accurate, reproducible, and specific reversed-phase high-performance liquid chromatography (RP-HPLC) method using ultraviolet (UV) detection for the quantitation of CPH was developed and optimized using a central composite design (CCD). The method was validated using International Conference on Harmonisation (ICH) guidelines and was found to be linear, precise, accurate, and specific for the analysis of CPH. Since the method is specific, it was used to quantify CPH in commercial and experimental formulations and monitor CPH released during in-vitro release testing. The compatibility of CPH and potential excipients was investigated during preformulation studies using Fourier transform infrared spectroscopy (FT-IR) and differential scanning calorimetry (DSC) to identify and select suitable excipients for use during formulation development activities. No apparent interactions were evident between CPH, and the excipients tested. The probe sonication method was used to manufacture CPH loaded niosomes using different surfactants/surfactant combinations, and a combination of Tween® 80: sodium lauryl sulfate (SLS) was found to be the best composition in terms of both entrapment efficiency and Zeta potential. The limits for the independent input variables used for the manufacture included amplitude, sonication time, and amount of cholesterol were determined. Design of experiments (DOE) was used to design the study. The input variables investigated included amplitude, amount of cholesterol, and sonication time. The output or responses monitored included Zeta potential, vesicle size, polydispersity index (PDI), and entrapment efficiency. Non-ionic surfactant systems are predominantly stabilized by steric stabilization, and there is only a minor electrostatic element from adsorbed hydroxyl ions. With the inclusion of SLS it is to be expected that Zeta potential will be a contributing factor. DOE using Box-Behnken design (BBD) and response surface methodology (RSM) in addition to Artificial Neural Networks (ANN) were used for the optimization of the formulation. The optimized formulation had a composition of 1 g cholesterol, 1 g of Tween® 80, 1 g of SLS and was prepared at an amplitude of 11.294 % with a sonication time of 3.304 minutes. The formulation exhibited zero-order release kinetics and had an average pH of 7.45. The formulation was stored at 4 ℃ and 25 ℃ and was assessed for vesicle size, entrapment efficiency, Zeta potential, colour, lamellarity, and PDI every 7 days for 4 weeks. The lead formulation stored at 4 ℃ was more stable than the formulation at 25 ℃ in terms of entrapment efficiency, PDI and vesicle size during the 4-week period. CPH loaded niosomes for transtympanic delivery in the treatment of otitis media were developed and optimized. The technology exhibits sustained release of CPH and has the potential for further development and optimization. , Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2022
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  • Date Issued: 2022-04-06

Pharmacists’ attitudes and perception of using pictograms as a communication tool in practice

  • Authors: Okeyo, Sam Juma
  • Date: 2022-04-06
  • Subjects: Picture-writing South Africa , Communication in public health South Africa , Pharmacists South Africa Attitudes , Health literacy South Africa , Patient education South Africa , Structural equation modeling , ‎Theory of planned behavior
  • Language: English
  • Type: Academic theses , Master's theses , text
  • Identifier: http://hdl.handle.net/10962/290693 , vital:56775
  • Description: Pictograms, when used in conjunction with verbal and written information, are known to be effective in improving comprehension and recall of medicines information and in supporting communication between healthcare professionals and patients. However, pictograms are seldom used in routine pharmacy practice, and little is known about pharmacists’ opinions of pictograms and their intention to possibly incorporate pictograms into routine practice. This study aimed to investigate pharmacists’ opinions relating to pictograms as a communication tool, and, by applying the Theory of Planned Behaviour (TPB), to explore their intention to use pictograms in pharmacy practice as well as the barriers to their use. The quantitative study design involved a two-phase approach. Phase 1 was a descriptive, cross-sectional online national survey of pharmacists. The 70-item, four-section survey was primarily based on the constructs of TPB, which included attitude, intention, subjective norm, and perceived behavioural control. The last survey section recruited pharmacists for a follow-up Phase 2 survey. Following a pilot study, the survey was emailed to all pharmacists registered with the South African Pharmacy Council. Descriptive statistics for survey items were generated. Pearson correlation investigated the correlation between participant characteristics, familiarity with pictograms and use of pictograms in practice. Structural Equation Modelling (SEM) determined if there was a significant relationship between attitude, subjective norm and perceived behavioural control with intention to use pictograms. A total of 426 pharmacists responded to the Phase 1 survey. Most pharmacists were familiar with the term ‘pictogram’; however, over three-quarters of pharmacists had never observed pictograms being routinely used in a pharmacy setting. When presented with pictograms designed for a low health literate population, most pharmacists thought the design and overall look of the pictograms would be easy for most patients in South Africa to understand (71.6 ± 24.0). Two-thirds of pharmacists (65.0 ± 30.6), felt that pictograms should be used for all patient populations. More than 85% of pharmacists agreed that pictograms should be used for dosage instructions, auxiliary or additional information, warnings, and storage instructions. However, fewer (58-68%) felt that indication, side effects and risk communication information should be accompanied by pictograms. Pharmacists demonstrated positive attitudes towards using pictograms in practice (mean = 4.2 ± 0.9; range: 1 - 5), while perceived behavioural control (mean = 3.0 ± 1.2; range: 1 - 5), subjective norm (mean = 3.8 ± 1.0; range 1 - 5) and intention (mean = 3.3 ± 1.0; range 1 - 5) were all neutral. Attitude (β = -0.25, p < 0.117), however, was not a significant predictor of intention while perceived behavioural control (β = -0.83, p < 0.000) presented with a significant negative correlation with intention. Subjective norm (β = 0.57, p <0.000) was the strongest predictor of intention. Scale reliability ranged from 0.770 to 0.865 for the TPB constructs. Phase 2 aimed to expand on, and further investigate Phase 1 findings relating to current and intended pharmacist behaviour and opinions concerning pictogram usage. As Phase 2 looked to investigate issues in greater depth, questions included open-ended response options. The survey link was emailed to all pharmacists who had voluntarily offered to participate in Phase 2. Frequency data for all questions were generated, and content analysis was undertaken for the free-response comments offered by pharmacists. A total of 35 pharmacists responded to the Phase 2 survey. Most pharmacists who routinely used pictograms initiated their use with support from pharmacists’ colleagues (8/12) and their supervisor/manager (6/7). Pharmacists who stated their intention to use pictograms anticipated receiving support from their pharmacists' colleagues (18/23) and manager/supervisor (15/23). All 12 pharmacists who were routinely using pictograms reported a positive effect on patient communication, with almost all having encountered no negative aspects of using pictograms (11/12). Almost all pharmacists intending to use pictograms could foresee benefits from their use (22/23). Misinterpretation of pictograms was a prevalent barrier common to both pharmacists routinely using pictograms and to those intending to use pictograms. Increased workload was regarded as a prevalent barrier only by pharmacists intending to use pictograms. This study was the first national study of pharmacists to investigate their opinion of pictograms and their use and to adopt a theoretical approach to consider pharmacist intention to use pictograms in routine pharmacy practice. Pharmacists generally expressed positive attitudes to pictograms but showed inadequate understanding of pictogram use. Pharmacists using pictograms reported the positive effect of pictograms on their patient communication, whereas those planning to use pictograms could foresee the benefits of using pictograms despite regarding increased workload as a barrier. As the strongest predictor of intention was subjective norm, this construct should therefore be targeted to motivate pharmacists to adopt the use of pictograms. , Thesis (MPharm) -- Faculty of Pharmacy, Pharmacy, 2022
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  • Date Issued: 2022-04-06

Rainwater and alternative potable water microbial water quality and DRM implications in Makana Local Municipality

  • Authors: Nhokodi, Tererai
  • Date: 2022-04-06
  • Subjects: Uncatalogued
  • Language: English
  • Type: Master's theses , text
  • Identifier: http://hdl.handle.net/10962/232227 , vital:49973
  • Description: Thesis (MSc (Pharm)) -- Faculty of Pharmacy, Pharmacy, 2022
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  • Date Issued: 2022-04-06

A self-emulsifying delivery system loaded with efavirenz: The case for flax-seed oil

  • Authors: Mazonde, Priveledge
  • Date: 2021-10-29
  • Subjects: Drug delivery systems , Linseed oil , Antiretroviral agents , HIV (Viruses) , Drug carriers (Pharmacy) , Solubility , High performance liquid chromatography , Efavirenz
  • Language: English
  • Type: Master's theses , text
  • Identifier: http://hdl.handle.net/10962/192944 , vital:45283
  • Description: The feasibility of incorporating efavirenz (EFV), an antiretroviral agent against HIV into a lipid-based self-emulsifying drug delivery system (SEDDS) containing vegetable oils was investigated. EFV has poor aqueous solubility and is classified under the Biopharmaceutical Classification System (BCS) as a class II compound with highly permeability, its aqueous solubility is less than 10 mg/ml and is defined as a practically insoluble compound with a consequent poor bioavailability of approximately 40%, and erratic dissolution behaviour. SEDDS formulations have been shown to improve the aqueous solubility and consequently the bioavailability of BCS II compounds such as EFV. EFV is a first line antiviral agent used in combination with other agents in antiretroviral therapy (ART). Among the number of NNRTIs approved for use in HIV treatment, EFV is one of the most commonly prescribed drug. Statistical methods and Design of Experiments (DoE) using Response Surface Methodology (RSM), specifically a Central Composite Design (CCD), were used to facilitate the development of a reversed-phase high performance liquid chromatographic (HPLC) method for the quantitation of EFV during formulation product and process development studies. A rapid, accurate, precise and sensitive HPLC method with ultraviolet (UV) detection was developed, optimised and validated for the in-vitro analysis of EFV in a total run time under 10 minutes for the elution of both EFV and loratidine which was used as the internal standard (IS). The method was then successfully applied to the determination of EFV in commercially available tablets. Excipient screening was undertaken using solubility studies and revealed that EFV had highest solubility in flaxseed oil in comparison to soybean, macadamia, grapeseed, sunflower and olive oils. The non-ionic Tween® 80 and Span® 20 were selected as surfactant and co-surfactant, respectively with ethanol co-solvent as they exhibited improved miscibility with co-solvent. Pre-formulation studies were undertaken to investigate the compatibility of the API with excipients and to identify a nano-emulsion region and other emulsion types using pseudoternary phase diagrams. The phase behaviour of crude cold pressed flaxseed oil with the selected non-ionic surfactants revealed an area within pseudo-ternary phase diagrams for different surfactant-mixtures formed gels/semisolid structures which can be exploited for other drug delivery strategies that require such properties. Fourier transform infrared spectroscopy (FT-IR), powder x-ray diffraction (XRD) and Raman spectroscopy were used to identify and assess the compatibility of EFV with chosen excipients. 2 A reduction in the peak intensity was observed for EFV when combined with each hydrophobic/lipid excipient evaluated revealing that there was a marked reduction in the crystallinity of the EFV. A decrease in crystallinity in comparison with the bulk API may indicate that EFV were amorphous or sequestered in a molecular dispersion and exhibited an increased solubility for the molecule. Flaxseed oil was used as the oil phase in studies for the optimization of surfactant mixtures undertaken using DoE, specifically a D-optimal mixtures design with the flaxseed oil content set at 10% m/m was performed. Solutions from the desired optimization function were produced based on desirability and five nanoemulsion formulations were produced and characterized in terms of in vitro release of efavirenz, drug loading capacity, Zeta Potential, droplet sizes and polydispersity index (PDI). Kinetically stable nanoemulsions containing 10% m/m flaxseed oil were successfully manufactured and assessed. Droplet sizes ranged between 156 and 225 nm, Zeta Potential between −24 and −41 mV and all formulations were found to be monodisperse with polydispersity indices ≤ 0.487. SEDDS formulations of EFV in nano-sized carriers were developed and optimised, in vitro drug release varied with varying amounts of ethanol in the formulation producing formulations that exhibited differently modulated drug in-vitro release profiles that may be further manipulated for better performance and therapeutic outcomes in terms of solubility and possibly bioavailability of EFV when delivered using SEDDS rather than using tablets which in turn may lead to better therapeutic outcomes for patients with HIV. , Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2021
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  • Date Issued: 2021-10-29

Bioethical analysis of selected biomedical issues in South Africa and other countries

  • Authors: Rusere, Jean
  • Date: 2021-04
  • Subjects: To be added
  • Language: English
  • Type: thesis , text , Masters , MPharm
  • Identifier: http://hdl.handle.net/10962/178530 , vital:42948
  • Description: Access restricted until April 2023. , Thesis (MPharm) -- Faculty of Pharmacy, Pharmacy, 2021
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  • Date Issued: 2021-04

Development and assessment of rifampicin loaded self-microemulsifying drug delivery systems

  • Authors: Mphaphuli, Mashudu Theodore
  • Date: 2021-04
  • Subjects: To be added
  • Language: English
  • Type: thesis , text , Masters , MSc
  • Identifier: http://hdl.handle.net/10962/178503 , vital:42945
  • Description: Access restricted until April 2023. , Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2021
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  • Date Issued: 2021-04

Development and characterisation of ciprofloxacin hydrochloride solid lipid nanoparticles for ocular delivery

  • Authors: Dhege, Clarence
  • Date: 2021-04
  • Subjects: To be added
  • Language: English
  • Type: thesis , text , Masters , MSc
  • Identifier: http://hdl.handle.net/10962/178446 , vital:42940
  • Description: Access restricted until April 2023. , Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2021
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  • Date Issued: 2021-04

Healthcare issues in disaster management : preparedness in the pharmacy profession

  • Authors: Vhiriri, Eunice Paidamoyo
  • Date: 2021-04
  • Subjects: To be added
  • Language: English
  • Type: thesis , text , Masters , MSc
  • Identifier: http://hdl.handle.net/10962/178591 , vital:42953
  • Description: Access restricted until April 2023. , Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2021
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  • Date Issued: 2021-04

Infant health: a community-based assessment and educational intervention in two rural communities in the Eastern Cape.

  • Authors: Kuzeeko, Faith
  • Date: 2021
  • Subjects: Angus Gillis Foundation (South Africa) , Infants -- Mortality -- South Africa , Infants -- Health and hygiene -- South Africa , Breastfeeding -- South Africa -- Eastern Cape , Infants -- Care -- Equipment and supplies , Infants -- Care -- South Africa -- Eastern Cape -- Case studies , Children -- Mortality -- South Africa , High throughput screening (Drug development)
  • Language: English
  • Type: text , Thesis , Masters , MPharm
  • Identifier: http://hdl.handle.net/10962/170837 , vital:41964
  • Description: South Africa is on track to attaining the 2030 Agenda on reducing under-five deaths to 25 deaths per 1000 live births at its current momentum, however an unacceptable amount of infants are still at risk from preventable illnesses. Malnutrition is the major underlined cause of infant mortality rates in South Africa. Exclusive breastfeeding rates are low nationwide due to low exposure to breastfeeding information, some mothers having other commitments and others having breastfeeding difficulties. Implementation and expansion of simple, cost-effective interventions, such as exclusive breastfeeding for six months to reduce and/or prevent infant mortality rates, remains low in South Africa. The aim of the study was to determine one infant health issue of major concern to participants in two rural villages in the Eastern Cape, namely Glenmore and Ndwayana. The identified infant health issue was used to design an educational intervention in the villages. This was the second phase of this study. A community-based participatory approach was utilized in which the Angus Gillis Foundation, a non-profit organization that works in these communities, was one of the stakeholders. Stock status of WHO priority medicines for infants, semi-structured interviews and focus group discussions were carried out during the baseline study. The intervention phase contained pre-2 intervention semi-structured interviews with ten pregnant women followed by an educational intervention with nine out of the ten; and finally, a post-intervention with seven out of the ten women. A questionnaire was completed by members of the Angus Gillis Foundation to provide feedback on the sustainability of the intervention. Semi-structured interviews revealed that medicines stocked at the clinic parallel those indicated in the WHO priority medicines list for infants. The results from the focus group discussions indicated that mothers do not exclusively breastfeed their infants during the first six months. Pre- and post-intervention results on exclusive breastfeeding illustrated a positive change in participants’ knowledge and intent to breastfeed exclusively for six months. They showed a better understanding of the importance of exclusive breastfeeding and indicated a more focussed intention and confidence to carry out optimal breastfeeding practices. In the questionnaire the members of the Angus Gillis Foundation stated that the intervention is sustainable as it was linked with the existing networks. These include educational programs carried out in the villages by the foundation together with positive health champions, community health workers and women self-help groups; which will be able to build on the present knowledge base. Finally, the study also included the design of a booklet on the identified infant health issue. In conclusion, participants highlighted lack of understanding regarding breastfeeding as an issue of concern during the baseline phase of the study. This community-based educational intervention improved the understanding of breastfeeding among the participants, resulting in a positive change in perception with regards to exclusive breastfeeding practices.
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  • Date Issued: 2021

Lipid nanocarriers : a novel approach to delivering ophthalmic clarithromycin

  • Authors: Makoni, Pedzisai Anotida
  • Date: 2021
  • Subjects: Clarithromycin , Nanomedicine , Nanostructures , Antibiotics , Eye -- Diseases -- Treatment , Ocular pharmacology , Ophthalmic drugs , Karatitis -- Chemotherapy
  • Language: English
  • Type: text , Thesis , Doctoral , PhD
  • Identifier: http://hdl.handle.net/10962/171678 , vital:42109 , 10.21504/10962/171678
  • Description: The feasibility of incorporating clarithromycin (CLA) into innovative solid lipid nanoparticles (SLN) and nanostructured lipi d carriers (NLC) using hot emulsification ultrasonication (HEUS) was investigated. This approach was investigated in an attempt to address the shortcomings associated with the use of lyophilized parenteral formulations administered via the ocular route suc h as toxic reactions, intolerance and patient discomfort due to frequent insti llation of topical solutions of CLA. In particular, sustained release approaches to delivery may enhance precorneal retention, increase ocular availability and permit dose reduction or use of a longer dosing frequency when treating ocular non - tuberculous m ycobacterial (NTM) keratitis infections. This approach may potentially improve the delivery of CLA to the eye, thereby addressing some or all of the unmet clinical needs described vide infra . Prior to initiating pre - formulation, formulation development a nd optimization studies of CLA - loaded SLN and/or NLC, Design of Experiments (DoE), specifically a Central Composite Design (CCD) was used in conjunction with Response Surface Methodology (RSM) to develop and optimize a suitable method for the quantitative determination of CLA in pharmaceutical formulations and for monitoring CLA release from SLN and/or NLC in vitro . A simple, accurate, precise, sensitive and stability - indicating reversed phase - high performance liquid chromatography (RP - HPLC) method with ele ctrochemical (EC) detection was developed, validated and optimized for the in vitro analysis of CLA loaded SLN and/or NLC formulations. Pre - formulation studies were undertaken to investigate the thermal stability of CLA and bulk lipids to facilitate the s election of lipid excipients for the manufacture of nanocarriers in addition to establishing compatibility of CLA with the excipients. It was established that CLA was thermostable up to a temperature of approximately 300 °C thereby indicating that HEUS cou ld be used for the manufacture of CLA - loaded SLN and/or NLC. Lipid screening revealed that CLA i s, in general, poorly soluble in solid and liquid lipids however a combination of stearic acid (SA) and Transcutol ® HP (THP) exhibited the best dissolution pote ntial for CLA of all lipids tested . Stearic acid appears to exist as polymorphic form B prior to exposure to heat however occurs as the form C polymorph following heating at 85 °C for one hour. The best ratio for the mixture of SA and THP for the manufactu re of CLA - NLC ii was an 80:20 ( w/w ) ratio of SA: THP as the two lipids are miscible in this ratio and exhibited the greatest dissolution potential for CLA. Furthermore, an investigation of binary mixtures of CLA/SA and SA/Transcutol ® HP, in addition to eutect ic mixtures of CLA, SA and Transcutol ® HP, revealed no obvious interaction between CLA and the lipids selected for the production of the nanocarriers. Due to the relatively high solubility of CLA in THP in comparison to SA, NLC are likely to exhibit a hig her loading capacity (LC) and encapsulation efficiency (EE) for CLA than SLN. Consequently the feasibility of incorporating CLA (10% w/w ) into NLC was investigated and evaluation of the production of SLN was not undertaken as the production of these might not result in the manufacture of a delivery technology with a high EE and LC for CLA. Tween ® 20 was used as the surfactant as it is readily available, exhibits little or no cytotoxicity and is relatively cheap. Polyethylene glycol (PEG) was used as a coati ng polymer to impart muco - adhesive properties the formulated CLA - NLC. Response surface methodology (RSM) in conjunction with DoE, specifically a Box - Behnken Design (BBD) used as a screening design was used to identify a formulation composition which would produce a product that would meet the pre - defined target critical quality attributes (CQA) for the nanoparticles viz. particle size (PS) in the nano - range, polydispersity index (PDI) < 0.5, Zeta Potential (ZP) ≥ ± 30 mV, and EE > 80%. The formulation composition identified was subsequently used for the optimization of the manufacturing parameters viz. sonication time and amplitude, using a Central Composite Design (CCD) . The LC and EE, in vitro CLA release, cytotoxicity, osmolarity, pH, degree of crystallinity and lipid modification, elemental analysis and surface morphology of the optimized batch was investigated and mon itored to ensure that CLA - loaded NLC, of the desirable quality, had been produced. On the day of manufacture the mean PS and PDI of the optimized CLA - loaded NLC formulation adjusted to physiological osmolarity (250 – 450 mOsm/kg) was 461.9 ± 40.16 nm and 0. 523 ± 0.104, respectively. The ZP for the optimized NLC generated on the day of manufacture using HPLC grade water as the dispersion medium was - 20.5 ± 4.82 mV. The pH and osmolarity of the optimized CLA - loaded NLC formulation was 7.76 ± 0.01 and 316 ± iii 2 m Osm/Kg, respectively and the EE was 88.62 ± 0.23 %. The optimized NLC exhibited a decreased crystallinity in comparison to the bulk lipid materials. DSC, WAXS and FT - IR revealed that CLA was molecularly dispersed in the nanocarriers. The optimized CLA - load ed NLC exhibited muco - adhesive properties, when tested under stationary conditions using laser doppler anemometry (LDA). The optimized formulation also exhibited sustained release of CLA over 24 hours during in vitro release testing and CLA release was bes t described using the Baker - Lonsdale model . The cumulative % CLA released over 24 hours was 56.13 ± 0.23% and mass balance analysis revealed 41.38 ± 0.02% CLA had been retained in the NLC. In vitro cytotoxicity testing revealed that the optimized CLA - NLC w ere less cytotoxic to HeLa cells when compared to CLA alone and further confirmed that the lipids and excipients used in these studies were of GRAS status . Stability studies revealed that the EE reduced over 28 days by 14.42% and 5.14% when stored at 4 °C and 22 °C , respectively. In addition, the particle size increased from the nm to μm range for samples stored at 22 °C. The findings are a good starting point but require further optimization to ensure prolongation of stability. In addition , the technology requires additional developmental studies and a powder for reconstitution for use as a single - dose considered as single dose packaging may be a solution to the compromised formulation stability observed in these studies. The CLA - NLC produced in these stu dies exhibit sound product attributes which serve as a useful foundation for the novel delivery of antibiotics to the eye. The results suggest that the optimized NLC have the potential to enhance precorneal retention and increase ocular availability of CLA , which in turn may be useful to reduce the required dose and dosing frequency when administering CLA as a reconstituted solution to treat susceptible organisms that infect ocular tissues.
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  • Date Issued: 2021

A drug utilisation review of lithium at a public sector psychiatric hospital

  • Authors: Mapfumo, Charlotte
  • Date: 2020-04
  • Subjects: Lithium -- Therapeutic use , Psychiatric hospitals -- South Africa -- Grahamstown , Drug utilization , Psychiatric hospital care , Manic-depressive illness , Lithium -- Toxicology , Drug monitoring
  • Language: English
  • Type: text , Thesis , Masters , M.Pharm
  • Identifier: http://hdl.handle.net/10962/150541 , vital:38983
  • Description: Bipolar disorder (BD) is a common mental condition that affects about 60 million people globally. Lithium is among the drugs of choice used to treat BD and other affective disorders such as schizoaffective disorder (SD). Lithium is a mood stabiliser with antimanic, antidepressant and anti-suicidal properties. Lithium has complex mechanisms of action and a narrow therapeutic index (NTI). Therapeutic drug monitoring (TDM) is a vital component of lithium therapy due to its NTI. Lithium toxicity can occur at therapeutic levels and is characterised by symptoms such as blurred vision and convulsions. Lithium interacts with a number of drugs resulting in lithium toxicity or diminished effects of lithium. Symptoms of lithium toxicity range from abdominal pain, convulsions and death. Lithium use is associated with serious adverse effects on renal and thyroid function. Other adverse effects include tremor and weight gain. Monitoring of lithium serum levels, renal and thyroid function are therefore recommended for patients on lithium therapy. Monitoring of these parameters assists in the early detection of any problems associated with lithium use. The metabolic monitoring of lithium is vital due to the adverse effect profile of lithium and the current South African Standard Treatment Guidelines Hospital level: Adults, do not have any recommendations for the monitoring of metabolic parameters. The National Institute for Health and Care Excellence (NICE) may be used and adapted for the South African setting. Aim and Objectives: The general aim of the study was to conduct a drug utilisation review (DUR) on lithium through investigating its prescribing and monitoring patterns in both inpatients and outpatients at Fort England Hospital. Methodology: The study was in the form of a retrospective DUR. Data was collected from 40 files (n=40) of patients who were on treatment with lithium between 1 January 2017-31 December 2017 at Fort England Hospital. The data was collected retrospectively for both in- and outpatients. Compliance of the monitoring requirements with both South African and international guidelines was analysed. Results and Discussion: In 87.50% (n=37) of the cases, patients had been on lithium therapy before 2017 with most patients (n=13; 37.50%) being maintained on 500 mg of lithium. Non-compliance with the South African and NICE guidelines for renal baseline monitoring was 65.00% (n=26) in both guidelines. Non-compliance for baseline thyroid monitoring was 70.00% (n=28) for both guidelines. There was non-compliance in 45.00% (n=18) of the cases for lithium serum level monitoring for both guidelines. Non-compliance with follow-up renal monitoring was 47.50% (n=19) for both guidelines. Compliance with the NICE guidelines for follow-up metabolic monitoring was 67.50% (n=27). Conclusion: There was non-compliance in most cases leaving room for clinical improvement in the monitoring of lithium. Healthcare professionals should be educated on the recommended monitoring guidelines to promote the rational use of lithium in South Africa. Pharmacists should be more involved in the TDM of lithium to promote its safe and effective use.
  • Full Text:
  • Date Issued: 2020-04

Application of quality by design to the manufacture of a multiparticulate prednisone dosage form

  • Authors: Manda, Arthur
  • Date: 2020-04
  • Subjects: Drugs -- Quality control , Drugs -- Design -- Quality control , Drugs -- Dosage forms , Drug development -- Quality control , Pharmaceutical industry -- Quality control , Prednisone , High throughput screening (Drug development)
  • Language: English
  • Type: text , Thesis , Masters , MSc (Pharmacy)
  • Identifier: http://hdl.handle.net/10962/117986 , vital:34583
  • Description: For many years, quality by testing was the only approach to guarantee quality of drug products before the Food and Drug Administration launched the concept of current Good Manufacturing Practice. In order to gain more knowledge of the manufacturing process, a new system known as Quality by Design was introduced into the pharmaceutical industry. Quality by Design is based on thorough understanding of how materials, process parameters and interaction thereof impact final product quality. Quality by Design is a systematic approach to product development which ensures that quality is built into a product during product development and not just tested into it. The aim of Quality by Design is to achieve optimum product quality with consistent dosage form performance and minimal risk of failure in patients. The objective of these studies was to implement a Quality by Design approach to establish a design space for the development and manufacture of a safe, effective and stable multi-partite solid oral dosage form for prednisone as an alternative to currently marketed prednisone formulations. Multi-particulate dosage forms offer significant advantages over conventional technologies. In addition to lowering the incidence of gastrointestinal irritation they exhibit a reduced risk of dose dumping and a large surface area which favours dissolution. Furthermore, their free flowing nature facilitates reproducible capsule filling and consequently uniformity of dosing. Different multi-particulate dosage forms exist however a multiple-unit pellet system was investigated during these studies. Quality by Design principles were used to develop and establish a reversed-phase high performance liquid chromatographic method for quantifying prednisone from solid oral dosage forms. A Central Composite Design was used to generate multivariate experiments and to investigate the impact of input variables on the quality and performance of the analytical method. The optimized method was validated according to International Council for Harmonization guidelines and was found to be linear, precise, accurate and specific for the quantitation of prednisone. Pre-formulation studies were conducted and included the assessment of particle size, particle shape, powder flow properties and compatibility studies. Carr’s index, Hausner ratio and the Angle of Repose were used to evaluate powder flow properties and results generated from all studies suggest the need for adding a glidant and lubricant to improve pellet flow. The images generated from Scanning Electron Microscopy were used to analyze particle shape and size. Differential Scanning Calorimetry and Fourier Transform Infrared Spectroscopy were used to evaluate API-excipient compatibility. All excipients investigated were found to be compatible with prednisone and suitable for formulation development studies. Extrusion-spheronization was used to manufacture prednisone pellets. Extrusion-spheronization is a multi-step process involving many factors. Quality risk management tools particularly an Ishikawa Fishbone (cause and effect) diagram and failure mode and effects analysis were used to narrow down potentially significant factors to a reasonable number that could be investigated experimentally. Risk priority numbers were used to quantify risk and factors above a set threshold value were considered to be of high risk. A total of eleven risk factors were identified as high. A Plackett-Burman study was conducted to narrow down the eleven high risk factors to identify the most impactful factors viz., microcrystalline cellulose content, sodium starch glycolate content, extrusion speed and spheronization time. Evaluation of four factors was carried over to optimization studies using a Box-Behnken Design and following identifaction of the optimum process settings and excipient content a design space for the manufacture of a multi-partite dosage form containing prednisone was established.
  • Full Text:
  • Date Issued: 2020-04

Evaluating the prescribing and management practices of clozapine at a public sector psychiatric hospital

  • Authors: Mukoko, Vimbisai Millicent
  • Date: 2020-04
  • Subjects: Clozapine , Schizophrenia -- Chemotherapy , Schizophrenia -- South Africa -- Treatment
  • Language: English
  • Type: text , Thesis , Masters , M.Pharm
  • Identifier: http://hdl.handle.net/10962/123266 , vital:35422
  • Description: Approximately one percent (1%) of the South African population suffers from schizophrenia. Clozapine has proven to be more effective than conventional antipsychotics in the treatment of schizophrenia, particularly in alleviating positive symptoms. Clozapine is primarily indicated for treatment-resistant schizophrenia due to its severe adverse effect profile. The prescribing guidelines recommend a trial of at least two different antipsychotic drugs before the initiation of clozapine. At least one should be a non-clozapine second generation antipsychotic. Compared to other atypical antipsychotics, clozapine poses the greatest risk of causing a haematological event, such as neutropenia and agranulocytosis. Agranulocytosis (estimated prevalence of 1.3%) is a life-threatening adverse effect. Common adverse effects include weight gain and metabolic syndrome, hypersalivation and constipation. These can also predispose the patient to co-morbid diseases which further complicate their current diagnosis. Haematological and metabolic monitoring is paramount throughout the duration of clozapine therapy. International (NICE guidelines, Clozapine REMS, and Maudsley prescribing guidelines) and national (South African STGs, SASOP treatment guidelines and the SAMF) guidelines recommend these monitoring patterns to assist with the prevention and management of the adverse effects of clozapine.
  • Full Text:
  • Date Issued: 2020-04

Evaluating the prescribing and management practices of venlafaxine at a public sector psychiatric hospital

  • Authors: Naidu, Bavika
  • Date: 2020-04
  • Subjects: Venlafaxine , Anxiety disorcers -- Treatment , Depression, Mental -- Treatment
  • Language: English
  • Type: text , Thesis , Masters , M.Pharm
  • Identifier: http://hdl.handle.net/10962/123200 , vital:35414
  • Description: Neuropsychiatric conditions have been ranked third in South Africa according to some of the most recent reviews of disease burden, following human immunodeficiency virus/acquired immune deficiency syndrome and other infectious diseases (Bateman, 2012:70; South African Depression and Anxiety Group, 2018). For depressive disorders, the conventional selective serotonin reuptake inhibitors (e.g. fluoxetine), are common first-step treatments due to their relatively low toxicity and high tolerability (Rush et al., 2006:1231). The class of selective noradrenaline reuptake inhibitors (e.g. venlafaxine) is relatively new on the market. The first SNRI to be marketed in the United States was venlafaxine immediate-release (IR). It was approved by the United States FDA in 1993 (Sansone and Sansone, 2014:37) and was soon followed by the introduction of a micro-encapsulated extended-release (XR) formulation in 1997. Currently there is no published or readily available information concerning the prescribing and management patterns of venlafaxine as well as the incidence and types of adverse effects experienced by patients in the public health sector of South Africa besides the established increased in blood pressure.
  • Full Text:
  • Date Issued: 2020-04

Preparation, characterization and optimization of carbamazepine based pellets prepared by extrusion-spheronization technique

Science engagement with school learners for microbial quality testing of water in Makhanda

  • Authors: Nqowana, Thandiswa
  • Date: 2020-04
  • Language: English
  • Type: text , Thesis , Masters , MSc (Pharmacy)
  • Identifier: http://hdl.handle.net/10962/124754 , vital:35677
  • Description: Expected release date-April 2022
  • Full Text: false
  • Date Issued: 2020-04

The relative suitability of knowledge paradigms to indigenous African resource management and their implications for environmental bioethics, environmental policy and food security

  • Authors: Agbor Ambang, Oscar Mbi
  • Date: 2020-04
  • Subjects: Uncatalogued
  • Language: English
  • Type: thesis , text , Masters , M.Pharm
  • Identifier: http://hdl.handle.net/10962/163091 , vital:41011
  • Description: Thesis (M.Pharm)--Rhodes University, Faculty of Pharmacy, Pharmacy, 2020.
  • Full Text:
  • Date Issued: 2020-04
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