http://vital.seals.ac.za:8080/vital/access/manager/Index en-us 5 http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26603 0.9. The release mechanism was confirmed using the Korsmeyer-Peppas model that revealed that most of the formulations exhibited anomalous transport kinetics with the release exponent, n, ranging from 0.5 Wed 12 May 2021 23:42:25 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:31475 Wed 12 May 2021 20:33:38 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:29088 Wed 12 May 2021 18:23:57 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:28086 Wed 12 May 2021 17:14:03 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:29930 Wed 12 May 2021 17:04:13 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:41964 Wed 12 May 2021 15:07:56 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:42948 Wed 12 May 2021 15:07:02 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:27444 Tue 13 Jun 2023 11:29:15 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26599 0.999 were obtained for each assessment of linearity and FTC, TNF and EFV are linear in the range 0.4-40 μg/ml, 0.6-60 μg/ml and 1.2-120 μg/ml. The equation of the best-fit least squares regression lines for FTC, TNF and EFV were y = 0.0191x+0.0007, y = 0.0163x+0.0116 and y = 0.01x+0.016, respectively. The method is accurate as the y-intercept was < 2% of the detector response for all ARV, and the method is precise in terms of intra- and inter-assay precision as all % RSD < 2%. The stability-indicating nature of the method was demonstrated under acidic, alkaline and oxidative stress in addition to UV exposure and elevated temperatures, and the individual chromatograms were overlaid using Empower® 3 Software to establish whether there was interference with the peaks of interest. The forced degradation studies demonstrated the selectivity of the method for the ARV compounds. The method was applied to assay and in vitro dissolution studies of commercially available tablets. The amount of each active ingredient released from Atripla® was determined and compared to the amount of each drug released from Aspen Efavirenz® and Truvada® (a combination of FTC and TNF). The percent FTC released from Atripla® and Truvada® was similar based on the acceptance criteria for immediate-release BCS class 1 compounds. Statistical analysis was undertaken to compare the dissolution profiles of FTC, TNF and EFV. The percent of these compounds released in these studies indicate that bioequivalence testing would be required to declare these products interchangeable. The validated RP-HPLC and in vitro dissolution test method are suitable for routine quality control testing of solid oral dosage forms containing EFV, FTC and TNF, and as the dissolution method can discriminate between different formulations of the same molecule, these tools can also be used for analysis during formulation development studies. The method is not suitable for the analysis of the ARV plasma due to lack of sensitivity and an inability to quantitate the compounds at the required concentration levels. The use of HPLC with mass spectroscopy for quantitation would enhance the sensitivity of the method and may eliminate the quantitation of the molecules in the presence of interference that was observed when using UV detection. Fixed dose combination tablets are convenient for patient therapy and it is likely that in the future more molecules will be formulated into such dosage forms. However formulations such as these can pose significant difficulties when developing and using analytical methods for the quantitation of all compounds in the dosage form at the same time, in particular when the compounds have vastly different physico-chemical properties that impact the quality of a separation and therefore the analysis. Therefore when embarking on the development of FDC product cognisance of the difficulties of developing single methods for the analyses is required and approaches to overcome these difficulties should be considered.]]> Thu 13 May 2021 08:54:37 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26602 Thu 13 May 2021 06:31:38 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26598 Thu 13 May 2021 05:29:58 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26704 Thu 13 May 2021 04:45:06 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26600 Thu 13 May 2021 02:49:04 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:31466 Thu 13 May 2021 02:05:15 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26601 5% w/v led to a reduction in DLC and EE and an increase in PS with minimal impact on the ZP. Stability studies conducted at 25°C/65% RH and 40°C/75% RH for up to 30 days following manufacture revealed that batch SLM 15 manufactured using 10% w/v Labrafil® M2130 CS, 5% w/v KTZ and a combination of 4% w/v Pluronic® F-68, 2% w/v Tween 80 and 1% w/v sodium cholate produced the most stable dosage form when stored at 25°C/65% RH for up to 30 days. However, storage at 40°C/75% RH resulted in instability of the formulation. An aqueous dispersion of KTZ-loaded SLM has been developed and assessed and may offer an alternative to extemporaneous preparations used for KTZ therapy in paediatric and immuno-compromised patients.]]> Thu 13 May 2021 01:07:54 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:26597 Thu 13 May 2021 01:03:47 SAST ]]> http://vital.seals.ac.za:8080/vital/access/manager/Repository/vital:27447 Fri 06 Aug 2021 10:31:06 SAST ]]>