Browsing by Author "Omoteso, Omobolanle Ayoyinka"

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    The formulation of a microsphere based fixed dose combination for oral antiretroviral delivery
    (University of the Western Cape, 2023) Omoteso, Omobolanle Ayoyinka; Aucamp, Marique Elizabeth
    The cost of providing antiretroviral therapy (ART) remains a significant economic burden on African countries due to poverty and a lack of resources. To reduce the economic burden of HIV infection, a formulation scientist must use the limited resources available in Africa to develop drug dosage forms of antiretrovirals (ARVs) that are cost-effective, adaptable, and accessible, as well as result in successful therapeutic outcomes of HIV/AIDS treatment, raise the average life expectancies of HIV-positive adults, and increase the availability of the limited resources for other purposes. According to the literature, lamivudine (3TC) is still used in firstline HIV treatment regimens, and several 3TC-based fixed-dose combinations (FDCs) are on the market. These FDCs are typically relatively large and require patients to take medication daily. As a result, patients will accept a flexible dosage form that can be ingested once and provides adequate therapeutic efficacy for more than 24 hours, thereby increasing treatment adherence, decreasing drug resistance, and improving therapeutic efficacy. Formulation scientists must create dosage forms that provide better patient treatment and patient experience, focusing on patientcentred medicine development. Hence, this study focused on 3TC and tenofovir disoproxil fumarate (TDF), which are still among the cornerstones of many HIV treatment regimens.
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    The validation of a simple, robust, stability-indicating rp-hplc method for the simultaneous detection of lamivudine, tenofovir disoproxil fumarate, and dolutegravir sodium in bulk material and pharmaceutical formulations
    (Hindawi, 2022) Omoteso, Omobolanle Ayoyinka; Milne, Marnus; Aucamp, Marique
    An effective analytical method is requisite to ensure the accurate identification and quantification of drug(s), either in bulk material or in complex matrices, which form part of finished pharmaceutical products. For the purpose of a pharmaceutical formulation study, it became necessary to have a simple, yet robust and reproducible reversed-phase HPLC method for the simultaneous detection and quantification of lamivudine (3TC), tenofovir disoproxil fumarate (TDF), and dolutegravir sodium (DTG) in bulk form, complex polymeric matrices, and during drug release studies. A suitable method was developed using a Kinetex® C18, 250 × 4.6 mm column as stationary phase and a mobile phase consisting of 50 : 50 v/v methanol and water with 1 mL orthophosphoric acid, with a flow rate of 1.0 mL/min and column temperature maintained at 35°C. A detection wavelength of 260 nm and an injection volume of 10 μL were used. ,e method was validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1), and the parameters of linearity and range, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ), robustness, and stability were all determined. Acceptable correlation coefficients for linearity (R2) of >0.998 for each of the three drugs were obtained. ,e LOD was quantified to be 56.31 μg/mL, 40.27 μg/mL, and 7.00 μg/mL for 3TC, TDF, and DTG, respectively, and the LOQ was quantified as 187.69 μg/mL, 134.22 μg/mL, and 22.5 μg/mL for 3TC, TDF, and DTG, respectively. In relation to all the determined validation parameters, this method proves to be suitable for the accurate identification and quantification of the three ARVs, either alone or in combination, as well as when incorporated into polymeric matrices. Furthermore, the method proves to be suitable to detect degradation of the compounds.