Development and Evaluation of Dispersible Tablet comprising Tenofovir, Bictegravir and Emtricitabine

Maximum Anti-HIV Drugs Dosage Forms are available as tablets or capsule dosage forms. Such Dosage Forms are not suitable for patient who is having difficulty to swallowing. Antiretroviral therapy for treatment of HIV Infection contains more than two drugs so dose of drugs are more and most of these drugs are having issues like high bitterness, low solubility, highly moisture sensitivity and drugs incompatibility issue so to formulate HIV drugs into dispersible tablet is challenging. In present research, fixed dose combination of Tenofovir, Bictegravir and Emtricitabine were used to formulate the dispersible bilayer tablet. Bictegravir sodium is BCS class II drug hence with this drug eight different formulation for solubility enhancement was performed. All the physicochemical parameters were evaluated for the granules, Dissolution, assay for the granules were determined. For second layer of Tenofovir, and Emtricitabine, disintegrant concentration was optimized with three different formulations and evaluation was done like flow properties of granules, DT, assay and dissolution. All the results were compared with the marketed product. The formulation F10 showed desirable DT, assay, and dissolution hence it was selected as best formulation.