Process Validation of Dispersible Tablet Comprising of Tenofovir, Bictegravir and Emtricitabine

In the formulation of Orodispersible tablets, process parameters were checked to ensure consistent tablet quality, including factors like uniformity in size, shape, and coating. Monitoring these parameters helps optimize disintegration, dissolution, and hardness, ensuring the tablet meets its intended release profile and complies with regulatory standards. In this research, process validation for drying time, prelubrication time, lubrication time, hardness and % weight gain parameters were checked. Drying time was set as 20 min, 25 min and 30 min, Prelubrication time was set as 8 min, 10 min and 12 min and lubrication time was set as 1 min, 3 min and 5 min. Evaluation was done for the optimum selection of these parameters which affects the dissolution, disintegration, assay and LOD. In this research, three validation batches were taken amongst batch F2 showed the results in acceptable range. Disintegration time for the batch F2 was found in acceptable range i.e 1min 23 sec. % weight check was determined during coating of the tablets and it was found is acceptable range. Optimum hardness was selected which was15 to 17 kp, For F2 it was found to be16.56±0.6 The dissolution for the batches observed in the acceptable ranges amongst F2 showed maximum release it may be due to optimum selection of the hardness, % weight gain lubrication time and prelubrication time. F2 batch was found to be stable for 3 months at accelerated condition and long-term conditions.