ABSTRACT
Objective: This study emphasis on roll compaction variable and how the processing parameters influence the formation of granules in process of formulations of antiretroviral IR Tablet with help of optimization technique. Methods: In this present work we aimed to develop a stable pharmaceutical dosage form with anti-retroviral drug tenofovir disoproxil fumarate. % retention of granules over # 60 mesh in roll compaction method by sizing with 50G co-mill screen was assessed by optimization and results were evaluated by Design expert 12.0 software. Various parameters and optimization of the parameter for formulation for better product was done by using 23 factorial design and dry granulation technique for manufacturing tablets. Three operating parameters the roller speed, the hydraulic pressure and the gap width on the Chamunda CPMRC-200/150 Roll Compactor were varied. The planned response variable for study was % retention over #60 ASTM mesh. % retention of granules was calculated by weighing granules on digital electronic balance with respect to how much premix material was taken for compaction. Results: Excipients compatibility study gave positive way showing no change in physical appearance of drug-excipients mix. It reviled that drug was compatible with excipients used. By formation of granules with required ratio, the value of Compressibility index changed from 29 to 21.89, showed that flow properties were improved i.e. from poor to passable. Design expert 12.0 gave optimized solution for formation of required quantity of granules. Pareto chart showed envaulted positive and negative impact of factors on response as explained in results. The results clearly indicate that how granules manufacturing in roll compaction process are influenced by roller pressure, roller gap and speed. 70 % flakes formation and granules retention were observed with 4000 kg/cm2 pressure, 1 mm roller gap width and 6 rpm speed of roller. Pareto chart clearly indicate major impact is of roller pressure. Comparative dissolution profile graph showed that drug release pattern is similar with the innovator tablet. A stable, robust tablets were formed at the end of process. Conclusion: In this study, by optimizing processing variables stable antiretroviral immediate release oral solid dosage form was formed.