Optimization of Slugging and Compression Process for Bicalutamide Tablets

Abstract

The critical nature of pharmaceutical dosage forms necessitates the optimization of manufacturing process variables to achieve the desired product quality. In this study, slugging (Dry granulation) was selected as an appropriate granulation method to mitigate poor flow properties in the final bicalutamide blend. The chosen process variables include slug hardness, mill screen size, and mill speed. A 23-factorial design was employed to investigate these variables. Process parameters were reproducible, with minimal impact on tablet properties, even when roller speeds varied. Response surface models effectively examine the relationship between response variables and quantitative parameters. The input and process variables for the compression process were predetermined based on the desired quality attributes of bicalutamide tablets. Notably, the p-value for the slugging process was not more than 0.05, indicating their insignificance in tablet content uniformity. Product quality attributes affected by the compression process step include content uniformity, disintegration time, and dissolution. The optimal hardness range was found to be 2.0 to 7.0 kp.