ABSTRACT:
The robustness of pharmaceutical dosage forms entails optimizing both the formulation and the level of excipients to obtain the desired quality features. To optimize the formulation in this investigation, a factorial design approach was adopted. For enhancing the dissolution of a Biopharmaceutics Classification (BCS) Class II drug, a two-level four-factor partial factorial design was advocated. Factorial design is a method for systematically determining the relationship between independent process factors and their effect on the response variable. Partial factorial designs were applied in this research work. The particle size distribution of Lactose Anhydrous is used as a dependent variable and Sodium Starch Glycolate (Primojel/Type A) and Magnesium Stearate, Pregelatinised starch (Lycatab)/Anhydrous Lactose/Lactose Anhydrous (Super Tab 21 AN) ratio and the Particle size distribution were used as independent variables for optimization. Response parameters for the final Bicalutamide Tablets 50mg were the percentage of Bicalutamide Tablets 50mg dissolved at thirty minutes. The factorial design models were validated for accurate prediction of response characteristics and used to identify the optimum formulation. Response parameters for final Bicalutamide Tablets 50mg were the percentage of Bicalutamide Tablets 50mg dissolved at thirty minutes. The data were analyzedand response surfaces were generated for tablet percentage of dissolution and content uniformity.