Development of a Discriminating Dissolution Method for Immediate Release Soft Gelatin Capsules Containing a BCS Class II Compound
The purpose of this study was to develop a robust dissolution procedure for liquid filled, soft gelatin capsules (SGCs) that can distinguish small but real changes in drug product formulation. SGCs were manufactured using different ratios of fill formulations. The formulations were evaluated by performing dissolution testing on fresh capsules and capsules that were aged at different time points and conditions. USP Apparatus 1 (basket) and 2 (paddle) at rotating speeds of 50, 75, or 100 rpm were used to evaluate the release characteristics of the formulations. The model independent method using difference factor (f1) and similarity factor (f2) was employed to compare dissolution profiles. Dissolution data showed that fill material characteristics played a major role in controlling the rate of dissolution of our drug products. The basket increased the discriminatory power of the dissolution process regardless of speed. We observed that the paddle rotation speed may impact discrimination power but not the ability of the method to discriminate. The basket was successful for the quality assessment and characterization of formulation changes of our drug products. Through understanding of drug product characteristics and evaluating parameters of dissolution testing, a methodology can be established to enable batch to batch evaluation.