Formulation Optimization Study for an Immediate-Release Tablet

Abstract

A simple method based on statistical analysis was used to optimize an immediate-release tablet formulation that includes a water-soluble drug. The objective of this study was to optimize different factors to develop a tablet formulation that has good tablet characteristics (hardness of 85 to 90 Newtons), disintegration time between 3 to 6 minutes, and friability <1%. The critical formulation/process factors were the type and concentration of microcrystalline cellulose, the ratio of lactose to microcrystalline cellulose, the concentration of croscarmellose, and the compression force. A two-step approach was implemented. First an optimization study was performed to determine the type of microcrystalline cellulose and its ratio to lactose. Subsequently, a final optimization formulation study was performed based on the results obtained in the preliminary study. Data were analyzed using the SPSS 15 (Statistical Software for Social Sciences). The differences in means between the formulation and the targeted product