FORMULATION, DEVELOPMENT, AND EVALUATION OF IMMEDIATE-RELEASE CAFFEINE ANHYDROUS CAPSULES (100 MG)

The aim of this study is to formulate, develop, and evaluate immediate-release capsules containing 100 mg of Caffeine Anhydrous. Three different formulations (F1, F2, F3) were developed using the wet granulation technique. These formulations were developed to compare the influence of different diluent-based excipient matrices (specifically Mannitol, Lactose Monohydrate, and Dicalcium Phosphate) on drug release profiles. Pre-filling evaluations of the prepared granules of all batches showed excellent micromeritic flow properties, with Carr's index ranging from 5.71% to 9.72% and angle of repose between 21.94° and 22.44°. The prepared granules were filled into size-0 hard gelatin capsules. All formulations successfully passed the acceptable limits for weight variation, locking length, and content uniformity. In-vitro disintegration times were also rapid, occurring within 2 to 6 minutes. In-vitro dissolution studies were conducted in a pH 1.2 buffer as the dissolution medium. Formulation F1 (Mannitol-based) exhibited the most rapid and complete drug release compared to F2 and F3. Microbial content testing confirmed that F1 is microbiologically safe. Therefore, the wet granulation method successfully produced immediate-release caffeine capsules.