Study of Different Granulation Processes during Formulation Development, Evaluation, Characterization of Granules and Capsule Formulations

Fluoxetine Hydrochloride showed poor blend flow properties and weight variation issue by simple dry mixing and dry granulation/slugging for immediate release capsule/granules. Disintegration is also little faster than requirement. Wet granulation method by using different grades of MCC and by using different concentration of binder was evaluated and scale batch taken for optimum formula check the reproducibility of optimized batch and robustness. The formula with combined approach of half quantity of MCC 102 intra granular and half quantity of MCC extra granular showed good flow and disintegration time was in accordance with innovator. Laboratory scale up batch was taken which was comparable with innovator product in all dissolution media. Reproducible batch study helped to know about important parameters like granulating fluid, kneading time, drying time required to develop immediate release capsule with good characteristics granules. An immediate release formulation of an Anti-depressant Fluoxetine Hydrochloride was successfully formulated having attributes comparable with innovator and also disintegrant or surfactant was not used so formulation is economic compared to innovator.