Preparation and Evaluation of Multi-Particulate System (Pellets) of Prasugrel Hydrochloride

Abstract

Multiparticulate systems (pellets) of prasugrel hydrochloride were prepared by extrusion spheronization method using MCC (micro crystalline cellulose). Optimum spheronization time and method of drying were selected as the process parameters for the preparation of final batches. Various pellet properties were evaluated like size & shape analysis, flow properties, bulk & tapped density, friability, moisture content, drug content, in vitro release rate and in vivo pharmacodynamic studies. All pellet batches showed a narrow particle size distribution, good sphericity and excellent flow properties. Drug content and moisture content of different pellet batches were found in specified limits. The release kinetics of drug loaded MCC pellets followed Peppas model with Fickian diffusion of prasugrel from the pellets. In vivo pharmacodynamic studies exhibited improved bleeding time in pellet group when compared with the marketed tablet formulation.