Studies on Gastro Retentive Clopidrogrel Tablets for Peripheral Vascular Disease Treatment

The purpose of present work was for formulation and characterization of Clopidrogrel floating tablets to improve bioavailability and to minimize the side effects of the drug. FTIR studies were conducted for drug polymer compatibility. The Clopidrogrel sustained release floating tablets were formulated by wet granulation method.  Tablets were subjected to pre and post compressional evaluation studies. The different concentrations of HPMC K4M, HPMC K15M, xanthan gum, guargum, and sodium bi carbonate 25% w/w is used as gas generating agent and micro cellulose crystalline MCC are used in different concentrations (75%, 50%, 25%) as diluent. The tablets were tested for thickness, weight variation, hardness, friability, drug content; In vitro floating parameters and drug release studies were also conducted. Compatibility studies revealed that there is no interaction between drug and polymers in the formulations. The flow properties were within the limits and the granular bed exhibited uniform flow and ease for compression. Clopidogrel floating tablets showed uniform post compressional properties with minimum standard deviation. The formulations showed minimum floating lag time and prolonged duration of floating. In vitro drug release of clopidogrel was sustained up to 12 h. Clopidrogrel release followed zero order, first order, Higuchi drug release kinetics for drug release. The peppas diffusion coefficient ranged from 0.455 - 0.895 indicating drug release by non fickian diffusion followed by erosion. The F4 floating tablet was optimized formulation which showed 100% release sustained for 12 h. The stability studies indicated stability of drug in the optimized formulation against temperature and humidity.