FORMULATION OF AN INSITU FORMING INJECTABLE SUSTAINED RELEASE SPONGE OF GRANISETRON HYDROCHLORIDE

摘要

The overall aim of this work was to develop sustained release parenteral drug delivery system involving formation of an insitu sponge of an anti-emetic drug typically co-administered inchemotherapy induced nausea and vomiting. The study involved formulation of the drug Granisetron Hydrochloride in a sponge forming gelatin matrix as a dry powder for reconstitution into a suspension to be injected into the body forming a sponge insitu intended to release the drug over a period of 5 days. The formulation was prepared by the method cryogelation and optimised using gelatin5% as a sponge forming polymer, crosslinking agent glutaraldehyde 0.3% , sustained release retardant Hydroxypropylmethyl cellulose K100M 1% (HPMC K100M) and suspending agent sodium carboxymethylcellulose 1% (NaCMC) to form a solution intended to be administered subcutaneously. The formulation was evaluated for all prerequisites of parenteral and other parameters of gelatin matrix like swelling index, surface scanning microscopy .for injectable suspension, sedimentation study, particle size,zeta measurement, invitro drug release, and stability studies. The formulation was found tosterile, isotonic, having swelling index 88% and SEM 100-120 μm,particle size 0.765μm.with zeta potential-14.2 mV, swelling time was 10 min. The in vitro drug release was found to be over 93.20% in Simulated Body fluid pH 7.4 at 37°C over a prolong period of 5days The formulation was physically and chemically stable at accelerated conditions for period of 1 month.