Design and Evaluation of Buccal Patches of Granisetron Hydrochloride

Abstract:

The goal of the present investigation was to design and evaluate mucoadhesive bilayered buccal devices comprising a drug containing mucoadhesive layer and a drug free backing membrane. Bilaminated films were composed of mixture of drug (granisetron hydrochloride) and chitosan, with hydroxypropyl methylcellulose (15 cps) and backing layer (ethyl cellulose). Films were fabricated by solvent casting technique and were evaluated for thickness, drug content uniformity, in situ bioadhesion strength, tensile strength, percent elongation at break, swelling index, folding endurance and in vitro drug release. Formulation CH containing chitosan and hydroxypropyl methylcellulose (1:1) 8 using propylene glycol (50% by weight of polymer) as plasticizer gave promising results. The optimized film exhibited an in vitro drug release of more than 90% in 5 hours along with satisfactory bioadhesive strength and tensile strength. This promising film was tested for short-term stability for three months at 30±20C and 40±2ºC/75±5% relative humidity and drug-excipient interaction (FTIR). Stability study of the above formulation indicated that there is no significance change in drug content (p<0.05). FTIR spectra indicated that there are no drug-excipient interactions.

Key words: Granisetron hydrochloride; hydroxypropyl methylcellulose; chitosan; polyvinyl pyrrolidone; mucoadhesive buccal films.