Abstract:
Buccal drug delivery system using mucoadhesive polymers has been recently interested due to avoidance of the first pass effect and high blood level. In the present study, an attempt was made to develop buccoadhesive patch of Ivabradine hydrochloride an If inhibitor by solvent casting method intended for treatment of chronic stable angina and selection of most satisfactory formulation by in vitro evaluation. Drug-excipients incompatibility study was carried out using Infrared spectroscopy (IR) which shows that drug and excipients were compatible to each other. Buccoadhesive patch of Ivabradine hydrochloride containing Hydroxy Propyl Methylcellulose K15, Carbopol 934 and Polyvinyl pyrrolidone K-30 were developed by solvent casting method. An optimized formulation was having excellent % elongation, tensile strength, residence time, folding endurance and bioadhesivity by releasing 93.78 ±0.3% drug release in 6 hrs in pH 6.8 phosphate buffer and 84.13±1.65 % release in ex-vivo diffusion using got buccal mucosa in franz diffusion cell. Stability studies of an optimized batch showed no significant change in bioadhesivity, folding endurance and drug release in in vitro and as well as ex-vivo after storage at 40 ±2 oC and 75±5% RH and 30±2˚C and 65±5 % RH for a period of two months. This approach suggested that the buccoadhesive patch of Ivabradine hydrochloride using carbopol 934 and PVP K-30 gives sustained release upto 6 hrs and may increase the bioavailability of the drug in treatment of chronic stable angina.
Key words : Buccal drug delivery, buccoadhesive patch, solvent casting method, Ivabradine hydrochloride, Chronic stable angina.
