Abstract

Shubham R. Biyani*, Rajkumar S. Moon, Surendra G. Gattani and Sagar A. Kothawade

ABSTRACT

The aim of present study includes formulation and optimization of oral film loaded with cevimeline HCL by two factors and their three levels as optimal (custom) designs. The two viz. factor A (HPMC E15) and factor B (PEG 400) was selected on the basis of preliminary feasibility study. The percent drug dissolution in 10 minutes (R1), Disintegration time in sec (R2) and folding endurance (R3) were selected as dependent variables. Cevimeline hydrochloride is Para-sympathomimetic agent which stimulates muscarinic receptor (M3). It can significantly help to improve symptoms of dry mouth as well as increases salivary output in sjogrens syndrome. Orally dissolving film which produces local action in dry mouth condition, prevents first pass metabolism, and ultimately increase in systemic bioavailability. The oral film is formulated by solvent casting method using HPMC E15 as film forming agent, PEG 400 as plasticizer, tween 80 as surfactant, citric acid as saliva stimulating agent, sodium saccharin as sweetener and orange flavour etc. These films were evaluated for parameter like their appearance, weight variation, thickness, surface pH, folding endurance, percent elongation, percent moisture loss, drug content, In-vitro disintegration time and In-vitro dissolution study. The formulation F5 has more promising responses as per D-optimal design are % drug dissolution in 10 min about 99.90 %, average disintegration time about 23.66 second and folding endurance is 127. The formulation F5 was selected as optimised formulation.