Full factorial design, physicochemical characterization of phenylephrine HCl loaded oral thin film

Abstract

Oral dissolving drug delivery system offers a solution for those patients having difficulty in swallowing tablets/capsules. The primary objective of the present research work was to optimize oral thin film (OTF) formulation of phenylephrine HCl, a water soluble drug with three loading concentrations: High, medium and low and also to evaluate their effect on the final product attributes.The OTF was prepared by solvent casting method. All the formulations were evaluated for film forming properties, appearance, thickness, folding endurance, tensile strength, percent moisture absorption, surface morphology, in vitro and in vivo disintegration. Formulations containing low and medium loading concentration gave acceptable results while formulation with higher loading concentration resulting poor film forming properties. Hence, another objective of the present study was to investigate the effect of anti‐tacking agent namely magnesium aluminum silicate (MAS), microcrystalline cellulose and colloidal silicon dioxide (CSD) by applying 23 full factorial design on improving the film properties of high concentration phenylephrine HCl. Formulation containing microcystalline cellulose and CSD at low level and MAS at high level was found to be suitable for film formation with desirable physicochemical properties, faster disintegration and optimum in vitro release. Key words: Anti‐tacking agents, effect of variables, loading concentration, water soluble drugs