%0 Journal Article
%T Design Optimization and In Vitro-In Vivo Evaluation of Orally Dissolving Strips of Clobazam
%A Rajni Bala
%A Sushil Khanna
%A Pravin Pawar
%J Journal of Drug Delivery
%D 2014
%I Hindawi Publishing Corporation
%R 10.1155/2014/392783
%X Clobazam orally dissolving strips were prepared by solvent casting method. A full 32 factorial design was applied for optimization using different concentration of film forming polymer and disintegrating agent as independent variable and disintegration time, % cumulative drug release, and tensile strength as dependent variable. In addition the prepared films were also evaluated for surface pH, folding endurance, and content uniformity. The optimized film formulation showing the maximum in vitro drug release, satisfactory in vitro disintegration time, and tensile strength was selected for bioavailability study and compared with a reference marketed product (frisium5 tablets) in rabbits. Formulation (F6) was selected by the Design-expert software which exhibited DT (24£¿sec), TS (2.85£¿N/cm2), and in vitro drug release (96.6%). Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product. The mean ratio values (test/reference) of (95.87%), (71.42%), (98.125%), and (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles. 1. Introduction Oral route is one of the most preferred routes of drug administration due to its safety, ease of administration, and acceptability by patients. About 60% of conventional dosage forms are available as the oral solid dosage forms [1]. The low bioavailability, longer onset of action, and dysphasia patients turned the manufacturer towards the parenterals and liquid dosage forms. But the liquid dosage forms (syrup, suspension, emulsion, etc.) have the problem of accurate dosing and parenterals are painful drug delivery systems, so they result in patient incompliance. The most popular oral dosage forms are tablets and capsules; one major drawback of these dosage forms is the difficulty to swallow [2]. Drinking water plays an important role in the swallowing of oral dosage forms. People experience inconvenience in swallowing tablet dosage forms when water is not available particularly in the case of traveling (motion sickness) and sudden episodes of coughing during the common cold, allergic condition, and bronchitis. Under such circumstances, tablets that can rapidly dissolve or disintegrate in the oral cavity known as fast dissolving tablets have attracted a great deal of attention. Fast dissolving tablets are also known as mouth-dissolving tablets, orodispersible tablets, rapidmelts, and porous tablets. Fast dissolving tablets dissolve or disintegrate within 60 seconds when placed in the mouth without drinking
%U http://www.hindawi.com/journals/jdd/2014/392783/