Abstract

DESIGN AND EVALUATION OF FAST DISSOLVING FILMS CONTAINING ITOPRIDE HYDROCHLORIDE USING DIFFERENT POLYMERS

Muthukumar S.*, Hemalatha K.K., Kanniyammal M., Praveena S., Vaishnavi D., Gayathri S. and Kamalakkannan Mani

ABSTRACT

Itopride hydrochloride is a gastroprokinetic agent, that acts both as a dopamine D2 receptor antagonist and as an acetylcholinesterase inhibitor which is preferable in the treatment of gastrointestinal disorders. Itopride hydrochloride is a BCS class I drug. Oral thin films are the most advanced form of oral solid dosage form due to more flexibility and comfort. The oral thin film serves as a major benefit over the conventional dosage form which when placed in the oral cavity and quickly gets dissolved in the saliva without the use of water. It sticks onto the site of application and then disintegrates to release the drug. The advantages of oral thin films are for pediatric and geriatric patients where there is difficulty in swallowing and chewing conventional dosage forms like tablets and capsules. Oral thin films provide an alternate platform for improving patient compliance. The aim of the study was to formulate and evaluate an oral thin film of Itopride hydrochloride using natural and synthetic polymers like HPMC and xanthan gum in different ratios by solvent casting method. Itopride hydrochloride oral thin films were prepared by using polymer, PEG 400 acts as a plasticizer, citric acid acts as the saliva stimulating agent, tween 80 acts as the surfactant, DMSO acts as the permeation enhancer and aspartame acts as the sweetening agents. The formulated films were categorized for weight variation, thickness, surface pH, folding endurance, drug content, percentage moisture loss, disintegration studies, and invitro dissolution studies. In the polymer formulations, F2 (1:5) showed 96.15% drug release from the films within 30 minutes. So, among the formulations from F1 to F4, F2(1:5) was chosen as the best formulation.

Keywords: Itopride hydrochloride, Oral thin film, HPMC, Xanthan gum, Solvent casting method.