Abstract

PREPARATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS CONTAINING METOCLOPRAMIDE HYDROCHLORIDE

Amal S. M. Abu El-Enin* and Dina Ali Osman

ABSTRACT

Objective: The aim of this study is to formulate and evaluate fast dissolving oral films of an antiemetic drug (Metoclopramide HCl) to deliver maximum amount of the drug in shortest duration of time to enhance bioavailability and avoid pre systemic metabolism as compared to conventional oral dosage forms. Methods: Ten Metoclopramide HCl film formulations were prepared by solvent casting technique using Hydroxy Propyl Methyl Cellulose and Carboxy Methyl Cellulose Sodium as film forming polymers with two different concentrations of superdisintegrants [Croscarmellose sodium and Crospovidone (5&10%)], using propylene glycol as plasticizer. The prepared films were evaluated for their thickness, folding endurance, weight uniformity, % drug content, surface pH, disintegration time, in-vitro dissolution studies and finally, ex vivo buccal permeation study to evaluate the amount of drug permeation. Results and Discussion: All films prepared were smooth and elegant in appearance; were uniform in thickness, weight and drug content; showed good folding endurance. The surface pH of all the films was found to be neutral. Formulation (Fc2) which contains Carboxy Methyl Cellulose Sodium and 10% Crospovidone is considered to be the best formula as it showed faster disintegration rate (13 sec.), highest dissolution rate of 101.41% within 100 sec., and showed satisfactory permeation through the sheep oral mucosa (101.95% of drug permeated at the end of 15 minutes). Conclusion: It was concluded that Metoclopramide HCl fast dissolving oral films can be made by solvent casting technique for the treatment of nausea and vomiting with enhanced dissolution rate, better patient compliance and effective therapy.

Keywords: Metoclopramide HCl; Fast dissolving oral films; Solvent casting method; In vitro dissolution; Ex vivo buccal permeation.