Formulation and evaluation of polymer based, rapid onset, patient friendly, oral film of domperidone maleate

Abstract

Mouth dissolving films have emerged as an advanced alternative to the traditional oral solid drug delivery systems.  Generally the films are prepared using hydrophilic polymers that dissolves or hydrate on the tongue or buccal cavity, releasing the drug for enhanced absorption. The present study was undertaken with the objective of formulating mouth dissolving film(s) of anti-emetic drug Domperidone maleate to impart immediate action and enhance the convenience and compliance by the patients specifically elderly and paediatric. The films were formulated by solvent casting method with different concentrations of HPMC 15cps, Methyl Cellulose and Hydroxy Ethyl Cellulose as film forming polymers and glycerin as plasticizer. Prepared films were evaluated for their dissolution, disintegration, and physico-mechanical properties and short-term stability study. The formulations having polymers at low concentrations showed better results. Among these, formulation containing HPMC 15cps was found to show much superior film properties compared to Methyl Cellulose and Hydroxy Ethyl Cellulose. HPMC based film showed the high drug dissolution (99.54% or more within 5 min), satisfactory in vitro disintegration time (85 sec) and physico-mechanical properties that are indicative of good mouth dissolving films.