Formulation and Evaluation of Orally Disintegrating Films of Levocetirizine Dihydrochloride

Abstract

The present investigation was undertaken with the objective of formulating taste-masked orally-disintegrating films of the bitter levocetirizine dihydrochloride to enhance the convenience and compliance by the elderly or paediatric or bedridden and non-cooperative patients due to its ease of administration. Scope of this study was to explore the film forming properties of various film formers like modified starch, pullulan, hydroxypropyl methylcellulose and polyvinyl alcohol-polyethylene glycol based polymers. Plasticizers like glycerin, propylene glycol, sorbitol and polyethylene glycol 400 were evaluated by studying their effect on folding endurance, peelablity and in vitro disintegration time. Films were prepared by solvent casting method. Drug loaded films, which composed of the selected polymers with the suitable plasticizer showed excellent film forming capacity along with good folding endurance, in vitro disintegration time within 22 s and >95% drug release in 10 min as compared to marketed immediate release tablets, which showed on 30.4% at the end of 10 min The films prepared were 30-40 mg in weight with pleasant taste with bitter active being successfully taste masked by a mixture of sucralose and monoammonium glycerrhizinate producing an extended sweetness profile. Furthermore, the orally disintegrating films were stable for at least 3 mon when stored at 40° and 75% relative humidity. The formulation developed is simple, easy to prepare and economical with great applicability during the emergency cases such as allergic reactions, whenever immediate onset of action is desired.