Publication

Abstract : The aim of present work deals with formulation of Propranolol hydrochloride oral thin films for migraine prophylaxis. Propranololhydrochloride is a non-selective beta-adrenergic antagonist and completely absorbed from the gastrointestinal tract. On the otherhand, nearly 75% of drug undergoes pre-systemic metabolism by the liver, thus bioavailability is reduced to 25%. The purpose ofdeveloping this dosage form is to reduce the dose by bypassing its first pass metabolism. Films were prepared from F1-F6 by solventcasting technique. Pullulan was selected as polymer because of its good water solubility and propylene glycol as plasticizer.Polyvinyl pyrollidone was selected as disintegrate, citric acid as saliva stimulating agent, mannitol as sweetening agent and mentholwas used as flavoring agent. The compatibility of the drug in the formulation was confirmed by FT-IR and DSC. Formulated filmswere subjected to various evaluation parameters. Based on the evaluation parameters, F4 has disintegration time of 47 sec andshowed promising drug release of 93% after 20 min. Scanning Electron Microscopy (SEM) of F4 showed smooth surface and littlepores. The stability study proved that the formulation F4 was found to be stable in both refrigerator and room temperature. Ex vivopermeation study of F4 showed 91% of drug permeation through goat oral mucosa: hence formulation F4 was selected as bestformulation.