Journal of Pharmacovigilance

Abstract

Formulation and Evaluation of Fast Dissolving Oral Films of Diazepam

Ali MS, Vijendar C, Sudheer Kumar D and Krishnaveni J

Oral films dissolve rapidly along with drug in mouth and majority of the drug is absorbed through buccal/oral mucosa in to systemic circulation avoiding first pass metabolism. The aim of present investigation was to formulate the Fast dissolving oral films (FDOF) of Diazepam an anti epileptic drug which is normally administered by intramuscular route or as rectal suppository in acute conditions of seizure emergencies. Oral films were prepared by solvent casting method using HPMC E3, E5, and E15 as a film formers and propylene glycol, PEG 400 as plasticizers and evaluated for mechanical properties, disintegration and in vitro dissolution. All formulations showed good mechanical properties and in vitro drug release. The optimized (F4A) Formulation (HPMC E5 and PEG 400) Exhibited drug release of 99.89% in 15 minutes which was significantly high when compared to marketed tablet valium (68.81%).