Formulation and in vitro evaluation of orally disintegrating film of alprazolam

Background: Over the past years, orally disintegrating films (ODFs) have been a suitable alternative to conventional oral dosage forms such as tablets and capsules, especially for patients with dysphagia. ODF is relatively a new dosage form which is prepared using hydrophilic polymers, which rapidly dissolve on tongue or buccal cavity and has other advantages of rapid onset of action and improved bioavailability. The aim of this study was formulation of ODF dosage forms containing alprazolam, which is a short-acting anxiolytic of the benzodiazepines class of psychoactive drugs. Materials and methods: Various polymers like hydroxy propyl methyl cellulose (HPMC6cps), sodium carboxy methyl cellulose (Na CMC), polyvinyl alcohol (PVA72000), and different plasticizers like propylene glycol (PG), polyethylene glycol (PEG400) with different percentage using solvent casting technique were used to prepare ODF formulations. Physicochemical tests including weight and thickness determination, disintegration time, assay and dissolution time were performed to find the optimum formulation. Results: The optimized formulation contained PVA72000 and PEG400 with disintegration time less than 60 seconds and acceptable dissolution rate. Conclusion: ODT dosage form of alprazolam with acceptable dissolution behavior and proper disintegration time was successfully formulated in this study. Keywords: Alprazolam, Orally disintegrating films, Formulation, In vitro evaluation