Abstract

FORMULATION AND IN VITRO EVAULATION OF FAST DISSOLVING ORAL FILMS CONTAINING SUMATRIPTAN SUCCINATE

*P.Satish Kumar Reddy, Venkatesh D P., Anudeep Balla, Satya Sivaram M.

ABSTRACT

Sumatriptan Succinate is a potent anti-migraine agent with shorter half-life. It shows low oral bioavailability due to high first pass metabolism. Therefore, the current study wasfocussedto bypass first pass effect by formulating Sumatriptan succinate into oral films using solvent casting method. The fast dissolving oral films reduces the lag time, which in turn produces quicker onset of action. A natural polymer Pullulan along with synthetic polymers like HPMC E15, HPMC E10, PVA, is used in different proportions to formulate oral films. The physicochemical compatibility of the drug with different polymers was studied by FTIR spectroscopy. The results suggested no physicochemical incompatibility between the drug and polymers. The prepared films were evaluated for uniformity of weight, thickness, folding endurance, surface pH, drug content, tensile strength, % moisture content, % moisture uptake and in vitro dissolution studies.Formulation (F6) that contains Pullulan alone found to be releasing drug in a rapid manner, 96.5±1.02% for 30min with good releasing property. From the results F6 was taken as most satisfactory formulation and is subjected to stability studies for 60 days at 30±2 ºC 65±5 % RH. The results of stability studies showed no significant change in physicochemical properties, in vitro drug release. The drug release from films varied with the type of polymer used. Fast dissolving oral films of Sumatriptan succinate were made by solvent casting technique to bypass first pass effect with better compliance and effective therapy.

Keywords: Sumatriptan succinate, Oral Films, Pullulan, HPMC E15, HPMC E10, PVA.