DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL THIN FILM CONTAINING PROCHLORPERAZINE MALEATE

*Sujith S. Nair, Roopitha Padmanabhan and Sreena K.

ABSTRACT

The main aim of the work is to develop a novel, fast dissolving product on the technology platform of a small and thin drug loaded film called oral thin films or oral wafers for achieving faster disintegration and dissolution with improved bioavailability. Prochlorperazine maleate which is a phenothiazine antipsychotic is used as the model drug for the development of oral thin films. It is used in the prevention and treatment of nausea, vomiting associated with migraine (or severe head ache) or drug induced emesis. Fast dissolving oral thin films from Prochlorperazine maleate were formulated by solvent casting method by using HPMC E15 as film forming polymer, glycerol and propylene glycol as plasticizers, tween 80 as surfactant, mannitol as sweetening agent, citric acid as saliva stimulating agent and sodium starch glycolate as superdisintegrating agent. The prepared films were then evaluated for physical appearance test, surface pH, thickness, weight variation, tensile strength, content uniformity, in vitro disintegration test and in vitro dissolution test. From the evaluation studies, all the films were found to show satisfactory results. The film F7 containing 200 mg of HPMC E15, 0.5 ml of tween 80, 0.6 ml of glycerol and 0.8 ml of PEG 400 was found to show more release of drug i.e. 99.23 % at the end of 16 minutes was selected as the best formulation. To the best formulation F7 5% of sodium starch glycolate was added and evaluated. The film was found to disintegrate in 25.67±0.5774 seconds and released 94.59 % of drug at the end of 10 minutes. The kinetics studies indicated that the film showed zero order with Korsmeyer – Peppas plot indicating non- fickian diffusion.

Keywords: Oral thin films, Prochlorperazine maleate, Non-fickian diffusion, Fast dissolving.