Effect of sweetening agents and disintegrating agenton the properties of oral disintegrating film of verapamil hydrochloride

Abstract

Introduction: Oral disintegrating film (ODFs) is a dosage form that rapidly disintegrates or dissolves in oral cavity without chewing or water intake. ODFs have many advantages as compared to the conventional tablets including the improvement of patientQs compliance. These are beneficial for patients who have difficulty in swallowing tablets, such as pediatric andelderly patients. Methods: ODFs composed of verapamil HCl 3.34%, film former 5%, plasticizer 0.75%, disintegrating agent (Sodium starch glycolate; SSG)1%, and sweetening agents(maltodextrin, mannitol and xylitol)0.2, 1 and 2% and purified water. ODFs were prepared by casting 5.6 and 10 g/petri dish and drying at 60°C in hot air oven for 60 minutes. The viscosity and pH of the film dispersions, thickness, disintegration time, content uniformity, in vitro dissolution and identification of the functional group of verapamil hydrochloride within ODFs by Fourier transform infrared spectroscopy were carried out. Results: pH values of film dispersions were 6.0-6.3.The higher concentration of maltodextrin addition, the increasing in viscosity, thickness and disintegration time was observed. The content uniformity was within the acceptable range of 90.0-110.0, excluding those of ODFs containing SSG.ODF with 0.2%mannitol and SSG showed the significantly rapid disintegration (P<0.05).ODF with mannitol showed the higher the dissolution rate. Moreover, mannitol and maltodextrin were compatible with active drug and excipients. Conclusion: Type and concentration of sweetening agents and disintegrating agent influenced on the properties of ODFs of verapamil HCl. Maltodextrin and mannitol should not be used more than 1%, regarding it affected a peeling ability and disintegration time. Moreover, SSG affected the content of active pharmaceutical ingredient.