| Oral disintegrating film (ODFs) is a dosage form that rapidly disintegrates or dissolves in oral cavity without chewing or water intake. Objectives:To investigate the effect of sweetening agents and disintegrating agents on the ODFs properties of verapamil HCl. Methods:ODFs composed of verapamil HCl3.34%, film former 5%, plasticizer0.75%,disintegrating agents(Explotab™) 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 dishand drying at 60 °C in hot air oven for 60 minutes. The viscosity and pH of the film dispersions, thickness, disintegration time,content uniformity and in vitro dissolution were carried out.Results:pH value of film dispersions were 6.0-6.3. The higher concentration ofmaltodextrin addition, the increasing in viscosity, thickness and disintegration time were observed. The content uniformitywas within the acceptable range of 90.0-110.0%, excepted those of ODFs containing Explotab™. ODF with 2% mannitol and Explotab™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, mannitoland Explotab™ should be used less than 1%, regarding its poor aqueous solubility and increasing of disintegration time. |