Design and in Vitro Evalution of Sustained Release Film Coated Tablets of Verapamil Hydrochloride

An attempt was made to formulate the sustained release tablet of verapamil hydrochloride by using the wet granulation method for the treatment of hypertension. In the present formulation the tablets releases the loading dose by immediate drug release and maintenance dose up to 15 hours by extended release. The drug excipient compatability study was carried out with HPLC method and there was no interaction found. Immediate release fraction was formulated by using croscarmellose sodium as a disintegrating agent and extended release fraction was formulated by using Hypromellose E4 as a rate controlling polymer. The granules were evaluated for pre and post compressional character which showed satisfactory results. In vitro dissolution study was carried out for 15 hrs using USP dissolution apparatus type II with 0.1 N HCl and 7.4 pH phosphate buffer as dissolution medium. From the dissolution profile, F2 & F3 values were calculated which were within the specification. Stability study was carried out for the optimized formulation at 40°C/75% RH for 1 month, the result showed that there was no significant change in physical and chemical parameter of the tablet. 1. INTRDUCTION Verapamil Hydrochloride is a calcium channel blocker and class IV antiarrhythmic agent used in the supraventricular arrhythmias, and in the management of angina pectoris, hypertension and myocardial infarction. Hypertension, commonly referred to as " high blood pressure " , is a medical condition where the pressure is chronically elevated is one of the commonly found diseases, affecting most of the populations in the world. So, for treating hypertension effectively is main criterion of study. For treating hypertension, commonly used drugs include ACE inhibitors, alpha blockers, beta blockers, calcium channel blockers, diuretics and combination of any of these categories in immediate action required. The objective of this study is to develop immediate and sustained release formulation of Verapamil hydrochloride coated Tablets. a) Co mixed ingredients verapamil hyochloride and mannitol SD 200 geometrically and sifted through 40 mesh b) Co mixed other granulation ingredients in a polybag c) Mixed steps a and b in RMG (Rapid Mixer and Granulator) for dry mixing for 10 minutes. d) Binder was dissolved in water to get clear binder solution. e) Binder solution was added to the dry mixed ingredients in RMG with both mixing and chopper blades on initially at high speeds and finally at low speed for 5 minutes. f) Dried the granules in FBD (fluidized bed drier) at 60 …