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Development and in Vitro Evaluation of Gastroretentive High Density Tablet of Propafenone HCL
A novel Propafenone HCl gastric-resident tablet was developed. A controlled release matrix tablet was prepared by using various controlled release polymers i.e. HPMC E5 and HPMC K100M. Pharmaceutical zinc oxide powder was used as a density-increasing agent. The formulations were evaluated for pharmacopoeial quality control tests and all the physical parameters evaluated were within the acceptable limits. Prepared high density tablet showed density up to 1.63 gm/cm3 which is higher than the gastric fluid. Also it shows good dimensional stability till the 12 h. In vitro release study shows the good drug release up to the 12 h. Stability studies were carried out on the optimized formulation for period of 3 months at 40°c / 75%RH. Finally it was observed that there was no change in physiochemical and physical properties as well as in drug release profile even after storage at 45°C and 75 % for three months. Zinc oxide increases the system density, making the system resident in stomach to prolong the drug delivery time in absorption zone.
Keywords
Propafenone HCl, High Density Tablet, Dimensional Stability, Zinc Oxide.
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