Abstract

DEVELOPMENT AND EVALUATION OF ORAL GASTRORETENTIVE FLOATING MATRIX TABLET OF RANITIDINE HYDROCHLORIDE

Swati S. Rawat*

Abstract

In the present study an attempt was made to formulate and evaluate the 650 mg of floating drug delivery system containing Ranitidine Hydrochloride, prepared by direct compression method. Floating tablet of Ranitidine Hydrochloride, increases the gastric residence time as well as bioavailability and there by showed increased therapeutic efficacy. The addition of gel forming polymers (HPMCK4M, HPMCK15M and Carbopol 940P) and gas generating agent sodium bicarbonate and citric acid was essential to achieve in vitro buoyancy. Pre formulation studies were conducted to select suitable excipient. Combination of different excipient were used to formulate Ranitidine Hydrochloride floating tablets. In pre compressible powder blend the Angle of repose was found to be 25.37-31.15. hence indicating good flow properties. Bulk density found to be 0.458-0.516. Tapped density was found to be 0.589-0.643. Carr’s index was found to be 17.01-26.63 and Hausner’s Ratio was found to be 1.21-1.36. In FTIR studies Ranitidine Hydrochloride, also present in the physical mixture, which indicates that there is no interaction between drug and the polymers, which confirms the stability of the drug. The evaluation parameter such as weight variation (641.3-652.1), thickness (4.09-4.16), Hardness (5.1-5.6 kg/cm3), Friability (0.46-0.61), Drug content (96.56-99.70) In vitro drug release (86-95%), and lag time (1-2 min) studies was conducted. The results were within the limit. From the results obtained Formulation A7, Optimized batch, showed that the drug release at floating sustained manner for 12 hrs. However, the lag time of A7 was 90 sec. Thus, the Ranitidine hydrochloride floating drug delivery system can be developed, so that it can retained in stomach for longer period of time, reducing dosing frequency and also increases patient compliance.

Keywords: Ranitidine Hydrochloride, HPMCK4M, HPMCK15M, Carbopol 940P, Floating Tablets.