DRUG DEVELOPMENT AND OPTIMIZATION FORMULA OF RANITDIN HCl GASTRORETENTIVE MUCCOADHESIVE FLOATING SYSTEM TABLET

Ranitidine hydrochloride (RHCl) is a histamine H2 receptor antagonist, it’s widely in active duodenum ulcers, gastric ulcers, Zollinger-Ellison syndrome, gastroesophageal reflux disease, and erosive esophagitis. Ranitidine HCl has a short biological half-life of drug 2 – 3 h, has 50% absolute bioavailability, colonic metabolism of ranitidine HCl was partly responsible for the poor bioavailability. Based on these, gastroretentive drug delivery system (GRDDS) using floating-mucoadhesive system dosage form of Ranitidine HCl has been developed that makes less frequent administering of the drug also improve bioavailability. Factorial design 2³ was applied to optimize the formula of ranitidine HCl floating-mucoadhesive tablet by the varying level of polymer, it was chitosan 50 – 100 mg as a mucoadhesive agent, HPMC K4M 20 – 50 mg as a swelling agent, and drug release controlled, and sodium bicarbonate 20 – 40 mg as gas generating agent. The optimum formula determined by superimposed contour plot from various parameters: physical properties of granule, tablet, and drug release 6 h using a design expert ® program. Based on superimposed contour plot design expert ® obtained an optimum formula for the area in the range of chitosan 100 mg; HPMC K4M 50 mg; and Sodium bicarbonate 26, 25 mg.