DRUG DEVELOPMENT AND OPTIMIZATION FORMULA OF RANITDIN HCl GASTRORETENTIVE MUCCOADHESIVE FLOATING SYSTEM TABLETAbstract
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.
A. N. Putri * and D. Forestryana
Department of Pharmacy, Sekolah Tinggi IlmuKesehatan Borneo Lestari, Banjarbaru, South Kalimantan, Indonesia.
29 March 2019
09 August 2019
12 August 2019
01 January 2020