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THE PHARMA REVIEW (NOVEMBER 2009)

Formulation and In Vitro Evaluation of Floating Tablets of Ranitidine Hydrochloride

A.C.Rana, Amul N. Mishra

Abstract: Recently many drugs are formulated as floating drug delivery systems with an objective to sustain release and restrict the region of drug release to stomach. Present investigation highlights the formulation and evaluation of floating tablets of Ranitidine Hydrochloride. Two different grades of hydroxy propyl methylcellulose namely Methocel K 100 M and Methocel K 15 M were used. It was observed that viscosity had a major influence on drug release from hydrophilic matrices as well as on floating properties. Dissolution profiles were subjected various kinetic drug release equations and found that drug release from hydrophilic matrices occurred via different mechanism following square root of time profile (Higuchi equation). Prepared tablets were evaluated for Hardness (Kg/cm2), Thickness (MM), Average weight (mg), Weight variation, Hardness (Kg/cm2), Friability (%), Drug content (mg/tab.), Floating Lag Time (Sec.), and total floating time (hr.). The granules were characterized for Angle of repose, Bulk Density (gm/cm3), Tapped density (gm/cm3), Carr’s index (%), and Hausners ratio, loss on drying and porosity. In vitro drug release study of these tablets indicated controlled sustained release for Ranitidine HCL and 70 to 93% at the end of 10m hrs. Hence, it is evident from this investigation that gas powered floating matrix tablets could be promising delivery system for RHCL with sustained release action and improved drug availability. The formulations were found to be stable at Rt/60o/75%+5%RH for the period of three weeks.

Introduction
Ranitidine hydrochloride (RHCL) is histamine H2 – receptor antagonist. It is widely prescribed in a active duodenal ulcers, gastric ulcers, Zollinger- Ellison syndrome, gastro esophageal reflux disease and erosive esophagitis. The recommended adult oral dosage of ranitidine is 150mg twice daily or 300mg once daily. The effective treatment of erosive esophagitis requires administration of 150mg of ranitidine 4 times a day. A conventional dose of 150mg can inhibit gastric acid secretion up to 5hrs. But not up to 10 hrs. An alternative dose of 300mg leads to plasma fluctuations; thus a sustained release dosage form of RHCL is desirable. The short biological half- life of drug (~ 2.5- 3hrs.) also favors development of a sustained release formulation.
 
Several approaches are currently used to prolong gastric retention time. These include floating drug delivery systems; also known as hydro dynamically balanced systems, swelling and expanding systems, polymeric bioadhesive systems, modified- shape systems, high-density systems, and other delayed gastric emptying devices. 

 

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