A Design Research on Formulation and Characterization of Gastro-retentive Tablet to Target Ulcer and Control Emesis

Abstract

Targeted release of bilayer tablet for combination therapy of pantoprazole sodium and ondansetron hydrochloride for the treatment of gastric and duodenum ulcers associated with vomiting. In bilayer tablet release profiles may be modified by combining layers with various release patterns. Both Ondansetron hydrochloride and Pantoprazole sodium have short biological half-life and frequent administration may lead to patient incompliance. Thus, bilayer tablet is to be prepared imparting delayed release for pantoprazole sodium and sustained release for ondansetron hydrochloride.

Pantoprazole Na, an anti-ulcer drug, has several advantages compared to its analogues (e.g., omeprazole and lansoprazole) such as specific site of binding, greater stability in neutral pH environ-ment, and longer duration of action. Besides, it presents no potential to induce or inhibit the CYP 450. It is a more selective inhibitor of acid secretion than other proton pump inhibitors. Pantoprazole Na is absorbed in the intestine. It possesses an irritant effect on the stomach and is unstable under acidic conditions. Hence enteric delivery system is required. Such formulation would avoid the stomach's acidic exposure, delivering them to a basic pH environment (intestines pH 5.5 and above) and  give their desired action.

Ondansetron HCl is a potent, highly selective 5-HT3 receptor-antagonist. It is widely prescribed to control or prevents nausea and vomiting. It has narrow absorption window in stomach.  Once a day ondansetron HCl  gastroretentive  tablets  offer  better  patient compliance  through  less  frequent administration and thus would lower the cost of total  therapy. Hence, the focus of present work is to prepare and evaluate gastro retentive floating tablet of the ondansetron HCl to increase its residence time in to achieve prolonged therapeutic action.