Journal of Pharmacovigilance

Abstract

Design and Evaluation of Floating Multi Unit Mini Tablets (MUMTS) Muco Adhesive Drug Delivery System of Famotidine to Treat Upper Gastro Intestinal Ulcers

Nagaraju Banala, Mahipal Reddy Donthi, Narendhar Reddy Dudipala, Devendhar Reddy Komalla, Dinesh Suram and Vinay Thallapally

Ulcer is one of the most common evaluated diseases caused by many reasons like, H. pylori bacteria infection, over secretion of acid levels in the stomach, irregular formation of mucosa and some of the NSAIDs treatment. Famotidine is a H2 receptor antagonist, used to reduce the gastric acid secretion in the stomach. The aim of the present investigation was the development and evaluation of famotidine multi-unit tablet encapsulated system to treat upper gastro intestinal ulcers.

The drug release was controlled with matrix polymers like POLYOXWSR 1105 and HPMC K4M. The tablets were prepared by direct compression technique. The prepared tablets were evaluated for physico chemical parameters like weight variation, hardness, friability, buoyancy studies, drug content, in vitro dissolution and mucoadhesive property in porcine gastric mucosa. Further, the intra gastric behaviour of optimized formulation was evaluated in human volunteers under fasting conditions. All the parameters of prepared tablets were within the acceptable limits as per USP. The optimized formulation exhibited floating lag time of 10 ± 2 sec with total floating time of 12 h and in vitro release profile of 99.14 ± 3.21% in 12 h. The mucoadhesion time was found to be visually >12 h in ph 6.8 phosphate buffer. In vivo radiographic imaging studies revealed that the mean residence time of single mini tablet in stomach was found to be 8h in healthy human volunteers.