Abstract

DEVELOPMENT AND IN VITRO EVALUATION OF AN IN SITU GELLING ORAL LIQUID SUSTAINED RELEASE FORMULATION OF NIZATIDINE

Namrata Hallur, Rajashekhar, Swamy NGN*, Abbas Z

ABSTRACT

The objective of this study was to develop a novel, floating in situ gelling liquid dosage system for sustained delivery of Nizatidine for the ulcer therapy. The study evaluates gellan gum and sodium alginate as gelling agents, calcium chloride as source of cations and sodium bicarbonate as the gas forming agent. Different Solutions (sols) coded FSA1 to FSA6 were prepared with varying amounts of sodium alginate ranging from 0.5 % w/v to 1.75 % w/v and formulations FGG1 to FGG6 with 0.25% w/v to 1.25 % w/v of gellan gum. The sols were evaluated for pH, surface morphology, rheological properties, in vitro gelation, in vitro floating ability and in vitro drug release. The pH of the prepared in situ gels was found to be in the range of 7.1 to 7.3, suitable for oral delivery. The formulations exhibited thixotropic flow behaviour. With the increase in the polymer concentration, immediate gelation was observed which led to increase in the duration of floating. The in situ gels exhibited drug content uniformity ranging from 97.72 0.6 to 99.25 0.3%. A significant decrease in the rate and extent of drug release was observed with the increase in polymer concentration. Stability studies were carried out on select formulations at 250C 20C / 60% RH 5% RH and 400C 20C / 75% RH 5% RH for 6 months. The drug content was observed to be within permissible limits and there were no significant deviations in the in vitro gelation, floating ability and in vitro drug release characteristics.

Keywords: Nizatidine, Floating in situ gels, Gastroretentive in situ gels, Gellan gum, Sodium Alginate.