Abstract

DESIGN OF FLOATING IN SITU GEL OF MUCOLYTIC AGENT BY CATION INDUCED GELATION OF NATURAL POLYSACCHARIDES

K. S. Srilatha*, M. Gnana Ruba Priya, G. Sangeetha and Niraj Pathak

ABSTRACT

The aim of this study is to formulate and evaluate of oral floating in situ gel of Ambroxol hydrochloride by using natural polymer i.e. gelrite and sodium alginate. Ambroxol hydrochloride is an oral systemically active mucolytic agent Materials and Methods: This study involved formulation of Ambroxol hydrochloride oral solution which become gel upon direct contact with acidic environment pH 1.2 and then floated. The floating oral in situ gel under goes gelation by ion sensitive mechanism. These floating in situ gel formulations were prepared by using different concentration of gelrite (F1 to F3), sodium alginate (F4 to F6) and in combination of gelrite and sodium alginate (F7 to F8). The prepared formulations were evaluated for physicochemical parameters like pH, in vitro gelling capacity, gelling time, viscosity, floating lag time, floating duration, drug content uniformity, in vitro drug release study. The best formulation was selected and stability studies were performed as per ICH guidelines. Results And Discussion: Formulation F3 (1% w/v gelrite) and F9 (0.75% w/v gelrite and 0.25% w/v sodium alginate) were selected as best formulation regarding %CDR, in vitro gelling capacity, viscosity and other factors. During stability study, no any evidence of significant changes was observed in terms of physicochemical properties which confirm stability. Physicochemical parameters and in vitro drug release of the formulation found proportional to the concentration of polymer used in the formulation. The best formulations were found to have viscosity which favors oral administration, acceptable drug content and %CDR and acceptable stability. Conclusion: Study indicates that floating in situ gel of Ambroxol hydrochloride can be formulated as F3 follows Korsmeyer- Peppas used for stomach specific controlled drug delivery system through 24h.

Keywords: Ambroxol hydrochloride, mucolytic agent, In situ gel, Gelrite and sodium alginate.