FORMULATION, EVALUATION AND VALIDATION OF SWELLABLE CONTROLLED RELEASE SYSTEMS OF METFORMIN HYDROCHLORIDE USING NATURAL POLYMERS

Abstract

Natural polymers such as Chitosan, Acacia, and Pectin were used as matrix forming materials for sustained
release formulat ions. Var ious formulat ions of Met formin hydrochlor ide, as a model drug, were
prepared by wet granulation technique with different concentrations of above polymers and complexes
of Chitosan-Acacia, Chitosan-Pectin. The granules and tablets were studied for physical properties. Invitro
drug release studies revealed that with the increase in concentrations of polymers, complexes and
physical mixtures in the tablets retardation of the drug release also increases. The release of drug from
the tablets containing dr ied complexes was near ly same as those containing physical mixtures. To
study the drug release kinetics of examined tablets, the dissolution profiles were analyzed according to
zero- order , first -order , higuchi s square root , and peppas korsmeyer s equat ions. Co-efficient of correlation
(r) value was used for the selection of most appropriate model. Formulation F 18 showed 92.34 %
of drug release within 12 h and was used for validation studies. Five different batches were prepared and
to the result s of character izat ion of granules and tablets one-way ANOVA was applied. All the results
show no significant difference and thus the process was validated. Chitosan Acacia and Chitosan-Pect in
polymer complexes can be used as mat r ix forming mater ials for the formulat ion of sustained release
Metformin hydrochloride tablets.