Development and Evaluation of Hydrodynamically Balanced System of Tramadol Hydrochloride by Using Chitosan and Locust Bean Gum

Abstract

The main purpose of the study was the development and evaluation of a hydrodynamically balanced capsule of Tramadol HCl by using chitosan and locust bean gum as a natural polymer that prolongs the gastric residence time. Chitosan with different grades (low molecular weight, medium and high molecular weight) and locust bean gum were used as drug release retarding agents. The hydrodynamically balanced capsule of tramadol HCl was prepared by ordered mixing technique. The concentration of both the polymers was optimized to achieve the sustained release of the drug (TH) for 10 hours. Then the prepared capsules were evaluated for buoyancy test and in vitro drug release was performed and another characterization analysis was also considered like FTIR study, DSC/DTG/TGA study and interaction study were also performed based on characterization analysis. From these studies, it was confirmed that there is no interaction observed between drug and excipient. The drug release studies show that the retarding drug release pattern is dependent on the concentration and molecular weight of the polymer as the concentration /molecular weight increases the retarding drug release pattern was also improved. And the synergistic action of retarding drug release was observed by the addition of another polymer i.e locust bean gum. Release pattern was fitted with the different kinetic models like Zero order, First order, Higuchi model and KorsmeyerPeppas and it was concluded from the models that the drug release pattern obeys zero-order model which signifies high therapeutic efficacy and minimum side effects.