DESIGN, DEVELOPMENT AND CHARACTERIZATION OF MUCOADHESIVE GASTRO SPHERES OF CARVEDILOL
Objective: The purpose of this study was to design mucoadhesive gastro spheres of carvedilol targeting to upper GIT, and optimize it in terms of its entrapment efficiency and drug release. A 3 2 full factorial design was employed to study the effect of independent variables like sodium alginate and sodium carboxyl methyl cellulose on entrapment efficiency and in vitro drug release. Methods: Mucoadhesive gastro spheres were prepared by Orifice Ionic gelation method, in which drug is uniformly distributed in the polymer solution so drug can be loaded easily in the polymer.3 2 full factorial designs were used to study the effect of process variables on formulation characteristics by applying statistical analysis. Results: FTIR, XRD and DSC analyses apparently did not indicate any interaction of the drug with the polymers. However, the drug content, drug entrapment efficiency and morphology of the gastro spheres were found to be influenced by the method of preparation, composition of gastro spheres as well as exposure to the cross linking agent. In vitro drug release study showed that drug release can be modified by varying drug to polymer ratio. The release rate was found to be decreased in accordance with the increase in the ratio of polymer used. Conclusion: From the study, we successfully developed carvedilol gastro spheres by using mucoadhesive polymer like SCMC and rate retardant sodium alginate polymer.