DESIGN AND DEVELOPMENT OF ORAL CONTROLLED RELEASE FORMULATIONS OF GLICLAZIDE USING NATURAL POLYMERS

Abstract

Gliclazide is an oral hypoglycemic agent used in the treatment of non-insulin dependent diabetes mellitus (NIDDM). Among the people who are suffering from long term disorders, the major had been categorized under the people who are suffering from diabetes and a dosage form is needed for them that should provide continuous therapy and should have a high margin of safety. Microencapsulation plays a great role in providing such a kind of dosage form. Gliclazide microspheres with a coat consisting of alginate and gum konda gogu were prepared by orifice-ionic gelation method and emulsification gelation technique. The prepared gliclazide microspheres were evaluated for surface morphology and particle shape, Carr’s index, microencapsulation efficiency, drug release characteristics, compatibility studies rheological studies. The microspheres were found discrete, more spherical and free flowing with emulsion ionic gelation technique. The microsphere size was found in the range 420-585µm. Sharp endothermic peaks were found from the microspheres formulated with polymers indicating the compatibility between the drug and the polymer gum konda gogu. The encapsulation efficiency was found around 86.23%±0.56 to 94.46% ±0.86 and percentage drug content is in the range of 55±0.65% - 68±0.86%. Drug release from the microspheres was found slow, followed zero order release kinetics with non-fickian release mechanism stating release depended on the coat: core ratio and the method employed in the preparation of microspheres. Among two techniques emulsification gelation technique was found to be more suitable for slow and complete release over a long period. These microspheres showed good mucoadhesive property in the in vitro wash of test.