Development and evaluation of extended release dosage forms of Anti-diabetic Drugs

Abstract

In the present research work extended release formulation technologies was investigated. Based on different drug release mechanisms, to formulate extended release tablets different technologies such as matrix , hot melt granulation and pellet technology have been used, where gliclazide was investigated. Gliclazide belongs to sulphonylurea class of anti-diabetic drugs. Gliclazide (oral hypoglycemic drug) is widely used in the treatment of non insulin dependent diabetes mellitus. However, usage can be limited as in certain patients an immediate release form can result in higher short term concentration in blood. An extended release dosage form makes it possible for such peaks in blood to be avoided and enables consistent concentration in blood to be obtained. This makes it possible to reduce undesirable effects that may occur as a result of the peak effect which are accompanied by hydro electrolytic and metabolic type disorders associated with variations in the plasma levels of the active ingredients. For developing gliclazide extended release tablets by non infringing route indepth patent search was done. The main body of project deals with complete experimental work. It starts with analytical validation followed by preformulation studies, formulation development and evaluation of formulations made by three different technologies, scale up and stability studies and bioequivalence studies in human subjects in fasting condition.