Vaishali Thakkar
Gujarat Technological University, India
Title: Examination of intricacies involved in designing of once a day tablet containing newer combination of anti diabetic drugs for type ii diabetes
Biography
Biography: Vaishali Thakkar
Abstract
Type II diabetes is a lifelong (chronic) disease in which there are high levels of sugar (glucose) in the blood. Currently, India leads the world with the largest number of diabetic patients and this is expected to further rise in the coming years. The combination therapy is used to provide an optimal level of glycerin control over non-insulin dependent diabetes mellitus (NIDDM) patient. One of the extended released formulation available in market, TRIEXER contains three oral anti-hyperglycaemic drugs namely glimepiride, pioglitazone hydrochloride and metformin hydrochloride in the management of type II diabetes (NIDDM). The disadvantages of Pioglitazone hydrochloride are weight gain, slow onset of action, liver toxicity etc. Clinical trial data shows that Sitagliptin 100 mg once daily significantly improved glycaemic control and beta-cell function in patients with type II diabetes who had inadequate glycaemic control with glimepiride or glimepiride plus metformin therapy In the light of above reserch, the objective of the present project work is to develop fixed dose triple combination of antidiabetic drugs wherein Sitagliptine and Glimepride are as immediate release form and Metformin is as extended release (ER) form. Primarily, formulation optimization of metformin was done for extended release by factorial design. In the second set of experiments, design space for process parameters ( inlet, outlet temp, atomizing pressure and flow rate) and its influence on coated tablet characteristics was developed. Result of above study was revealed that clinically relevant newer fix dose combination formulation successfully design by implementing principal of Quality By design.