The ORMULATION OF GLIMEPIRIDE AND ATORVASTATIN CALCIUM NANOPARTICLES BY 1 LIQUID ANTISOLVENT PRECIPITATION METHOD THROUGH DOUBLE STEP COMMINUTION 2 TECHNIQUE AND ITS EVALUATION

Objective: The present research is to formulate Glimepiride and Atorvastatin Calcium Nanoparticles for the type-2 diabetes mellitus for improvement of glucose tolerance associated with dyslipidemia formulated by liquid antisolvent precipitation technique. Method: Glimepiride nanoparticles and atorvastatin calcium nanoparticles were prepared by using a liquid antisolvent precipitation technique. Solvent to antisolvent ratio used was 3.5:6.5 and 2.5:7.5 and the drug concentration used was 40 mg/ml and 60mg/ml respectively. Result: The XRD was determined, the data of the optimized Glimepiride formulation revealed that the prepared nanosized Glimepiride powder was existed in crystalline form. The percent yield for the formulations of Glimepiride and atorvastatin calcium nanoparticles was found to be 72.8±1.8%, 75.3±2.2% respectively. In-vivo studies in albino wistar rats demonstrated that the Cmax and AUC0−24h of optimized Glimepiride and atorvastatin calcium  nanosized formulation was found to be 24451.14±2170.5 ng/ml, 162945.12±241.5 ng/ml and 1385.43±153.3 ng/ml,3636.57±65.2 ng/ml respectively. Dissolution study of optimized formulations shows that marked enhancement of dissolution rate. The stability studies of mixture of Glimepiride and atorvastatin calcium powder when stored at 4±3oC refrigerated temperature has shown no significant changes in physical appearance, drug content, particle size and PDI. Conversely the sample stored at room temperature has shown significant increase in particle size and PDI, with no significant changes in drug content and physical appearance. Conclusion: The Formulation of glimepiride and atorvastatin calcium drug nanoparticles shows increase in the surface-to-volume ratio of API, resulting in better drug solubility and hence increasing the bio-availability when compared to its pure form.