Formulation and optimization of oral polymeric Coated vildagliptin nanoformulations using quality By design concept

Abstract

ABSTRACT Background Diabetes mellitus is an alarming metabolic disorder, posing a global public health concern due to its association with high blood sugar levels. Vildagliptin, a DPP-4 inhibitor, is an antidiabetic agent used for the management of type 2 diabetes mellitus. The present research explores the formulation and optimization of two types of Vildagliptin-based nanoparticle systems—Vildagliptin-Eudragit RL 100 coated nanoparticles (VLD Eud NPs) and Chitosan- Vildagliptin nanoparticles (CS VLD NPs)—for sustained drug delivery using a QbD approach. Objectives In the present study, an attempt was made to formulate and optimize oral polymeric-coated Vildagliptin nanoformulations using the QbD approach and to evaluate their in vivo antidiabetic activity in Streptozotocin-induced diabetic Wistar rats.