Formulation and Evaluation of Sustained Release Mucoadhessive Bilayer Tablets Saxagliptin, Dapagliflozin of the Active Medicament using statistical optimization Technique

Abstract

This study aimed to formulate & Investigate sustained-release mucoadhesive bilayer tablets containing Saxagliptin and Dapagliflozin for the treatment of diabetes mellitus (type 2) using statistical optimization techniques. Saxagliptin, a DPP-4 inhibitor, was incorporated into the immediate-release (IR) layer for rapid action, while Dapagliflozin, an SGLT2 inhibitor, was included in the sustained-release (SR) layer for prolonged therapeutic effect. A design of experiments (DoE) approach was applied to optimize key parameters of formulation, along drug release rates, mucoadhesive strength, and tablet stability. The optimized bilayer tablet demonstrated immediate release of Saxagliptin, followed by a controlled release of Dapagliflozin over an extended period. Mucoadhesive properties increased gastrointestinal residence time, enhancing drug absorption and bioavailability. The formulation offers the potential to improve compliance of patient by decreasing dosing intensity& maintaining effective plasma drug concentrations, making it a promising therapeutic option for type 2 diabetes management.