FORMULATION, OPTIMIZATION AND EVALUATION OF SOLID LIPID NANOPARTICLES FOR CO-DELIVERY OF VILDAGLIPTIN AND DAPAGLIFLOZIN IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS

Abstract

Type 2 diabetes mellitus (T2DM) is a chronic progressive metabolic disorder characterized by insulin resistance, impaired insulin secretion, excessive hepatic glucose production, dysregulated incretin activity, and altered renal glucose handling. Despite the availability of several pharmacological interventions, achieving sustained glycemic control remains challenging because of disease progression, poor medication adherence, frequent dosing schedules, and long-term complications. Combination therapy targeting multiple pathogenic pathways has therefore emerged as an effective strategy for improving therapeutic outcomes. Among contemporary antidiabetic agents, vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and dapagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, demonstrate complementary mechanisms that collectively improve glycemic control while providing favorable cardiovascular and renal benefits.

Conventional oral dosage forms, however, present limitations including pharmacokinetic mismatch, repeated dosing requirements, and variable drug bioavailability. Nanotechnology-based drug delivery systems, particularly solid lipid nanoparticles (SLNs), have gained considerable attention as promising carriers capable of overcoming these limitations. SLNs offer enhanced drug stability, controlled drug release, improved intestinal absorption, protection against enzymatic degradation, and greater patient compliance. Furthermore, the simultaneous encapsulation of hydrophilic and lipophilic antidiabetic drugs within a single lipid matrix provides a novel strategy for synchronized once-daily therapy.