Formulation and Evaluation of Bilayer Fixed Dose Combination Tablets Containing Empagliflozin, Sitagliptin and Metformin as Triple Therapy in Diabetes
Abstract
Empagliflozin, Sitagliptin, and Metformin are oral medications used to manage type 2 diabetes.As the disease progresses, monotherapy often becomes inadequate to maintain glycemic control.Thus, clinically triple therapy is recommended.The aim of this study is to formulate bilayer fixed-dose combination (FDC) tablets containing Empagliflozin, Sitagliptin, and Metformin as a singledosage regimen.Bilayer tablets were formulated by direct compression method, incorporating Empagliflozin and Sitagliptin in the immediate-release (IR) layer were prepared by Croscarmellose sodium and Sodium starch glycolate.The sustained-release (SR) layer contained Metformin was formulated by HPMC K-100 and Konjac gum.Drug excipient compatibility was assessed using (FT-IR).The powder blends were evaluated for pre-compression parameters, Angle of repose, Bulk density, Tapped density, Hausner's ratio, Compressibility.Formulations were assessed for Thickness, Hardness, weight variation, Friability, Disintegrations, In vitro dissolution, Drug content, Invitro enzymatic activity.Based on the dissolution profiles, F6 and E6 were selected as the optimized IR and SR formulations, respectively.F6 showed 95.25% for empagliflozin and 94.50% for sitagliptin within 30 minutes, while E6 exhibited 96.87% for metformin over 12 hours.These were compressed into bilayer tablets.The optimized SR formulation E6 followed firstorder kinetics and fit the Korsmeyer Peppas model.The optimized formulation provided effective…
Read the paper
Related studies
- The Role of AMPK Activation for Cardioprotection in Doxorubicin-Induced Cardiotoxicity
- Hypoglycemic medicines in the treatment of Alzheimer’s disease: Pathophysiological links between AD and glucose metabolism
- Isorhamnetin Reduces Glucose Level, Inflammation, and Oxidative Stress in High-Fat Diet/Streptozotocin Diabetic Mice Model
- Modulating Sirtuin Biology and Nicotinamide Adenine Diphosphate Metabolism in Cardiovascular Disease—From Bench to Bedside
- Characterization of the SGLT2 Interaction Network and Its Regulation by SGLT2 Inhibitors: A Bioinformatic Analysis
- Early Treatment with Empagliflozin and GABA Improves β-Cell Mass and Glucose Tolerance in Streptozotocin-Treated Mice
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.