Volume : 13, Issue : 06, June – 2026
Title:
DESIGN AND EVALUATION OF MODIFIED-RELEASE BILAYER TABLETS FOR BIPHASIC DRUG DELIVERY IN THE MANAGEMENT OF TYPE 2 DIABETES MELLITUS
Authors :
Madhav Datta Gadme*, Dr. Ravi Uttamrao Kurhade, Mr. Tajammul Hussain Shaikh
Abstract :
Objectives: The research aimed to design and evaluate modified-release bilayer tablets containing Linagliptin (LINA) and Empagliflozin (EMPA) to achieve a biphasic release profile. It sought to integrate both drugs into a single dosage form, optimizing drug release and evaluating the tablets’ physical, chemical, and performance properties.
Materials and Methods: The study utilized 32 factorial designs to optimize the bilayer tablet formulation, with HPMC K 100 M and Ethyl Cellulose as independent variables. The % drug release after 8 hours and 12 hours were the dependent variables. Pre-compression and post-compression evaluations, including spectroscopic analysis, Differential Scanning Calorimetry (DSC), and FT-IR, were conducted to assess the tablets. The E7 batch was selected as optimized based on these evaluations.
Results and Discussion: The optimized bilayer tablets exhibited favorable characteristics: angle of response of 24.16°C, bulk density of 0.346 g/cm³, tapped density of 0.414 g/cm³, compressibility of 14.38%, and Hausner ratio of 1.178. The tablets showed low weight variation (288.16±2.0 mg), uniform thickness (3.90±0.2 mm), sufficient hardness (7.84±0.3 Kg/cm²), low friability (0.116%), and rapid disintegration (7.64 min). The drug release profile was optimal, with 84.763% release after 8 hours and 99.972% after 12 hours for the sustained release layer. In-vivo studies indicated that the bilayer tablets performed significantly better than marketed tablets.
Conclusion: The modified-release bilayer tablets of LINA and EMPA demonstrated effective drug delivery with optimized release characteristics. Stability testing over 30 days confirmed the tablets’ consistency and suitability for therapeutic use, highlighting their potential to improve treatment outcomes in diabetes management.
KEYWORDS: Linagliptin, Empagliflozin, Immediate drug release, Sustain drug release.
Cite This Article:
Please cite this article in press Madhav Datta Gadme et al., Design And Evaluation Of Modified-Release Bilayer Tablets For Biphasic Drug Delivery In The Management Of Type 2 Diabetes Mellitus, Indo Am. J. P. Sci, 2026; 13(06).
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