In vitro assessment of immediate release Dapagliflozin tablets for type 2 diabetes mellitus treatment

Authors

  • Shaymjit Paul Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh
  • Tanvir Mahtab Uddin Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh
  • Md Abdus Samadd Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh
  • Md Abdur Rahim Biomedical and Toxicological Research Institute (BTRI), Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka-1205, Bangladesh
  • Mohammad Sabbir Hossain Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh
  • Md Raihan Sarkar Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka-1000, Bangladesh
  • S R Rony Pharmaceutical Sciences Research Division, BCSIR Laboratories, Dhaka, Bangladesh Council of Scientific and Industrial Research, Dhaka-1205, Bangladesh
  • Farhana Rizwan Department of Pharmacy, East West University, A/2, Jahurul Islam Avenue, Jahurul Islam City, Aftabnagar, Dhaka-1212, Bangladesh

DOI:

https://doi.org/10.5564/bjsir.v59i3.73411

Keywords:

Diabetes Mellitus, dapagliflozin, immediate release, super-disintegrating agents

Abstract

The study explores therapeutic strategies for diabetes mellitus, focusing on improving therapeutic outcomes and patient compliance through the development and characterization of an immediate release formulation of dapagliflozin. Eight formulations were developed using a wet granulation process with several super-disintegrating agents and characterized by pre-compression parameters such as angle of repose (40.2 to 61.02), Hausner ratio (1.30 to 1.5), Carr’s index (23.5 to 33.3), physical attributes (weight (145–155 mg), thickness (4.42±0.04 to 4.46±0.05 mm), hardness (3.7–5.6 kg/cm2), friability (<1%)), and disintegration time. Furthermore, FT-IR, SEM, and TGA were conducted, which revealed no plausible drug-excipient interaction. In-vitro dissolution studies were conducted and the release profile was determined as F1 (80.50±5.2) > F3 (75.97±1.4) > F2 (75.30±3.3) > F5 (74.14±2.3) > F8 (70.13±3.7) > F7 (68.12±4.1) > F6 (66.45±3.1) > F4 (54.74±1.3) > pure drug (38.14±2.1) within 30 minutes, while the F1 formulation complied with the USP requirements for immediate release formulation. Additionally, the F1 formulation's drug release profile significantly outperformed commercially available options, indicating its potential to enhance glycemic control and patient adherence in T2DM management, as per the findings.

Bangladesh J. Sci. Ind. Res. 59(3), 139-148, 2024

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Published

2024-09-18

How to Cite

Paul, S., Uddin, T. M., Samadd, M. A., Rahim, M. A., Hossain, M. S., Sarkar, M. R., Rony, S. R., & Rizwan, F. (2024). In vitro assessment of immediate release Dapagliflozin tablets for type 2 diabetes mellitus treatment. Bangladesh Journal of Scientific and Industrial Research, 59(3), 139–148. https://doi.org/10.5564/bjsir.v59i3.73411

Issue

Vol. 59 No. 3 (2024)

Section

Articles

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