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Mitigation of poor physical and chemical properties of SGLT2 inhibitor by drug-drug cocrystallization with DPP4 inhibitor and comparative pharmacokinetic study with their respective co-administered drug products

Implementing Organization

Birla Institute of Technology
Principal Investigator
Dr. Animesh Ghosh
Birla Institute of Technology

About

The revised project proposal focuses on the development of multi-drug cocrystals of anti-diabetic agents, specifically Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP4i), for the management of Type 2 diabetes mellitus (T2DM). The study aims to improve the physical and chemical properties of these agents, which are often associated with SGLT2i's. The proposal proposes preparing drug-drug cocrystals from SGLT2i and DPP4i, aiming to improve their physical and chemical properties. Sub-chronic oral toxicity studies in rodents will be performed, along with the preparation of oral solid dosage formulations. A comparative bioavailability study of cocrystal tablets in human volunteers will be performed, and pharmacometrics study will be conducted to predict the dose range for the cocrystals using pharmacokinetic modeling and simulation. The study aims to address the issues associated with the arrangement of supramolecular synthons in the crystal lattice, which could lead to the development of new solid forms of these drugs with modulated physicochemical properties. This multimodal treatment approach could be more advantageous than fixed-dose combination (FDC) or co-administration of SGLT2i and DPP4i.
Funding Organization
Funding Organization
Science and Engineering Research Board (SERB), New Delhi
Anusandhan National Research Foundation (ANRF)
Quick Information
Area of Research
Chemical Sciences
Start Year
2022
End Year
2025
Sanction Amount
₹ 28.44 L
Status
Completed
Output
No. of Research Paper
00
Technologies (If Any)
00
No. of PhD Produced
N/A
Startup (If Any)
00
No. of Patents
Filed :00
Grant :00
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