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US 2021/0260084 A1Published application
Pharmaceutical composition comprising dapagliflozin
AssigneeInventia Healthcare Limited
InventorsVaibhavi Shah, Vijayendrakumar Redasani, Anant Ghongade
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Abstract
The present invention relates to solid oral pharmaceutical compositions comprising amorphous dapagliflozin. The invention further relates to a process for the preparation of the said pharmaceutical compositions. The said compositions are administered orally for the treatment of diabetes mellitus. The said compositions provide the desired immediate release of dapagliflozin and were found to be stable under accelerated conditions.
Claims14
1-12. (canceled)
A solid oral composition comprising:
- a) amorphous dapagliflozin, as a first active ingredient, having a d (0.5) in the range from 20 μm to 75 μm;
- b) a second active ingredient selected from the group consisting of biguanides, sulfonylureas, thiazolidinediones, alpha-glucosidase inhibitors, DPP4 inhibitors, PPAR agonist, meglitinides, and SGLT2 inhibitors;
- and
- c) one or more surfactants,
- wherein the weight ratio of dapagliflozin to the surfactant is from about 1:0.1 to 1:10.
2 more elements
The composition as claimed in claim 12, wherein the second active ingredient is metformin.
Dependencies are inferred from the claim text.