Amorphous form of dapagliflozin 1,2-propanediol
AssigneeCadila Healthcare Limited
InventorsShri Prakash Dhar DWIVEDI, Brij KHERA, Jagdish Maganlal PATEL, Sanjay Jagdish DESAI, Jayprakash Ajitsingh PARIHAR, Mahesh Laljibhai RUPAPARA
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Abstract
The invention provides an amorphous form of dapagliflozin 1,2-propanediol of Formula (A) or hydrates thereof and their process for preparation. The present invention also provides a pharmaceutical composition comprising art amorphous solid dispersion containing dapagliflozin 1,2-propanediol or hydrates thereof.
Claims21
An amorphous form of dapagliflozin 1,2-propanediol or hydrates thereof of Formula (A),
- wherein n is 0.8 to 1.2 and x is 0-2.
A process for the preparation of an amorphous form of dapagliflozin 1,2-propanediol or hydrates thereof of Formula (A),
- wherein n is 0.8 to 1.2 and x is 0-2,
- the process comprising:
- (a) heating dapagliflozin 1,2-propanediol or hydrates thereof of Formula (A), optionally in the presence of one or more excipients in one or more solvents at a first temperature;
- and
- (b) cooling to obtain the amorphous form of dapagliflozin 1,2-propanediol or hydrates thereof to a second temperature.
An amorphous solid dispersion comprising dapagliflozin 1,2-propanediol or hydrates thereof and one or more pharmaceutically acceptable excipients.
Dependencies are inferred from the claim text.