Process for the preparation of DL-proline co-crystal of Dapagliflozin
AssigneeAurobindo Pharma Ltd
InventorsSenthilkumar NATRAJAN, Kishore KARUMANCHI, Vittal TANGIRALA, Sivakumaran MEENAKSHISUNDERAM
Life of this patent
Estimating the term…
Abstract
The present invention relates to a process For the preparation of Dapagliflozin DL—Proline co-crystal and its use in the preparation/purification of Dapagliflozin. The invention also provides a process for the preparation of Dapagliflozin (R,S)-1.2-propanediol monohydrate.
Claims10
A process for the preparation of crystalline Dapagliflozin DL-proline co-crystals, comprising the steps of:
- a) providing a solution or suspension of Dapagliflozin and DL-proline in a solvent or mixture of solvents;
- b) optionally heating and concentrating the reaction mass;
- and
- c) isolating Dapagliflozin DL-proline co-crystals.
A process for preparation of amorphous Dapagliflozin (I), comprising the steps of:
- a) providing a solution of Dapagliflozin DL-proline co-crystal in a solvent or mixture of solvents;
- b) treating the reaction mass obtained in step (a) with a base;
- c) optionally separating the organic layer;
- d) optionally removing the solvent;
- e) adding antisolvent;
- and
- f) isolating amorphous Dapagliflozin.
(canceled)
(canceled)
(canceled)
A Crystalline DL-proline Dapagliflozin co-crystal characterized by an x-ray diffraction pattern (XRD) as shown in FIG. 3.
Dependencies are inferred from the claim text.