Crystalline Darunavir
AssigneeMylan Laboratores LTD
InventorsSiva Rama Prasad Vellanki, Arabinda Sahu, Naveen Kumar Phadhuri, Ravindrababu Kilaru
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Abstract
The present invention relates to a non-solvated crystalline Darunavir, process for its preparation and pharmaceutical composition comprising it. The present invention also relates to a process for the preparation of amorphous Darunavir from a non-solvated crystalline Darunavir.
Claims10
A non-solvated crystalline Darunavir is characterized by Powder X-ray diffraction pattern having 2θ angle positions at about 7.03, 13.77, 16.67, 19.12, 21.22 and 22.75±0.2 degrees.
The non-solvated crystalline Darunavir is characterized by a powder X-ray diffraction pattern as depicted in FIG. 1.
A process for the preparation of non-solvated crystalline Darunavir comprising the steps of:
- a) dissolving Darunavir in an ester solvent,
- b) adding an anti solvent, and
- c) isolating non-solvated crystalline Darunavir.
A process for the preparation of amorphous Darunavir comprising the steps of:
- a) dissolving non-solvated crystalline Darunavir in a solvent,
- b) removing the solvent, and
- c) isolating amorphous Darunavir.
Dependencies are inferred from the claim text.