Crystalline forms of (s)-5-benzyl-n-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido [3,2-b][1,4]oxazepin-3-yl)-4h-1,2,4-triazole-3-carboxamide
AssigneeDenali Therapeutics Inc.
InventorAnantha Sudhakar
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Abstract
Described herein are crystalline forms of (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido [3,2-b][1,4]oxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide, the process of preparing the forms, and pharmaceutical compositions methods of use thereof.
Claims15
1-20. (canceled)
A pharmaceutical composition comprising crystalline Form A of (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido [3,2-b][1,4]oxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide and a pharmaceutically acceptable excipient.
A pharmaceutical composition comprising crystalline Form B of (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido [3,2-b][1,4]oxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide and a pharmaceutically acceptable excipient.
A process for preparing crystalline Form B of (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido [3,2-b][1,4]oxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide, the process comprising the following steps:
- a) dissolving (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido [3,2-b][1,4]oxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide in a solvent selected from ethanol, isopropyl alcohol, ethyl acetate, n-propyl acetate, isopropanol/water, ethanol/isopropyl acetate, methanol/isopropyl acetate, methanol/toluene, methyl isobutyl ketone, isopropyl acetate, ethanol/methyl acetate, water, dimethyl carbonate, tetrahydrofuran/water, and N,N-dimethylacetamide/water to form a slurry or suspension;
- b) stirring the slurry or suspension at a set temperature;
- c) filtering the solid material;
- and
- d) drying the solid material to provide crystalline Form B.
Dependencies are inferred from the claim text.