Polymorphs of bis(fluoroalkyl)-1,4-benzodiazepinone compounds and uses thereof
AssigneeBristol-Myers Squibb Company
InventorsMarta Dabros, Joshua Engstrom, Daniel Richard Roberts
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Abstract
The present invention provides a crystalline form of (2R,3S)—N-((3S)-5-(3-fluorophenyl)-9-methyl-2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl)-2,3-bis(3,3,3-trifluoropropyl)succinimide, represented by the structure of Compound (1), wherein the crystalline form comprises N-2 crystalline form, IPA2-1 crystalline form, M3-1 crystalline form, P4 crystalline form, P5 crystalline form, P6 crystalline form, or any combination thereof. The present invention also provides processes for the preparation of a the crystalline form, and pharmaceutical compositions comprising one or more of the crystalline forms.
Claims35
A crystalline form of (2R,3S)—N-((3S)-5-(3-fluorophenyl)-9-methyl-2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl)-2,3-bis(3,3,3-trifluoropropyl) succinimide, represented by the structure of Compound 1:
- wherein the crystalline form comprises
- a. N-2 crystalline form, M3-1 crystalline form, P2 crystalline form, P3 crystalline form, P4 crystalline form, P5 crystalline form, P6 crystalline form, or any combination thereof;
- b. P2 crystalline form, crystallized from crystalline form P1 which was slurried in ethyl acetate;
- c. P3 crystalline form, crystallized from crystalline form P1 which was slurried in acetonitrile;
- d. P1 crystalline form, crystallized via desolvation of IPA2-1 or M3-1;
- or
- e. IPA2-1 crystalline form, crystallized from isopropyl alcohol (IPA).
Dependencies are inferred from the claim text.