Process for preparing a crystalline form of halobetasol propionate
OwnerDaniella Gutman, Shimon Chernyakinventors
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Abstract
The present invention provides a process for preparing a crystalline form of halobetasol propionate, comprising the step of crystallizing halobetasol propionate from absolute ethanol or a mixture of ethanol and water, wherein the crystalline form of halobetasol propionate is characterized by an x-ray powder diffraction pattern having peaks at 10.0, 11.6, 12.9, 13.4, 14.5, 16.4, 17.6, and 23.5±0.2 degrees 2θ.
Claims45
A process for preparing a crystalline form of halobetasol propionate, comprising the step of crystallizing halobetasol propionate from absolute ethanol or a mixture of ethanol and water, wherein the crystalline form of halobetasol propionate is characterized by an x-ray powder diffraction pattern having peaks at 10.0, 11.6, 12.9, 13.4, 14.5, 16.4, 17.6, and 23.5±0.2 degrees 2θ.
A process for preparing a crystalline form of halobetasol propionate, comprising the steps of:
- (a) crystallizing halobetasol propionate from a first ethanol;
- (b) isolating the crystallized halobetasol propionate from the first ethanol;
- (c) crystallizing the isolated halobetasol propionate from a second ethanol;
- and
- (d) isolating the crystallized halobetasol propionate from the second ethanol, wherein the crystalline form of halobetasol propionate is characterized by an x-ray powder diffraction pattern having peaks at 10.0, 11.6, 12.9, 13.4, 14.5, 16.4, 17.6, and 23.5±0.2 degrees 2θ.
A commercial scale composition of a crystalline form of halobetasol propionate characterized by an x-ray powder diffraction pattern having peaks at 10.0, 11.6, 12.9, 13.4, 14.5, 16.4, 17.6, and 23.5±0.2 degrees 2θ, wherein the composition contains about 0.1% or less of each of diflorasone, diflorasone 17-propionate, halobetasol, diflorasone 21-propionate, diflorasone 17-propionate 21-mesylate, and 6α,9α-difluoro-11β-hydroxy-16β-methyl-3-oxoandrosta-1,4-diene-17(R)-spiro-2′-[4′-chloro-5′-ethylfuran-3-(2′H)-one].
Dependencies are inferred from the claim text.