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Last Updated: December 16, 2025

Claims for Patent: 11,938,141

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Summary for Patent: 11,938,141

Title:	Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Abstract:	The present invention refers to a new enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives starting from the corresponding 17α,21-diesters which comprises an enzymatic alcoholysis reaction. Furthermore, the present invention refers to new crystalline forms of cortexolone-17α-propionate and 9,11-dehydro-cortexolone 17α-butanoate.
Inventor(s):	Mauro Ajani, Luigi Moro
Assignee:	Cosmo SpA , Cassiopea SpA
Application Number:	US17/455,538
Patent Claims:	1. A topical composition comprising crystalline cortexolone-17α-propionate in at least two crystalline forms selected from the group consisting of crystalline Form I, crystalline Form II, crystalline Form III, and crystalline Form IV, wherein crystalline Form I is characterized by a DRX with at least peaks at about: 7.6, 8.4, 17.0, and 20.1 degrees 2theta, crystalline Form II is characterized by a DRX with at least peaks at about: 10.8, 13.3, 16.5, and 21.9 degrees 2theta, crystalline Form III is characterized by a DRX with at least peaks at about: 6.2, 12.6, 22.4, and 23.7 degrees 2theta, and crystalline Form IV has a DRX with at least peaks at about: 4.8, 12.9, and 19.5 degrees 2theta. 2. The topical composition of claim 1, wherein the composition comprises crystalline Form I and any of crystalline Forms II, III, or IV, or any combination thereof. 3. The topical composition of claim 1, wherein the composition comprises crystalline Form II and any of crystalline Forms I, III, or IV, or any combination thereof. 4. The topical composition of claim 1, wherein the composition comprises crystalline Form III and any of crystalline Forms I, II, or IV, or any combination thereof. 5. The topical composition of claim 1, wherein the composition comprises crystalline Form IV and any of crystalline Forms I, II, or III, or any combination thereof. 6. The topical composition of claim 1, wherein cortexolone-17α-propionate is present in the formulation in a total amount ranging from 0.1 to 2% by weight. 7. The topical composition of claim 5, wherein the composition comprises crystalline Forms III and IV. 8. The topical composition of claim 5, wherein the composition comprises crystalline Form I, II, and IV. 9. The topical composition of claim 5, wherein the composition comprises crystalline Forms I, III, and IV. 10. The topical composition of claim 5, wherein the composition comprises crystalline Forms I and IV. 11. The topical composition of claim 5, wherein the composition comprises crystalline Forms II, III, and IV. 12. The topical composition of claim 5, wherein the composition comprises crystalline Forms II and IV.

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