US 11,883,415 B2
High concentration formulation
Luigi Maria Longo, Figino Serenza (IT)
Assigned to Cassiopea S.P.A., Lainate (IT)
Filed by Cassiopea S.P.A., Lainate (IT)
Filed on Nov. 23, 2021, as Appl. No. 17/456,218.
Application 17/456,218 is a continuation of application No. 16/828,727, filed on Mar. 24, 2020, granted, now 11,213,531.
Application 16/828,727 is a continuation of application No. 16/400,262, filed on May 1, 2019, abandoned.
Application 16/400,262 is a continuation of application No. 15/738,151, granted, now 10,603,327, issued on Mar. 31, 2020, previously published as PCT/IB2016/053662, filed on Jun. 20, 2016.
Claims priority of provisional application 62/182,988, filed on Jun. 22, 2015.
Claims priority of application No. 15173860 (EP), filed on Jun. 25, 2015.
Prior Publication US 2022/0193093 A1, Jun. 23, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/573 (2006.01); A61K 9/14 (2006.01); A61P 17/14 (2006.01); A61K 9/00 (2006.01); A61K 47/10 (2017.01); A61K 9/08 (2006.01); A61K 9/06 (2006.01); A61P 1/00 (2006.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01)
CPC A61K 31/573 (2013.01) [A61K 9/0014 (2013.01); A61K 9/06 (2013.01); A61K 9/08 (2013.01); A61K 47/10 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61P 1/00 (2018.01); A61P 17/14 (2018.01)] 18 Claims
OG exemplary drawing
 
1. A method of treating androgenetic alopecia, the method comprising topically administering to a subject in need thereof, an effective amount of a pharmaceutical formulation comprising:
a) cortexolone-17α-propionate at a concentration of about 5 weight percent to about 15 weight percent,
b) a pharmaceutically acceptable amount of one or more pharmaceutically acceptable solvents, and
c) less than about 5% water,
wherein:
the cortexolone-17α-propionate is fully solubilized in the formulation;
the formulation has a pH between about 4 and about 5; and
wherein the formulation has a storage stability of at least about 6 months at room temperature as measured by the formulation comprising less than 5 weight percent of cortexolone-21-propionate (17α-hydroxy-21-propionyloxy-pregna-4-ene-3,20-dione) or other degradation products.