US 12,295,961 B2
Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Om Dhingra, Morrisville, NC (US)
Assigned to Marius Pharmaceuticals, Inc., Raleigh, NC (US)
Filed by Marius Pharmaceuticals, Inc., Raleigh, NC (US)
Filed on Jan. 27, 2023, as Appl. No. 18/102,136.
Application 18/102,136 is a continuation of application No. 16/696,159, filed on Nov. 26, 2019, granted, now 11,590,146.
Application 16/696,159 is a continuation of application No. 13/936,036, filed on Jul. 5, 2013, granted, now 10,576,089, issued on Mar. 3, 2020.
Application 13/936,036 is a continuation of application No. 12/983,216, filed on Dec. 31, 2010, abandoned.
Claims priority of provisional application 61/291,769, filed on Dec. 31, 2009.
Prior Publication US 2024/0000798 A1, Jan. 4, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/568 (2006.01); A61K 9/00 (2006.01); A61K 9/107 (2006.01); A61K 9/48 (2006.01); A61K 31/4985 (2006.01); A61K 45/06 (2006.01)
CPC A61K 31/568 (2013.01) [A61K 9/0053 (2013.01); A61K 9/107 (2013.01); A61K 9/1075 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 9/4875 (2013.01); A61K 31/4985 (2013.01); A61K 45/06 (2013.01); Y02A 50/30 (2018.01)] 8 Claims
 
1. A method of treating male hypogonadism in a subject in need thereof, the method comprising administering to the subject the oral formulation comprising:
a) testosterone undecanoate;
b) from about 10% to about 90% by weight of a non-sterol solubilizing agent effective for solubilization of the testosterone undecanoate; and
c) from about 2% to about 45% by weight of a mixture of phytosterol esters, wherein the mixture of phytosterol esters comprises esters of beta-sitosterol and stigmasterol.