US 12,357,643 B2
Emulsion formulations
Om Dhingra, Morrisville, NC (US); and James S. Bernstein, Raleigh, NC (US)
Assigned to Marius Pharmaceuticals, Inc., Raleigh, NC (US)
Filed by Marius Pharmaceuticals, Inc., Raleigh, NC (US)
Filed on Nov. 13, 2023, as Appl. No. 18/389,167.
Application 18/389,167 is a continuation of application No. 18/176,166, filed on Feb. 28, 2023, abandoned.
Application 18/176,166 is a continuation of application No. 16/834,277, filed on Mar. 30, 2020, granted, now 11,617,758, issued on Apr. 4, 2023.
Application 16/834,277 is a continuation of application No. 15/699,872, filed on Sep. 8, 2017, abandoned.
Application 15/699,872 is a continuation of application No. 13/843,223, filed on Mar. 15, 2013, abandoned.
Prior Publication US 2024/0342194 A1, Oct. 17, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/568 (2006.01); A61K 9/107 (2006.01); A61K 9/48 (2006.01); A61K 45/06 (2006.01); A61K 47/14 (2017.01); A61K 47/22 (2006.01); A61K 47/44 (2017.01)
CPC A61K 31/568 (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 45/06 (2013.01); A61K 47/14 (2013.01); A61K 47/22 (2013.01); A61K 47/44 (2013.01)] 6 Claims
 
1. A pharmaceutical composition comprising:
(a) 2.5-37.5 percent by weight of a solubilized testosterone undecanoate (TU);
(b) 5-37.5 percent by weight of a hydrophilic surfactant selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, hydrogenated castor oil ethoxylate, polyethylene glycol mono- or di-esters of palmitic or stearic acid, fatty acid ethoxylate, or a combination thereof;
(c) 15-65 percent by weight of a hydrophobic surfactant selected from the group consisting of octanoic acid, decanoic acid, undecanoic acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, propylene glycol monolaurate, glycerol/glyceryl monolinoleate, glyceryl mono- and dicaprylocaprate, or a combination thereof;
(d) 5-37.5 percent by weight of one or more phytosterol esters; and
(e) 0-15 percent by weight of dl-alpha-tocopherol;
wherein the composition is a self-emulsifying oral formulation.