US 11,052,096 B2
Steroidal compositions
Chandrashekar Giliyar, Plymouth, MN (US); Nachiappan Chidambaram, Sandy, UT (US); Mahesh V. Patel, Salt Lake City, UT (US); and Srinivasan Venkateshwaran, Salt Lake City, UT (US)
Assigned to Lipocine Inc., Salt Lake City, UT (US)
Filed by Lipocine Inc., Salt Lake City, UT (US)
Filed on Oct. 16, 2020, as Appl. No. 17/72,779.
Application 17/072,779 is a continuation of application No. 12/350,930, filed on Jan. 8, 2009.
Prior Publication US 2021/0038615 A1, Feb. 11, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/569 (2006.01); A61K 9/48 (2006.01); A61K 31/568 (2006.01); A61K 47/44 (2017.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 9/00 (2006.01)
CPC A61K 31/569 (2013.01) [A61K 9/0053 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 9/4875 (2013.01); A61K 31/568 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/44 (2013.01)] 7 Claims
 
1. A method of treating a hypogonadal male comprising orally administering to the male twice-daily a composition comprising a capsule and a semi-solid formulation encased within the capsule, the formulation comprising:
a) 20-25 percent by weight of testosterone undecanoate (TU),
b) 10-21 percent by weight of hydrophilic surfactant, and
c) 48-70 percent by weight of lipophilic carrier selected from lipophilic surfactant, triglycerides, or Vitamin E compounds,
wherein the formulation in the capsule administered twice daily comprises about 120 mg to about 400 mg of TU, and wherein the composition, when orally administered to a plurality of hypogonadal males provides, a mean plasma concentration of testosterone at steady state of between 300 ng/dL and 1000 ng/dL in at least 75% of the males, a plasma Cmax concentration of testosterone less than 1800 ng/dL in at least 95% of males, less than 1500 ng/dL in at least 85% of males, and less than 2500 ng/dL in all males.