Claims for Patent: 10,226,473

Summary for Patent: 10,226,473

Title:	High-strength testosterone undecanoate compositions
Abstract:	The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone C.sub.max to serum testosterone C.sub.ave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration C.sub.ave range for a male subject is provided.
Inventor(s):	Giliyar; Chandrashekar (Plymouth, MN), Chickmath; Basawaraj (Minneapolis, MN), Chidambaram; Nachiappan (Sandy, UT), Patel; Mahesh V. (Salt Lake City, UT), Venkateshwaran; Srinivansan (Salt Lake City, UT)
Assignee:	Lipocine Inc. (Salt Lake City, UT)
Application Number:	15/955,429
Patent Claims:	1. A method for replacement therapy in a male having a condition associated with a deficiency or absence of endogenous testosterone said method comprising: (a) orally administering to said male two unit dosage forms of a pharmaceutical composition twice a day in a daily dosing regimen, said pharmaceutical composition comprising testosterone undecanoate and a pharmaceutical carrier, that provides about 450 mg testosterone undecanoate to said male per day; (b) determining the serum level of testosterone of said male during the daily dosing regimen at from 1-12 hours after single dose administration of said pharmaceutical composition at steady state; and (c) orally administering two unit dosage forms of the pharmaceutical composition twice a day in the daily dosing regimen to provide a serum testosterone Cave in said male in the range of from about 300-1100 ng/dL. 2. The method of claim 1, wherein said pharmaceutical carrier comprises a solubilizer and a dispersant. 3. The method of claim 1, wherein said pharmaceutical carrier comprises a solidifying agent. 4. The method of claim 1, wherein said pharmaceutical carrier comprises a monoglyceride. 5. The method of claim 1, wherein said pharmaceutical carrier comprises a diglyceride. 6. The method of claim 1, wherein said pharmaceutical carrier comprises a triglyceride. 7. The method of claim 1, wherein said pharmaceutical carrier comprises a fatty acid. 8. The method of claim 1, wherein said pharmaceutical carrier comprises medium chain monoglycerides and diglycerides. 9. The method of claim 1, wherein said pharmaceutical carrier comprises a tocopherol. 10. The method of claim 1, wherein said pharmaceutical carrier comprises a hydrophilic surfactant. 11. The method of claim 1, wherein said pharmaceutical composition has at least 5% of the testosterone undecanoate not dissolved and at least 35% dissolved in said pharmaceutical carrier. 12. A method for replacement therapy in a male having a condition associated with a deficiency or absence of endogenous testosterone said method comprising: orally administering to said male two unit dosage forms of a pharmaceutical composition twice a day, said pharmaceutical composition comprising testosterone undecanoate and a pharmaceutical carrier, that provides about 450 mg to said male per day to provide a serum testosterone Cave in said male in the range of from about 300-1100 ng/dL, wherein said pharmaceutical composition has at least 5% of the testosterone undecanoate not dissolved and at least 35% dissolved in said pharmaceutical carrier. 13. The method of claim 12, wherein orally administering is twice a day. 14. The method of claim 12, wherein said pharmaceutical carrier comprises one or more of the following: a fatty acid, a monoglyceride, a diglyceride, a triglyceride, and a tocopherol. 15. The method of claim 12, wherein said pharmaceutical carrier comprises a hydrophilic surfactant. 16. The method of claim 12, wherein said pharmaceutical carrier comprises a solidifying agent. 17. The method of claim 12, wherein said pharmaceutical carrier comprises a monoglyceride. 18. The method of claim 12, wherein said pharmaceutical carrier comprises a diglyceride. 19. The method of claim 12, wherein said pharmaceutical carrier comprises a triglyceride. 20. The method of claim 12, wherein said pharmaceutical carrier comprises a fatty acid. 21. The method of claim 12, wherein said pharmaceutical carrier comprises medium chain monoglycerides and diglycerides.