Claims for Patent: 9,943,527

Summary for Patent: 9,943,527

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 (North Maple Grove, MN), Chickmath; Basawaraj (Plymouth, 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:	15/594,508
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: Orally administering to said male a daily dosing regimen of a pharmaceutical composition comprising about 14 weight % (wt %) to about 35 wt % testosterone undecanoate and a carrier, that provides about 450 mg of testosterone undecanoate to said male per day 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 comprise 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 carrier comprises a hydrophilic surfactant. 11. The method of claim 1 wherein said orally administering is twice a day. 12. The method of claim 1 wherein said orally administering is three times a day. 13. 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 carrier. 14. 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 a daily dosing regimen of a pharmaceutical composition comprising about 14 weight % (wt %) to about 35 wt % testosterone undecanoate and a carrier, that provides about 450 mg of testosterone undecanoate 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 carrier. 15. The method of claim 14 wherein said orally administering is twice a day. 16. The method of claim 14 wherein said orally administering is three times a day. 17. The method of claim 14 wherein said carrier has one or more of the following: a fatty acid, a monoglyceride, a diglyceride, a triglyceride, and a tocopherol. 18. The method of claim 14 wherein said carrier has a hydrophilic surfactant. 19. The method of claim 14 wherein said carrier has a solidifying agent.