Claims for Patent: 11,311,555

Summary for Patent: 11,311,555

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:
Application Number:	16/843,837
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 a male identified as having below normal serum testosterone, a pharmaceutical composition, twice a day with food in a daily dosing regimen, said pharmaceutical composition comprising: (1) testosterone undecanoate in an amount of 15-20 wt % of the composition; and (2) a pharmaceutical carrier having a polyoxyl vegetable oil in an amount of from 8-16 wt % of the composition and maize oil monoglycerides in an amount of from 63-68 wt % of the composition 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 to said male the pharmaceutical composition twice a day with food in the daily dosing regimen to provide a serum testosterone Cave in the range of from about 300-1100 ng/dL. 2. The method of claim 1, wherein said polyoxyl vegetable oil is polyoxyl hydrogenated vegetable oil. 3. The method of claim 1, wherein said polyoxyl vegetable oil is polyoxyl 40 hydrogenated castor oil. 4. The method of claim 1, wherein said pharmaceutical composition further comprises glyceryl monolinoleate. 5. The method of claim 3, wherein said pharmaceutical carrier further comprises glyceryl monolinoleate. 6. The method of claim 1, wherein said pharmaceutical carrier further comprises oleic acid. 7. The method of claim 3, wherein said pharmaceutical carrier further comprises oleic acid. 8. The method of claim 4, wherein said pharmaceutical carrier further comprises oleic acid. 9. The method of claim 1, wherein said pharmaceutical carrier further comprises a diglyceride. 10. The method of claim 3, wherein said pharmaceutical carrier further comprises a diglyceride. 11. The method of claim 4, wherein said pharmaceutical carrier further comprises a diglyceride. 12. The method of claim 5, wherein said pharmaceutical carrier further comprises a diglyceride. 13. The method of claim 6, wherein said pharmaceutical carrier further comprises a diglyceride. 14. The method of claim 1, wherein said pharmaceutical composition provides a serum testosterone Cmax to Cave ratio of 2.7 or less upon single dose administration. 15. The method of claim 4, wherein said pharmaceutical composition provides a serum testosterone Cmax to Cave ratio of 2.7 or less upon single dose administration. 16. The method of claim 5, wherein said pharmaceutical composition provides a serum testosterone Cmax to Cave ratio of 2.7 or less upon single dose administration. 17. The method of claim 12, wherein said pharmaceutical composition provides a serum testosterone Cmax to Cave ratio of 2.7 or less upon single dose administration. 18. The method of claim 1, wherein said pharmaceutical composition provides a dose normalized serum testosterone Cave of 1.9.times.10-6 dL-1 or greater upon single dose administration. 19. The method of claim 4, wherein said pharmaceutical composition provides a dose normalized serum testosterone Cave of 1.9.times.10-6 dL-1 or greater upon single dose administration. 20. The method of claim 5, wherein said pharmaceutical composition provides a dose normalized serum testosterone Cave of 1.9.times.10-6 dL-1 or greater upon single dose administration. 21. The method of claim 12, wherein said pharmaceutical composition provides a dose normalized serum testosterone Cave of 1.9.times.10-6 dL-1 or greater upon single dose administration. 22. The method of claim of 1, said method providing a serum testosterone Cmax of less than 2500 ng/dL. 23. The method of claim of 1, said method providing a serum testosterone Cmax of less than 1500 ng/dL. 24. The method of claim of 5, said method providing a serum testosterone Cmax of less than 2500 ng/dL. 25. The method of claim of 5, said method providing a serum testosterone Cmax of less than 1500 ng/dL.