Claims for Patent: 8,778,922

Summary for Patent: 8,778,922

Title:	Steroidal compositions
Abstract:	Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.
Inventor(s):	Giliyar; Chandrashekar (Salt Lake City, UT), Chidambaram; Nachiappan (Sandy, UT), Patel; Mahesh V. (Salt Lake City, UT), Venkateshwaran; Srinivasan (Salt Lake City, UT)
Assignee:	Lipocine Inc. (Salt Lake City, UT)
Application Number:	13/592,258
Patent Claims:	1. An oral pharmaceutical composition comprising: 10-30% w/w of a steroidal compound, wherein the steroidal compound is testosterone undecanoate; 10-30% w/w of a hydrophilic carrier, wherein the hydrophilic carrier is a hydrophilic surfactant; 40-70% w/w of a lipophilic carrier, wherein the lipophilic carrier is a lipophilic surfactant, and wherein the lipophilic surfactant is glyceryl monolinoleate; and 1-20% w/w of a solidifying agent, wherein said pharmaceutical composition has from 70 mg to 150 mg testosterone undecanoate and said oral pharmaceutical composition is a jelly, solid, semi-solid, glassy or paste-like composition in a capsule. 2. The pharmaceutical composition of claim 1, the pharmaceutical composition providing a plasma C.sub.max of testosterone of less than 2500 ng/dL when orally administered as one or multiple unit dosage forms, with a meal twice daily to a hypogonadal male. 3. An oral dosage form of testosterone undecanoate in a carrier comprising: 10-20% w/w testosterone undecanoate; 10-20% w/w of polyoxyl 40 hydrogenated castor oil; 50-70% w/w of glyceryl monolinoleate; and a solidifying agent; wherein said carrier is a jelly, solid, semi-solid, glassy or paste-like. 4. The oral dosage form of claim 3, wherein said oral dosage form is free of ethanol. 5. The oral dosage form of claim 3, the oral dosage form providing a testosterone equivalent dose to mean testosterone AUC.sub.0-.infin. ratio of about 600.times.10.sup.3 mL/h or less when orally administered, as one or multiple unit dosage forms, with a meal twice daily to a hypogonadal male. 6. The oral dosage form of claim 3, wherein the solidifying agent present in an amount of from 5% to 10% w/w. 7. The oral dosage form of claim 1, providing a plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL at steady state when orally administered as one or multiple unit dosage forms, twice daily with a meal to a hypogonadal male. 8. The oral pharmaceutical composition of claim 3, providing a plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL at steady state when orally administered as one or multiple unit dosage forms, twice daily with a meal to a hypogonadal male. 9. The oral dosage form of claim 3, wherein the solidifying agent is high molecular weight PEG. 10. The oral formulation of claim 1, wherein the solidifying agent is high molecular weight PEG. 11. The oral dosage form of claim 1, the oral dosage form providing a testosterone equivalent dose to mean testosterone AUC.sub.0-.infin. ratio of about 600.times.10.sup.3 mL/h or less when orally administered, as one or multiple unit dosage forms, with a meal twice daily to a hypogonadal male. 12. The oral dosage form of claim 1, the oral dosage form providing a testosterone equivalent dose to mean testosterone AUC.sub.0-.infin. ratio of about 600.times.10.sup.3 mL/h or less and a plasma C.sub.max of testosterone of less than 2500 ng/dL when orally administered, as one or multiple unit dosage forms, with a meal twice daily to a hypogonadal male.