Claims for Patent: 8,865,695

Summary for Patent: 8,865,695

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:	14/191,278
Patent Claims:	1. A method of treating a hypogonadal male, said treatment comprising: (a) identifying a hypogonadal male in need of treatment; and administering orally, with a. meal, to said hypogonadal male in need of treatment, one, or multiple, unit dosage forms having a pharmaceutical composition which is a solid, semi-solid, gel, jelly or paste comprising (i) testosterone undecanoate and (ii) a pharmaceutically acceptable carrier, said pharmaceutical composition comprising 10-30% w/w testosterone undecanoate; 10-30% w/w of a hydrophilic surfactant; 40-70% w/w glyceryl inonolinoleate and 1-20% w/w solidifying agent, wherein said pharmaceutical composition releases 90% or less of the testosterone undecanoate at 30minutes and 80% or more of the testosterone undecanoate at 2 hours when tested in a USP type 2 apparatus in 1000 mL 8% w/w octoxynol-9 in deionized water at 100 rpm at 37.+-.0.5.degree. C. 2. The method of claim 1, wherein the amount of testosterone undecanoate is from about 70 mg to about 150 mg per unit dosage form. 3. The method of claim 1, wherein the ratio of glyceryl monolinoleate to total hydrophilic surfactant falls between 5.5:1 to 3.5:1. 4. The method of claim 1, wherein administering to a population of hypogonadal males provides a plasma Cmax of testosterone that is less than 1500 ng/dL in at least 85% or less of the population of hypogonadal males. 5. The method of claim 1, wherein the hypogonadal male is a hypogonadal pubescent male. 6. The method of claim 1, wherein administering to a population of hypogonadal males provides a plasma concentration of testosterone at steady state that is between about 200 ng/dL and 1300 ng/dL in at least 75% of the population of hypogonadal males. 7. The method of claim 1, wherein the hydrophilic carrier is hydrogenated polyoxylated castor oil. 8. The method of claim 1, wherein the solidifying agent is present in an amount of 5-10% w/w. 9. The method of claim 1 wherein said unit dosage form comprises: (a) from about 110 mg to about 130 mg testosterone undecanoate; (b)about 80 mg testosterone undecanoate; (c)about 15% w/w testosterone undecanoate; or (d) a combination of (a) and (c), or a combination of (b) and (c).