Steroidal Compositions
AssigneeLipocine Inc.
InventorsChandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
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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.
Claims29
-44. (canceled)
A method of treating a hypogonadal male, said treatment comprising:
- (a) identifying a hypogonadal male in need of treatment;
- and
- (b) 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 that provides a testosterone equivalent dose to mean testosterone AUC0-∞ ratio of about 600×103 mL/h or less,
- wherein said pharmaceutical composition comprises a therapeutically effective amount of testosterone undecanoate and a pharmaceutically acceptable carrier, and
- wherein the pharmaceutically acceptable carrier comprises at least one lipophilic carrier and at least one hydrophilic carrier for delivering the therapeutically effective amount of testosterone undecanoate to said hypogonadal male in need of treatment.
A method of treating a hypogonadal male comprising (a) identifying a hypogonadal male and (b) administering to said hypogonadal male twice a day, with a meal, one or multiple unit dosage forms comprising from about 70 mg to about 150 mg testosterone undecanoate per unit dosage form and a pharmaceutically acceptable carrier that provides a testosterone equivalent dose to mean testosterone AUC0-∞ ratio of about 600×103 mL/h or less.
A method of treating a population of males having testosterone deficiency comprising:
- (a) identifying a population of males having testosterone deficiency;
- and
- (b) administering to said male population of males having testosterone deficiency, with a meal, twice a day, one or multiple unit dosage forms having from about 70 mg to about 150 mg per unit dosage form of testosterone undecanoate.
Dependencies are inferred from the claim text.