Steroidal compositions
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.
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 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 0-∞ ratio of about 600×10 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 0-∞ ratio of about 600×10 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 0-∞ ratio of about 600×10 3 mL/h or less and a plasma C 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.