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. 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° 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).