ORAL PHARMACEUTICAL COMPOSITIONS OF TESTOSTERONE ETHERS AND METHODS FOR TREATING A TESTOSTERONE DEFICIENCY WITH THEIR USE

摘要

1. An oral pharmaceutical composition containing testosterone undecanoate, dissolved in a carrier containing at least one lipophilic surfactant and at least one hydrophilic surfactant in the ratio of the total amount of lipophilic surfactant to the total amount of hydrophilic surfactant (w / w) located in the range from about 6: 1 to 3.5: 1, while the dissolved testosterone undecanoate is from 18 to 22 mass. % composition. 2. Oral pharmaceutical composition according to claim 1, characterized in that at least one hydrophilic surfactant contains Cremophor RH 40 (polyoxyethylene glycerol trihydroxystearate). An oral pharmaceutical composition according to claim 1, characterized in that at least one lipophilic surfactant contains oleic acid. An oral pharmaceutical composition according to claim 1, characterized in that the testosterone undecanoate is dissolved in a carrier substantially free of ethanol. An oral pharmaceutical composition according to claim 1, characterized in that it contains from 15 to 17 mass. % of at least one hydrophilic surfactant. 6. An oral pharmaceutical composition according to claim 1, characterized in that it contains from 50 to 55 mass. % of at least one lipophilic surfactant. 7. A method of treating a lack of testosterone or its symptoms, comprising oral administration to a patient suffering from a lack of testosterone or its symptoms, an effective amount of a pharmaceutical composition according to any one of claims. 1-6.8. The use of an oral pharmaceutical composition according to any one of claims. 1-6 for the manufacture of a medicament for the treatment of testosterone deficiency or its symptoms. 9. A method of treating a testosterone deficiency or its symptoms, comprising oral administration of a patient suffering from a testosterone deficiency or