Claims
- 1. A pharmaceutical composition comprising:
a. an active agent; b. a vitamin E substance; and c. a surfactant,
wherein upon dilution of the composition, the active agent increases the extent of dispersion of the vitamin E substance by at least 20% relative to the dispersion of the composition without the active agent.
- 2. The pharmaceutical composition of claim 1, wherein the active agent is a hydrophobic drug.
- 3. The pharmaceutical composition of claim 2, wherein the hydrophobic drug is a steroid.
- 4. The pharmaceutical composition of claim 2, wherein the hydrophobic drug is a benzoquinone.
- 5. The pharmaceutical composition of claim 1, wherein the vitamin E substance is selected from the group consisting of alpha tocopherol, alpha tocopherol acetate, alpha tocopherol succinate, and alpha tocopherol polyethyleneglycol succinate.
- 6. The pharmaceutical composition of claim 5, wherein the vitamin E substance is selected from the group consisting of d-alpha tocopherol, dl-alpha tocopherol, d-alpha tocopherol acetate, dl-alpha tocopherol acetate, d-alpha tocopherol succinate, and dl-alpha tocopherol succinate.
- 7. The pharmaceutical composition of claim 1, wherein the surfactant is selected from the group consisting of polyoxyl 35 castor oil, PEG-40 hydrogenated castor oil, caprylocaproyl macrogol-8 glycerides, polysorbate 80, lauroyl macrogol-32 glycerides, stearoyl macrogol-32 glycerides, and tocopherol polyethyleneglycol 1000 succinate.
- 8. A pharmaceutical composition comprising:
a. a steroid; b. a vitamin E substance; and c. a surfactant,
wherein after a 100× dilution of the composition in an aqueous medium, at least 30% of the hydrophobic drug or the vitamin E substance is dispersed in the aqueous phase.
- 9. The pharmaceutical composition according to claim 8, wherein at least 50% of the active agent or the vitamin E substance is dispersed in the aqueous phase.
- 10. The pharmaceutical composition according to claim 8, wherein at least 30% of the active agent or the vitamin E substance is finely dispersed in the aqueous phase.
- 11. The pharmaceutical composition according to claim 10, wherein at least 50% of the active agent or the vitamin E substance is finely dispersed in the aqueous phase.
- 12. The pharmaceutical composition of claim 8, wherein the steroid is present in an amount ranging from 0.01% to 30% w/w of the composition, the vitamin E substance is present in an amount ranging from about 1% to 95% w/w of the composition, and the surfactant is present in an amount ranging from about 5 to 85% w/w of the composition.
- 13. The pharmaceutical composition of claim 12, wherein the steroid is progesterone.
- 14. The pharmaceutical composition of claim 12, wherein the steroid is testosterone.
- 15. The pharmaceutical composition of claim 12, wherein the steroid is dehydroepiantrosterone.
- 16. The pharmaceutical composition of claim 8, wherein the vitamin E substance is selected from the group consisting of alpha tocopherol, alpha tocopherol acetate, alpha tocopherol succinate, and alpha tocopherol polyethyleneglycol succinate.
- 17. The pharmaceutical composition of claim 16, wherein the vitamin E substance is selected from the group consisting of d-alpha tocopherol, dl-alpha tocopherol, d-alpha tocopherol acetate, di-alpha tocopherol acetate, d-alpha tocopherol succinate, and di-alpha tocopherol succinate.
- 18. The pharmaceutical composition of claim 8, wherein the surfactant is selected from the group consisting of polyoxyl 35 castor oil, PEG-40 hydrogenated castor oil, caprylocaproyl macrogol-8 glycerides, polysorbate 80, lauroyl macrogol-32 glycerides, stearoyl macrogol-32 glycerides, and tocopherol polyethyleneglycol 1000 succinate.
- 19. The pharmaceutical composition of claim 8, wherein the steroid is progesterone, the vitamin E substance is alpha tocopherol, and the surfactant is polyoxyl 35 castor oil.
- 20. The pharmaceutical composition of claim 19, wherein the progesterone is present in an amount ranging from about 0.1% to 30% w/w.
- 21. The pharmaceutical composition of claim 20, wherein the progesterone is present in an amount ranging from about 0.01% to 0.3% w/w.
- 22. The pharmaceutical composition of claim 8, wherein the steroid is dehydroepiantrosterone, the vitamin E substance is alpha.tocopherol, and the surfactant is polyoxyl 35 castor oil.
- 23. The pharmaceutical composition of claim 22, wherein the dehydroepiantrosterone is present in an amount of at least 5% w/w.
- 24. The pharmaceutical composition of claim 8, wherein the steroid is testosterone, the vitamin E substance is alpha tocopherol succinate, and the surfactant is tocopherol polyethyleneglycol 1000 succinate.
- 25. The pharmaceutical composition of claim 24, wherein the testosterone is present in an amount of at least 1% w/w.
- 26. The pharmaceutical composition of claim 8, wherein the steroid is progesterone, the vitamin E substance is alpha tocopherol succinate, and the surfactant is tocopherol polyethyleneglycol 1000 succinate.
- 27. The pharmaceutical composition of claim 26, wherein the progesterone is present in an amount ranging from about 1% to 30%.
- 28. A method of improving the bioavailability of a hydrophobic drug administered to a patient comprising administering to said patient a therapeutically effective amount of the pharmaceutical composition of claim 2 in a suitable dosage form.
- 29. A method of improving the bioavailability of a steroid administered to a patient comprising administering to said patient a therapeutically effective amount of the pharmaceutical composition of claim 8 in a suitable dosage form.
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09/716,029, filed Nov. 17, 2000, and a continuation-in-part of U.S. patent application Ser. No. 09/877,541, filed Jun. 8, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/345,615, filed Jun. 30, 1999, and a continuation-in-part of U.S. application Ser. No. 09/751,968, filed Dec. 29, 2000, which is a continuation-in-part of U.S. application Ser. No. 09/375,636, filed Aug. 17, 1999, the disclosures of which are incorporated herein by reference in their entireties.
Continuation in Parts (5)
|
Number |
Date |
Country |
Parent |
09716029 |
Nov 2000 |
US |
Child |
10444935 |
May 2003 |
US |
Parent |
09877541 |
Jun 2001 |
US |
Child |
10444935 |
May 2003 |
US |
Parent |
09345615 |
Jun 1999 |
US |
Child |
09877541 |
Jun 2001 |
US |
Parent |
09751968 |
Dec 2000 |
US |
Child |
09877541 |
Jun 2001 |
US |
Parent |
09375636 |
Aug 1999 |
US |
Child |
09751968 |
Dec 2000 |
US |