Clinical uses of polyene macrolides

US-Patent, March 1999

Abstract

The present invention relates to the use of at least one polyene macrolide for the preparation of pharmaceutical compositions for the treatment of diseases that are associated with an impaired energy turnover. Particularly, the present inventions allows to specifically stimulate the energy conversion in human cell, i.e. to stimulate the cell metabolism, and thus to treat or prevent a series of diseases.

Claims

I claim:

1. A method for modulating the energy conversion in the body cells of a mammal, comprising the oral, topical and/or intranasal administration to the mammal, of at least one polyene macrolide or functional derivative thereof in an amount influencing the frequency of variations in the cellular potential.

2. A method for treating a disease comprising the topical, oral and/or intranasal administration of a therapeutically effective amount of at least one polyene macrolide or a functional equivalent thereof to a mammal suffering from said disease wherein said disease is not caused by a fungus.

3. A method for treating HIV infections, wherein after the diagnosis of seroconversion and preferably before the manifestation of AIDS symptoms the polyene macrolide is given to a HIV-infected patient by chronic oral administration.

4. The method according to claim 3, wherein the polyene macrolide is administered in a daily dose of about 0.5 to 5 g, preferably about 1 to 3 g.

5. The method according to claim 2 for treating herpes simplex virus infections, wherein the polyene macrolide formulated into a suitable pharmaceutical composition having an active ingredient content of about 40 to 200 mg per g of the composition is applied several times daily onto the inflammation focus until the symptoms disappear; and/or the polyene macrolide is chronically administered in a daily oral dose of about 0.5 to 5 g.

6. The method according to claim 2 for treating varicella zoster infections, wherein the polyene macrolide formulated into a suitable pharmaceutical composition having an active ingredient content of about 40 to 200 mg per g of the composition is applied several times onto the inflammation focus until the efflorescences disappear.

7. The method according to claim 2 for treating hepatitis B virus infections, wherein the polyene macrolide is orally administered in a daily dose of about 0.5 to 3 g over a period of about 3 or 6 months or more until the symptoms disappear.

8. The method according to claim 2 for treating recurrent aphthous stomatitis, wherein the polyene macrolide formulated into a suitable pharmaceutical composition having an active ingredient content of about 20 to 200 mg/g of the pharmaceutical composition is applied onto the lesions optionally several times a day until the lesions disappear.

9. The method according to claim 2 for treating rheumatoid arthritis, osteoarthritis or other rheumatic diseases, wherein the polyene macrolide is orally administered to the patient in a daily dose of about 0.5 to 4 g until the symptoms disappear.

10. The method according to claim 2 for treating multiple sclerosis, wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g.

11. The method according to claim 2 for treating food allergies, wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g.

12. The method according to claim 2 for treating allergies, such as pollen, dust, mite and food allergies and the like, wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g.

13. The method according to claim 2 for treating liver cirrhosis wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g.

14. The method according to claim 2 for treating Lichen ruber, wherein the polyene macrolide is orally administered to the patient in a daily dose of about 1 to 4 g until the efflorescences have disappeared completely.

15. The method according to claim 2 for treating neurodermatitis, wherein the polyene macrolide formulated into a suitable pharmaceutical composition having an active ingredient content of about 20 to 200 mg/g of the composition is applied onto the affected skin portions several times a day until the symptoms have disappeared completely.

16. The method according to claim 2 for treating the cold agglutinin disease, wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g.

17. The method according to claim 2 for treating polyneuroradiculitis, wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g until the pareses and the pain symptoms disappear.

18. A method according to claim 2 for prophylactically treating sepsis, wherein the polyene macrolide is orally administered to the patient in a daily dose of about 1 to 5 g.

19. The method according to claim 2 for treating immunological disorders produced by antibiotics, wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g.

20. The method according to claim 2 for treating the chronic fatigue syndrome, wherein the polyene macrolide is orally administered to the patient in a daily dose of about 0.5 to 4 g until the symptoms have disappeared completely.

21. The method according to claim 2 for treating the postmenopausal syndrome, wherein the polyene macrolide is orally administered to a patient in a daily dose of about 0.5 to 4 g until the symptoms have disappeared completely.

22. The method according to claim 2 for treating cancer, wherein the polyene macrolide is chronically administered to a patient in a daily oral dose of 0.5 to 5 g.

23. The method according to claim 2 for treating soft-tissue wounds, wherein the polyene macrolide formulated into a suitable pharmaceutical composition having an active ingredient content of about 50 to 200 mg/g of the pharmaceutical composition is applied optionally several times a day to the affected site until the wounds have healed.

24. The method according to claim 2 for treating burns, including sun burn, wherein the polyene macrolide formulated into a suitable pharmaceutical composition having an active ingredient content of about 50 to 200 mg/g of the composition is applied optionally several times a day until relief from the symptoms is brought about.

25. The method according to claim 2 for treating ulcus cruris and decubitus, wherein the polyene macrolide formulated into a suitable pharmaceutical composition is applied to the lesion in a concentration of about 50 to 200 mg/g of the applied composition until healing is brought about, and, optionally, treatment is chronically continued.

26. The method according to claim 2 for treating hypercholesterinemia, wherein the polyene macrolide is chronically administered to the patient in a daily oral dose of about 0.5 to 4 g.

27. The method according to claim 2 for treating prostatic hyperplasia, wherein the polyene macrolide is chronically administered to the patient in a daily dose of about 0.5 to 4 g.

28. The method according to claim 2 for treating gallstones, wherein the polyene macrolide is administered to the patient in a daily dose of about 0.5 to 4 g at least until the gallstones have disappeared, preferably administration is chronic.

29. The method according to claim 2 for treating acne wherein the polyene macrolide formulated into a suitable pharmaceutical composition having an active ingredient content of about 20 to 200 mg/g of the composition is applied several times a day to the affected skin parts and/or the polyene macrolide is administered in a daily oral dose of 0.5 to 4 g until the acne disappears, optionally treatment is chronic.

30. The method according to claim 2 or 3, wherein the polyene macrolide is administered in a daily oral dose of about 1 to 2 g, or is topically applied as a composition having an active ingredient content of about 50 to 100 mg/g of the composition.

31. The method according to any one of claims 1 to 3, wherein the polyene macrolide is nystatin.

32. The method according to claim 3, wherein the polyene macrolide is amphotericin B.

33. A pharmaceutical composition for topical administration, containing a polyene macrolide or a functional derivative thereof in a concentration of about 40 to 200 mg/g of the composition together with usual pharmaceutically acceptable auxiliaries.

34. A pharmaceutical composition for oral administration containing a polyene macrolide or a functional derivative thereof in a dose of about 200 to 500 mg optionally in combination with usual pharmaceutically acceptable auxiliaries.

35. A method for modulating the energy conversion in the body cells of a mammal, comprising the oral administration to the mammal, of at least one polyene macrolide or functional derivative thereof in an amount influencing the frequency of variations in the cellular potential.

36. The method according to claim 2, wherein the polyene macrolide is nystatin.

37. The method according to claim 2, wherein the polyene macrolide is amphotericin B.

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