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Claims for Patent: 5,534,554

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Claims for Patent: 5,534,554

Title: Sucrose ester-C20 to C28 alcohol formulations
Abstract:A stable, efficacious therapeutic cream wherein a principal therapeutic compounds are one or more C-20 to C-28 long chain aliphatic alcohols, of which n-docosanol is exemplary, comprising sucrose cocoate, sucrose stearates or sucrose distearate, or mixtures thereof, is disclosed.
Inventor(s): Katz; David H. (La Jolla, CA), Khalil; Mohammed H. (San Diego, CA), Marcelletti; John F. (San Diego, CA), Pope; Laura E. (Carlsbad, CA), Katz; Lee R. (La Jolla, CA)
Assignee: Lidak Pharmaceuticals (La Jolla, CA)
Application Number:08/299,944
Patent Claims: 1. A therapeutic cream for application to skin and membranes consisting essentially of a sugar-based ester surfactant, greater than about 5% by weight n-docosanol, mineral oil, an emollient co-solvent, and water, for the treatment of viral and inflammatory diseases, wherein said cream is stable at temperatures of at least 40.degree. C. for a period of at least three months and after repeated freeze-thaw cycles.

2. The therapeutic cream of claim 1 wherein the sugar-based ester surfactant is selected from the group consisting of sucrose cocoate, sucrose stearates and sucrose distearate.

3. The therapeutic cream of claim 2 wherein the emollient co-solvent is selected from the group consisting of polyoxypropylene stearyl ether, ethyl hexanediol, and benzyl alcohol, or combinations thereof.

4. A therapeutic cream for application to skin and membranes consisting essentially of a sugar-based ester surfactant, greater than about 5% by weight of at least one long chain aliphatic alcohol having from 20 to 28 carbon atoms selected from the group consisting of n-icosanol, n-henicosanol, n-docosanol, n-tricosanol, n-tetracosanol, n-pentacosanol, n-hexacosanol, n-heptacosanol, and n-octacosanol, or mixtures thereof, mineral oil, an emollient co-solvent, and water, for the treatment of viral and inflammatory diseases, wherein said cream is stable at temperatures of at least 40.degree. C. for a period of at least three months and after repeated freeze-thaw cycles.

5. The therapeutic cream of claim 4 wherein the sugar-based ester surfactant comprises at least one compound selected from the group of sucrose esters consisting of sucrose cocoate, sucrose stearates and sucrose distearate, wherein sucrose ester(s) comprise at least about 3% by weight of the cream.

6. The therapeutic cream of claim 4 wherein sucrose ester(s) comprise at least about 10%.+-.5% by weight of the cream.

7. The therapeutic cream of claim 6 wherein the emollient co-solvent is selected from the group consisting of polyoxypropylene stearyl ether, ethyl hexanediol, and benzyl alcohol, or combinations thereof.

8. The therapeutic cream of claim 7 wherein the long chain aliphatic alcohol comprises at least approximately 10% by weight of the cream.

9. A therapeutic cream comprising a therapeutic composition and a cream base, wherein said therapeutic composition consists essentially of at least one long chain aliphatic alcohol having from 20 to 28 carbon atoms selected from the group consisting of n-icosanol, n-henicosanol, n-docosanol, n-tricosanol, n-tetracosanol, n-pentacosanol, n-hexacosanol, n-heptacosanol, and n-octacosanol, or mixtures thereof, and wherein said cream base comprises one or more compounds selected from the group consisting of sucrose cocoate, sucrose stearates and sucrose distearate and one or more compounds selected from the group consisting of polyoxypropylene stearyl ether, ethyl hexanediol and benzyl alcohol,

10. The therapeutic cream of claim 9 wherein at least one member of the group consisting of sucrose cocoate, sucrose stearates and sucrose distearate is at least about 10%.+-.5% by weight of the cream.

11. The therapeutic cream of claim 10 wherein the long chain aliphatic alcohol having from 20 to 28 carbon atoms comprises at least approximately 10% by weight of the cream.

12. The therapeutic cream of claim 10 wherein the therapeutic composition consists essentially of n-docosanol.

13. The therapeutic cream of claim 10 having the formulation: at least one long chain aliphatic alcohol having from 20 to 28 carbon atoms selected from the group consisting of n-icosanol, n-henicosanol, n-docosanol, n-tricosanol, n-tetracosanol, n-pentacosanol, n-hexacosanol, n-heptacosanol, and n-octacosanol, or mixtures thereof comprising from 5% to 15% by weight of the cream; sucrose stearates comprising from 0% to 15% by weight of the cream; sucrose cocoate comprising from 0% to 10% by weight of the cream; sucrose distearate comprising from 0% to 10% by weight of the cream; with the proviso that at least one sucrose ester be present and comprise at least about 3% by weight of the cream; mineral oil comprising from 3% to 15% by weight of the cream, benzyl alcohol comprising from 0.5% to 10% by weight of the cream; and water comprising from 45% to 70% by weight of the cream.

14. A method of treating viral infections and inflammations of skin and mucous membranes comprising applying a stable therapeutic topical cream to a person in need thereof, said cream comprising a therapeutically active composition consisting essentially of n-docosanol, a cream base consisting essentially of sugar-based ester surfactant, at least one long chain aliphatic alcohol having from 20 to 28 carbon atoms selected from the group consisting of n-icosanol, n-henicosanol, n-docosanol, n-tricosanol, n-tetracosanol, n-pentacosanol, n-hexacosanol, n-heptacosanol, and n-octacosanol, or mixtures thereof, mineral oil, an emollient co-solvent, and water.

15. The method of claim 14 wherein n-docosanol comprises more than one-half of the long chain aliphatic alcohol mixture.

16. A method of treating viral infections and inflammations of skin and mucous membranes comprising applying a topical cream to a person in need thereof having the formulation:

with the proviso that at least one sucrose ester by present and, wherein sucrose ester(s) comprise about 3% by weight or more of the cream,

with the proviso that either polyoxypropylene-15-stearyl ether or benzyl alcohol be present in an amount of at least 1% by weight, and

17. The method of claim 16 wherein sucrose ester(s) comprise about 10%.+-.5% by weight or more of the cream.

18. A cream having the formulation:

with the proviso that at least one sucrose ester be present and wherein sucrose ester(s) comprise about 3% by weight or more of the cream,

with the proviso that either polyoxypropylene stearyl ether or benzyl alcohol be present in an amount of about 1% by weight or more; and

for the prevention or treatment of inflammation or viral infection.

19. The cream of claim 18 wherein sucrose ester(s) comprise about 10%.+-.5% by weight or more of the cream.

20. A method of reducing the pain of a surface inflammation of the skin or membrane comprising applying to an inflamed surface a composition comprising at least one long chain aliphatic alcohol having from 20 to 28 carbon atoms selected from the group consisting of n-icosanol, n-henicosanol, n-docosanol, n-tricosanol, n-tetracosanol, n-pentacosanol, n-hexacosanol, n-heptacosanol, and n-octacosanol, or mixtures thereof, in a physiologically compatible carrier, said alcohol comprising from about 5% to about 25% by weight of said composition.

21. The method of claim 20 wherein the physiologically compatible carrier is a cream base comprising at least one compound selected from the group consisting of sucrose cocoate, sucrose stearates and sucrose distearate and at least one compound selected from the group consisting of polyoxypropylene stearyl ether, ethyl hexanediol and benzyl alcohol.

22. The method of claim 21 wherein the long chain aliphatic alcohol consists essentially of n-docosanol.
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