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Claims for Patent: 6,670,335

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Claims for Patent: 6,670,335

Title: Fluorouracil-containing formulation
Abstract:Oil-in-water emulsion formulations contain both free fluorouracil and fluorouracil impregnated in porous microparticles. The formulations are suitable for topical administration, and are useful for the treatment of solar keratoses, actinic keratoses, and superficial basal cell carcinomas.
Inventor(s): Singh; B. Sandhya (San Jose, CA), Saxena; Subhash J. (Belmont, CA)
Assignee: A. P. Pharma, Inc. (Redwood City, CA)
Application Number:09/799,792
Patent Claims: 1. A topical formulation containing fluorouracil, comprising: (i) an oil-in-water emulsion; and (ii) dispersed within the oil-in-water emulsion, (a) fluorouracil; and (b) fluorouracil-impregnated porous microparticles, where the formulation has a total fluorouracil content that the sum of the fluorouracil in (ii)(a) and the fluorouracil in the fluorouracil-impregnated porous microparticles of (ii)(b) of from about 0.01% to about 10% by weight and a free fluorouracil content that is the fluorouracil in (ii)(a) of from 20% to 50% by weight of the total fluorouracil content.

2. The formulation of claim 1, where the formulation has a total fluorouracil content of from about 0.1% to about 5% weight.

3. The formulation of claim 2, where the formulation has a total fluorouracil content of 0.5% by weight.

4. The formulation of claim 1, where the formulation has a free fluorouracil content of 30% by weight of the total fluorouracil content.

5. The formulation of claim 1, where the formulation has a total fluorouracil content of 0.5% by weight and a free fluorouracil content of 30% by weight of the total fluorouracil content.

6. The formulation of claim 1, where the porous microparticles have a weight average diameter less than 50 .mu.m.

7. The formulation of claim 6, where the porous microparticles have a weight average diameter of about 20 .mu.m.

8. The formulation of claim 1, where the porous microparticles comprise a cross-linked polymer selected from the group consisting of a styrene/divinylbenzene crosspolymer, a vinyl stearate/divinylbenzene crosspolymer, a methyl methacrylate/ethylene glycol dimethacrylate crosspolymer, and a lauryl methacrylate/ethylene glycol dimethacrylate crosspolymer.

9. The formulation of claim 8, where the porous microparticles comprise a methyl methacrylate/ethylene glycol dimethacrylate crosspolymer.

10. The formulation of claim 1, further comprising at least one additional component selected from an antioxidant, a chelating agent, a colorant, a fragrance, and a preservative.

11. The formulation of claim 1, where the formulation has a total fluorouracil content of 0.50%, a free fluorouracil content of 30% by weight of the total fluorouracil content, and the porous microparticles have a weight average diameter of about 20 .mu.m and comprise a methyl methacrylate/ethylene glycol dimethacrylate crosspolymer.

12. A method for the topical application of fluorouracil, comprising topical administration of the formulation of claim 1.

13. A method for the topical application of fluorouracil, comprising topical administration of the formulation of claim 2.

14. A method for the topical application of fluorouracil, comprising topical administration of the formulation of claim 3.

15. A method for the topical application of fluorouracil, comprising topical administration of the formulation of claim 4.

16. A method for the topical application of fluorouracil, comprising topical administration of the formulation of claim 5.

17. A method for the topical application of fluorouracil, comprising topical administration of the formulation of claim 11.

18. A method of treating an animal having a disease capable of treatment by topical administration of fluorouracil, comprising topically administering to that animal a therapeutically effective amount of the formulation of claim 1.

19. A method of treating an animal having a disease selected from solar keratosis, actinic keratosis, and superficial basal cell carcinoma, comprising topically administering to that animal a therapeutically effective amount of the formulation of claim 1.

20. A method of treating an animal having a disease selected from solar keratosis, actinic keratosis, and superficial basal cell carcinoma, comprising topically administering to that animal a therapeutically effective amount of the formulation of claim 11.
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