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Claims for Patent: 6,469,015

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Claims for Patent: 6,469,015

Title: Pharmaceutical formulation
Abstract:An oil-in-water topical pharmaceutical formulation or an aqueous formulation for the treatment of virus infections of the skin or mucosa, comprising at least 30% of propylene glycol and solubilized penciclovir.
Inventor(s): Griffiths; Hazel-Ann (Dorking, GB), Goodall; Alan John (Worthing, GB), Oduro-Yeboah; Joshua (Worthing, GB)
Assignee: Novartis International Pharmaceutical Ltd (Hamilton, BM)
Application Number:08/462,257
Patent Claims: 1. An oil in water or an aqueous topical pharmaceutical formulation comprising at least 30% propylene glycol and 0.5 to 10% solubilized penciclovir.

2. A pharmaceutical formulation according to claim 1 containing from 30 to 60% propylene glycol and at least 15% water.

3. A pharmaceutical formulation according to claim 2 containing from 30 to 50% propylene glycol and at least 20% water.

4. A pharmaceutical formulation according to claim 3 comprising 0.75 to 5% penciclovir, 35 to 45% propylene glycol and 25 to 40% water together with an oil phase.

5. A pharmaceutical formulation according to claim 4, comprising 1% penciclovir.

6. A pharmaceutical formulation according to claim 1 further comprising an emulsifier.

7. A method of treating a herpes viral infection in a mammal in need thereof, which method comprises topically administering to said mammal an effective amount of a pharmaceutical formulation comprising at least 30% propylene glycol and 0.5 to 10% w/w solubilized penciclovir.

8. The method according to claim 7 wherein the herpes virus is varicella-zoster virus.

9. A pharmaceutical formulation according to claim 6 wherein the emulsifier is selected from the group consisting of polyoxyethylene sorbitan monostearate (polysorbate 60), sorbitan monostearate, sorbitan monooleate, cetostearyl alcohol, myristyl alcohol, glyceryl monostearate, sodium lauryl sulphate, Cetomacrogol 1000 and Carbomer 940.

10. A pharmaceutical formulation according to claim 9 wherein the emulsifier is polyoxyethylene sorbitan monostearate (polysorbate 60).

11. A pharmaceutical formulation according to claim 9 wherein the emulsifier is sorbitan monostearate.

12. A pharmaceutical formulation according to claim 9 wherein the emulsifier is sorbitan monooleate.

13. A pharmaceutical formulation according to claim 9 wherein the emulsifier is cetostearyl alcohol.

14. A pharmaceutical formulation according to claim 9 wherein the emulsifier is myristyl alcohol.

15. A pharmaceutical formulation according to claim 9 wherein the emulsifier is glyceryl monostearate.

16. A pharmaceutical formulation according to claim 9 wherein the emulsifier is sodium lauryl sulphate.

17. A pharmaceutical formulation according to claim 9 wherein the emulsifier is Cetomacrogol 1000.

18. A pharmaceutical formulation according to claim 9 wherein the emulsifier is Carbomer 940.

19. The method according to claim 7 wherein the herpes virus is herpes simplex-1 or herpes simplex-2 virus.

20. The method according to claim 7 wherein the pharmaceutical formulation further comprises an emulsifier selected from the group consisting of polyoxyethylene sorbitan monostearate (polysorbate 60), sorbitan monostearate, sorbitan monooleate, cetostearyl alcohol, myristyl alcohol, glyceryl monostearate, sodium lauryl sulphate, Cetomacrogol 1000 and Carbomer 940.

21. The method according to claim 20 wherein the emulsifier is polyoxyethylene sorbitan monostearate (polysorbate 60).

22. The method according to claim 20 wherein the emulsifier is sorbitan monostearate.

23. The method according to claim 20 wherein the emulsifier is sorbitan monooleate.

24. The method according to claim 20 wherein the emulsifier is cetostearyl alcohol.

25. The method according to claim 20 wherein the emulsifier is myristyl alcohol.

26. The method according to claim 20 wherein the emulsifier is glyceryl monostearate.

27. The method according to claim 20 wherein the emulsifier is sodium lauryl sulphate.

28. The method according to claim 4 wherein the emulsifier is Cetomacrogol 1000.

29. The method according to claim 20 wherein the emulsifier is Carbomer 940.
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