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Claims for Patent: 8,377,919

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Claims for Patent: 8,377,919

Title:Therapeutic compositions
Abstract: Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.
Inventor(s): Brown; Marc Barry (Watford, GB), Crowthers; Michael Edward Donald (Hillsborough, GB), Nazir; Tahir (Isleworth, GB)
Assignee: LEO Laboratories Limited (Dublin, IE)
Application Number:13/563,698
Patent Claims: 1. A pharmaceutical formulation for topical use in treatment of a subject, said pharmaceutical formulation comprising ingenol angelate in an amount from about 0.001% to about 0.15% w/w, wherein at least about 95% of the ingenol angelate is ingenol-3-angelate (isoform `b`) and said pharmaceutical formulation has a pH of less than 4.

2. The pharmaceutical formulation of claim 1 having a pH of about 3.5 or less.

3. The pharmaceutical formulation of claim 1 having a pH of about 3.0.

4. The pharmaceutical formulation of claim 1 having a pH within the range of about 2.5 to less than 4.0.

5. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a gel.

6. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a cream.

7. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is an ointment.

8. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a paint.

9. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a lotion.

10. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a foam.

11. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a transdermal patch.

12. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a sustained release formulation.

13. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is an emulsion.

14. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is an oil.

15. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation is a buccal formulation.

16. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation further comprises a penetration enhancer, a preservative, a gelling agent or a buffer.

17. A pharmaceutical formulation for topical use in treatment of a subject, said pharmaceutical formulation comprising ingenol-3-angelate (isoform `b`) and having a pH of less than 4, whereby, when an effective amount of said pharmaceutical formulation is applied to the skin, the rate of permeation of the ingenol-3-angelate (isoform `b`) across the skin is between about 11 ng cm.sup.-2h.sup.-1 and about 2 .mu.g cm.sup.-2h.sup.-1.

18. The pharmaceutical formulation of claim 17, wherein the rate of permeation of the ingenol-3-angelate (isoform `b`) across the skin is between about 11 ng cm.sup.-2h.sup.-1 and about 1 .mu.g cm.sup.-2h.sup.-1.

19. The pharmaceutical formulation of claim 18, wherein the amount of ingenol-3-angelate applied to the skin is between about 0.01 .mu.g cm.sup.-2 and 1000 .mu.g cm.sup.-2.

20. The pharmaceutical formulation of claim 18, wherein the amount of ingenol-3-angelate applied to the skin is between about 0.01 .mu.g cm.sup.-2 and 100 .mu.g cm.sup.-2.

21. The pharmaceutical formulation of claim 18 having a pH of about 3.5 or less.

22. The pharmaceutical formulation of claim 18 having a pH of about 3.0.

23. The pharmaceutical formulation of claim 18 having a pH within the range of about 2.5 to less than 4.0.

24. The pharmaceutical formulation of claim 18, wherein said pharmaceutical formulation is a gel.
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