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Claims for Patent: 7,198,796

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Claims for Patent: 7,198,796

Title:Antifungal parenteral products
Abstract:Parenteral pharmaceutical formulations containing an echinocandin antifungal compound and an aqueous solvent are provided, wherein the formulation includes ethanol, for example about 20% w/v ethanol. The parenteral pharmaceutical formulation may further include one or more additives, such as a stabilizing agent, buffer or tonicity agent. The parenteral pharmaceutical formulations are useful in extending the shelf life and improving the solubility of the echinocandin antifungal compound.
Inventor(s): Stogniew; Martin (Blue Bell, PA)
Assignee: Vicuron Pharmaceuticals Inc. (New York, NY)
Application Number:11/195,498
Patent Claims: 1. A pharmaceutically acceptable parenteral formulation comprising anidulafungin wherein the anidulafungin is stored in solid form for greater than 9 months prior to forming said formulation, and an aqueous solvent, wherein the formulation includes from about 5% w/v to about 50% w/v ethanol.

2. The formulation of claim 1, wherein the aqueous solvent is water or saline.

3. The formulation of claim 1, wherein the formulation includes about 10% to about 40% w/v ethanol, and about 0.2% to about 2.0% w/v anidulafungin.

4. The formulation of claim 1, wherein the formulation includes about 15 to about 30% w/v ethanol.

5. The formulation of claim 1, wherein the formulation includes about 20% w/v ethanol.

6. The formulation of claim 1, further comprising about 10% to about 50% w/v of at least one of propylene glycol and polyethylene glycol.

7. The formulation of claim 1, further comprising a stabilizing agent.

8. The formulation of claim 7, wherein the stabilizing agent is selected from the group consisting of mannitol, histidine, lysine, glycine, sucrose, fructose, trehalose, lactose and mixtures thereof.

9. The formulation of claim 1, further comprising a bulking agent.

10. The formulation of claim 9, wherein the bulking agent is selected from the group consisting of mannitol, glycine, lactose, sucrose, trehalose, dextran, hydroxyethyl starch, ficoll and gelatin.

11. The formulation of claim 1, further comprising a solubilizing agent.

12. The formulation of claim 11, wherein the solubilizing agent is a polysorbate.

13. The formulation of claim 11, wherein the solubilizing agent is polysorbate 80.

14. The formulation of claim 1, further comprising a buffer.

15. The formulation of claim 14, wherein the buffer is selected from the group consisting of acetates, citrates, tartrates, lactates, succinates, and phosphates.

16. The formulation of claim 1, further comprising a tonicity agent.

17. The formulation of claim 16, wherein the tonicity agent is selected from the group consisting of glycerin, lactose, mannitol, dextrose, sodium chloride, sodium sulfate and sorbitol.

18. The formulation of claim 1, further comprising an antioxidant.

19. The formulation of claim 18, wherein the antioxidant is selected from the group consisting of acetone sodium bisulfite, bisulfite sodium, butylated hydroxy anisole, butylated hydroxy toluene, cysteine, cysteinate HC1, dithionite sodium, gentisic acid, gentisic acid ethanolamine, glutamate monosodium, formaldehyde sulfoxylate sodium, metabisulfite potassium, metabisulfite sodium, monothioglycerol, propyl gallate, sulfite sodium, thioglycolate sodium, and ascorbic acid.

20. The formulation of claim 1, wherein the formulation comprises: 5.0 30% w/v ethanol; 0.1 2.0% w/v anidulafungin; 0.1 1.0% w/v of a stabilizing agent; 0.1 1 0.0% w/v of a bulking agent; 0.01 5.0% w/v of a buffer; and 0.1 5.0% w/v of a solubilizing agent.

21. The formulation of claim 1, wherein the formulation comprises: 5.0 30% w/v ethanol; 0.1 2,0% w/v anidulafungin; 0.1 1.0% w/v fructose; 0.1 10.0% w/v mannitol; 0.01 5.0% w/v tartaric acid; and 0.1 5.0% w/v polysorbate 80.

22. The formulation of claim 1, wherein the formulation comprises about 2 to 50% w/v of at least one of polyethylene glycol and propylene glycol.

23. The composition of claim 1, wherein the anidulafungin is stored in solid form for greater than 12 months prior to forming said formulation, and wherein said formulation is suitable for use as a parenteral formulation.
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