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Claims for Patent: 8,685,460

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Claims for Patent: 8,685,460

Title:Treatment using dantrolene
Abstract: Provided are low-volume, safe for injection formulations of dantrolene yielding significant advantages over the currently approved and marketed dantrolene for malignant hyperthermia (MH) threatening anesthetic crisis. Once dantrolene can be made immediately available to patients triggered of MH, the anesthesiologist will be able to focus exclusively on the management of the patient's physiologic status in this complex and evolving crisis, not on the laborious and time consuming reconstitution process of the rescue agent. The low volume, safe for injection formulations of dantrolene have significant advantages over currently used approaches to the prevention and treatment of pumphead, and other neurological, cognitive and motor dysfunction incident to iatrogenically or trauma induced situations of altered blood flow, including those incurred during surgical procedures involving CPB or related procedures, as well as those incurred during non-normothermic episodes caused iatrogenically or by disease.
Inventor(s): Anderson; David (Ashland, VA), Cameransi, Jr.; Benjamin G. (Georgetown, SC), Conklin; Vincent M. (Richmond, VA)
Assignee: Lyotropic Therapeutics, INc (Ashland, VA)
Application Number:13/353,478
Patent Claims: 1. A method for treating heat stroke in mammal, comprising the step of: administering to a mammal in need of treatment for heat stroke a therapeutically effective amount of a safe for injection, low volume liquid formulation of dantrolene sodium comprising: dantrolene sodium at a concentration in the range of 3.33 mg/ml to 166.67 mg/ml; a water-soluble polysorbate; a compound selected from the group consisting of sorbitol and mannitol; and water as a liquid carrier, wherein said dantrolene sodium and water are present together as a colloidal dispersion of dantrolene sodium particles in the water, wherein the dantrolene sodium particles are less than about 2 microns in average diameter, and wherein the formulation is safe for intravenous administration.

2. The method of claim 1, wherein the formulation comprises dantrolene sodium at a concentration in the range of 30-80 mg/ml or in the range of 10-60 mg/ml.

3. The method of claim 1, wherein the formulation consists essentially of: dantrolene sodium at a concentration in the range of 3.33 mg/ml to 166.67 mg/ml; a water-soluble polysorbate; a compound selected from the group consisting of sorbitol and mannitol: and water as a liquid carrier, wherein said dantrolene sodium and water are present together as a colloidal dispersion of dantrolene sodium particles in the water, wherein the dantrolene sodium particles are less than about 2 microns in average diameter, and wherein the formulation is safe for intravenous administration.

4. The method of claim 3, wherein the formulation comprises dantrolene sodium at a concentration in the range of 30-80 mg/ml or in the range of 10-60 mg/ml.

5. The method of claim 1, wherein the dantrolene sodium is the primary modulator of intracellular calcium present in the formulation.

6. The method of claim 1, wherein the formulation further comprises polyvinylpyrrolidone (PVP).

7. The method of claim 6, wherein the formulation consists essentially of: dantrolene sodium at a concentration in the range of 3.33 mg/ml to 166.67 mg/ml; a water-soluble polysorbate; a compound selected from the group consisting of sorbitol and mannitol; polyvinylpyrrolidone (PVP); and water as a liquid carrier, wherein said dantrolene sodium and water are present together as a colloidal dispersion of dantrolene sodium particles in the water, wherein the dantrolene sodium particles are less than about 2 microns in average diameter, and wherein the formulation is safe for intravenous administration.

8. The method of claim 7, wherein the formulation comprises dantrolene sodium at a concentration in the range of 30-80 mg/ml or in the range of 10-60 mg/ml.

9. The safe method of claim 1, wherein the compound is mannitol and the formulation comprises no more than 30 milligrams of mannitol per milligram of dantrolene.

10. The method of claim 1, wherein the administering step further comprises administering a quantity of 3-150 milliliters of the formulation to the mammal.

11. The method of claim 10, wherein the quantity is 10 milliliters or less.

12. The method of claim 11, wherein the quantity is 5 milliliters or less.

13. The method of claim 1, wherein the administering step further comprises administering a dose of 250-300 mg dantrolene sodium to the mammal.

14. The method of claim 10, wherein the administering step further comprises administering a dose of 250-300 mg dantrolene sodium to the mammal.

15. The method of claim 1, further comprising a step of: preparing the safe for injection, low volume liquid formulation of dantrolene sodium by combining a dry formulation comprising: dantrolene sodium consisting essentially of dantrolene sodium particles less than about 2 microns in average diameter; a water-soluble polysorbate; and a compound selected from the group consisting of sorbitol and mannitol, said dry formulation being reconstitutable by water to provide a colloidal dispersion of dantrolene sodium particles less than about 2 microns in average diameter in the water that is safe for intravenous administration, with water to form a liquid formulation that is a colloidal dispersion of dantrolene sodium particles less than about 2 microns in average diameter in the water that is safe for intravenous administration, and in which the dantrolene sodium is present at a concentration in the range of 3.33 mg/ml to 166.67 mg/ml, and whereupon said combining, the liquid formulation is ready for injection.

16. The method of claim 15, wherein said combining comprises mechanical agitation.

17. The method of claim 16, wherein said combining is performed in one minute or less.

18. The method of claim 15, wherein the dry formulation consists essentially of: dantrolene sodium consisting essentially of dantrolene sodium particles less than about 2 microns in average diameter; a water-soluble polysorbate; and a compound selected from the group consisting of sorbitol and mannitol.

19. The method of claim 15, wherein the dry formulation further comprises polyvinylpyrrolidone (PVP).

20. The method of claim 19, wherein the dry formulation consists essentially of: dantrolene sodium consisting essentially of dantrolene sodium particles less than about 2 microns in average diameter; a water-soluble polysorbate; a compound selected from the group consisting of sorbitol and mannitol; and polyvinylpyrrolidone (PVP).

21. A method for treating a non-normothermia condition in mammal, comprising the step of: administering to a mammal in need of treatment for a non-normothermic condition a therapeutically effective amount of a safe for injection, low volume liquid formulation of dantrolene sodium comprising: dantrolene sodium at a concentration in the range of 3.33 mg/ml to 166.67 mg/ml; a water-soluble polysorbate; a compound selected from the group consisting of sorbitol and mannitol; and water as a liquid carrier, wherein said dantrolene sodium and water are present together as a colloidal dispersion of dantrolene sodium particles in the water, wherein the dantrolene sodium particles are less than about 2 microns in average diameter, and wherein the formulation is safe for intravenous administration.

22. The method of claim 21, wherein the formulation comprises dantrolene sodium at a concentration in the range of 30-80 mg/ml or in the range of 10-60 mg/ml.

23. The method of claim 21, wherein the non-normothermic condition is selected from the group consisting of malignant hyperthermia and heat stroke.

24. The method of claim 23, wherein the formulation comprises dantrolene sodium at a concentration in the range of 30-80 mg/ml or in the range of 10-60 mg/ml.

25. The method of claim 21, further comprising a step of: preparing the safe for injection, low volume liquid formulation of dantrolene sodium by combining a dry formulation comprising: dantrolene sodium consisting essentially of dantrolene sodium particles less than about 2 microns in average diameter; a water-soluble polysorbate; and a compound selected from the group consisting of sorbitol and mannitol, said dry formulation being reconstitutable by water to provide a colloidal dispersion of dantrolene sodium particles less than about 2 microns in average diameter in the water that is safe for intravenous administration, with water to form a liquid formulation that is a colloidal dispersion of dantrolene sodium particles less than about 2 microns in average diameter in the water that is safe for intravenous administration, and in which the dantrolene sodium is present at a concentration in the range of 3.33 mg/ml to 166.67 mg/ml, and whereupon said combining, the liquid formulation is ready for injection.
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