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Claims for Patent: 8,110,225

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Claims for Patent: 8,110,225

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:12/717,588
Patent Claims: 1. A dry formulation of dantrolene sodium which, upon addition of water, produces a safe for injection, low volume formulation of dantrolene sodium, for administration to mammals, comprising: in dry form, 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 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 with a concentration of dantrolene sodium in the range of 3.33 mg/ml to 167 mg/ml that is safe for intravenous administration and ready for injection.

2. The dry formulation of claim 1, consisting essentially of: in dry form, 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 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 with a concentration of dantrolene sodium in the range of 3.33 mg/ml to 167 mg/ml that is safe for intravenous administration and ready for injection.

3. The dry formulation of claim 1, wherein the concentration is in the range of 30-80 mg/ml or in the range of 10-60 mg/ml.

4. The dry formulation of claim 1, wherein the concentration is 50 mg/ml.

5. The dry formulation of claim 1, wherein at least 95% of the dantrolene sodium particles are no more than 0.8 microns in diameter.

6. The dry formulation of claim 1, wherein the compound is mannitol and the formulation comprises no more than 30 milligrams of mannitol per milligram of said dantrolene.

7. The dry formulation of claim 1, wherein said water soluble polysorbate has a solubility of 5 mg/ml or greater.

8. The dry formulation of claim 1, further comprising polyvinylpyrrolidone (PVP).

9. The dry formulation of claim 8, consisting essentially of: in dry form, 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), said 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 with a concentration of dantrolene sodium in the range of 3.33 mg/ml to 167 mg/ml that is safe for intravenous administration and ready for injection.

10. A method for preparing a safe for injection, low volume formulation of dantrolene sodium, consisting essentially of the step of: 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, said combining step being performed according to one or more of the following: (a) by a single person, (b) by hand shaking, (c) in a single vial or syringe, and (d) in one minute or less, and whereupon said combining, the liquid formulation is ready for injection.

11. The method of claim 10, wherein the concentration is in the range of 30-80 mg/ml or in the range of 10-60 mg/ml.

12. The method of claim 11, wherein the concentration is 50 mg/ml.

13. The method of claim 10, 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.

14. The method of claim 10, wherein the dry formulation further comprises polyvinylpyrrolidone (PVP).

15. The method of claim 14, 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).

16. A method for preparing a safe for injection, low volume formulation of dantrolene sodium, consisting essentially of the step of: 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 3 to 150 milliliters of 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 in a concentration wherein 3 to 150 milliliters of the liquid formulation provides approximately 500 milligrams of dantrolene sodium, whereupon said combining, the liquid formulation is ready for injection.

17. The method of claim 16, wherein said combining step is performed according to one or more of the following: (a) by hand shaking, (b) by vortexing, and (c) in one minute or less.

18. The method of claim 16, 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 16, 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).
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