Resiniferatoxin composition

Abstract

This invention provides a resiniferatoxin composition that can be stored for a long period of time without significant degradation. [Solution] The present invention provides non-aqueous solid and liquid compositions comprising resiniferatoxin and a surfactant. These non-aqueous solid and liquid compositions can be used to prepare aqueous compositions used for the treatment of pain, particularly osteoarthritis-related joint pain. Furthermore, the present invention provides a kit comprising the non-aqueous solid and liquid compositions and a diluent, as well as a method for preparing the compositions. The non-aqueous solid and liquid compositions allow for longer storage and recovery of resiniferatoxin compared to reconstitution with the diluent.

Claims

1. A non-aqueous composition of resiniferatoxin, (a) Resiniferatoxin and (b) Surfactants and Includes, The composition wherein the surfactant is D-α-tocopherol polyethylene glycol succinate.

2. The composition according to claim 1, wherein the composition is a solid composition.

3. The composition according to claim 2, wherein the solid composition is a freeze-dried composition.

4. (d) polyethylene glycol and / or (e) Further surfactants Furthermore, The composition according to any one of claims 1 to 3, wherein the further surfactant is optionally a poloxamer.

5. The composition according to any one of claims 1 to 4, wherein at least 90% of the resiniferatoxin is recovered after the dissolution of the solid in the aqueous diluent.

6. The aforementioned composition contains resiniferatoxin, D-α-tocopherol polyethylene glycol succinate, NaCl, and CaCl ２ ×2H ２ A composition according to any one of claims 1 to 5, comprising O, KCl, and tris(hydroxymethyl)aminomethane.

7. (a) a first kit component comprising the composition according to any one of claims 2 to 6, and (b) a second kit component comprising a diluent. A kit that includes this.

8. The composition according to claim 1, wherein the composition is a liquid composition.

9. The composition according to claim 8, wherein the concentration of resiniferatoxin is about 0.005 μM to about 10 μM, and the concentration of the surfactant is about 0.01 vol% to about 10 vol%.

10. (a) a first kit component comprising the composition according to any one of claims 8 to 9, and (b) a second kit component comprising a diluent. A kit that includes this.

11. A aqueous composition of resiniferatoxin, (a) Resiniferatoxin in a concentration of approximately 0.005 μM to approximately 10 μM, (b) A surfactant in an amount of approximately 0.01 vol% to approximately 10 vol%, (c) at least one buffer and Includes, The composition has a pH of about 7.7 to about 8.3, and the surfactant is D-α-tocopherol polyethylene glycol succinate.

12. A composition according to any one of claims 1 to 11 for use in a method for treating pain.

13. The composition according to any one of claims 1 to 11, wherein the composition does not contain a monosaccharide or a sugar alcohol.

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