Application US20190314296

PARENTERAL FORMULATIONS
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US20190314296

1. An aqueous parenteral formulation comprising: (11) (4)

(i) a cannabinoid;

(ii) an isotonic agent;

(iii) a surfactant; and

(iv) one or more stability enhancers.

2. The formulation of claim 1 wherein the cannabinoid is selected from: cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabigerol (CBG), cannabigerol propyl variant (CBGV), cannabicyclol (CBL), cannabinol (CBN), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV) and tetrahydrocannabivarinic acid (THCVA). (0)

3. The formulation of claim 1, wherein the cannabinoid is CBD or CBDV. (0)

4. The formulation of claim 1, wherein the cannabinoid is present in an amount of 0.3 to 50 mg/ml. (0)

6. The formulation of claim 1, wherein the isotonic agent is selected from: polyethylene glycol, glycerol, saline and glucose. (0)

7. The formulation of claim 1, wherein the formulation has an osmolality is in the range of from 100-500 mOsMol/Kg. (0)

8. The formulation of claim 1, wherein the isotonic agent is glycerol, and wherein the glycerol is present in an amount of 5 to 50 mg/ml. (0)

10. Formulation of claim 1, wherein the surfactant is a non-ionic surfactant selected from Polyoxyethylene (20) sorbitan monooleate, Polysorbate 80; Macrogol 15 hydroxystearate and Polyoxamers. (1) (0)

13. The formulation of claim 1 wherein the one or more stability enhancers comprises one or more antioxidants selected from ascorbic acid, monothioglycerol, cysteine HCl and Glutathione. (1) (0)

20. The formulation of claim 1 wherein the one or more stability enhancers comprises a chelating agent selected from: disodium EDTA and calcium disodium EDTA. (1) (0)

30. A method of preparing the formulation of claim 1, comprising preparing a stock solution of a cannabinoid in a surfactant; preparing an aqueous solution comprising the isotonic agent and one or more stability enhancers; and slowly adding the aqueous solution to the stock solution of the cannabinoid in the surfactant. (1) (0)

31. The method of claim 30 wherein the cannabinoid is CBD or CBDV, the surfactant is macrogol 15 hydroxystearate, the isotonic agent is glycerol, and the stability enhancers are ascorbic acid, monothioglycerol and calcium disodium EDTA; and the method further comprises: (0) (3)

36. A method of treating a subject comprising administering the aqueous parenteral formulation of claim 1 to the subject. (2) (0)

5. (canceled) (0)

9. (canceled) (0)

12. (canceled) (0)

16.-19. (canceled) (0)

22.-29. (canceled) (0)

32.-35. (canceled) (0)

37.-38. (canceled) (0)

40.-43. (canceled) (0)

46.-47. (canceled) (0)

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Application US20190314296

PARENTERAL FORMULATIONS

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