WO2019094625A1 – May 16, 2019 – METHODS AND COMPOSITIONS FOR PARENTERAL ADMINISTRATION OF CANNABIDIOL IN THE TREATMENT OF CONVULSIVE DISORDERS

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Inventors :

WASYL, Alexander, M. - 31 Beidler Drive, Washington Crossing, PA 18977; REEH, Jeremy, R. - 11 Tankard Lane, Washington Crossing, PA 18977

Owner :

NEXIEN BIOPHARMA, INC.

Application Number :

WOUS18059871

Document Number :

WO2019094625A1

Priority Date :

January 1, 1970

Filing Date :

November 8, 2018

Date of Grant/ Publication :

May 16, 2019

Class :

; A61K31 / 352; A61K9 / 127; A61K9 / 51; A61P25 / 08

Abstract

The present disclosure provides pharmaceutical compositions, parenteral delivery methods and methods for the manufacture of a cannabidiol drug delivery system. The system comprises pharmaceutical compositions having therapeutically active amounts of cannabidiol in a nanoparticle formulation for delivery of an API to a mammal, preferably a human in the treatment of seizures and epilepsy. Also described herein are devices for their delivery such as an auto-injector device for rapid and safe delivery of cannabidiol as an auto-injector rescue. Other delivery devices are described for in a long-term treatment regimen for epilepsy. The platform has clinical applications in the treatment of subjects suffering from epilepsy or epileptic-induced seizures.

Claim(s)

1. A sterile parenteral formulation for treating a convulsive disorder comprising: a. an API having at least cannabidiol as an active component in pharmaceutically acceptable salts or solvates; and b. stable and adjustable nano-sized carrier containing a therapeutically effective amount of API wherein the parenteral delivery of the formulation is effective in treating epilepsy.;
2. The formulation of claim 1 wherein the cannabidiol is a highly-enriched plant extract or synthetic compound.;
3. The formulation in claim 1 wherein the cannabidiol is selected from a group consisting of a synthetic cannabidiol, an analog of cannabidiol, a derivative of cannabidiol, and combinations thereof.;
4. The formulation of claim 1 wherein the nano-sized carriers are nanoparticles.;
5. The formulation of claim 4 wherein the nanoparticles are solid lipid nanoparticles.;
6. The formulation of claim 1 wherein the solid lipid nanoparticles are coated with at least one polymer.;
7. The formulation of claim 6 wherein the polymer is PEG or HPMA.;
8. The formulation of claim 6 wherein the polymer is PEG 400 or PEG 2000.;
9. The formulation of claim 6 wherein the solid lipid nanoparticles are coated with PEG 400 and propylene glycol as co-polymers.;
10. The formulation of claim 1 wherein the nano-sized carriers are nanostructured lipid carriers.;
11. The formulation of claim 10 wherein the nanostructured lipid carriers are coated with at least one polymer.;
12. The formulation of claim 11 wherein the polymer is PEG or HPMA.;
13. The formulation of claim 11 wherein the polymer is PEG 400 or PEG 2000.;
14. The formulation of claim 11 wherein the nanostructured lipid carriers are coated with PEG 400 and propylene glycol as co-polymers.;
15. The formulation of claim 1 wherein the nano-sized carriers are lipid drug conjugates.;
16. The formulation of claim 15 wherein the lipid drug conjugates are coated with at least one polymer.;
17. The formulation of claim 16 wherein the polymer is PEG or HPMA. 23;
18. The formulation of claim 16 wherein the polymer is PEG 400 or PEG 2000.;
19. The formulation of claim 16 wherein the lipid drug conjugates are coated with PEG 400 and propylene glycol as co-polymers.;
20. The formulation of claim 1 wherein the nano-sized carrier is a niosome.;
claim 21: 21. The formulation of claim 1 wherein the convulsive disorder is epilepsy.;
claim 22: 22. A method for treating a subject having a convulsive disorder comprising a parenteral administration of a therapeutically effective formulation comprising i. an API having at least cannabidiol as an active component in pharmaceutically acceptable salts or solvates; and ii. stable and adjustable nano-sized carriers containing a therapeutically effective amount of API wherein the therapeutically effective formulation reduces the seizure episodes in the epileptic subject.;
claim 23: 23. The method of claim 22 wherein the cannabidiol is a highly-enriched plant extract or synthetic compound.;
claim 24: 24. The method of claim 22 wherein the cannabidiol is selected from a group consisting of a synthetic cannabidiol, an analog of cannabidiol, a derivative of cannabidiol, and combinations thereof.;
claim 25: 25. The method of claim 22 wherein the nano-sized carriers are solid lipid nanoparticles.;
claim 26: 26. The method of claim 25 wherein the solid lipid nanoparticles are coated with at least one polymer.;
claim 27: 27. The method of claim 26 wherein the polymer is PEG or HPMA.;
claim 28: 28. The method of claim 27 wherein the polymer is PEG 400 or PEG 2000.;
claim 29: 29. The method of claim 26 wherein the solid lipid nanoparticles are coated with PEG 400 and propylene glycol as co-polymers.;
claim 30: 30. The method of claim 22 wherein the nano-sized carriers are nanostmctured lipid carriers.;
claim 31: 31. The method of claim 30 wherein the nanostmctured lipid carriers are coated with at least one polymer.;
claim 32: 32. The method of claim 31 wherein the polymer is PEG or HPMA.;
claim 33: 33. The method of claim 31 wherein the polymer is PEG 400 or PEG 2000. 24;
claim 34: 34. The method of claim 31 wherein the nanostructured lipid carriers are coated with PEG 400 and propylene glycol as co-polymers.;
claim 35: 35. The method of claim 22 wherein the nano-sized carriers are lipid drug conjugates.;
claim 36: 36. The method of claim 32 wherein the lipid drug conjugates are coated with at least one polymer.;
claim 37: 37. The method of claim 33 wherein the polymer is PEG or HPMA.;
claim 38: 38. The method of claim 33 wherein the polymer is PEG 400.;
claim 39: 39. The method of claim 33 wherein the lipid drug conjugates are coated with PEG 400 and propylene glycol as co-polymers.;
claim 40: 40. The method of claim 22 wherein the nano-sized carrier is a noisome.;
claim 41: 41. The method of claim 22 wherein the convulsive disorder is epilepsy.;
claim 42: 42. The method of claim 22 wherein the administration is intermuscular.;
claim 43: 43. The method of claim 22 wherein the administration is an injection device.;
claim 44: 44. The method of claim 43 wherein the injection device is an auto-injector.;
claim 45: 45. The method of claim 22 wherein the administration is an implant delivery system.;
claim 46: 46. The method of claim 45 wherein the implant delivery system is active.;
claim 47: 47. The method of claim 45 wherein the implant delivery system is passive.;
claim 48: 48. A method for the manufacture of a parenteral nanoparticle formulation containing cannabidiol for use in treating epilepsy comprising: a. obtaining an API having cannabidiol as at least one active component wherein the cannabidiol is a highly-enriched extract or synthetic compound in a therapeutically effective amount; and b. forming a nanoparticle comprising: i. adding the API in a melted lipid; ii. combining (i) with a hot aqueous surfactant solution; iii. stirring to obtain a good dispersion; iv. homogenizing with a piston-gap homogenizer; and v. cooling to room temperature wherein the cooling forms the nanoparticles.;
claim 49: 49. The method of claim 48 wherein the nanoparticle is selected from a group consisting of SLN, NLC, and LDC.;
claim 50: 50. The method of claim 49 further adding at least one polymer. 25;
claim 51: 51. The method of claim 50 where the polymer is PEG.;
claim 52: 52. The method of claim 50 where the polymer is PEG 400 or PEG 2000.;
claim 53: 53. The method of claim 50 where the polymers are PEG 400 and propylene glycol as copolymers 26

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