IP Library Granted Patent US 11,504,350
Granted Patent B2
US 11,504,350 · App. 16/758,857 · Granted Nov 22, 2022

Cannabinoid compositions and methods of use thereof

Inventors: William Z. Levine (Jerusalem, IL); Shimon Lecht (Petah Tikva, IL); Olga Gabay (Jerusalem, IL)
Assignee: DAY THREE LABS MANUFACTURING INC.
A61K31/352A61K31/05A61K36/185A61P25/20A61K9/007A61K9/0043A61K9/0053
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Quick Facts
Patent No.
US 11,504,350
App. No.
16/758,857
Granted
Nov 22, 2022
Kind
B2
Abstract

Embodiments relate to a method for treatment of a sleep disorder and to compositions comprising tetrahydrocannabinol (THC), cannabidiol (CBD), and cannabinol (CBN), wherein the ratio of THC:CBD:CBN by weight is A:B:C where A is between 0.0001 and 1, B is 1, and C is between 0.05 and 1. Optionally A is between 0.001 and 0.02, B is 1 and C is between 0.2 and 0.7.

Claims (20)

1. A method for treatment of a sleep disorder, the method comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising a tetrahydrocannabinol (THC), a cannabidiol (CBD), and a cannabinol (CBN), wherein the ratio of THC:CBD:CBN by weight is A:B:C where A is between 0.0001 and 1, B is 1, and C is between 0.05 and 1.

2. The method according to claim 1 wherein A is between 0.001 and 0.02, B is 1 and C is between 0.2 and 0.7.

3. The method according to claim 2 wherein A is between 0.00125 and 0.0125, B is 1 an C is between 0.25 and 0.5.

4. The method according to claim 3 wherein A is 0.0025.

5. The method according to claim 3 wherein A is 0.00125.

6. The method according to claim 1 wherein C is 0.25.

7. The method according to claim 1 wherein C is 0.5.

8. The method according to claim 1 wherein C is 0.375.

9. The method according to claim 1 wherein the sleep disorder is selected from the group consisting of: decreased sleep duration, prolonged sleep onset, increased number of transient awakenings during a sleep session, aberrant sleep-awake cycles, aberrant sleep architecture, parasomnia, and insomnia.

10. The method according to claim 1 wherein the composition is free of terpenes.

11. The method according to claim 1 wherein the composition comprises a whole plant extract.

12. The method according to claim 1 wherein the composition is administered through the pulmonary, nasal, oral, or oral cavity route.

13. The method according to claim 1 wherein the composition is administered once daily.

14. The method according to claim 1 wherein the composition is administered within 1 hour before sleep.

15. The method according to claim 1 wherein the amount of CBD administered per day is between 0.375 and 3.75 mg per kg of bodyweight of the subject.

16. The method according to claim 1 wherein the amount of CBN administered per day is between 0.09375 and 1.875 mg per kg of bodyweight of the subject.

17. The method according to claim 1 wherein the amount of THC administered per day is between 0.4 and 50 micrograms per kg of bodyweight of the subject.

18. The method according to claim 1 wherein the composition comprises less than 5% of other cannabinoids relative to the combined weight of THC, CBD and CBN in the composition.

19. The method according to claim 18 , wherein the composition comprises no cannabinoids other than THC, CBD and CBN.

20. A composition comprising a tetrahydrocannabinol (THC), a cannabidiol (CBD), and a cannabinol (CBN), wherein the ratio of THC:CBD:CBN by weight is A:B:C where A is between 0.0001 and 1, B is 1, and C is between 0.05 and 1.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 16, 2022
From: IZUN PHARMACEUTICALS CORPORATION
To: DAY THREE LABS MANUFACTURING INC.
Reel/Frame 059911/0287 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2020
From: LECHT, SHIMON; GABAY, OLGA; LEVINE, WILLIAM Z.
To: IZUN PHARMACEUTICALS CORP.
Reel/Frame 052567/0311 →
Continuity (2)
Provisional Application 62576685 · Oct 25, 2017
Related Publication 20200289460A1 · Sep 17, 2020