Abstract: The present invention relates to stable liquid oral pharmaceutical formulations of cannabidiol (CBD). The invention further discloses methods of producing a stabilized formulation of cannabidiol using cannabidiol from a synthetic source.
We Claim,
Claim 1: A liquid oral formulation of cannabidiol comprising:
(i) synthetic cannabidiol,
(ii) one or more solvents selected from the group comprising ethanol, N-methyl-2-pyrrolidone (NMP), tertiary butyl alcohol (TBA), glycerol, propylene glycol, polyethylene glycol,
wherein the formulation is
(a) completely free of antioxidants,
(b) completely free of THC,
(c) completely free of CBDV.
Claim 2: The formulation of claim 1, wherein the formulation is substantially free of impurities A, B, C, D, E, F, G, H, I and J.
Claim 3: The formulation of claim 1, wherein the formulation is a solution.
Claim 4: The formulation of claim 1, wherein the formulation is a suspension.
Claim 5: The formulation claim 1, wherein the formulation is an oral spray.
Claim 6: The formulation claim 1, wherein the formulation is an emulsion.
Claim 7: The formulation claim 1, wherein the formulation additionally comprises a buffer.
Claim 8: The formulation claim 1, additionally comprising an oil selected from the group comprising soybean oil, olive oil, com oil, vitamin E, grapeseed oil, walnut oil, avocado oil, flax seed oil, coconut oil, olive oil, hemp seed oil, ginger oil.
Claim 9: The formulation of claim 1, wherein the proportion of cannabidiol is 2%
to 50% w/v.
Claim 10: A liquid oral formulation of cannabidiol comprising:
(i) synthetic cannabidiol,
(ii) one or more solvents selected from the group comprising ethanol, N-methyl-2-pyrrolidone (NMP), tertiary butyl alcohol (TBA), glycerol, propylene glycol, polyethylene glycol,
(iii) an oil selected from the group comprising soyabean oil, olive oil, corn oil, vitamin E, grapeseed oil, walnut oil, avocado oil, flax seed oil, coconut oil, olive oil, hemp seed oil, ginger oil,
wherein the formulation is
(a) completely free of antioxidants,
(b) completely free of THC,
(c) completely free of CBDV.
Claim 11: An oral spray formulation of cannabidiol comprising:
(i) synthetic cannabidiol,
(ii) one or more solvents selected from the group comprising ethanol, N-methyl-2-pyrrolidone (NMP), tertiary butyl alcohol (TBA), glycerol, propylene glycol, polyethylene glycol,
wherein the formulation is
(a) completely free of antioxidants,
(b) completely free of THC,
(c) completely free of CBDV, and
wherein the formulation is packed in a suitable container for effective delivery
of spray.
Claim 12: An oral spray formulation of cannabidiol comprising:
(i) synthetic cannabidiol
(ii) one or more solvents selected from the group comprising ethanol, N-methyl-2-pyrrolidone (NMP), tertiary butyl alcohol (TBA), glycerol, propylene glycol, polyethylene glycol,
(iii) an oil selected from the group comprising soyabean oil, olive oil, com oil, vitamin E, grapeseed oil, walnut oil, avocado oil, flax seed oil, coconut oil, olive oil, hemp seed oil, ginger oil.
wherein the formulation is
(a) completely free of antioxidants,
(b) completely free of THC
(c) completely free of CBDV, and
wherein the formulation is packed in a suitable container for effective delivery
of spray.
Claim 13: An oral solution formulation of cannabidiol comprising:
(iii) synthetic cannabidiol,
(iv) one or more solvents selected from the group comprising ethanol, N-methyl-2-pyrrolidone (NMP), tertiary butyl alcohol (TBA), glycerol, propylene glycol, polyethylene glycol,
wherein the formulation is
(a) completely free of antioxidants,
(b) completely free of THC,
(c) completely free of CBDV, and
(d) substantially free of impurities A, B, C, D, E, F, G, H, I and J.
| # | Name | Date |
|---|---|---|
| 1 | 202241058354-STATEMENT OF UNDERTAKING (FORM 3) [12-10-2022(online)].pdf | 2022-10-12 |
| 2 | 202241058354-PROVISIONAL SPECIFICATION [12-10-2022(online)].pdf | 2022-10-12 |
| 3 | 202241058354-FORM FOR SMALL ENTITY(FORM-28) [12-10-2022(online)].pdf | 2022-10-12 |
| 4 | 202241058354-FORM FOR SMALL ENTITY [12-10-2022(online)].pdf | 2022-10-12 |
| 5 | 202241058354-FORM 1 [12-10-2022(online)].pdf | 2022-10-12 |
| 6 | 202241058354-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [12-10-2022(online)].pdf | 2022-10-12 |
| 7 | 202241058354-EVIDENCE FOR REGISTRATION UNDER SSI [12-10-2022(online)].pdf | 2022-10-12 |
| 8 | 202241058354-FORM-9 [03-11-2022(online)].pdf | 2022-11-03 |
| 9 | 202241058354-FORM FOR SMALL ENTITY [03-11-2022(online)].pdf | 2022-11-03 |
| 10 | 202241058354-FORM 3 [03-11-2022(online)].pdf | 2022-11-03 |
| 11 | 202241058354-EVIDENCE FOR REGISTRATION UNDER SSI [03-11-2022(online)].pdf | 2022-11-03 |
| 12 | 202241058354-ENDORSEMENT BY INVENTORS [03-11-2022(online)].pdf | 2022-11-03 |
| 13 | 202241058354-COMPLETE SPECIFICATION [03-11-2022(online)].pdf | 2022-11-03 |
| 14 | 202241058354-MSME CERTIFICATE [23-01-2023(online)].pdf | 2023-01-23 |
| 15 | 202241058354-FORM28 [23-01-2023(online)].pdf | 2023-01-23 |
| 16 | 202241058354-FORM 18A [23-01-2023(online)].pdf | 2023-01-23 |
| 17 | 202241058354-FER.pdf | 2023-02-22 |
| 18 | 202241058354-RELEVANT DOCUMENTS [22-03-2023(online)].pdf | 2023-03-22 |
| 19 | 202241058354-POA [22-03-2023(online)].pdf | 2023-03-22 |
| 20 | 202241058354-FORM-26 [22-03-2023(online)].pdf | 2023-03-22 |
| 21 | 202241058354-FORM FOR SMALL ENTITY [22-03-2023(online)].pdf | 2023-03-22 |
| 22 | 202241058354-FORM 13 [22-03-2023(online)].pdf | 2023-03-22 |
| 23 | 202241058354-EVIDENCE FOR REGISTRATION UNDER SSI [22-03-2023(online)].pdf | 2023-03-22 |
| 24 | 202241058354-AMENDED DOCUMENTS [22-03-2023(online)].pdf | 2023-03-22 |
| 25 | 202241058354-FORM 3 [07-04-2023(online)].pdf | 2023-04-07 |
| 26 | 202241058354-FER_SER_REPLY [07-04-2023(online)].pdf | 2023-04-07 |
| 27 | 202241058354-COMPLETE SPECIFICATION [07-04-2023(online)].pdf | 2023-04-07 |
| 28 | 202241058354-CLAIMS [07-04-2023(online)].pdf | 2023-04-07 |
| 29 | 202241058354-Request Letter-Correspondence [29-06-2023(online)].pdf | 2023-06-29 |
| 30 | 202241058354-FORM28 [29-06-2023(online)].pdf | 2023-06-29 |
| 31 | 202241058354-Form 1 (Submitted on date of filing) [29-06-2023(online)].pdf | 2023-06-29 |
| 32 | 202241058354-Covering Letter [29-06-2023(online)].pdf | 2023-06-29 |
| 33 | 202241058354-US(14)-HearingNotice-(HearingDate-23-10-2024).pdf | 2024-10-03 |
| 34 | 202241058354-FORM-26 [17-10-2024(online)].pdf | 2024-10-17 |
| 35 | 202241058354-Correspondence to notify the Controller [17-10-2024(online)].pdf | 2024-10-17 |
| 36 | 202241058354-US(14)-ExtendedHearingNotice-(HearingDate-24-10-2024)-1430.pdf | 2024-10-23 |
| 37 | 202241058354-Form-4 u-r 138 [06-11-2024(online)].pdf | 2024-11-06 |
| 38 | 202241058354-Written submissions and relevant documents [09-12-2024(online)].pdf | 2024-12-09 |
| 39 | 202241058354-MARKED COPIES OF AMENDEMENTS [09-12-2024(online)].pdf | 2024-12-09 |
| 40 | 202241058354-FORM 3 [09-12-2024(online)].pdf | 2024-12-09 |
| 41 | 202241058354-FORM 13 [09-12-2024(online)].pdf | 2024-12-09 |
| 42 | 202241058354-AMMENDED DOCUMENTS [09-12-2024(online)].pdf | 2024-12-09 |
| 1 | Search202241058354E_15-02-2023.pdf |