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Novel Liquid Oral Formulations Of Cannabidiol

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.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
12 October 2022
Publication Number
04/2023
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

LEIUTIS PHARMACEUTICALS LLP
Plot No 23, TIE 1st Phase, Balanagar, Hyderabad, 500037,Telangana, India

Inventors

1. KOCHERLAKOTA CHANDRASHEKHAR
Plot no. 13, Sonali Cooperative Housing Society, Bhavana enclave, Bowenpally, Tadbund, Secunderabad
2. ARUTLA SRINIVAS
H.No.: J 2801, My home Bhooja Apartments, Biodiversity Park, Raidurg, Hyderabad, Telangana, India.

Specification

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.

Documents

Application Documents

# 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

Search Strategy

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