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EP-4739151-A1 - COMPOSITION

EP4739151A1EP 4739151 A1EP4739151 A1EP 4739151A1EP-4739151-A1

Abstract

The present invention relates to a synthetic composition comprising a first component and a second component, wherein the first component comprises cannabidiol and the second component comprises at least one monoterpene.

Inventors

  • CADDICK, Charlotte
  • DAVIES, ASHLEY
  • READ, Cai
  • IANNITTI, Tommaso

Assignees

  • Nicoventures Trading Limited

Dates

Publication Date
20260513
Application Date
20240704

Claims (20)

  1. 1 . A synthetic composition comprising a first component and a second component, wherein the first component comprises cannabidiol and the second component comprises at least one monoterpene.
  2. 2. The synthetic composition according to claim 1 , wherein the monoterpene is aliphatic.
  3. 3. The synthetic composition according to claim 2, wherein the monoterpene is selected from (R)-linalool, (S)-(-)-|3-citronellol, and linalyl acetate.
  4. 4. The synthetic composition according to claim 1 , wherein the monoterpene is cyclic.
  5. 5. The synthetic composition according to claim 4, wherein the monoterpene is carvacrol.
  6. 6. The synthetic composition according to any one of preceding claims, wherein the composition is formulated to deliver the first and second components to a user orally, nasally, respiratorily or transdermally.
  7. 7. The synthetic composition according to claim 6, wherein the composition is formulated to deliver the first and second components to a user respiratorily and is an aerosol generating material.
  8. 8. The synthetic composition according to claim 7, wherein the aerosol generating material comprises one or more aerosol former materials.
  9. 9. The synthetic composition according to claim 8, wherein the one or more aerosolformer materials may comprise one or more of glycerol, propylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1 ,3-butylene glycol, erythritol, meso- Erythritol, ethyl vanillate, ethyl laurate, a diethyl suberate, triethyl citrate, triacetin, a 36 SUBSTITUTE SHEET (RULE 26) diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, and propylene carbonate.
  10. 10. The synthetic composition according to claim 6, wherein the composition is formulated to deliver the composition to a user orally, nasally, or transdermally.
  11. 11 . The synthetic composition according to claim 10, wherein the delivery system is configured to deliver the composition orally and takes the form of a lozenge, tablet, gum, gel, powder, chew, melt, liquid, or semi-solid lozenges, or article comprising inhalable powders, and oral products such as oral tobacco which includes snus or moist snuff, wherein the synthetic composition may or may not comprise nicotine.
  12. 12. The synthetic composition according to claim 10, wherein the delivery system is configured to deliver the composition transdermally and takes the form of an ointment, cream or rub.
  13. 13. The synthetic composition according to claim 10, wherein the delivery system is configured to deliver the composition nasally and takes the form of a powder, liquid, or semi-solid.
  14. 14. The synthetic composition according to any of the preceding claims, wherein the molar ratio of cannabidiol to the monoterpene is in a range selected from: 6.4 (cannabidiol): 1 to 16 (monoterpene); 6.1 (cannabidiol): 1 to 16 (monoterpene); 1.6 to 6.4 (cannabidiol):1 (monoterpene); or 1.6 (cannabidiol):1 to 64.1 (monoterpene).
  15. 15. The synthetic composition according to any of the preceding claims, wherein the monoterpene is selected from (R)-linalool and carvacrol and the molar ratio of cannabidiol to the monoterpene is in the range of from 6.4 (cannabidiol):1 to 16 (monoterpene), preferably 6.1 (cannabidiol): 1 to 16 (monoterpene). 37 SUBSTITUTE SHEET (RULE 26)
  16. 16. The synthetic composition according to any of claims 1 to 14, wherein the monoterpene comprises (R)-linalool and the molar ratio of cannabidiol to the monoterpene is in the range of from 6.1 (cannabidiol): 1 to 16 (monoterpene).
  17. 17. The synthetic composition according to any of claims 1 to 14, wherein the monoterpene comprises (R)-linalool and the cannabinoid is present in an amount of about 2.5 pM and the monoterpene is present in an amount of from 0.39 to 6.25 pM.
  18. 18. The synthetic composition according to any of claims 1 to 14, wherein the monoterpene comprises carvacrol and the molar ratio of cannabidiol to the monoterpene is in the range of from 6.4 (cannabidiol): 1 to 16 (monoterpene).
  19. 19. The use of a synthetic composition as defined in any one of claims 1 to 18 to modulate the neural state of a user, preferably the relaxation state.
  20. 20. The use according to claim 19, wherein the relaxation state of the user is increased following administration to a user.

Description

COMPOSITION FIELD OF THE INVENTION The present invention relates to compositions comprising a first component and a second component, to articles comprising the compositions, as well as to uses, methods and systems for administering the compositions to a user. BACKGROUND It is known that certain active compounds have a pharmacological effect when administered to a user. In some instances, the pharmacological effect may be utilized to influence a medical state of the user, i.e. the active compound is administered as a medicine. In other instances, the pharmacological effect may be utilized to influence a non-medical state of the user, e.g. the active compound is not administered as a medicine. An example of influencing a non-medical state might be the administration of caffeine to modulate alertness. The pharmacological effect of a particular active compound may depend on its ability to interact with one or more biological targets within the body of the user. The extent of the interaction with the one or more targets will influence the extent to which a pharmacological effect is perceived. In some instances, multiple active compounds can be administered to a user. The active compounds may each act on one or more biological targets to a different extent. It would be advantageous to develop improved compositions comprising multiple actives. SUMMARY OF THE INVENTION In one aspect, the present invention relates to a synthetic composition comprising a first component and a second component, wherein the first component comprises cannabidiol and the second component comprises at least one monoterpene. 1 SUBSTITUTE SHEET (RULE 26) In a further aspect, the present invention relates to the use of a synthetic composition as defined herein to modulate the neural state of a user. In a further aspect, the present invention relates to a method of modulating the neural state of a user, the method comprising administering to the user a synthetic composition as defined herein. In a further aspect, the present invention relates to an article comprising a synthetic composition as defined herein. These and other aspects of the present invention will now be further described. BRIEF DESCRIPTION OF THE FIGURES Figure 1a provides a concentration-response curve for R-linalool used in combination 1 Figure 1 b provides a concentration-response curve for CBD from used in combination 1 Figure 2a provides a concentration-response curve for (S)-(-)-p-citronellol used in combination 2 Figure 2b provides a concentration-response curve for CBD from used in combination 2 Figure 3a provides a concentration-response curve for linalyl acetate used in combination 3 Figure 3b provides a concentration-response curve for CBD from used in combination 3 Figure 4a provides a concentration-response curve for carvacrol from used in combination 4 Figure 4b provides a concentration-response curve for CBD from used in combination 4 DETAILED DESCRIPTION Synergy The concept of “synergy” is generally understood as being present where the effect which results from a combination comprising multiple individual components is greater than the sum of the effect of each individual component in isolation. In the context of the present disclosure, the relevant effect is that which results from the application of the 2 SUBSTITUTE SHEET (RULE 26) components (in isolation and in combination) to biological targets of interest. To quantify the interaction between the components, the observed combination effect is compared to the expected effect predicted by a reference model. When the combination effect is greater than expected, the combination is classified as synergistic. This is further explained in Yadav et al (2015, Computational and Structural Biotechnology Journal 13 (2015) 504-513). Since the presence of synergy depends on the difference between the observed combination effect and the expected effect predicted by a reference model, the choice of the reference model can influence the conclusion as to whether synergy is determined to be present or not. Reference models commonly used for the determination of synergy in the context of active components include: the Loewe model (Loewe S. The problem of synergism and antagonism of combined drugs. Arzneimittelforschung. 1953 Jun;3(6):285-90) the Bliss model (Bliss Cl. The toxicity of poisons applied jointly. Ann App Biol. 1939; 26: 585-615); the zero interaction potency (ZIP) model (Yadav B, Wennerberg K, Aittokallio T, Tang J. Searching for Drug Synergy in Complex Dose-Response Landscapes Using an Interaction Potency Model. Comput Struct Biotechnol J. 2015 Sep 25;13:504-13) and the highest single agent (HSA) model (FoucquierJ, Guedj M. Analysis of drug combinations: current methodological landscape. Pharmacol Res Perspect. 2015 Jun;3(3):e00149. doi: 10. 1002/prp2. 149. Epub 2015 May 20. Erratum in: Pharmacol Res Perspect. 2019 Dec;7(6):e00549). These reference models will be referred to throughout the present disclosur