WO2019021005A1 – January 31, 2019 – PHARMACEUTICAL COMPOSITION COMPRISING A CANNABINOID

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Inventors :

CORR, Stuart - 31 Foxhills Close, Appleton, Warrington Cheshire WA4 5DH

Owner :

MEXICHEM FLUOR S.A. DE C.V. MEXICHEM UK LIMITED

Application Number :

WOGB18052109

Document Number :

WO2019021005A1

Priority Date :

July 28, 2017

Filing Date :

July 26, 2018

Date of Grant/ Publication :

January 31, 2019

Class :

A61K9 / 72; A61K9 / 12; A61K31 / 352; A61K31 / 05

Abstract

A pharmaceutical composition is described. The composition comprises; (i) a drug component comprising at least one cannabiooid or a pharmaceutically acceptable derivative or salt thereof; and (li) a propeliani component comprising 1,1- difiuoroethana (HFA-152a).

Claim(s)

1. A pharmaceutical composition comprising: (i) a drug component comprising at least one cannabinoid or a pharmaceutically acceptable derivative or salt thereof; and (ii) a propellant component comprising 1 , 1 -dlfluoroethane (HFA-152a),;
2. The pharmaceutical composition of claim 1 , wherein the composition contains less than 500 ppm, preferably less than 200 ppm, more preferably less than 150 ppm, still more preferably less than 50 ppm and especially less than 20 ppm of water based on the total weight of the pharmaceutical composition.;
3. The pharmaceutical composition of claim 2, wherein the composition contains greater than 0.5 ppm, e.g. greater than 1 ppm, of water based on the total weight of the pharmaceutical composition.;
4. The pharmaceutical composition of any one of the preceding claims, wherein the composition contains less than 1000 ppm, preferably less than 500 ppm, more preferably less than 100 ppm arid particularly less than 50 ppm of oxygen based on the total weight of the pharmaceutical composition.;
5. The pharmaceutical composition of claim 4, wherein the composition contains greater than 0.5 ppm, e.g. greater than 1 ppm, of oxygen based on the total weight of the pharmaceutical composition.;
6. The pharmaceutical composition of any one of the preceding claims, wherein the drug component comprises at least one cannabinoid.;
7. The pharmaceutical composition of any one of the preceding claims, wherein the at least one cannabinoid is selected from the tetrahydrocannabinols (THC), preferably delta-9-tetrahydrocannabinol and delta-8-tetrahydrocannabinol, and cannabidiol (CBD).;
8. The pharmaceutical composition of claim 7, wherein the drug component comprises or consists essentially of at least one tetrahydrocannabinol (THC).;
9. The pharmaceutical composition of claim 7, wherein the drug component comprises or consists essentially of cannabldlol (CBD).;
10. The pharmaceutical composition of claim 7, wherein the drug component comprises or consists essentially of at least one tetrahydrocannabinol (THC) and cannabidiol (CBD) in a THC:CBD weight ratio of between 0.4:0.6 to 0.6:0.4.;
11. The pharmaceutical composition of claim 7, wherein the drug component comprises or consists essentially of cannabidiol (CBD) containing less than 1% by weight of tetrahydrocannabinols (THC),;
12. The pharmaceutical composition of claim 7, wherein the drug component consists essentially of at least one cannabinoid selected from the tetrahydrocannabinols (THC), preferably delta-9-tetrahydrocannabinol and delta-8- tetrahydrocannabinol, and cannabidiol (CBD).;
13. The pharmaceutical composition of any one of claims 1 to 11, wherein the drug component additionally contains at least one non-cannabinoid drug compound.;
14. The pharmaceutical composition of claim 13, wherein the at least one non- cannabinoid drug compound comprises at least one corticosteroid, preferably at least, one corticosteroid selected from the group consisting of budesonide, mometasone, beclomethasone, fluticasone and the pharmaceutically acceptable derivatives thereof, such as the pharmaceutically acceptable salts and esters thereof.;
15. The pharmaceutical composition of claim 13 or 14, wherein the at least one non-cannabinoid drug compound comprises at least one long acting muscarinic antagonist (LAMA), preferably at least one long acting muscarinic antagonist (LAMA) selected from the group consisting of umeclidinium, Ipratropium, tlotropium, aclidinium and the pharmaceutically acceptable derivatives thereof, such as the pharmaceutically acceptable salts thereof, and the pharmaceutically acceptable salts of glycopyrrotate.;
16. The pharmaceutical composition of any one of claims 13 to 15, wherein the at least one non-cannabinoid drug compound comprises at least one short acting muscarinic antagonist (SAMA). 17. The pharmaceutical composition of any one of claims 13 to 16, wherein the at least one non-cannabinoid drug compound comprises at least one long acting beta-2-agoniet (LABA), preferably at least one long acting beta-2-agonist (LABA) selected from the group consisting of formoterol, arformoterol, bambuterol, clenbuterol, salmeterol, indacaterol, oiodaterol, vilanterol and the pharmaceutically acceptable derivatives thereof, such as the pharmaceutically acceptable salts and esters thereof.;
18. The pharmaceutical composition of any one of claims 13 to 17, wherein the at least one non-cannabinoid drug compound comprises at least one opioid, such as morphine or methadone,;
19. The pharmaceutical composition of any one of the preceding claims, wherein the drug component comprises from 0.01 to 15,0 weight %, preferably from 0.01 to 10.0 weight %, more preferably from 0.05 to 5.0 weight % and especially from 0.05 to 3.0 weight % of the total weight of the pharmaceutical composition.;
20. The pharmaceutical composition of any one of the preceding claims, wherein the propellent component comprises from 65.0 to 99.9 weight %, preferably from 75.0 to 99.9 weight %, more preferably from 85,0 to 99.9 weight % and especially from 95.0 to 99.9 weight % of the total weight of the pharmaceutical composition.;
21. The pharmaceutical composition of any one of the preceding claims, wherein at least 90 weight %, preferably at least 95 weight % and more preferably at (east 99 weight % of the propellant component is 1 , 1 -difluoroethane (HFA-152a).;
claim 21: 22. The pharmaceutical composition of any one of claims 1 to 20, wherein the propellant component is entirely 1,1 -difluoroethane (HFA-152a).;
claim 22: 23. The pharmaceutical composition of claim 21 or 22, wherein the propellent component contains from 0.5 to 10 ppm, e.g. from 1 to 5 ppm, of unsaturated impurities. 24. The pharmaceutical composition of any one of the preceding claims, wherein at least 95 weight %, preferably at least 98 weight % and more preferably at. least 99 weight % of the composition consists of the two components (i) and (ii).;
claim 23: 25. The pharmaceutical composition of any one of the preceding claims further comprising a co-solvent.;
claim 24: 26. The pharmaceutical composition of claim 25, wherein the co-solvent comprises ethanol and/or glycerol. 27. The pharmaceutical composition of any one of the preceding claims further comprising a surfactant component comprising one or more surfactant compounds.;
claim 25: 28. The pharmaceutical composition of any one of the preceding claims further comprising at least one TAS2R taste receptor agonist.;
claim 26: 29. The pharmaceutical composition of any one of the preceding claims further comprising a flavour component comprising at least one favour compound.;
claim 27: 30. The pharmaceutical composition of any one of claims 1 to 23 which consists entirely of the two components (i) and (ii).;
claim 28: 31. The pharmaceutical composition of any one of the preceding claims in the form of a suspension. 32. The pharmaceutical composition of any one of claims 1 to 30 in the form of a solution.;
claim 29: 33. The pharmaceutical composition of any one of claims 1 to 30 in the form of a partial solution.;
claim 30: 34. A. sealed container that contains a pharmaceutical composition as claimed in any one of claims 1 to 33.;
claim 31: 35. The sealed container of claim 34 which Is an uncoated aluminium can.;
claim 32: 36. The sealed container of claim 34 or claim 35 which Is a pressurized aerosol container for use with an inhaler, such as a metered dose inhaler (MDI).;
claim 33: 37. An Inhaler fitted with a sealed container as claimed in claim 36.;
claim 34: 38. A metered dose inhaler (MDI) fitted with a sealed container as claimed in claim 36.;
claim 35: 39. The inhaler of claim 37 or metered dose inhaler of claim 38 which comprises a nozzle and valve assembly attached to the pressurized aerosol container and a gasket made from an elastomeric material selected from EPDM, chlorobutyl, bromobutyl and cycloolefin copolymer rubbers to provide a seal between the container and the nozzle/valve assembly. 40, A method for treating a patient suffering or likely to suffer from a medical disorder which comprises administering to the patient a therapeutically or prophylactically effective amount of a pharmaceutical composition as claimed in any one of claims 1 to 33. 41. The method of claim 40, wherein the pharmaceutical composition is delivered to the patient using an inhaler. 42. The method of claim 40, wherein the pharmaceutical composition is delivered to the patient using a metered dose inhaler.

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