Pharmaceutical composition comprising a cannabinoid
The present invention relates to a novel cannabinoid oral pharmaceutical dosage form, based on a Type IV or Type IV-like formulation, as classified using the Lipid Formulation Classification System. The formulation is contained in a container. By Type IV-like, it is meant that the formulation comprises no oil, for example no triglycerides or mixed glycerides.
1. An oral pharmaceutical formulation comprising:
cannabidiol (CBD) or cannabidivarin (CBDV);
poloxamer 124 or poloxamer 188, or a mixture thereof; and
diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate, or a mixture thereof;
wherein the oral pharmaceutical formulation is contained in a container,
wherein the container is a blister pack, and
wherein the blister pack comprises a cavity forming film comprising aluminium and a lidding material comprising aluminium.
2. The formulation according to claim 1 , wherein the poloxamer 124 or poloxamer 188, or the mixture thereof is present in an amount of from about 25 to 75 wt %, based on the total composition.
3. The formulation according to claim 1 , which comprises propylene glycol, propylene glycol diacetate, triethyl citrate, or a mixture thereof.
4. The formulation according to claim 1 , which comprises propylene glycol, triethyl citrate, or a mixture thereof.
5. The formulation according to claim 1 , which comprises triethyl citrate.
6. The formulation according to claim 1 , wherein the diacetin, propylene glycol, triacetin, monoacetin, propylene glycol diacetate, triethyl citrate, or the mixture thereof is present in an amount of from about 10 to 80 wt %, based on the total composition.
7. The formulation according to claim 1 , wherein the cannabidiol (CBD) or cannabidivarin (CBDV) is present in an amount of from about 10 to 50 wt %, based on the total composition.
8. The formulation according to claim 1 , further comprising an antioxidant.
9. The formulation according to claim 8 , wherein the antioxidant comprises butylated hydroxyltoluene, butylated hydroxyl anisole, alpha- tocopherol (Vitamin E), ascorbyl palmitate, ascorbic acid, sodium ascorbate, ethylenediamino tetraacetic acid, cysteine hydrochloride, citric acid, sodium citrate, sodium bisulfate, sodium metabisulfite, lecithin, propyl gallate, sodium sulfate, monothioglycerol, or a mixture thereof.
10. The formulation according to claim 9 , wherein the antioxidant comprises alpha-tocopherol (Vitamin E), monothioglycerol, ascorbic acid, citric acid, or a mixture thereof.
11. The formulation according to claim 1 , wherein the formulation is substantially oil-free.
12. The formulation according to claim 1 , wherein the formulation is a solid at 20° C. and 1 atm.
13. The formulation according to claim 1 , wherein the container comprises a desiccant.
14. The formulation according to claim 13 , wherein the desiccant comprises silica gel, a clay desiccant, calcium sulfate, calcium chloride, calcium oxide, zeolite, activated alumina, activated charcoal, alumina, bauxite, anhydrous calcium sulphate, activated bentonite clay, water-absorbing clay, molecular sieve, or a combination thereof.
15. The formulation according to claim 1 , wherein the formulation is a mucoadhesive gel, a tablet, a powder, a liquid gel capsule, a solid capsule, an oral solution, a granule, or an extrudate.
16. The formulation according to claim 15 , wherein the formulation comprises a modified-release agent.
17. The formulation according to claim 1 , wherein the blister pack is a cold-form foil blister pack.
18. The formulation according to claim 1 , wherein the cavity forming film comprises a laminated material.