Method of preparing cannabinoids
AssigneeJazz Pharmaceuticals Research UK Limited
InventorsMichael Simon LOFT, Alejandro Montellano LOPEZ, Alan James SILCOCK
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Abstract
The pharmaceutical industry is highly regulated to ensure the safety, efficacy, and quality of medicines and drug discolouration is one of the leading causes for drug recall. An object of the present invention is to provide an improved method of manufacturing cannabinoids for use in pharmaceuticals that is both stable and substantially pure. Such use of stable and substantially pure cannabinoids in pharmaceuticals will improve patient compliance to medication. The main steps of the method are decarboxylation, extraction, winterization and crystallisation.
Claims17
Stable substantially pure cannabinoid obtained by a process comprising:
- a) A decarboxylation step;
- b) An extraction step to produce crude extract;
- and
- c) A combined winterisation and crystallization step, wherein sub-steps comprise of:
- i) Precipitating alkanes in a solvent by cooling and removing them by filtration;
- ii) Removing the solvent by partial distillation;
- iii) Solvent exchanging into heptane;
- iv) Removing the remaining solvent by aqueous phase separation, resulting in a heptane solution;
- v) Heating the heptane solution and filtering it;
- vi) Cooling the solution whilst agitating at a constant speed;
- vii) Seeding the solution and propagating the seed, resulting in a suspension;
- viii) Cooling, stirring, filtering and washing the suspension, resulting in a product;
- and
- ix) De-liquoring and drying the product.
The process as claimed in any of the preceding claims wherein the extraction step is carried out using liquid CO2 at a temperature of 25° C. and pressure of 100 Barg.
The process as claimed in any of the preceding claims wherein the winterisation step uses methanol as a solvent.
The process as claimed in any of the preceding claims wherein the winterisation step is carried out at a temperature between 0° C. to 5° C.
The process as claimed in any of the preceding claims wherein the aqueous phase separation consists of three or less than three aqueous washes.
The process as claimed in any of the preceding claims wherein the winterisation step uses a filter aid that does not contain vanadium.
The process as claimed in claim in any of the preceding claims wherein one or more antioxidants are added.
The product as claimed in any of the preceding claims wherein the CBD has a purity of >95%, more preferably greater than 96% (w/w), more preferably 97% (w/w), more preferably 98% (w/w), most preferably 99% (w/w) and greater.
The product as claimed in any of the preceding claims wherein THC is present at less than 0.15%.
The product as claimed in any of the preceding claims wherein CBDV is present at up to 1%.
Dependencies are inferred from the claim text.