Cannabinoid Formulations

Abstract

The present invention provides stable, fast-acting liposomal and micelle formulations of cannabinoids that are suitable for pharmaceutical and nutraceutical applications.

1 .- 27 . (canceled) 
     
     
         28 . A formulation comprising a unilamellar micelle suspension of one or more cannabinoids or cannabinoid analogues, wherein the unilamellar micelle suspension is thermostable at temperatures greater than 50° C. 
     
     
         29 . The formulation of  claim 28 , wherein the one or more cannabinoids or cannabinoid analogues are one or more of a natural compound, a synthetic compound, a semi-synthetic compound, or mixtures thereof. 
     
     
         30 . The formulation of  claim 29 , wherein the cannabinoid or cannabinoid analogue comprises one or more of cannabinol, cannabidiol, Δ9-tetrahydrocannabinol, Δ8-tetrahydrocannabinol, 11-hydroxy-tetrahydrocannabinol, 11-hydroxy-Δ9-tetrahydrocannabinol, levonantradol, Δ11-tetrahydrocannabinol, tetrahydrocannabivarin, dronabinol, amandamide, nabilone, a combination thereof, a natural or synthetic analogue thereof, or a natural or synthetic molecule with a basic cannabinoid structure. 
     
     
         31 . The formulation of  claim 28 , wherein the formulation is a composition for parenteral injection, a dietary composition for oral delivery, or a composition dosage form for topical administration. 
     
     
         32 . The formulation of  claim 31 , wherein the formulation is a liquid dosage form, wherein the liquid dosage form is an emulsion, a solution, a suspension, a syrup, or an elixir. 
     
     
         33 . The formulation of  claim 31 , wherein the formulation is a solid dosage form comprising an extract, a capsule, a tablet, a pill, a dragee, a powder or a granule, and wherein the formulation further comprises one or more of a pharmaceutically acceptable excipient, a carrier, a filler, a binder, a disintegrating agent, a humectant, an absorption accelerator, a wetting agent, an absorber, a lubricant and a buffering agent. 
     
     
         34 . The formulation of  claim 33 , wherein the solid dosage form comprises a coating, and wherein the coating is an enteric coating, an extended-release coating, a sustained-release coating, a delayed release coating, or an immediate release coating. 
     
     
         35 . The formulation of  claim 31 , wherein the formulation is a dosage form for topical administration comprising an ointment, a cream, an emulsion, a lotion, a gel, a sunscreen or an agent that favors penetration into the skin. 
     
     
         36 . The formulation of  claim 31 , wherein the formulation is a composition for parenteral injection, wherein the composition comprises a pharmaceutically acceptable sterile aqueous or non-aqueous solution, a dispersion, a suspension, an emulsion, a powder or a depot injectable formulation. 
     
     
         37 . The formulation of  claim 31 , wherein the dietary composition is nutraceutical, a soup, a baking good, a dairy product, a meat product, a fish product, a vegetable product or a fruit product. 
     
     
         38 . The formulation of  claim 28 , further comprising a stabilizer selected from the group consisting of guar gum, xanthan gum cellulose hyaluronic acid, polyvinyl pyrrolidone (PVP), alginate, chondritin sulfate, poly gamma glutamic acid, gelatin, chitisin, corn starch and flour, in an amount from about 0.25% to about 2% (w/v). 
     
     
         39 . The formulation of  claim 28 , wherein the average micelle diameter size is in a range between 50 and 1000 nm. 
     
     
         40 . The formulation of  claim 39 , wherein the concentration of cannabinoids or cannabinoid analogues in the suspension is from about 1 g/l to about 2 g/liter. 
     
     
         41 . A method of producing a formulation comprising a unilamellar suspension of one or more cannabinoids or cannabinoid analogues according to  claim 28 , wherein the method comprises the steps of:
 (a) dissolving one or more cannabinoids or cannabinoid analogues in a solvent;   (b) adding a phospholipid to the cannabinoid solution;   (c) injecting the cannabinoid solution from step (b) into distilled water to obtain a cannabinoid suspension;   (d) removing the solvent;   (e) adding an encapsulant to the formulation of step (d) to obtain an encapsulated cannabinoid formulation;   (f) cold-pressing and air-drying or shell-freezing the encapsulated cannabinoid formulation to obtain a dry cannabinoid powder; and   (h) milling and re-suspending the dry cannabinoid powder in an aqueous solution;   and wherein the amount of cannabinoids or cannabinoid analogues in the aqueous cannabinoid solution is greater than 40%.   
     
     
         42 . The method of  claim 41 , wherein the one or more cannabinoids or cannabinoid analogues are one or more of a natural compound, a synthetic compound, a semi-synthetic compound, or mixtures thereof. 
     
     
         43 . The method of  claim 42 , wherein the cannabinoid or cannabinoid analogue comprises one or more of cannabinol, cannabidiol, Δ9-tetrahydrocannabinol, Δ8-tetrahydrocannabinol, 11-hydroxy-tetrahydrocannabinol, 11-hydroxy-Δ9-tetrahydrocannabinol, levonantradol, Δ11-tetrahydrocannabinol, tetrahydrocannabivarin, dronabinol, amandamide, nabilone, a combination thereof, a natural or synthetic analogue thereof, or a natural or synthetic molecule with a basic cannabinoid structure. 
     
     
         44 . The method of  claim 41 , wherein the encapsulant is calcium alginate, L-leucine or a sugar. 
     
     
         45 . A method of alleviating pain or reducing undesirable side effects associated with radiation therapy or chemotherapy in a subject having a compromised immune system, a cancer, a pulmonary disease or a condition that causes violent tremors comprising administering to the subject the formulation of  claim 28 .