Formulated Cannabis Oil Powder By Nanoemulsifycation, Methods Of Producing And Uses Thereof

Abstract

The invention discloses particular water-dispersible solid formulation of a cannabinoid or a cannabis extract, wherein they are present in the form of a nanoemulsion, and upon dispersion in water said formulation produces nanoparticles (droplets of a submicron size) with an average size of up to about 500 nm. The present disclosure further relates to methods of making thereof, as well as therapeutic applications in humans for treating disorders and broader application for a range of medical conditions.

1 . A water-dispersible powder comprising lipophilic nanospheres having an averaged size between 50 and 900 nm as measured by dynamic light scattering (DLS), the nanospheres comprising a cannabinoid material and having an adsorbed layer comprising at least one solid surfactant, wherein the at least one solid surfactant is selected from the group consisting of Poloxamer 407, Poloxamer 188, and ammonium glycyrrhizinate;
 the powder further comprising at least one solid cryoprotectant selected from the group consisting of sucrose, trehalose and mannitol, and optionally at least one solid carbohydrate selected from the group consisting of maltodextrin and carboxymethyl cellulose (CMC);   wherein the nanospheres' structure and size is substantially maintained upon dissolution in a water containing environment.   
     
     
         2 . The powder according to  claim 1 , comprising at least one solid carbohydrate. 
     
     
         3 - 33 . (canceled) 
     
     
         34 . The powder according to  claim 1 , wherein said cannabinoid material is a synthetic or natural cannabinoid is-selected from tetrahydrocannabinol (THC), cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), a derivative, a precursor and an acid-form thereof. 
     
     
         35 - 37 . (canceled) 
     
     
         38 . The powder according to  claim 1 , adapted for enteral, parenteral, subligual, topical or transdermal administrations. 
     
     
         39 . A method for producing a water-dispersible powder of  claim 1 , the method comprising converting a nanoemulsion to a powder by lyophilization, the nanoemulsion being of an oil phase and an aqueous phase; the aqueous phase comprising a solid cryoprotectant, a solid surfactant and optionally at least one solid carbohydrate, and the oil phase comprising a cannabinoid material. 
     
     
         40 . The method according to  claim 39 , the method comprising:
 (i) preparing an initial nanoemulsion by adding an oil phase into an aqueous phase; the aqueous phase comprising a solid cryoprotectant, a solid surfactant and optionally at least one solid carbohydrate, the oil phase comprising a cannabinoid material,   (ii) preparing a final nanoemulsion by sonicating or homogenizing the initial nanoemulsion;   (iii) converting the final nanoemulsion to a powder by lyophilization.   
     
     
         41 . The method according to  claim 40 , comprising:
 (i) preparing an aqueous phase comprising a solid cryoprotectant, a solid surfactant and optionally at least one solid carbohydrate,   (ii) preparing an oil phase comprising a cannabinoid material,   (iii) preparing an initial nanoemulsion by adding the oil phase into the aqueous phase during homogenization,   (iv) preparing a final nanoemulsion by sonicating or homogenizing the initial nanoemulsion, and   (v) converting the final nanoemulsion to a powder by lyophilization.   
     
     
         42 - 48 . (canceled) 
     
     
         49 . A pharmaceutical composition comprising the water-dispersible powder of  claim 1 , optionally further comprising a pharmaceutically acceptable carrier or excipient. 
     
     
         50 - 55 . (canceled) 
     
     
         56 . A dosage form for oral or sublingual administration, the dosage form comprising a water-dispersible powder of  claim 1 . 
     
     
         57 - 63 . (canceled) 
     
     
         64 . A method of treating a disease or a medical condition related to beneficial effects of cannabinoids or cannabis, the method comprising administering to a subject a therapeutically effective amount of a powder of  claim 1 . 
     
     
         65 - 66 . (canceled) 
     
     
         67 . A nanoemulsion comprising lipophilic nanodroplets containing a cannabinoid material and having an averaged size between 50 and 900 nm as measured by dynamic light scattering (DLS); at least one soluble solid surfactant selected from the group consisting of Poloxamer 407, Poloxamer 188, and ammonium glycyrrhizinate; at least one soluble solid cryoprotectant selected from the group consisting of sucrose, trehalose and mannitol, and optionally containing maltodextrin and/or carboxymethyl cellulose (CMC). 
     
     
         68 . The powder according to  claim 1 , wherein Poloxamer 407 has a structure in the range of HO[CH 2 CH 2 O] 95-105 [CH 2 CH(CH 3 )O] 54-60 [CH 2 CH 2 O] 95-105 H. and Poloxamer 188 has a structure in the range of [CH 2 CH 2 O] 75-85 [CH 2 CH(CH 3 )O] 25-30 [CH 2 CH 2 O] 75-85 H. 
     
     
         69 . The powder according to  claim 68 , wherein Poloxamer 407 has an average molecular weight of 10000 to 14600 g/mol and Poloxamer 188 has an average molecular weight of 7680 to 9510 g/mol.