US20190030103A1 – January 31, 2019 – PHARMACEUTICAL COMPOSITION AND METHOD OF MANUFACTURING

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Inventors :

Gary J. Speier

Owner :

Speier, Gary J.

Application Number :

US16151436

Document Number :

US20190030103A1

Priority Date :

October 4, 2018

Filing Date :

October 4, 2018

Date of Grant/ Publication :

January 31, 2019

Class :

A61K36 / 185; A61K36 / 00; A61K31 / 352; A61K9 / 00; A61K9 / 70

Abstract

The present invention provides for methods of obtaining an extract of Cannabis plant material as well as subsequent processing of the extract to provide a concentrate of Cannabis . The present invention also provides for pharmaceutical dosage forms (e.g., oral thin films and transdermal patches) that include the concentrate (or extract) of Cannabis , as well as methods of medical treatment that include administering the pharmaceutical dosage forms.

Claim(s)

1 . (canceled);
2 – 21 . (canceled);
22 . A process for obtaining a concentrate of cannabis enriched with cannabigerolic acid (CBGA), the process comprising: (a) contacting cannabis plant material with a supercritical fluid solvent system, at a pressure of about 750-3,000 psi, at a temperature of about 2° C.?70° C. and for a period of time of up to about 8 hours, to provide an extract of cannabis ; and (b) removing the supercritical fluid solvent system from the extract: wherein, the (a) contacting of the plant material with the supercritical fluid solvent system and the (b) removing the supercritical fluid solvent system, is carried out two or more times, such that the process is a fractional supercritical fluid extraction; and at least one of the fractional supercritical fluid extractions is carried out at a temperature above about 25° C.;
23 . The method of claim 22 , wherein relative to the cannabis plant material, the cannabis concentrate that is enriched with cannabigerolic acid (CBGA) contains at least about a 10% higher concentration of cannabigerolic acid (CBGA).;
24 . The method of claim 22 , wherein relative to the cannabis plant material, the cannabis concentrate that is enriched with cannabigerolic acid (CBGA) contains at least about a 20% higher concentration of cannabigerolic acid (CBGA).;
25 . The method of claim 22 , wherein each one of the fractional supercritical fluid extractions is carried out in a solvent system that comprises carbon dioxide (CO 2 ).;
26 . The method of claim 22 , wherein any one of the fractional supercritical fluid extractions is carried out in a solvent system that comprises carbon dioxide (CO 2 ) and optionally at least one of hydrogen (H 2 ), neon (Ne), nitrogen (N 2 ), argon (Ar), methane (CH 4 ), ethane (CH 3 CH 3 ), propane (CH 3 CH 2 CH 3 ), ammonia (NH 3 ), water (H 2 O), xenon (Xe), methanol, ethanol, 1-propanol, 2-propanol, 1-hexanol, 2-methoxy ethanol, tetrahydrofuran (THF), 1,4-dioxane, acetonitrile, methylene chloride, dichloroethane, chloroform, ethyl acetate, propylene carbonate, N,N-dimethylaceamide, dimethyl sulfoxide (DMSO), formic acid, carbon disulfide, acetone, toluene, hexanes, pentanes, trifluoromethane (Freon® 23), nitrous oxide (N 2 O), sulfur hexafluroide (SF 6 ), butane (n-C 4 H 10 ), isobutane (i-C 4 H 10 ), ethyl ether ((C 2 H 5 ) 2 O), benzotrifluoride (C 6 H 5 CF 3 ), (p-chlorophenyl)trifluoromethane (ClC 6 H 4 CF 3 ), chlorofluorocarbon (CFC), hydrofluorocarbon (HFA), and HFA-134a (1,1,1,2-tetrafluoroethane).;
27 . The process of claim 22 , wherein each fractional supercritical fluid extraction is carried out with a different supercritical fluid solvent system.;
28 . The process of claim 22 , wherein each fractional supercritical fluid extraction is carried out with a different supercritical fluid solvent system, each independently selected from: (i) polar aprotic, (ii) polar protic, (iii) nonpolar aprotic, and (iv) nonpolar protic.;
29 . The process of claim 22 , wherein each fractional supercritical fluid extraction is carried out with the same supercritical fluid solvent system.;
30 . The process of claim 22 , wherein each fractional supercritical fluid extraction is carried out with the same supercritical fluid solvent system, selected from: (i) polar aprotic, (ii) polar protic, (iii) nonpolar aprotic, and (iv) nonpolar protic.;
31 . The process of claim 22 , wherein each fractional supercritical fluid extraction is carried out at the same temperature.;
32 . The process of claim 22 , wherein each fractional supercritical fluid extraction is carried out at a different temperature.;
33 . The method of claim 22 , further comprising purifying the cannabis concentrate that is enriched with cannabigerolic acid (CBGA) employing at least one of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, and sublimation.;
34 . The method of claim 22 , wherein relative to the cannabis plant material, the cannabis concentrate that is enriched with cannabigerolic acid (CBGA) contains a lower concentration of at least one of (i)-(vi): (i) cannabinol (CBN), (ii) alkaloids, (iii) terpenes, (iv) terpenoids, (v) cannabinoid acids, and (vi) hemp oil.;
35 . The method of claim 22 , wherein relative to the cannabis plant material, the cannabis concentrate that is enriched with cannabigerolic acid (CBGA) contains at least a 10% lower concentration of at least one of (i)-(vi): (i) cannabinol (CBN), (ii) alkaloids, (iii) terpenes, (iv) terpenoids, (v) cannabinoid acids, and (vi) hemp oil.;
36 . The method of claim 22 , wherein relative to the cannabis plant material, the cannabis concentrate that is enriched with cannabigerolic acid (CBGA) contains a lower concentration of at least one of (i)-(ii): (i) tetrahydrocannabinol (THC), and (ii) cannabidiol (CBD).;
37 . The method of claim 22 , wherein relative to the cannabis plant material, the cannabis concentrate that is enriched with cannabigerolic acid (CBGA) contains at least a 10% lower concentration of at least one of (i)-(ii): (i) tetrahydrocannabinol (THC), and (ii) cannabidiol (CBD).;
38 . The process of claim 22 , wherein each fractional supercritical fluid extraction is carried out with carbon dioxide (CO 2 ) as the sole solvent.

Summary

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