Pharmaceutical composition and method of manufacturing

摘要

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.

主权项

1. A process for obtaining a concentrate of Cannabis sativa or Cannabis indica, the process comprising:
(a) contacting Cannabis sativa or Cannabis indica plant material with a supercritical fluid solvent system, at a pressure between about 750 psi and 25,000 psi, and at a temperature between about −15° C. and 200° C., to provide an extract of Cannabis sativa or Cannabis indica; and (b) removing the supercritical fluid solvent system from the extract; wherein the (a) contacting of the Cannabis sativa or Cannabis indica plant material with the supercritical fluid solvent system and the (b) removing the supercritical fluid solvent system, is carried out multiple times, such that the process is a fractional supercritical fluid extraction; wherein each contacting of the Cannabis sativa or Cannabis indica with a supercritical fluid solvent system independently occurs at a pressure between about 750 psi and 25,000 psi, and independently occurs at a temperature between about −15° C. and 200° C.; wherein at least one of the supercritical fluid extractions is carried out at a temperature of at least about 80° C.; and wherein each supercritical fluid solvent system independently comprises carbon dioxide (CO2) and optionally one or more additional solvents and optionally one or more co-solvents, selected from the group consisting of hydrogen (H2), neon (Ne), nitrogen (N2), argon (Ar), methane (CH4), ethane (CH3CH3), propane (CH3CH2CH3), ammonia (NH3), water (H2O), 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 (N2O), sulfur hexafluoroide (SF6), butane (n-C4H10), isobutane (i-C4H10), ethyl ether ((C2H5)2O), benzotrifluoride (C6H5CF3), (p-chlorophenyl) trifluoromethane (ClC6H4CF3), chlorofluorocarbon (CFC), hydrofluorocarbon (HFA), HFA-134a (1,1,1,2-tetrafluoroethane), and mixtures thereof.