Pharmaceutical composition and method of manufacturing
View Patent ↗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.
1. A process for obtaining a first concentrate of Cannabis sativa, Cannabis indica , or combination thereof, enriched with tetrahydrocannabinols (THCs) and a second concentrate of Cannabis sativa, Cannabis indica , or combination thereof, enriched with cannabidiols (CBDs), the process comprising:
(a) contacting plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, with a supercritical fluid solvent system, at a pressure of about 750-3,000 psi, and at a temperature of about 35-60° C., to provide an extract of Cannabis sativa, Cannabis indica , or combination thereof; and
(b) removing the supercritical fluid solvent system from the extract;
wherein the (a) contacting of the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, 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;
wherein a first fractional supercritical fluid extraction is carried out such that (a) contacting of the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical fluid solvent system is carried out at a pressure of about 900 psi to about 1,100 psi and a temperature of about 35° C. to about 60° C. for a period of time of about 1-8 hours, to provide a first concentrate enriched with tetrahydrocannabinols (THCs);
wherein a second fractional supercritical fluid extraction is carried out such that (a) contacting of the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical fluid solvent system is carried out at a pressure of about 1,900 psi to about 2,100 psi and a temperature of about 35° C. to about 60° C., for a period of time of about 1-8 hours, to provide a second concentrate enriched with cannabidiols (CBDs).
2. The process of claim 1 , wherein the first fractional supercritical fluid extraction is carried out at a temperature of about 55° C. to about 65° C.
3. The process of claim 1 , wherein the first fractional supercritical fluid extraction is carried out with carbon dioxide (CO 2 ) as the sole solvent.
4. The process of claim 1 , wherein the second fractional supercritical fluid extraction is carried out at a temperature of about 55° C. to about 65° C.
5. The process of claim 1 , wherein the second fractional supercritical fluid extraction is carried out with carbon dioxide (CO 2 ) as the sole solvent.
6. The process of claim 1 , wherein the (a) contacting of the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical fluid solvent system and the (b) removing the supercritical fluid solvent system, is carried out two times.
7. The process of claim 1 , wherein the first concentrate of Cannabis sativa, Cannabis indica , or combination thereof, relative to the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, is at least partially purified from at least one of terpenes, alkaloids, hemp oil, and cannabinoid acids.
8. The process of claim 1 , wherein the second concentrate of Cannabis sativa, Cannabis indica , or combination thereof, relative to the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, is at least partially purified from at least one of terpenes, alkaloids, hemp oil, and cannabinoid acids.
9. The process of claim 1 , further comprising purifying the concentrate of Cannabis sativa, Cannabis indica , or combination thereof, employing at least one of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, and sublimation.
10. The process of claim 1 , wherein the first concentrate is enriched with tetrahydrocannabinols (THCs) comprising at least one of:
Δ(9)-tetrahydrocannabinol (Δ(9)-THC), which is 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol; and
Δ(8)-tetrahydrocannabinol (Δ(8)-THC), which is 6a,7,10,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol.
11. The process of claim 1 , wherein the second concentrate is enriched with cannabidiols (CBDs) comprising:
Δ(2)-cannabidiol (Δ(2)-CBD), which is 2-(6-isopropenyl-3-methyl-2-cyclohexen-1-yl)-5-pentyl-1,3-benzenediol.
12. The process of claim 1 , wherein the first concentrate is enriched with tetrahydrocannabinols (THCs), such that the first concentrate comprises at least about 90 wt. % tetrahydrocannabinols (THCs).
13. The process of claim 1 , wherein the first concentrate is enriched with tetrahydrocannabinols (THCs), such that the first concentrate comprises less than about 10 wt. %, in the aggregate, of terpenes, alkaloids, hemp oil, and cannabinoid acids.
14. The process of claim 1 , wherein the second concentrate is enriched with cannabidiols (CBDs), such that the second concentrate comprises at least about 90 wt. % tetrahydrocannabinols (THCs).
15. The process of claim 1 , wherein the second concentrate is enriched with cannabidiols (CBDs), such that the second concentrate comprises less than about 10 wt. %, in the aggregate, of terpenes, alkaloids, hemp oil, and cannabinoid acids.
16. A process for obtaining a first concentrate of Cannabis sativa, Cannabis indica , or combination thereof, enriched with tetrahydrocannabinols (THCs) and a second concentrate of Cannabis sativa, Cannabis indica , or combination thereof, enriched with cannabidiols (CBDs), the process comprising:
(a) contacting plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, with a supercritical fluid solvent system, at a pressure of about 750-3,000 psi, and at a temperature of about 35-65° C., to provide an extract of Cannabis sativa, Cannabis indica, or combination thereof; and
(b) removing the supercritical fluid solvent system from the extract;
wherein the (a) contacting of the plant material comprising Cannabis sativa, Cannabis indica, or a combination thereof, with the supercritical fluid solvent system and the (b) removing the supercritical fluid solvent system, is carried out two times, such that the process is a fractional supercritical fluid extraction;
wherein a first fractional supercritical fluid extraction is carried out such that (a) contacting of the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical fluid solvent system is carried out at a pressure of about 900 psi to about 1,100 psi and a temperature of about 35-65° C. for a period of time of about 1-8 hours, to provide a first concentrate enriched with tetrahydrocannabinols (THCs);
wherein a second fractional supercritical fluid extraction is carried out such that (a) contacting of the plant material comprising Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical fluid solvent system is carried out at a pressure of about 1,900 psi to about 2,100 psi and a temperature of about 35-65° C., for a period of time of about 1-8 hours, to provide a second concentrate enriched with cannabidiols (CBDs).
17. The process of claim 16 , wherein the first concentrate is enriched with tetrahydrocannabinols (THCs) comprising at least one of:
Δ(9)-tetrahydrocannabinol (Δ(9)-THC), which is 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol;
(−)-trans-Δ(9)-tetrahydrocannabinol, which is (6aR,10aR)-Δ9-tetrahydrocannabinol;
(−)-cis-Δ9-tetrahydrocannabinol, which is (6aS,10aR)-Δ9-tetrahydrocannabinol; and
Δ(8)-tetrahydrocannabinol (Δ(8)-THC), which is 6a,7,10,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol.
18. The process of claim 16 , wherein the second concentrate is enriched with cannabidiols (CBDs) comprising:
Δ(2)-cannabidiol (Δ(2)-CBD), which is 2-(6-isopropenyl-3-methyl-2-cyclohexen-1-yl)-5-pentyl-1,3-benzenediol.
19. The process of claim 16 , wherein the first fractional supercritical fluid extraction is carried out at a temperature of about 55° C. to about 65° C.
20. The process of claim 16 , wherein the second fractional supercritical fluid extraction is carried out at a temperature of about 55° C. to about 65° C.