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 extract of Cannabis sativa, Cannabis indica , or combination thereof, enriched with terpenes and a second extract of Cannabis sativa, Cannabis indica , or combination thereof, enriched with cannabinoids, the process comprising:
(a) contacting Cannabis sativa, Cannabis indica , or a combination thereof, with carbon dioxide as the sole supercritical fluid solvent, at a pressure of about 750 psi to about 3,000 psi, and at a temperature of about 30° C. to about 60° C., to provide an enriched extract of Cannabis sativa, Cannabis indica , or combination thereof; and
(b) removing the supercritical carbon dioxide from the extract;
wherein the (a) contacting of the Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical carbon dioxide and then the (b) removing the supercritical carbon dioxide, is carried out two or more times, such that the process is a supercritical carbon dioxide fluid extraction;
wherein a first supercritical carbon dioxide fluid extraction is carried out such that (i) the contacting of the Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical carbon dioxide, is carried out at a pressure of about 800 psi to about 1,200 psi and at a temperature of about 25° C. to about 40° C., for about 0.5 hour to about 2 hours, to provide a first extract enriched with terpenes; and
wherein a second supercritical carbon dioxide fluid extraction is carried out such that (ii) the contacting of the Cannabis sativa, Cannabis indica , or a combination thereof, with the supercritical carbon dioxide, is carried out at a pressure of about 2,000 psi to about 2,800 psi and at a temperature of about 45° C. to about 55° C., for about 5 hours to about 15 hours, to provide a second extract enriched with cannabinoids.
2. The process of claim 1 , wherein the first supercritical carbon dioxide fluid extraction is carried out at a pressure of about 1,000 psi to about 1,200 psi.
3. The process of claim 1 , wherein the first supercritical carbon dioxide fluid extraction is carried out at a temperature of about 37° C. to about 39° C.
4. The process of claim 1 , wherein the first supercritical carbon dioxide fluid extraction is carried out for a period of time of about 1 hour to about 2 hours.
5. The process of claim 1 , wherein the terpenes are selected from the group consisting of β-caryophyllene epoxide; mentha-1,8(9)-dien-5-ol; pulegone; limonene; limonene oxide; α-terpinene; terpinen-4-ol; carvacrol; carvone; 1,8-cineole; p-cymene; fenchone; pulegone-1,2 epoxide; 13-myrcene; and combinations thereof.
6. The process of claim 1 , wherein the first extract enriched with terpenes is further purified employing a technique selected from the group consisting of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, lyophilization, sublimation, and combinations thereof.
7. The process of claim 1 , further comprising purifying the first extract enriched with terpenes employing a technique selected from the group consisting of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, lyophilization, sublimation, and combinations thereof, such that the first extract enriched with terpenes after the purification comprises at least 90 wt. % terpenes.
8. The process of claim 1 , wherein the first extract enriched with terpenes is further purified employing a technique selected from the group consisting of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, lyophilization, sublimation, and combinations thereof, such that the first extract enriched with terpenes after the purification comprises at least about 98 wt. % terpenes.
9. The process of claim 1 , wherein relative to the cannabis in step (a), the first extract enriched with terpenes has a lower concentration of cannabinoids.
10. The process of claim 1 , wherein the second supercritical carbon dioxide fluid extraction is carried out at a pressure of about 2,300 psi to about 2,500 psi.
11. The process of claim 1 , wherein the second supercritical carbon dioxide fluid extraction is carried out at a temperature of about 48° C. to about 51° C.
12. The process of claim 1 , wherein the second supercritical carbon dioxide fluid extraction is carried out for a period of time of about 8 hours to about 12 hours.
13. The process of claim 1 , wherein the second extract enriched with cannabinoids comprises at least about 65 wt. % cannabinoids.
14. The process of claim 1 , wherein relative to the cannabis in step (a), the second extract enriched with cannabinoids includes a lower concentration of terpenes.
15. The process of claim 1 , wherein the cannabinoids are selected from the group consisting of
cannabinol;
cannabinolic acid;
Δ9-tetrahydrocannabinol;
Δ(9)-tetrahydrocannabinolic acid;
Δ(9)-cannabidiol;
Δ(9)-tetrahydrocannabidiolic acid;
Δ(8)-tetrahydrocannabinol;
Δ(8)-tetrahydrocannabinolic acid;
Δ(8)-tetrahydrocannabidiol;
Δ(8)-tetrahydrocannabidiolic acid;
Δ(9)-tetrahydrocannabivarin;
cannabigerol;
cannabigerolic acid;
cannabichromene;
cannabichromenic acid;
cannabicyclol;
cannabicyclolic acid;
and combinations thereof.
16. The process of claim 1 , wherein the cannabinoids are selected from the group consisting of
Δ9-tetrahydrocannabinol;
Δ(9)-cannabidiol;
Δ(8)-tetrahydrocannabinol;
Δ(8)-tetrahydrocannabidiol;
cannabigerol;
and combinations thereof.
17. The process of claim 1 , further comprising purifying the second extract enriched with cannabinoids employing a technique selected from the group consisting of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, lyophilization, sublimation, and combinations thereof.
18. The process of claim 1 , further comprising purifying the second extract enriched with cannabinoids employing a technique selected from the group consisting of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, lyophilization, sublimation, and combinations thereof, such that the second extract enriched with cannabinoids after the purification comprises at least about 90 wt. % cannabinoids.
19. The process of claim 1 , further comprising purifying the second extract enriched with cannabinoids employing a technique selected from the group consisting of chromatography, adsorption, crystallization, distillation, liquid-liquid extraction, filtration, fractional distillation, precipitation, recrystallization, lyophilization, sublimation, and combinations thereof, such that the second extract enriched with cannabinoids after the purification comprises at least about 95 wt. % cannabinoids.