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 800 psi-2800 psi, at a temperature of 25° C.-54° C., for a period of time of 0.5 hours-14 hours, to provide an enriched extract of Cannabis sativa, Cannabis indica , or combination thereof; and
(c) 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 800 psi-1,200 psi, at a temperature of 25° C.-35° C., for a period of time of 0.5 hours-2.5 hours, to provide a first extract enriched with terpenes;
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 2,000 psi-2,800 psi, at a temperature of 44° C.-54° C., for a period of time of 6 hours-14 hours, to provide an enriched extract of Cannabis sativa, Cannabis indica , or combination thereof, to provide a second extract enriched with cannabinoids; and
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.
2. The process of claim 1 , wherein the first supercritical fluid extraction is carried out at a pressure of 1,000 psi-1,200 psi.
3. The process of claim 1 , wherein the first supercritical fluid extraction is carried out at a temperature of 37° C.-39° C.
4. The process of claim 1 , wherein the first supercritical fluid extraction is carried out for a period of time of 1 hour-2 hours.
5. The process of claim 1 , wherein the first extract enriched with terpenes is 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.
6. The process of claim 1 , wherein the first extract enriched with terpenes is 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 85 wt. % terpenes.
7. The process of claim 1 , wherein the first extract enriched with terpenes is 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 98 wt. % terpenes.
8. The process of claim 1 , wherein relative to the cannabis in step (a), the first extract enriched with terpenes includes a lower concentration of cannabinoids.
9. 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.
10. The process of claim 1 , wherein the second supercritical fluid extraction is carried out at a pressure of 2,300 psi-2,500 psi.
11. The process of claim 1 , wherein the second supercritical fluid extraction is carried out at a temperature of 48° C.-50° C.
12. The process of claim 1 , wherein the second supercritical fluid extraction is carried out for a period of time of 8 hours-12 hours.
13. The process of claim 1 , wherein the second extract enriched with cannabinoids is 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.
14. The process of claim 1 , wherein the second extract enriched with cannabinoids is 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 second extract enriched with cannabinoids after the purification comprises at least 85 wt. % cannabinoids.
15. The process of claim 1 , wherein the second extract enriched with cannabinoids is 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 second extract enriched with cannabinoids after the purification comprises at least 95 wt. % cannabinoids.
16. The process of claim 1 , further comprising removing the supercritical fluid solvent from the second extract enriched with cannabinoids.
17. The process of claim 1 , wherein the second extract enriched with cannabinoids comprises at least about 65 wt. % cannabinoids.
18. 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.
19. 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.
20. 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; and wherein cannabinoids are selected from the group consisting of: Δ9-tetrahydrocannabinol; Δ(9)-cannabidiol; Δ(8)-tetrahydrocannabinol; Δ(8)-tetrahydrocannabidiol; cannabigerol; and combinations thereof.