Pharmaceutical composition and method of manufacturing

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;

(b) removing the supercritical carbon dioxide from the extract; and

(c) purifying at least one of the enriched extracts 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;

wherein the (a) contacting of the Cannabis saliva, 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 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 90 wt. % terpenes.

8. 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 about 98 wt. % terpenes.

9. 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.

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 , further comprising removing the supercritical fluid solvent from the second extract enriched with cannabinoids.

14. The process of claim 1 , wherein the second extract enriched with cannabinoids comprises at least about 65 wt. % cannabinoids.

15. 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.

16. The process of claim 1 , wherein the cannabinoids are selected from the group consisting of

cannabinol (CBN);

cannabinolic acid (CBNA);

Δ9-tetrahydrocannabinol (Δ(9)-THC);

Δ(9)-tetrahydrocannabinolic acid (Δ (9)-THCA);

Δ(9)-cannabidiol (Δ(9)-CBD);

Δ(9)-tetrahydrocannabidiolic acid (Δ(9)-CBDA);

Δ(8)-tetrahydrocannabinol (Δ(8)-THC);

Δ(8)-tetrahydrocannabinolic acid (Δ(8)-THCA);

Δ(8)-tetrahydrocannabidiol (Δ(8)-CBD);

Δ(8)-tetrahydrocannabidiolic acid (Δ(8)-CBDA);

Δ(9)-tetrahydrocannabivarin (Δ(9)-THV);

cannabigerol (CBG);

cannabigerolic acid (CBGA);

cannabichromene (CBC);

cannabichromenic acid (CBCA);

cannabicyclol (CBL);

cannabicyclolic acid (CBLA);

and combinations thereof.

17. The process of claim 1 , wherein the cannabinoids are selected from the group consisting of

Δ9-tetrahydrocannabinol (Δ(9)-THC);

Δ(9)-cannabidiol (Δ(9)-CBD);

Δ(8)-tetrahydrocannabinol (Δ(8)-THC);

Δ(8)-tetrahydrocannabidiol (Δ(8)-CBD);

cannabigerol (CBG);

and combinations thereof.

18. 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 about 85 wt. % cannabinoids.

19. 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 about 90 wt. % cannabinoids.

20. 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 about 95 wt. % cannabinoids.