Pharmaceutical Composition Comprising Cannabinoid

Abstract

The present disclosure provides a pharmaceutical composition comprising a first pharmaceutically active portion comprising one or more cannabinoids extracted from Cannabis plant material; a second pharmaceutically active portion comprising glutathione extracted from Cannabis plant material and optionally one or more excipients; wherein the molar ratio of the second pharmaceutically active portion to the first pharmaceutically active portion is at least 0.5:1. The present disclosure also provides a method of manufacturing a pharmaceutical composition comprising the steps of: extracting a first fraction containing one or more cannabinoids from a Cannabis plant material using a polar solvent; extracting a second fraction containing from the glutathione from the same Cannabis plant material using water; and drying and combining the first fraction and the second fraction to form the pharmaceutical composition.

Claims

1. A pharmaceutical composition comprising: a first pharmaceutically active portion comprising one or more cannabinoids extracted from Cannabis plant material; a second pharmaceutically active portion comprising glutathione extracted from Cannabis plant material, wherein the molar ratio of the second pharmaceutically active portion to the first pharmaceutically active portion is at least 0.5:1.

2. A pharmaceutical composition according to claim 1, wherein the molar ratio of the second pharmaceutically active portion to the first pharmaceutically active portion is at least 0.8:1.

3. A pharmaceutical composition according to claim 1, wherein the molar ratio of the second pharmaceutically active portion to the first pharmaceutically active portion is at least 1:1.

4. A pharmaceutical composition according to claim 1, wherein the first pharmaceutically active portion comprises cannabidiol.

5. A pharmaceutical composition according to claim 1, wherein the first pharmaceutically active portion comprises cannabinol.

6. A method of manufacturing a pharmaceutical composition according to claim 1 from Cannabis plant material, comprising the steps of: extracting a first fraction comprising the one or more cannabinoids from the Cannabis plant material using a polar solvent; extracting a second fraction comprising the glutathione from the Cannabis plant material using water; drying the first fraction; drying the second fraction; and, combining the first fraction and the second fraction to form the pharmaceutical composition.

7. A method according to claim 6, wherein the polar solvent is ethanol.

8. A method according to claim 6, wherein the Cannabis plant material consists of Cannabis plant cells.

9. A method according to claim 6, wherein the Cannabis plant material comprises dried Cannabis plant.

10. A method according to claim 6, wherein the first fraction and the second fraction are combined with one or more excipients to form the pharmaceutical composition.

11. A pharmaceutical composition according to claim 1, wherein the first pharmaceutically active portion comprises tetrahydrocannabionol.

Description

EXAMPLE

[0030] The components of a composition according to the present invention can be extracted from a single Cannabis sativa source in the following manner: [0031] i) Extraction of cannabinoids

[0032] Solvent extraction of cannabinoids from Cannabis plant and separating the specific cannabinoids is well known in the art. U.S. Pat. No. 6,403,126 discloses one such method and the method disclosed in that patent is suitable for use with the present invention. In particular, the method of U.S. Pat. No. 6,403,126 is suitable for use in extracting cannabinoids from Cannabis sativa.

[0033] In this method Cannabis powder is extracted with a solvent, for example ethanol, for a period for two to four hours. The solvent may then be evaporated to leave a residue. The extracted residue can then be passed over a chromatographic column arranged to fractionate at least one cannabinoid. The fractionated cannabinoid(s) can then be used to form a pharmaceutical composition. [0034] ii) Extraction of glutathione

[0035] Materials: 10 g dried Cannabis sativa leaf [0036] 100 ml de-ionised water [0037] 250 ml erhlingmeyer flask [0038] Magnetic stirrer and bar [0039] Filter paper [0040] Filter funnel [0041] Evaporating dish [0042] Drying oven

[0043] The Cannabis sativa powder and the de-ionised water are added to the Ehrlingmeyer flask. The stirrer bar is placed into the flask and the mixture is stirred at a speed of 30 rpm for two hours. Optionally, a buffer may be used to maintain the pH of the water to 7.5 pH.

[0044] After stirring, the mixture is poured through the filter paper into the evaporating dish. The evaporating dish is placed in the drying oven at a temperature of 106° C. until completely evaporated. The resulting residue is a mixture of water soluble plant compounds from the powdered Cannabis sativa and includes a high percentage of glutathione.

[0045] If necessary, the residue can be further purified by removing other dissolved compounds using ethanol as a solvent and then retaining the non-dissolved residue. The glutathione content of the residue may be assayed by high performance liquid chromatography.

[0046] It is noted that the glutathione extraction method set out above does not generally result in pure glutathione. Further processing is required to obtain pure glutathione. However, for the purposes of the present invention it is not necessarily essential that pure glutathione is utilised so long as the extract from the Cannabis contains sufficient glutathione to provide the appropriate ratio with the cannabinoid(s) it is not essential that the extract is pure glutathione. Any other components of the extract are natural components of the Cannabis plant and, as such, are unlikely to be harmful to a consumer. In alternative embodiments compositions according to the present invention in which pure components are advantageous pharmaceutically pure glutathione from alternative sources may be utilised or further processing can be used to obtain pharmaceutically pure glutathione.

[0047] Subsequent to extraction the cannabinoid(s) can be combined with the glutathione and any suitable excipients to form a pharmaceutical composition according to the present invention.