Compositions comprising thymoquinone and omega-3 fatty acids
The present invention provides a composition comprising a synergistic combination of thymoquinone and one or more omega-3 fatty acids, wherein the molar ratio between said thymoquinone and said one or more omega-3 fatty acids is at least 1:7. The present invention also provides a method of using said composition to treat or prevent inflammatory conditions.
1. A composition comprising a combination of thymoquinone (TQ), and one or more omega-3 fatty acids, wherein the molar ratio between said TQ and said one or more omega-3 fatty acids is equal to or less than 1:7, wherein the TQ and one or more omega-3 fatty acids are present in an effective amount to provide a synergistic anti-inflammatory effect, and wherein the one or more omega-3 fatty acids are highly concentrated oils containing a minimum of 85% w/w DHA & EPA in their ethyl ester forms, and wherein the molar ratio between DHA and EPA is in the range of 1:1000 to 1000:1.
2. The composition according to claim 1 , wherein the molar ratio between TQ and the omega-3 fatty acids is in the range of 1:7-1:200.
3. The composition according to claim 1 , wherein the molar ratio between TQ and the omega-3 fatty acids is in the range of 1:7-1:150.
4. The composition according to claim 1 , wherein the molar ratio between TQ and the omega-3 fatty acids is in the range of 1:7-1:140.
5. The composition according to claim 1 , wherein the TQ is present in the composition in a form selected from the group consisting of intact black cumin (BC) seeds, ground BC seeds, BC seed oil, solvent extracts of BC seeds, supercritical CO 2 extracts of BC oils, and/or partially purified extracts, purified extracts and/or fractions thereof.
6. The composition according to claim 1 , wherein the TQ is synthetic TQ.
7. The composition of claim 1 , further comprising 3,3-diindolylmethane (DIM).
8. A dosage form comprising the composition according to claim 1 , wherein said dosage form is selected from the group consisting of a soft gelatin capsule, a sprinkle capsule, a sachet, a tablet, a syrup or other pharmaceutically acceptable oral dosage form.
9. The dosage form according to claim 8 , wherein the amount of TQ in said dosage form is 1-15% of the amount of omega-3 fatty acid.
10. The dosage form according to claim 8 , further comprising 3,3-diindolylmethane (DIM), wherein the amount of TQ in said dosage form is 1-15% of the amount of omega-3 fatty acid and the amount of DIM is 1-15% of the amount of omega-3 fatty acid.
11. A composition according to claim 1 , comprising an effective amount of the combination of TQ and one or more omega-3 fatty acids, for the treatment, prevention, attenuation or inhibition of the progression of an inflammatory disease or a disease having an inflammatory component.
12. The composition according to claim 1 , in the form of a fixed dose composition, which optionally further comprises a nutritionally or pharmaceutically acceptable ingredient.
13. A unit dosage form, which is a soft gelatin capsule, wherein the soft gelatin capsule comprises: a) 10-200 mg of thymoquinone (TQ); and b) 300-900 mg of highly concentrated DHA & EPA ethyl esters, with a molar ratio of EPA/DHA ranging from 1:2 to 2:1.
14. The unite dosage form of claim 13 , wherein the soft gelatin capsule further comprises one or more ingredients selected from:
c) 1-20 mg lycopene or lutein;
d) 4-8 mg of vitamin E; and
e) a surface active material.