Pharmaceutical composition comprising (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine and a gabapentinoid
View Patent ↗The invention relates to a pharmaceutical composition comprising a first pharmacologically active ingredient selected from (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine and the physiologically acceptable salts thereof, and a second pharmacologically active ingredient selected from gabapentinoids and the physiologically acceptable salts thereof.
1. A pharmaceutical composition comprising:
a) a first pharmacologically active ingredient selected from
and the physiologically acceptable salts thereof, and
b) a second pharmacologically active ingredient selected from gabapentin and the physiologically acceptable salts thereof.
2. The pharmaceutical composition according to claim 1 , wherein the first pharmacologically active ingredient is
3. The pharmaceutical composition according to claim 1 , which contains the first and the second pharmacologically active ingredient in such a weight ratio that they will exert a synergistic therapeutic effect upon administration to a patient.
4. The pharmaceutical composition according to claim 1 , wherein the relative weight ratio of the first pharmacologically active ingredient to the second pharmacologically active ingredient is within the range of from 1:30 to 1:1,000,000.
5. A method of treating or preventing pain, anxiety, or epilepsy comprising administering the pharmaceutical composition according to claim 1 to a patient in need thereof.
6. The method according to claim 5 , wherein the pain is:
peripheral, central or muscle skeletal pain; and/or
acute, subacute or chronic pain; and/or
moderate to severe pain; and/or
neuropathic or psychogenic or nociceptive or mixed pain; and/or
low back pain, visceral pain or headache; and/or
post-operative, cancer or inflammatory pain.
7. A pharmaceutical dosage form comprising the pharmaceutical composition according to claim 1 .
8. The pharmaceutical dosage form according to claim 7 , which contains the first pharmacologically active ingredient in a dose of from 10 to 1,200 μg.
9. The pharmaceutical dosage form according to claim 7 , which contains the second pharmacologically active ingredient in a dose of from 0.05 to 5 g.
10. The pharmaceutical dosage form according to claim 7 , wherein the dosage of the first pharmacologically active ingredient is within the range of from 1:20 to 20:1 of the amount which is equieffective to the dosage of the second pharmacologically active ingredient.
11. The pharmaceutical dosage form according to claim 7 , which is for oral, intravenous, intraperitoneal, transdermal, intrathecal, intramuscular, intranasal, transmucosal, subcutaneous, or rectal administration.
12. The pharmaceutical dosage form according to claim 7 , which provides under in vitro conditions immediate release or controlled release of the first pharmacologically active ingredient and/or the second pharmacologically active ingredient.
13. A kit comprising a first pharmaceutical dosage form comprising the first pharmacologically active ingredient as defined in claim 1 , and a second pharmaceutical dosage form comprising the second pharmacologically active ingredient as defined in claim 1 .
14. The kit according to claim 13 , wherein the first and the second pharmaceutical dosage form are adapted for simultaneous or sequential administration, either by the same or a different pathway of administration.