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 the group consisting of pregabalin and the physiologically acceptable salts thereof, wherein the first pharmacologically active ingredient is in a dose of 40 to 1,000μg, and wherein the second pharmacologically active ingredient is in a dose of 0.1 to 3 g.
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 ingredients in such a weight ratio that they will exert a synergistic analgesic 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 1 : 30 to 1 : 1,000,000.
5. A method of preventing or treating pain, comprising administering a 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 (post-surgical), 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 , 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.
9. The pharmaceutical dosage form according to claim 7 , which is for oral, intravenous, intraperitoneal, transdermal, intrathecal, intramuscular, intranasal, transmucosal, subcutaneous, or rectal administration.
10. 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.
11. A kit comprising a first pharmaceutical dosage form and a second pharmaceutical dosage form, the first pharmaceutical dosage form comprising a first pharmacologically active ingredient selected from (1r,40-6′-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 the second pharmaceutical dosage form comprising the second pharmacologically active ingredient selected from the group consisting of pregabalin and the physiologically acceptable salts thereof.
12. The kit according to claim 11 , 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.