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 Paracetamol or Propacetamol

Abstract

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 paracetamol and propacetamol.

1 . A pharmaceutical composition comprising:
 (a) 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   (b) a second pharmacologically active ingredient selected from paracetamol and propacetamol.   
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the first pharmacologically active ingredient is (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 in form of the hydrochloride, hemicitrate or maleate salt. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the second pharmacologically active ingredient is paracetamol. 
     
     
         4 . 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. 
     
     
         5 . 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. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , for use in the prevention or treatment of pain, anxiety or epilepsy. 
     
     
         7 . The pharmaceutical composition according to  claim 6 , 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.   
     
     
         8 . A pharmaceutical dosage form comprising the pharmaceutical composition according to  claim 1 . 
     
     
         9 . The pharmaceutical dosage form according to  claim 8 , which contains the first pharmacologically active ingredient in a dose of from 10 to 1,200 μg. 
     
     
         10 . The pharmaceutical dosage form according to  claim 8 , which contains the second pharmacologically active ingredient in a dose of from 100 to 8,000 mg. 
     
     
         11 . The pharmaceutical dosage form according to  claim 8 , 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. 
     
     
         12 . The pharmaceutical dosage form according to  claim 8 , which is for oral, intravenous, intraperitoneal, transdermal, intrathecal, intramuscular, intranasal, transmucosal, subcutaneous, or rectal administration. 
     
     
         13 . The pharmaceutical dosage form according to  claim 8 , which provides under in vitro conditions immediate release or controlled release of the first pharmacologically active ingredient and/or the second pharmacologically active ingredient. 
     
     
         14 . 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 . 
     
     
         15 . The kit according to  claim 14 , 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.