US2004209906A1PendingUtilityA1

Composition comprising ketanserin AND AN ALKANOYL L-CARNITINE FOR THE TREATMENT OF CRPS

Assignee: SIGMA TAU IND FARMACEUTIPriority: Apr 10, 1998Filed: Apr 28, 2003Published: Oct 21, 2004
Est. expiryApr 10, 2018(expired)· nominal 20-yr term from priority
A61P 25/04A61P 29/00A61P 25/00A61K 31/505A61K 31/495
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Claims

Abstract

The use of ketanserin in combination with L-carnitine, some alkanoyl L-carnitines and the pharmacologically acceptable salts thereof is disclosed for the treatment of CRPS.

Claims

exact text as granted — not AI-modified
1 . A combination consisting of synergistic effective amounts of ketanserin and an alkanoyl L-carnitine or one pharmacologically acceptable salt thereof.  
     
     
         2 . Pharmaceutical composition comprising synergistic effective amounts of active ingredients ketanserin and an alkanoyl L-carnitine wherein the linear or branched-chain alkanoyl group has 2-6 carbon atoms or one pharmacologically acceptable salt thereof, in admixture with pharmacologically acceptable vehicle and/or excipient.  
     
     
         3 . The composition according to  claim 2 , for oral, parenteral or intravenous infusion administration.  
     
     
         4 . The composition according to  claim 2 , wherein the alkanoyl L-carnitine is selected from the group consisting of acetyl L-carnitine, propionyl L-carnitine, butyryl L-carnitine, valeryl L-carnitine and isovaleryl L-carnitine.  
     
     
         5 . The composition according to  claim 2 , wherein the pharmacologically acceptable salt of the alkanoyl L-carnitine is selected from the group consisting of chloride, bromide, orotate, aspartate, acid aspartate, acid citrate, acid phosphate, fumarate and acid fumarate, lactate, maleate and acid maleate, mucate, acid oxalate, acid sulphate, glucose phosphate, tartrate and acid tartrate.  
     
     
         6 . The composition according to  claim 2 , in unit dosage form, comprising 5-100 mg of Ketanserin and 100-3000 mg of an alkanoyl L-carnitine.  
     
     
         7 . The composition according to  claim 6 , for oral administration.  
     
     
         8 .- 9 . Cancelled.  
     
     
         10 . A kit comprising synergistric effective amounts in the same package a first set of vials for intravenous infusion, said first set of vials comprising 5-50 mg of ketanserin in admixture with pharmacologically acceptable vehicle and/or excipient, a second set of vials for intravenous infusion, said second set of vials comprising 500-2000 mg of an amount of an alkanoyl L-carnitine equivalent to L-carnitine wherein the linear or branched-chain alkanoyl group has 2-6 carbon atoms or one pharmacologically acceptable salts thereof, in admixture with pharmacologically acceptable vehicle and/or excipient.  
     
     
         11 . Canceled.  
     
     
         12 . A kit comprising in the same package a first orally administrable pharmaceutical composition comprising 5-100 mg of Ketanserin and a second orally administrable pharmaceutical composition comprising 100-3000 mg of an alkanoyl L-carnitine.  
     
     
         13 .- 17 . Canceled.  
     
     
         18 . A method of treating chronic regional pain syndrome comprising the coordinated administration of synergistic effective amounts of ketanserin and an alkanoyl L-carnitine or a pharmacologically acceptable salt thereof to a patient suffering from said syndrome.  
     
     
         19 . The method of  claim 18  wherein the linear or branched-chain alkanoyl group has 2-6 carbon atoms.  
     
     
         20 . The method of  claim 19 , wherein the alkanoyl L-carnitine is selected from the group consisting of acetyl L-carnitine, propionyl L-carnitine, butyryl L-carnitine, valeryl L-carnitine and isovaleryl L-carnitine.  
     
     
         21 . The method of  claim 18 , wherein the pharmacologically acceptable salt of the alkanoyl L-carnitine is selected from the group consisting of chloride, bromide, orotate, aspartate, acid aspartate, acid citrate, acid phosphate, fumarate and acid fumarate, lactate, maleate and acid maleate, mucate, acid oxalate, acid sulphate, glucose phosphate, tartrate and acid tartrate.  
     
     
         22 . The method of  claim 18 , wherein there is administered 5-100 mg of ketanserin and 100-3000 mg of an alkanoyl L-carnitine, in a single unit dosage form.  
     
     
         23 . The method of  claim 18 , wherein there is administered 5-100 mg of ketanserin in a first unit dosage form and 100-30000 mg of an alkanoyl L-carnitine in a second unit dosage form, said first and second unit dosage forms being physically separated.

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