Analgesic and anti-inflammatory compositions comprising domperidone and methods of using same

Abstract

The present invention provides a method for eliciting an onset hastened analgesic and anti-inflammatory response and combating nausea in acute migraine attacks. This method comprises administering a pharmaceutical composition comprising more than one active ingredient, wherein said more than one active ingredient consist essentially of: (i) domperidone or an analogue thereof in an amount sufficient to hasten the onset of the analgesic and anti-inflammatory response and to combat nausea in an acute migraine attack, and (ii) a NSAID, a pharmaceutically acceptable salt thereof or a pure (−) or pure (+) optical isomeric form thereof in an analgesically and anti-inflammatory effective amount, wherein said NSAID is selected from the group consisting of proprionic acid derivatives, acetic acid derivatives, fenamic acid derivatives, biphenylcarboxylic acid derivatives and oxicams.

1 . A method for eliciting an onset hastened analgesic and anti-inflammatory response and/or for combating nausea and vomiting in acute migraine attacks, comprising administering a pharmaceutical composition consisting of: 
 (i) an amount of domperidone or its analogues sufficient to hasten the onset of the analgesic and anti-inflammatory response and to combat nausea in acute migraine, and    (ii) an analgesically and anti-inflammatory effective amount of a NSAID comprising an acetic acid derivative or a pharmaceutically acceptable salt or an appropriate pure (−) or (+) isomeric form thereof from sulindac, diclofenac, fenclofenac, alclofenac, ibuprofen, isoxepac, furofenac, tiopinac, zidometacin, acemetacin, fentiazac, clidanac and oxpinac.    
     
     
         2 . A method for eliciting an onset hastened analgesic and anti-inflammatory response and/or for combating nausea and vomiting in acute migraine attacks, comprising administering a pharmaceutical composition consisting of: 
 (i) an amount of domperidone or its analogues sufficient to hasten the onset of the analgesic and anti-inflammatory response and to combat nausea in acute migraine, and    (ii) an analgesically and anti-inflammatory effective amount of a NSAID comprising an acetic acid derivative or a pharmaceutically acceptable salt or an appropriate (−) or (+) isomeric form thereof from sulindac, diclofenac, fenclofenac, alclofenac, ibuprofen, isoxepac, furofenac, tiopinac, zidometacin, acemetacin, fentiazac, clidanac and oxpinac; together with an analgesically and anti-inflammatory effective amount of a narcotic analgesic, or its pharmaceutically acceptable salt or an appropriate pure (−) or (+) pure optical isomer.    
     
     
         3 . A pharmaceutical composition of matter for use in eliciting an onset hastened analgesic and anti-inflammatory response and for combating nausea and vomiting in acute migraine attacks, comprising administering a pharmaceutical composition consisting of: 
 (i) an amount of domperidone or its analogues sufficient to hasten the onset of the analgesic and anti-inflammatory response and to combat nausea in acute migraine, and    (ii) an analgesically and anti-inflammatory effective amount of a NSAID comprising an acetic acid derivative or a pharmaceutically acceptable salt or an appropriate pure (−) or pure (+) isomeric form thereof from sulindac, diclofenac, fenclofenac, alclofenac, ibuprofen, isoxepac, furofenac, tiopinac, zidometacin, acemetacin, fentiazac, clidanac and oxpinac.    
     
     
         4 . A pharmaceutical composition of matter for use in eliciting an onset hastened analgesic and anti-inflammatory response and for combating nausea in acute migraine attacks, comprising administering a pharmaceutical composition consisting of: 
 i) an amount of domperidone or its analogues sufficient to hasten the onset of the analgesic and anti-inflammatory response and to combat nausea in acute migraine, and    (ii) an analgesically and anti-inflammatory effective amount of a NSAID comprising an acetic acid derivative or a pharmaceutically acceptable salt or an appropriate pure (−) or pure (+) isomeric form thereof from sulindac, diclofenac, fenclofenac, alclofenac, ibuprofen, isoxepac, furofenac, tiopinac, zidometacin, acemetacin, fentiazac, clidanac and oxpinac; together with an analgesically and anti-inflammatory effective amount of a narcotic analgesic, or its pharmaceutically acceptable salt or an appropriate pure (−) or pure (+) isomer.    
     
     
         5 . A pharmaceutical composition according to claims  3 & 4 , wherein the NSAID is a propionic acid derivative.  
     
     
         6 . A pharmaceutical composition according to claims  3 & 4 , wherein the NSAID is a fenamic acid derivative.  
     
     
         7 . A pharmaceutical composition according to claims  3 & 4 , wherein the NSAID is a biphenylcarboxylic acid derivative.  
     
     
         8 . A pharmaceutical composition according to claims  3 & 4 , wherein the NSAID is an oxicam derivative.  
     
     
         9 . A pharmaceutical composition according to claims  3 & 4 , said composition being adapted for oral administration.  
     
     
         10 . A pharmaceutical composition according to claims  3 & 4 , said composition being formulated as a tablet or capsule.  
     
     
         11 . A pharmaceutical composition according to  claim 10 , wherein said composition is being formulated as a dispersible or effervescent dosage form.  
     
     
         12 . A pharmaceutical composition according to  claim 10 , wherein said composition is in enteric coated dosage form.  
     
     
         13 . A pharmaceutical composition according to  claim 10 , wherein said composition is in sustained or modified or time release form.  
     
     
         14 . A pharmaceutical composition according to  claim 10 , wherein said composition is in microencapsulated dosage form.  
     
     
         15 . A pharmaceutical composition according to claims  3 & 4 , said composition being formulated as granules for oral administration.  
     
     
         16 . A pharmaceutical composition according to claims  3 & 4 , said composition being adapted for rectal administration.  
     
     
         17 . A pharmaceutical composition according to  claim 17 , said composition being formulated as a suppository.  
     
     
         18 . A pharmaceutical composition according to  claim 17 , said composition being formulated as an enema or rectal solution.