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 treating acute migraine attacks by eliciting an onset hastened analgesic and anti-inflammatory response and combating nausea in a subject in need of an analgesic, anti-inflammatory and anti-nausea response, comprising administering a pharmaceutical composition comprising effective amounts of more than one active ingredient to said subject, wherein said more than one active ingredient consists 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 (+) optical isomeric form thereof in an analgesically and anti-inflammatory effective amount, wherein said NSAID is selected from the group consisting of ibuprofen, naproxen, benoxaprofen, flurbiprofen, fenoprofen, fenbufen, ketoprofen, indoprofen, pirprofen, carprofen, oxaprozin, prapoprofen, miroprofen, 20 tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.   
   
   
       2 . A method according to  claim 1 , wherein the domperidone analogue is domperidone maleate. 
   
   
       3 . A pharmaceutical composition for treating acute migraine attacks which elicits an onset hastened analgesic and anti-inflammatory response and combats nausea, comprising effective amounts of 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) ibuprofen, a pharmaceutically acceptable salt thereof or a pure (−) or (+) optical isomeric form thereof in an analgesically and anti-inflammatory effective amount.   
   
   
       4 . A method according to  claim 1 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen. 
   
   
       5 . A pharmaceutical composition for treating acute migraine attacks by eliciting an onset hastened analgesic and anti-inflammatory response comprising effective amounts of 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 (+) optical isomeric form thereof in an analgesically and anti-inflammatory effective amount, wherein said NSAID is selected from the group consisting of ibuprofen, naproxen, benoxaprofen, flurbiprofen, fenoprofen, fenbufen, ketoprofen, indoprofen, pirprofen, carprofen, oxaprozin, prapoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.   
   
   
       6 . A pharmaceutical composition according to  claim 5 , wherein the NSAID is ibuprofen. 
   
   
       7 . A pharmaceutical composition according to  claim 5 , wherein the domperidone analogue is domperidone maleate. 
   
   
       8 . A pharmaceutical composition according to  claim 5 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen. 
   
   
       9 . A pharmaceutical composition according to  claim 5 , wherein said composition is formulated for oral administration. 
   
   
       10 . A pharmaceutical composition according to  claim 5 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       11 . A pharmaceutical composition according to  claim 10 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       12 . A pharmaceutical composition according to  claim 10 , wherein said composition is in a microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       13 . A pharmaceutical composition according to  claim 5 , said composition is formulated as granules for oral administration with the addition of a suitable pharmaceutically acceptable carrier 
   
   
       14 . A pharmaceutical composition according to  claim 5 , wherein said composition is formulated for rectal administration. 
   
   
       15 . A pharmaceutical composition according to  claim 14 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       16 . A pharmaceutical composition according to  claim 5 , wherein said composition is formulated as an enema or rectal solution. 
   
   
       17 . A pharmaceutical composition for treating acute migraine attacks by eliciting an onset hastened analgesic and anti-inflammatory response and combating nausea in a subject in need of an analgesic, anti-inflammatory and anti-nausea response, comprising effective amounts of 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 (+) optical isomeric form thereof in an analgesically and anti-inflammatory effective amount, wherein said NSAID is selected from the group consisting of ibuprofen, naproxen, benoxaprofen, flurbiprofen, fenoprofen, fenbufen, ketoprofen, indoprofen, pirprofen, carprofen, oxaprozin, prapoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.   
   
   
       18 . A pharmaceutical composition according to  claim 17 , wherein the NSAID is ibuprofen. 
   
   
       19 . A composition according to  claim 17 , wherein the domperidone analogue is domperidone maleate. 
   
   
       20 . A pharmaceutical composition according to  claim 17 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen. 
   
   
       21 . A composition according to  claim 18 , wherein said composition is formulated for oral administration. 
   
   
       22 . A composition according to  claim 21 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       23 . A composition according to  claim 21 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       24 . A composition according to  claim 21 , wherein said composition is in microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       25 . A composition according to  claim 21 , wherein said composition is formulated as granules for oral administration. 
   
   
       26 . A composition according to  claim 17 , wherein said composition is formulated for rectal administration. 
   
   
       27 . A composition according to  claim 17 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       28 . A composition according to  claim 17 , wherein said composition is formulated as an enema or rectal solution with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       29 . A pharmaceutical composition for combating nausea in acute migraine attacks comprising more than one active ingredient, wherein said more than one active ingredient consists 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 (+) optical isomeric form thereof in an analgesically and anti-inflammatory effective amount, wherein said NSAID is selected from the group consisting of ibuprofen, naproxen, benoxaprofen, flurbiprofen, fenoprofen, fenbufen, ketoprofen, indoprofen, pirprofen, carprofen, oxaprozin, prapoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.   
   
   
       30 . A pharmaceutical composition according to  claim 29 , wherein the NSAID is ibuprofen. 
   
   
       31 . A pharmaceutical composition according to  claim 30 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen. 
   
   
       32 . A pharmaceutical composition according to  claim 29 , further comprising a suitable pharmaceutically acceptable carrier. 
   
   
       33 . A pharmaceutical composition according to  claim 29 , wherein said composition is formulated for oral administration. 
   
   
       34 . A pharmaceutical composition according to  claim 33 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       35 . A pharmaceutical composition according to  claim 33 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       36 . A pharmaceutical composition according to  claim 33 , wherein said composition is in microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       37 . A pharmaceutical composition according to  claim 33 , wherein said composition is formulated as granules for oral administration. 
   
   
       38 . A pharmaceutical composition according to  claim 29 , wherein said composition is formulated for rectal administration. 
   
   
       39 . A pharmaceutical composition according to  claim 29 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       40 . A pharmaceutical composition according to  claim 38 , wherein said composition is formulated as an enema or rectal solution with the addition of a suitable pharmaceutically acceptable carrier. 
   
   
       41 . A pharmaceutical composition for treating acute migraine attacks by eliciting an onset hastened analgesic and anti-inflammatory response comprising effective amounts of only two pharmaceutically active ingredients, wherein:
 (i) said first pharmaceutical active ingredient comprises 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) said second pharmaceutical active ingredient comprises a NSAID, a pharmaceutically acceptable salt thereof or a pure (−) or (+) optical isomeric form thereof in an analgesically and anti-inflammatory effective amount, wherein said NSAID is selected from the group consisting of ibuprofen, naproxen, benoxaprofen, flurbiprofen, fenoprofen, fenbufen, ketoprofen, indoprofen, pirprofen, carprofen, oxaprozin, prapoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.