Analgesic and anti-inflammatory compositions comprising domperidone and methods of using the 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 - 18 . (Cancelled)  
     
     
         19 . 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.    
     
     
         20 . A method according to  claim 19 , wherein the domperidone analogue is domperidone maleate.  
     
     
         21 . A pharmaceutical composition according to  claim 19 , wherein the NSAID is ibuprofen.  
     
     
         22 . A method according to  claim 20 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen.  
     
     
         23 . A method according to  claim 19 , wherein said composition is formulated for oral administration.  
     
     
         24 . A method according to  claim 19 , wherein said composition is formulated as a tablet or capsule.  
     
     
         25 . A method according to  claim 23 , wherein said composition is formulated as a dispersible or effervescent dosage form.  
     
     
         26 . A method according to  claim 23 , wherein said composition is in microencapsulated dosage form.  
     
     
         27 . A method according to  claim 19 , wherein said composition is formulated as granules for oral administration.  
     
     
         28 . A method according to  claim 19 , wherein said composition is formulated for rectal administration.  
     
     
         29 . A method according to  claim 28 , wherein said composition is formulated as a suppository.  
     
     
         30 . A method according to  claim 28 , wherein said composition is formulated as an enema or rectal solution.  
     
     
         31 . 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 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, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.    
     
     
         32 . A pharmaceutical composition according to  claim 31 , wherein the NSAID is ibuprofen.  
     
     
         33 . A pharmaceutical composition according to  claim 31  wherein the domperidone analogue is domperidone maleate.  
     
     
         34 . A pharmaceutical composition according to  claim 32 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen.  
     
     
         35 . A pharmaceutical composition according to  claim 31 , wherein said composition is formulated for oral administration.  
     
     
         36 . A pharmaceutical composition according to  claim 31 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         37 . A pharmaceutical composition according to  claim 36 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         38 . A pharmaceutical composition according to  claim 36 , wherein said composition is in a microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         39 . A pharmaceutical composition according to  claim 31 , said composition is formulated as granules for oral administration with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         40 . A pharmaceutical composition according to  claim 31 , wherein said composition is formulated for rectal administration.  
     
     
         41 . A pharmaceutical composition according to  claim 40 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         42 . A pharmaceutical composition according to  claim 31 , wherein said composition is formulated as an enema or rectal solution.  
     
     
         43 . A method for treating acute migraine attacks by eliciting an onset hastened analgesic and anti-inflammatory response in a subject in need of an analgesic, anti-inflammatory 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, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.    
     
     
         44 . A method according to  claim 43 , wherein the NSAID is ibuprofen.  
     
     
         45 . A method according to  claim 43 , wherein the domperidon analogue is domperidone maleate.  
     
     
         46 . A method according to  claim 44 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen.  
     
     
         47 . A method according to  claim 43 , wherein said composition is formulated for oral administration.  
     
     
         48 . A method according to  claim 47 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         49 . A method according to  claim 47 , wherein said composition is formulated as granules for oral administration.  
     
     
         50 . A method according to  claim 47 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         51 . A method according to  claim 47 , wherein said composition is in microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         52 . A method according to  claim 43 , wherein said composition is formulated for rectal administration.  
     
     
         53 . A method according to  claim 52 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         54 . A method according to  claim 52 , wherein said composition is formulated as an enema or rectal solution with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         55 . 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 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, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.    
     
     
         56 . A pharmaceutical composition according to  claim 55 , wherein the NSAID is ibuprofen.  
     
     
         57 . A composition according to  claim 55  wherein the domperidone analogue is domperidone maleate.  
     
     
         58 . A pharmaceutical composition according to  claim 56 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen.  
     
     
         59 . A composition according to  claim 56 , wherein said composition is formulated for oral administration.  
     
     
         60 . A composition according to  claim 59 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         61 . A composition according to  claim 59 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         62 . A composition according to  claim 59 , wherein said composition is in microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         63 . A composition according to  claim 59 , wherein said composition is formulated as granules for oral administration.  
     
     
         64 . A composition according to  claim 55 , wherein said composition is formulated for rectal administration.  
     
     
         65 . A composition according to  claim 55 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         66 . A composition according to  claim 55 , wherein said composition is formulated as an enema or rectal solution with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         67 . A method for combating nausea in acute migraine attacks 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, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, flurprofen and bucloxic acid.    
     
     
         68 . A method according to  claim 67 , wherein the NSAID is ibuprofen.  
     
     
         69 . A method according to  claim 68 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen.  
     
     
         70 . A method according to  claim 67 , wherein said pharmaceutical composition further comprises a suitable pharmaceutically acceptable carrier.  
     
     
         71 . A method according to  claim 67 , wherein said composition is formulated for oral administration.  
     
     
         72 . A method according to  claim 71 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         73 . A method according to  claim 71 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         74 . A method according to  claim 71 , wherein said composition is in microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         75 . A method according to  claim 71 , wherein said composition is formulated as granules for oral administration.  
     
     
         76 . A method according to  claim 67 , wherein said composition is formulated for rectal administration.  
     
     
         77 . A method according to  claim 76 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         78 . A method according to  claim 76 , wherein said composition is formulated as an enema or rectal solution with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         79 . 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.    
     
     
         80 . A pharmaceutical composition according to  claim 79 , wherein the NSAID is ibuprofen.  
     
     
         81 . A pharmaceutical composition according to  claim 80 , wherein said more than one active ingredient consist of domperidone maleate and ibuprofen.  
     
     
         82 . A pharmaceutical composition according to  claim 79 , further comprising a suitable pharmaceutically acceptable carrier.  
     
     
         83 . A composition according to  claim 79 , wherein said composition is formulated for oral administration.  
     
     
         84 . A composition according to  claim 83 , wherein said composition is formulated as a tablet or capsule with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         85 . A composition according to  claim 83 , wherein said composition is formulated as a dispersible or effervescent dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         86 . A composition according to  claim 83 , wherein said composition is in microencapsulated dosage form with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         87 . A composition according to  claim 83 , wherein said composition is formulated as granules for oral administration.  
     
     
         88 . A composition according to  claim 79 , wherein said composition is formulated for rectal administration.  
     
     
         89 . A composition according to  claim 79 , wherein said composition is formulated as a suppository with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         90 . A composition according to  claim 88 , wherein said composition is formulated as an enema or rectal solution with the addition of a suitable pharmaceutically acceptable carrier.  
     
     
         91 . A pharmaceutical composition for treating acute migraine attacks by eliciting an onset hastened analgesic and anti-inflammatory response comprising administering a pharmaceutical composition comprising effective amounts of only two pharmaceutically active ingredients to said subject, 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.