Flurbiprofen and muscle relaxant combinations

Abstract

This invention is a novel pharmaceutical composition comprising flurbiprofen or a pharmaceutically acceptable salt thereof in combination with an α-2 adrenergic receptor agonist or a gamma-aminobutiric acid receptor agonist with anti-inflammatory, analgesic and myorelaxant activity.

1 . A pharmaceutical composition comprising flurbiprofen or a pharmaceutically acceptable salt thereof in combination with
 an α-2 adrenergic receptor agonist selected from tizanidine, clonidine, brimonidine, apraclonidine, guanfacine, guanabenz, mivazerol, dexmedetomidine and a pharmaceutically acceptable salt thereof, or   a GABA receptor agonist selected from thiocolchicoside, musimol, and a pharmaceutically acceptable salt thereof   
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the flurbiprofen or pharmaceutically acceptable salt thereof is present in an amount of between 100 and 500 mg. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the α-2 adrenergic receptor agonist is present in an amount of between 2 and 36 mg. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the GABA receptor agonist is present in an amount of between 2 and 20 mg. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein the flurbiprofen or pharmaceutically acceptable salt thereof and the α-2 adrenergic receptor agonist or GABA receptor agonist are combined together with at least one pharmaceutically acceptable carrier or excipient. 
     
     
         6 . The pharmaceutical composition according to  claim 5 , wherein the at least one pharmaceutically acceptable carrier or excipient is selected from water, salt solutions, alcohols, gum arable, vegetable oils, benzyl alcohols, polyethylene glycols, gelatin, carbohydrates, lactose, amylose, starch, magnesium stearate, talc, silicic acid, paraffin, perfume oil, fatty acid esters, hydroxymethylcellulose, polyvinyl pyrrolidone, lubricants, preservatives, disintegrants, stabilizers, wetting agents, emulsifiers, salts, buffers, coloring agents, flavoring agents, aromatic substances and sweetener. 
     
     
         7 . The pharmaceutical composition according to  claim 5 , wherein the at least one pharmaceutically acceptable excipient is selected from gelatin, carbohydrates, lactose, amylose, starch, magnesium stearate, talc, silicic acid, paraffin, perfume oil, fatty acid esters, hydroxymethylcellulose, polyvinyl pyrrolidone, lubricants, preservatives, disintegrants, stabilizers, wetting agents, emulsifiers, salts, buffers, coloring agents, flavoring agents, aromatic substances and sweetener. 
     
     
         8 . The pharmaceutical composition according to  claim 1 , wherein said pharmaceutical composition is administered orally, parenterally, intramuscularly or topically. 
     
     
         9 . The pharmaceutical composition according to  claim 1 , wherein said pharmaceutical composition is in the form of a tablet, capsule, sachet, injectable preparation, suspension, syrup, gel, cream or ointment. 
     
     
         10 . A method of treating painful muscle spasms associated with static and functional disorders of vertebra or occurred in post-operations of osteoarthritis, pain and inflammatory symptoms associated with tissue trauma, degenerative vertebra diseases as torticollis, dorsalgy, lombalgy, disk hernia, or neurologic and traumatic disorders associated with spasticity, composing the step of administering a therapeutically-effective amount of the pharmaceutical composition of  claim 1  to the patient in need thereof. 
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is a solid dosage form provided in the form of a bilayer tablet. 
     
     
         12 . The solid dosage form according to  claim 11 , wherein the solid dosage form takes the form of a bilayer tablet having flurbiprofen or pharmaceutically acceptable salt thereof in one layer and the α-2 adrenergic receptor agonist or GABA receptor agonist in another layer. 
     
     
         13 . The solid dosage form according to  claim 12 , having flurbiprofen or pharmaceutically acceptable salt thereof in one layer and the α-2 adrenergic receptor agonist in another layer. 
     
     
         14 . The solid dosage form according to  claim 12 , having flurbiprofen or pharmaceutically acceptable salt thereof in one layer and the GABA receptor agonist in another layer. 
     
     
         15 . The method according to  claim 10 , wherein said pharmaceutical composition is administered orally, parenterally, intramuscularly or topically. 
     
     
         16 . The method according to  claim 10 , wherein said pharmaceutical composition is in the form of a tablet, capsule, sachet, injectable preparation, suspension, syrup, gel, cream or ointment.