New self emulsifying drug delivery system

Abstract

The present invention claims and discloses a pharmaceutical composition suitable for oral administration, in form of an emulsion pre-concentrate, comprising (i) a compound of the formula (I) (ii) one or more surfactants; (iii) optionally an oil or semi-solid fat; said composition forming an in-situ oil-in-water emulsion upon contact with aqueous media such as gastrointestinal fluids. The composition may optionally also comprise one or more short-chain alcohols. The pharmaceutical composition is useful in the treatment of pain and inflammation.

1 . A pharmaceutical composition suitable for oral administration, in form of an emulsion pre-concentrate, comprising
 (i) a compound of the formula (I)   
       
         
           
           
               
               
           
         
         (ii) one or more surfactants; 
         (iii) an oil or semi-solid fat; 
         said composition forming an in-situ oil-in-water emulsion upon contact with aqueous media such as gastrointestinal fluids. 
       
     
     
         2 . A pharmaceutical composition according to  claim 1 , further comprising one or more short-chain alcohols. 
     
     
         3 . A pharmaceutical compositon according to  claim 1 , wherein the amount of the compound of formula (I) is from 50-1500 mg per unit dose. 
     
     
         4 . A pharmaceutical compositon according to  claim 3 , wherein the amount of the compound of formula (I) is 125-500 mg per unit dose. 
     
     
         5 . A pharmaceutical compositon according to  claim 1 , wherein the surfactant is a block co-polymer. 
     
     
         6 . A pharmaceutical compositon according to  claim 1 , wherein the surfactant is a non-ionic surfactant. 
     
     
         7 . A pharmaceutical composition according to  claim 6 , wherein the non-ionic surfactant is a poloxamer. 
     
     
         8 . A pharmaceutical compositon according to  claim 7 , wherein the surfactant is selected from any one of Poloxamer 407; Poloxamer 401; Poloxamer 237; Poloxamer 338; Poloxamer 331; Poloxamer 231; Poloxamine 908; Poloxamine 1307; Poloxamine 1107; and polyoxyethylene polyoxybutylene block copolymer. 
     
     
         9 . A pharmaceutical compositon according to  claim 1 , wherein the total amount of surfactant(s) is from 12.5-6000 mg. 
     
     
         10 . A pharmaceutical compositon according to  claim 9 , wherein the total amount of surfactant(s) is from 100-500 mg. 
     
     
         11 . A pharmaceutical compositon according to  claim 1 , wherein the ratio of compound of formula (I):surfactant is within the range of from 1:0.1-1:10. 
     
     
         12 . A pharmaceutical compositon according to  claim 11  wherein the ratio ratio of compound of formula (I):surfactant is within the range of from 1:0.3-1:3. 
     
     
         13 . A pharmaceutical compositon according to  claim 1 , wherein the oil is a vegetable oil. 
     
     
         14 . A pharmaceutical compositon according to  claim 13 , wherein the vegetable oil is selected from coconut oil, corn oil, soybean oil, rape seed oil, safflower oil and castor oil. 
     
     
         15 . A pharmaceutical composition according to  claim 1 , wherein the oil is an animalic oil. 
     
     
         16 . A pharmaceutical composition according to  claim 15 , wherein the animalic oil is a fish oil or one or more mono-, di- or triglycerides. 
     
     
         17 . A pharmaceutical composition according to  claim 1 , wherein a semi-solid fat is selected from mono-, di- and triglycerides. 
     
     
         18 . A pharmaceutical composition according to  claim 17 , wherein the mono-, di- and triglycerides are selected from glyceryl palmitostearate, or a mixture of mono-, di and tri-esters of glycerol, mono- and di-esters of polyethylene glycol or free polyethylene glycol. 
     
     
         19 . A pharmaceutical composition according to  claim 2 , wherein the short-chain alcohol is selected from ethanol, propylene glycol and glycerol. 
     
     
         20 . A pharmaceutical composition according to  claim 1 , further comprising a co-surfactant. 
     
     
         21 . A unit dosage form filled with a pharmaceutical composition according to  claim 1 . 
     
     
         22 . A unit dosage form according to  claim 21 , selected from any one of capsules, drinking ampoules, dose cushion, chewable soft pill, and chewy-base lozenges. 
     
     
         23 . A unit dosage form according to  claim 22 , in form of a capsule. 
     
     
         24 . A unit dosage form according to  claim 23 , wherein said capsule is a hard gelatine capsule. 
     
     
         25 . A unit dosage form according to  claim 22 , wherein said capsule is a soft gelatine capsule. 
     
     
         26 . An oral solution comprising a pharmaceutical composition according to  claims 1  dissolved in water. 
     
     
         27 . A method for the treatment of pain, whereby a pharmaceutical composition according to  claim 1 , is administered to a patient in need of such treatment. 
     
     
         29 . A method for the treatment of inflammation, whereby a pharmaceutical composition according to  claim 1 , is administered to a patient in need of such treatment.