Pharmaceutical composition with healing activity comprising at least one soluble dextran derivative and at least one platelet-derived growth factor

Abstract

Pharmaceutical composition with healing activity comprising at least one soluble dextran derivative and at least one platelet-derived growth factor. The present invention relates to a pharmaceutical composition with healing activity comprising at least one soluble dextran derivative and at least one platelet-derived growth factor, and also to the use thereof for the preparation of a medicament with healing action, in particular for use in the treatment of ulcers.

1 . Pharmaceutical composition, characterized in that it comprises, in a pharmaceutically acceptable support: 
 at least one platelet-derived growth factor (PDGF), and    at least one soluble dextran derivative corresponding to formula (I) below:      DMCaBbSuc  (I)    in which:    D represents a polysaccharide chain,    MC represents methylcarboxylic groups,    B represents N benzylmethylenecarboxamide groups,    Su represents sulphate groups,    a, b and c represent the degree of substitution (ds), respectively of the MC, B and Su groups, with    i) a strictly greater than 0;    ii) b  is such that: 
 either b is greater than or equal to 0.3 and c is between 0.1 and 0.5;  
 or b is strictly less than 0.3 and c corresponds to equation (1) below:  
   c 3 8.5b2−5.41b+0.86  (1).  
   
   
   
       2 . Composition according to  claim 1 , characterized in that D consists of series of glucoside units.  
   
   
       3 . Composition according to  claim 1 , characterized in that D has a molar mass of between 1000 and 2 000 000 Da.  
   
   
       4 . Composition according to  claim 1 , characterized in that the dextran derivatives are chosen from the compounds of formula (I) in which b is greater than or equal to 0.35.  
   
   
       5 . Composition according to  claim 4 , characterized in that the dextran derivatives are chosen from the compounds of formula (I) in which a is between 0.5 and 0.8, and c is between 0.1 and 0.5.  
   
   
       6 . Composition according to  claim 1 , characterized in that the dextran derivatives of formula (I) are chosen from the compounds in which a=0.66; b=0.38 and c is between 0.2 and 0.4.  
   
   
       7 . Composition according to  claim 6 , characterized in that the dextran derivatives of formula (I) in which a=0.66; b=0.38 and c=0.29.  
   
   
       8 . Composition according to  claim 1 , characterized in that the amount of dextran derivatives of formula (I) is between 0.5 and 100 mg/g of composition.  
   
   
       9 . Composition according to  claim 8 , characterized in that the amount of dextran derivatives of formula (I) is between 5 and 50 mg/g of composition.  
   
   
       10 . Composition according to  claim 1 , characterized in that the PDGFs are chosen from human recombinant PDGFs containing two B chains.  
   
   
       11 . Composition according to  claim 1 , characterized in that the amount of PDGF is between 1 and 200 μg/g of composition.  
   
   
       12 . Composition according to  claim 11 , characterized in that the amount of PDGF is between 10 and 100 μg/g of composition.  
   
   
       13 . Composition according to  claim 1 , characterized in that the dextran derivatives of formula (I)/PDGFs weight ratio is between 100 and 1000.  
   
   
       14 . Composition according to  claim 1 , characterized in that it is a composition for topical application in the form of gels, creams, sprays or patches.  
   
   
       15 . Composition according to  claim 14 , characterized in that it is in the form of a cellulose gel.  
   
   
       16 . Composition according to  claim 1 , characterized in that it contains one or more additives chosen from fillers, preserving agents, anti-oxidants, stabilizers, acidifying and basifying agents and opacifiers.  
   
   
       17 . Use of at least one pharmaceutical composition as defined in  claim 1 , for the preparation of a medicament with healing action.  
   
   
       18 . Use according to  claim 17 , characterized in that the medicament is for use in the treatment of ulcers by topical application.  
   
   
       19 . Use according to  claim 17 , characterized in that the medicament is for use in the treatment of ulcers of the lower limbs in diabetic patients.  
   
   
       20 . Use according to  claim 17 , characterized in that said medicament is intended to be administered as a treatment of 2 to 10 weeks at a rate of 1 or 2 applications a day on the lesioned portion.