Pharmaceutical compositions with hydrating and lubricating activity

Abstract

The present invention discloses pharmaceutical compositions comprising ester derivatives of hyaluronic acid for use as a topical treatment in disorders of the vaginal mucosa characterised by loss of elasticity and hydration, such as vaginal dryness and/or atrophic vaginitis; said compositions can also be used successfully to lubricate the genital mucosa.

1 . Pharmaceutical compositions in form of gel, ovules, douches, foam, mousse, comprising hyaluronic acid, wherein 50% of the hyaluronic acid carboxyl groups are esterified with benzyl alcohol, for use in the local treatment of vaginal dryness and/or atrophic vaginitis. 
     
     
         2 . Pharmaceutical compositions as claimed in  claim 1  wherein hyaluronic acid has an average molecular weight ranging between 100,000 and 250,000 Da, preferably between 180,000 and 230,000 Da. 
     
     
         3 . Pharmaceutical compositions as claimed in  claim 2 , wherein hyaluronic acid 50% esterified with benzyl alcohol has a concentration ranging between 0.1 and 1%, preferably between 0.2 and 5%, most preferably of 0.2% w/w. 
     
     
         4 . Pharmaceutical compositions as claimed in  claim 1 , for use in the treatment of bacterial or fungal infections concomitant with vaginal dryness and/or atrophic vaginitis. 
     
     
         5 . Pharmaceutical compositions according to  claim 1  in gel form for use in the local treatment of vaginal dryness and/or atrophic vaginitis, comprising hyaluronic acid 50% esterified with benzyl alcohol at the concentration of 0.2% w/w, wherein the starting hyaluronic acid has a weight-average molecular weight ranging between 180,000 and 230,000 Da and further comprising Carbomer 974P as gelling agent and pharmaceutically acceptable excipients. 
     
     
         6 . Pharmaceutical compositions as claimed in  claim 5 , free from paraben preservatives. 
     
     
         7 . Pharmaceutical compositions according to  claim 1  in form of hydrophilic vaginal ovules for use in the local treatment of vaginal dryness and/or atrophic vaginitis, comprising hyaluronic acid 50% esterified with benzyl alcohol at the concentration of 0.2% w/w, wherein the starting hyaluronic acid has a weight-average molecular weight ranging between 180,000 and 230,000 Da, optionally containing gelling and mucoadhesive polymers and further containing pharmaceutically acceptable excipients. 
     
     
         8 . Pharmaceutical compositions according to  claim 1  in form of vaginal douches for use in the local treatment of vaginal dryness and/or atrophic vaginitis, comprising hyaluronic acid 50% esterified with benzyl alcohol at the concentration of 0.2% w/w, wherein the starting hyaluronic acid has a weight-average molecular weight ranging between 180,000 and 230,000 Da, and optionally containing detergents. 
     
     
         9 . Pharmaceutical compositions according to  claim 1  in form of foams or mousses for use in the local treatment of vaginal dryness and/or atrophic vaginitis, comprising hyaluronic acid 50% esterified with benzyl alcohol at the concentration of 0.2% w/w, wherein the starting hyaluronic acid has a weight-average molecular weight ranging between 180,000 and 230,000 Da, and optionally containing propellants. 
     
     
         10 . Pharmaceutical compositions as claimed in  claim 2 , for use in the treatment of bacterial or fungal infections concomitant with vaginal dryness and/or atrophic vaginitis. 
     
     
         11 . Pharmaceutical compositions as claimed in  claim 3 , for use in the treatment of bacterial or fungal infections concomitant with vaginal dryness and/or atrophic vaginitis.