Topical composition for use in the treatment of inflammatory bowel disease

Abstract

The present invention relates to a topical composition containing a probiotic and hyaluronic acid or a pharmaceutically acceptable salt thereof, for use in the treatment and/or prevention of inflammatory bowel disease.

1 . A combination comprising
 a composition containing a probiotic and hyaluronic acid or a pharmaceutically acceptable salt thereof, and   an inflammatory bowel disease therapeutic agent selected from the group consisting of 5-ASA, corticosteroids, azathioprine/6-mercaptopurine, methotrexate, cyclosporine, and anti-TNFa agents,   
       wherein the composition is a rectally administered topical composition comprising the probiotic and the hyaluronic acid in an effective amount for treating inflammatory bowel disease, and wherein the hyaluronic acid has a molecular weight ranging from 500,000 to 3,000,000 dalton. 
     
     
         2 . The combination according to  claim 1 , further comprising at least one physiologically acceptable excipient. 
     
     
         3 . The combination according to  claim 1 , wherein said probiotic is selected from  Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus buchneri, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus catenaforme, Lactobacillus cellobiosus, Lactobacillus crispatus, Lactobacillus curvatus, Lactobacillus delbrueckii, Lactobacillus fermentum, Lactobacillus jensenii, Lactobacillus leichmannii, Lactobacillus minutus, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rogosae, Lactobacillus salivarius, Bifidobacterium adolescentis, Bifidobacterium angulatum, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium catenulatum, Bifidobacterium dentium, Bifidobacterium eriksonii. Bifidobacterium infants, Bifidobacterium longum, Bifidobacterium plantarum, Bifidobacterium pseudocatenulatum, Bifidobacterium pseudolongum, Streptococcus lactis, Streptococcus raffinolactis, Streptococcus thermophilus , or a mixture thereof. 
     
     
         4 . The combination according to  claim 1 , wherein the probiotic comprises an amount of living probiotic cells comprised between 200 million and 3 billion. 
     
     
         5 . The combination according to  claim 1 , wherein the probiotic comprises an amount of living probiotic cells comprised between 0.1 and 3% by weight with respect to the total weight of the composition. 
     
     
         6 . The combination according to  claim 1 , wherein said hyaluronic acid is a high molecular weight hyaluronic acid greater or equal to 1,000,000 dalton. 
     
     
         7 . The combination according to  claim 1 , wherein the hyaluronic acid or the pharmaceutically acceptable salt thereof is comprised between 3 and 15% by weight with respect to the total weight of the composition. 
     
     
         8 . The combination according to  claim 1 , wherein the hyaluronic acid or the pharmaceutically acceptable salt thereof is comprised between 0 mg and 300 mg. 
     
     
         9 . The combination according to  claim 1 , wherein the probiotic comprises a quantity of living probiotic cells comprised between 0.1 and 3%, and the hyaluronic acid comprised between 3 and 15%, with respect to the total weight of the composition. 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . The combination according to  claim 1 , wherein the composition is formulated in the form of a cream, ointment, pomade, solution, suspension, water or gel dispersible powder. 
     
     
         13 . (canceled) 
     
     
         14 . (canceled) 
     
     
         15 . The combination according to  claim 1 , wherein said probiotic is a  Lactobacillus.    
     
     
         16 . The combination according to  claim 1 , wherein said probiotic is  Lactobacillus casei.    
     
     
         17 . The combination of  claim 1 , wherein the probiotic is a  Lactobacillus casei  DG deposited at the Pasteur Institute in Paris with the deposit number I-1572CNCM. 
     
     
         18 . The combination according to  claim 1  wherein the probiotic comprises an amount of living probiotic cells comprised between 500 million and 2 billion. 
     
     
         19 . The combination according to  claim 1  wherein the probiotic comprises an amount of living probiotic cells comprised less than 1% by weight, with respect to the total weight of the composition. 
     
     
         20 . The combination according to  claim 1 , wherein the hyaluronic acid or the pharmaceutically acceptable salt thereof is comprised about 5% by weight, with respect to the total weight of the composition. 
     
     
         21 . The combination according to  claim 1 , wherein the hyaluronic acid or the pharmaceutically acceptable salt thereof is comprised between 50 mg and 150 mg. 
     
     
         22 . The combination according to  claim 1 , wherein the composition is formulated in the form of a water dispersible powder. 
     
     
         23 . A method of treating inflammatory bowel disease comprising rectally administering the combination according to  claim 1  to a patient in need thereof. 
     
     
         24 . The method of  claim 22  wherein the inflammatory bowel disease is Crohn's disease. 
     
     
         25 . The method of  claim 22  wherein the inflammatory bowel disease is ulcerative colitis. 
     
     
         26 . The method of  claim 22  wherein the composition is in the form of a cream, an ointment, a pomade, a solution, a suspension, a water dispersible powder or a gel dispersible powder. 
     
     
         27 . The method of  claim 22 , wherein the composition is in the form of a gel dispersible powder. 
     
     
         28 . The method of  claim 22 , wherein the composition is administered simultaneously with, separately from, or sequentially with the administration of the inflammatory bowel disease therapeutic agent. 
     
     
         29 . The method of  claim 22 , wherein said probiotic is a  Lactobacillus.    
     
     
         30 . The method of  claim 22 , wherein the probiotic is a  Lactobacillus casei  DG deposited at the Pasteur Institute in Paris with the deposit number I-1572CNCM.