Compositions for treating candidiasis infections

Abstract

The present invention relates to a composition comprising as antifungal active agent at least 2·1010 CFU of lactobacilli and a sulfur-containing compound for use as a first-line treatment for candidiasis and for recurrent candidiasis.

1 .- 14 . (canceled) 
     
     
         15 . A method for first-line treatment of candidiasis in a patient in need thereof, the method comprising vaginally administering to said patient a pharmaceutical composition comprising i) as therapeutic active agent at least 5×10 10  CFU of lactobacilli; and ii) at least 60 mg of thiosulfate, wherein the pharmaceutical composition is used as a substitute for a chemical antifungal. 
     
     
         16 . The method of  claim 15 , wherein pathogen is selected from the group consisting of:  Candida albicans, Candida glabrata  and  Candida tropicalis.    
     
     
         17 . The method of  claim 15 , wherein the pharmaceutical composition comprises from 60 mg to 300 mg of thiosulfate. 
     
     
         18 . The method of  claim 15 , wherein the pharmaceutical composition comprises from 60 mg to 120 mg of thiosulfate. 
     
     
         19 . The method of  claim 15 , wherein the pharmaceutical composition comprises from 60 mg to 80 mg of thiosulfate. 
     
     
         20 . The method of  claim 15 , wherein the pharmaceutical composition comprises at least 1×10 11  CFU of lactobacilli. 
     
     
         21 . The method of  claim 15 , wherein the pharmaceutical composition comprises from 1×10 11  to 1×10 12  CFU of lactobacilli. 
     
     
         22 . The method of  claim 15 , wherein the lactobacilli are selected from  Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus casei  and mixtures thereof. 
     
     
         23 . The method of  claim 15 , wherein the candidiasis is vulvovaginal candidiasis. 
     
     
         24 . The method of  claim 15 , wherein the pharmaceutical composition is formulated to be administered in one dose, once per day. 
     
     
         25 . The method of  claim 15 , wherein the pharmaceutical composition is in the form of an immediate-release tablet or capsule. 
     
     
         26 . The method of  claim 15 , wherein the pharmaceutical composition is in the form of a multilayer tablet comprising:
 at least one immediate-release layer comprising, in relation to the total weight of all the immediate-release layers, at least 5×10 10  CFU of lactobacilli and 60 to 300 mg of thiosulfate; and   at least one sustained-release layer, comprising, in relation to the total weight of all the sustained-release layers, from 1×10 7  to 1×10 10  CFU of lactobacilli.   
     
     
         27 . The method of  claim 26 , wherein in the multilayer tablet the sustained-release layer comprises from 10 to 40% by weight of HPMC hydroxypropylmethylcellulose in relation to the total weight of said layer. 
     
     
         28 . A method for first-line treatment of vulvovaginal candidiasis and its recurrence in a patient in need thereof comprising vaginally administering a pharmaceutical composition comprising:
 i) as therapeutic active agent at least 5×10 10  CFU of lactobacilli; and   ii) at least 60 mg of thiosulfate, optionally repeating the administration of the same pharmaceutical composition 2, 3, 4 or 5 days after the first dose is taken and administering a composition comprising lactobacilli at a concentration of 10 7  to 10 10  CFU/g and thiosulfate to prevent recurrence of vulvovaginal candidiasis,   
       wherein the pharmaceutical composition is used as a substitute for a chemical antifungal.