Mucoadhesive sustained-release vaginal tablet

Abstract

The disclosure relates to a mucoadhesive sustained-release vaginal tablet including at least one probiotic strain of the genus Lactobacillus compressed with an excipient suitable for conferring upon the tablet the properties of vaginal wall mucoadhesion and sustained release.

1 - 13 . (canceled) 
     
     
         14 . A mucoadhesive sustained-release vaginal tablet comprising at least one probiotic strain of a genus  Lactobacillus  compressed with an excipient suitable for conferring upon said tablet properties of vaginal wall mucoadhesion and sustained release, wherein said tablet comprises from 10% to 40% by weight of said excipient relative to a total weight of said tablet. 
     
     
         15 . The tablet according to  claim 14  wherein said probiotic strain is selected from  Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus iners, Lactobacillus gasseri, Lactobacillus jensenii, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus vaginalis, Lactobacillus casei, Lactobacillus reuteri  and combinations thereof. 
     
     
         16 . The tablet according to  claim 14  wherein the probiotic strain is  Lactobacillus rhamnosus.    
     
     
         17 . The tablet according to  claim 14  comprising from 10 5  to 10 11  CFU of said probiotic strain of said genus  Lactobacillus  per gram of said tablet. 
     
     
         18 . The tablet according to  claim 14  wherein said excipient is hydroxypropylmethylcellulose. 
     
     
         19 . The tablet according to  claim 14  comprising from 10% to 30% by weight of said excipient relative to said total weight of said tablet. 
     
     
         20 . The tablet according to  claim 14  wherein said probiotic strain and said excipient are compressed with a compressive stress of 50 to 400 MPa. 
     
     
         21 . The tablet according to  claim 14  further comprising cryoprotectants, preservatives, lubricants, flow agents, binders, diluents and combinations thereof. 
     
     
         22 . A method for preventing and/or treating vaginal infections by administering to a person in need thereof a mucoadhesive sustained-release vaginal tablet comprising at least one probiotic strain of a genus  Lactobacillus  compressed with an excipient suitable for conferring upon said tablet properties of vaginal wall mucoadhesion and sustained release, wherein said tablet comprises from 10% to 40% by weight of said excipient relative to a total weight of said tablet. 
     
     
         23 . The method according to  claim 22  for preventing and/or treating candidiases. 
     
     
         24 . The method according to  claim 22  for preventing and/or treating vaginoses. 
     
     
         25 . The method according to  claim 22  for preventing and/or treating vulvovaginal candidiases or recurrent vulvovaginal candidiases. 
     
     
         26 . The method according to  claim 22  for local administration at most every 2 days. 
     
     
         27 . A method for preparing a mucoadhesive sustained-release vaginal tablet according to  claim 14  comprising the following steps:
 a. mixing at least one probiotic strain of said genus  Lactobacillus  with 10% to 40% by weight, relative to said total weight of said tablet, of an excipient suitable for conferring upon said tablet said properties of vaginal wall mucoadhesion and sustained release; and 
 b. compressing a mixture obtained in step a. with a compressive stress of 50 to 400 MPa.