Article Comprising Calcium for Reducing the Production of TSST-1

Abstract

Articles comprising one or more calcium salts are provided. The articles can contain one or more calcium salts in an amount effective to reduce the production of TSST-1 by at least about 50% when measured by the Shake Flask Method. In certain embodiments, the one or more calcium salts can be substantially non-lethal to Staphylococcus aureus when measured by the Shake Flask Method, and/or to Lactobacillus crispatus, Lactobacillus gasseri , and/or Lactobacillus iners when measured by the Maximum Tolerated Dose Test.

What is claimed is: 
     
         1 . A vaginal article, comprising:
 a. a primary absorbent member;   b. an overwrap covering at least a portion of the primary absorbent member;   c. an optional secondary absorbent member situated proximate a withdrawal end of the primary absorbent member; and   d. a withdrawal cord attached to and extending from the primary absorbent member;   e. wherein at least one of the overwrap, the optional secondary absorbent member, and the withdrawal cord comprises one or more calcium salts in an amount greater than about 0.009 millimoles of calcium to reduce the production of TSST-1 by at least about 50% when measured by the Shake Flask Method; and   f. wherein the one or more calcium salts are substantially non-lethal to  Lactobacillus crispatus, Lactobacillus gasseri , and  Lactobacillus iners  when measured by the Maximum Tolerated Dose Test.   
     
     
         2 . The vaginal article of  claim 1 , wherein the one or more calcium salts are calcium lactate and/or calcium citrate malate. 
     
     
         3 . The vaginal article of  claim 1 , wherein the overwrap comprises the one or more calcium salts. 
     
     
         4 . The vaginal article of  claim 1 , wherein the vaginal article is a tampon. 
     
     
         5 . The vaginal article of  claim 1 , wherein the vaginal article is a pessary. 
     
     
         6 . A method for manufacturing a vaginal article, the method comprising the steps of:
 a. providing a tampon pledget;   b. adding one or more calcium salts to the tampon pledget;   c. compressing and/or shaping the tampon pledget into a finished tampon configuration that is different than that of the tampon pledget;   d. wherein the one or more calcium salts reduce TSST-1 production according to the Shake Flask Method; and   e. wherein the one or more calcium salts are substantially non-lethal to  Lactobacillus crispatus, Lactobacillus gasseri , and  Lactobacillus iners  when measured by the Maximum Tolerated Dose Test.   
     
     
         7 . The method of  claim 6 , wherein the one or more calcium salts are calcium lactate and/or calcium citrate malate. 
     
     
         8 . A method for identifying a compound and incorporation level of the same into a vaginal article to reduce the production of TSST-1, the method comprising the steps of:
 a. identifying a list of potential compounds;   b. measuring the reduction of TSST-1 production by individual or combinations of compounds versus control according to the Shake Flask Method;   c. measuring the change in  Lactobacillus  levels in the presence of the potential compounds versus control according to the Maximum Tolerated Dose Test;   d. selecting compounds from the potential compounds according to the results of steps (b) and (c), wherein the compounds are substantially non-lethal to  Lactobacillus crispatus, Lactobacillus gasseri , and/or  Lactobacillus iners.