Methods and compositions for treating diabetic foot ulcers

Abstract

In one aspect, the disclosure relates to methods and compositions, i.e., pharmaceutical formulations, for treating and preventing diabetic foot ulcers. In a particular aspect, the disclosed methods and compositions pertain to water-based pharmaceutical formulations that are useful for administration in an aqueous foot bath. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present disclosure.

What is claimed is: 
     
         1 . A pharmaceutical composition comprising:
 a first antimicrobial agent, a second antimicrobial agent, a third antimicrobial agent, and a powder excipient base;   wherein the first antimicrobial agent is an aminoglycoside antibiotic or a fluoroquinolone, and is present in an amount of from about 15 wt% to about 35 wt%;   wherein the second antimicrobial agent is glycopeptide antibiotic, and is present in an amount of from about 15 wt% to about 40 wt%;   wherein the third antimicrobial agent is an azole antifungal or an imidazole antifungal, and is present in an amount of from about 1 wt% to about 15 wt%;   wherein the powder excipient base is present in an amount of from about 10 wt% to about 50 wt%;   wherein the wt% is based on a total weight of the first antimicrobial agent, the second antimicrobial agent, the third antimicrobial agent, and the powder excipient base such that the total wt% for foregoing components is 100 wt%; and   wherein the first antimicrobial agent, the second antimicrobial agent, the third antimicrobial agent, and the powder excipient base are a homogeneously dispersed powder mixture.   
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the first antimicrobial agent is an aminoglycoside antibiotic. 
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein the aminoglycoside antibiotic is tobramycin, or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the first antimicrobial agent is a fluoroquinolone. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the fluoroquinolone is ciprofloxacin, or a pharmaceutically acceptable salt thereof. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the second antimicrobial agent is vancomycin, or a pharmaceutically acceptable salt thereof. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the third antimicrobial agent is an azole antifungal. 
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein the azole antifungal is itraconazole, or a pharmaceutically acceptable salt thereof. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the third antimicrobial agent is an imidazole antifungal. 
     
     
         10 . The pharmaceutical composition of  claim 7 , wherein the imidazole antifungal is clotrimazole, or a pharmaceutically acceptable salt thereof. 
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein the first antimicrobial agent is present in an amount of from about 20 wt% to about 30 wt%. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the third antimicrobial agent is present in an amount of from about 5 wt% to about 10 wt%. 
     
     
         13 . The pharmaceutical composition of  claim 1 , wherein the powder excipient base comprises a sugar alcohol, a non-ionic surfactant, or combinations thereof. 
     
     
         14 . The pharmaceutical composition of  claim 13 , wherein the sugar alcohol comprises xylitol, sorbitol, erythritol, or combinations thereof. 
     
     
         15 . The pharmaceutical composition of  claim 13 , wherein the non-ionic surfactant is a nonionic triblock copolymer comprising a central hydrophobic chain of polyoxypropylene flanked by two hydrophilic chains of polyoxyethylene. 
     
     
         16 . An irrigation therapy solution comprising about 1 gram to about 10 grams of the pharmaceutical composition of  claim 1  dissolved in a volume of about 1.5 to about 5 liters of water. 
     
     
         17 . The irrigation therapy solution of  claim 12 , wherein a pH of the aqueous solution is about 7.5 to about 8.8. 
     
     
         18 . The irrigation therapy solution of  claim 13 , wherein the pH of the aqueous solution is about 8.2 to about 8.8. 
     
     
         19 . The irrigation therapy solution of  claim 12 , wherein about 2 gram to about 5 grams of the pharmaceutical composition is dissolved in a volume of about 2.5 to about 3.5 liters of water. 
     
     
         20 . The irrigation therapy solution of  claim 12 , further comprising from about 0.050% to about 0.200% Dakin’s solution.