Stabilizing compositions for antibiotics and methods of use

Abstract

The present invention is directed to improved liquid antibiotic formulations. In some embodiments, the present invention is directed to a composition comprising an antibiotic in a liquid comprising triglycerides, wherein the composition has less than about 5% water (w/v).

1 - 25 . (canceled) 
     
     
         26 . A liquid pharmaceutical composition comprising a β-lactamase inhibitor; one or more of dried silicon dioxide, dried colloidal silicon dioxide and dried magnesium trisilicate; and a low moisture content medium chain triglyceride vehicle, wherein the composition is a liquid, the concentration of medium chain triglycerides ranges from about 50% to about 99% (w/v) of the composition, and the composition contains less than about 1.0% (w/v) water. 
     
     
         27 . The composition of  claim 26 , wherein the composition is a suspension. 
     
     
         28 . The composition of  claim 26 , wherein the one or more of silicon dioxide, colloidal silicon dioxide and magnesium trisilicate are dried prior to inclusion in the pharmaceutical composition. 
     
     
         29 . The composition of  claim 26 , wherein the medium chain triglycerides contain less than about 0.1% (w/w) water. 
     
     
         30 . The composition of  claim 26 , wherein the composition is suitable for oral delivery. 
     
     
         31 . The composition of  claim 26 , wherein the β-lactamase inhibitor is selected from the group consisting of clavulanic acid, sulbactam, tazobactam, and mixtures thereof. 
     
     
         32 . The composition of  claim 26 , wherein the β-lactamase inhibitor is clavulanic acid. 
     
     
         33 . The composition of  claim 26 , wherein the β-lactamase inhibitor is stable for at least about ten days when stored at a temperature of about 20° C. to about 25° C. 
     
     
         34 . A liquid pharmaceutical composition, comprising a β-lactamase inhibitor, one or more dried hygroscopic excipients and a low moisture content medium chain triglyceride vehicle, wherein the composition is a liquid and the composition contains less than about 1.0% (w/v) water. 
     
     
         35 . The composition of  claim 34 , wherein the composition is a suspension. 
     
     
         36 . The composition of  claim 34 , wherein the β-lactamase inhibitor is selected from the group consisting of clavulanic acid, sulbactam, tazobactam, and mixtures thereof. 
     
     
         37 . The composition of  claim 34 , wherein the β-lactamase inhibitor is clavulanic acid. 
     
     
         38 . The composition of  claim 34 , wherein the one or more hygroscopic excipients comprise one or more of silicon dioxide, colloidal silicon dioxide and magnesium trisilicate. 
     
     
         39 . The composition of  claim 34 , wherein the hygroscopic excipients are dried prior to inclusion in the pharmaceutical composition. 
     
     
         40 . The composition of  claim 34 , wherein the medium chain triglycerides contain less than about 0.1% (w/w) water. 
     
     
         41 . The composition of  claim 34 , wherein the concentration of medium chain triglycerides is from about 50% (w/v) to about 99% (w/v). 
     
     
         42 . The composition of  claim 34 , wherein the β-lactamase inhibitor is stable for at least about ten days when stored at a temperature of about 20° C. to about 25° C. 
     
     
         43 . The composition of  claim 34 , wherein the composition is suitable for oral delivery. 
     
     
         44 . A liquid pharmaceutical composition for oral delivery consisting essentially of a β-lactamase inhibitor, one or more of silicon dioxide, colloidal silicon dioxide and magnesium trisilicate, and a low moisture content medium chain triglyceride vehicle, wherein the composition is a liquid, the concentration of medium chain triglycerides ranges from about 50% to about 99% (w/v) of the composition, and the composition contains less than about 1.0% (w/v) water.