Crystalline forms of a macrolide, and uses therefor

Abstract

New crystalline forms of macrolide compounds, and pharmaceutical compositions thereof, are described herein. In addition, processes for preparing the crystalline forms are described herein.

1 .- 32 . (canceled) 
     
     
         33 . A composition comprising CEM-101 in a crystalline form, the composition prepared by a process comprising adding water to a solution comprising CEM-101 and a water miscible, polar organic solvent; or a process comprising adding a solution comprising CEM-101 and a water miscible, polar organic solvent to water. 
     
     
         34 . A composition comprising CEM-101 in a crystalline form, the composition characterized by differential scanning calorimetry and having an endotherm at about 170° C., in the range from about 194° C. to about 199° C., in the range from about 215° C. to about 225° C., in the range from about 219° C. to about 225° C., at about 225° C., or a combination thereof. 
     
     
         35 . A unit dose comprising CEM-101, where the CEM-101 comprises crystalline Form I or crystalline Form II, or a mixture of crystalline Form I and crystalline Form II. 
     
     
         36 . The unit dose of  claim 35  comprising about 200 mg of CEM-101. 
     
     
         37 . The unit dose of  claim 35  configured as a capsule 
     
     
         38 . The unit dose of  claim 35  configured as a tablet 
     
     
         39 . A method for treating community-acquired bacterial pneumonia in a host animal, the method comprising administering the unit dose of  claim 35  to the host animal.