CRYSTALLINE FORMS OF A MACROLIDE, AND USES THEREFOR
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.