PROCESS FOR THE PREPARATION OF CEFUROXIME AXETIL IN AN AMORPHOUS FORM

摘要

A process for preparing cefuroxime axetil in substantially amorphous form comprises forming a mixture of crystalline cefuroxime axetil and at least one pharmaceutically acceptable excipient, and subjecting the mixture to milling for a period of time sufficient to convert the crystalline cefuroxime axetil to substantially amorphous form, i.e., the crystallinity is less than 5%. The amorphous cefuroxime axetil has a chemical purity of at least 95%. Desirably, the particles of the milled material are reduced to a size of less than 2 mu m. The amorphous cefuroxime axetil prepared by this method may consist of R isomer, S isomer, or a racemic mixture of the R and S isomers.