A CO-SPRAY DRIED COMPOSITION OF CEFEPIME WITH BASE AND PROCESS FOR PREPARATION THEREOF

摘要

Stable and sterile composition of cefepime and a process for preparing the same. Amorphous composition containing cefepime acid addition salt or solvates thereof and organic or inorganic base obtained by spray drying of their aqueous solution. The process comprises dissolving a composition containing mixture of cefepime acid addition salt and a pharmaceutically acceptable non-toxic organic or inorganic base in water to obtain aqueous solution, filtration of aqueous solution through 0.2 micron membrane filter and subjecting the clear aqueous solution to spray drying, or dissolving a cefepime acid addition salt in water, dissolving a pharmaceutically acceptable non-toxic organic or inorganic base in water, addition of solution from operation (v) to solution from operation (iv) at 0-30°C, preferably at 0-10°C to obtain a solution having a pH in the range of 3.0-7.0, filtration of aqueous solution through 0.2 micron membrane filter, and subjecting the clear aqueous solution to spray drying.