Method of preparing stable sterile crystalline...

Details Method of preparing stable sterile crystalline... Method of preparing stable sterile crystalline...

C - Chemistry, Metallurgy

07

D

260/109

C07D 501/24 (2006.01) A61K 31/545 (2006.01)

Patent

CA 1068680

ABSTRACT OF THE DISCLOSURE The present invention relates to a process for preparing sterile, essentially crystalline cephalothin sodium, cephaloridine betaine and cefazolin sodium for parenteral administration by a freeze-drying process where- in, after rapidly cooling a solution of such cephalosporins to at least -15°C. in no more than 3 hours, the frozen solution is held between <0°C. and -10°C. until the nucle- ation of the cephalosporin is substantially complete before subjecting said frozen solution to a high vacuum and a moderate amount of heat to sublime the water therefrom. The instant invention provides an improved freeze-drying process wherein cephalosporins are prepared which are sterile, essentially crystalline and have good storage stability.

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