화학공학소재연구정보센터
KAGAKU KOGAKU RONBUNSHU, Vol.30, No.6, 745-751, 2004
Process development to obtain agglomerate crystals suitable for powder filling
Wincef, an injectable cephalosporin antibiotic, was adapted to the powder filling method as a pharmaceutical process. The effects of temperature, supersaturation degree, stirring rate and seed crystals oil the specific volume, crystal size and crystal size distribution of Wincef were studied, and crystallization conditions were established to obtain spherical agglomerate crystals suitable for powder filling. As the degree of supersaturation increased, the specific volume of Wincef decreased. The optimum stirring rate was found from the viewpoint of breakage and agglomeration of products, and power consumption per unit volume was applied as a scale-up factor. Wincef obtained from a 500 l crystallizer was used in a powder filling experiment, and the expected result was obtained. Finally, it was confirmed that the Wincef obtained in a 3000 l commercial crystallizer had the expected powder characteristics.