Additive Effect and Scale-up in Selective Crystallization of Sodium Cefazolin Polymorphs.

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  • Momonaga Masashi
    Manufacturing Technology Laboratories, Fujisawa Pharmaceutical Co., Ltd.
  • Onishi Ken
    Manufacturing Technology Laboratories, Fujisawa Pharmaceutical Co., Ltd.
  • Yazawa Hisatoyo
    Manufacturing Technology Laboratories, Fujisawa Pharmaceutical Co., Ltd.

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  • 多形を持つセファゾリンナトリウムの選択晶析における媒晶剤効果とスケールアップ
  • タケイ オ モツ セファゾリン ナトリウム ノ センタク ショウセキ ニ オケ

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Crystallization of polymorphic form β of sodium cefazolin having desired powder characteristics was studied. Selective crystallization using the solubility differences in water -solmix solutions was found to produce crystals of the β form, stable both physically and chemically. Additional studies using crystallization to control the crystal habit were made by the addition of a small amount of compounds having the structure of diaminocarboxylic acids similar to sodium cefazolin, or amino acids such as L-argine and L-lysine. <BR>This crystallization produced crystals suitable for vial and capsule medicines.<BR>Furthermore, it was found that control of particle size and distribution, as well as scale -up, was possible by application of the Z parameter defined as the power consumption ratio of agitation.

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