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Merck

Preparation of cefpodoxime proxetil fine particles using supercritical fluids.

International journal of pharmaceutics (2008-12-02)
Junho Chu, Guanghua Li, Kyung Ho Row, Hwayong Kim, Youn-Woo Lee
RÉSUMÉ

Fine particles of cefpodoxime proxetil (CPD) were prepared using an Aerosol Solvent Extraction System (ASES) with supercritical CO(2). The resulting primary particles were approximately 0.1-0.2microm in size and were almost spherical in shape. The secondary particles were approximately 0.2-0.6microm in size and had irregular shapes. The larger particle size and irregular shapes were due to the agglomeration of the primary particles. The effects of solvent type, CO(2)-to-CPD solution weight ratio, and CPD solution concentration on the extent of agglomeration were investigated. As a result, the use of ethyl acetate and acetone as solvents also reduced the degree of agglomeration. The degree of agglomeration was reduced with the use of a high CO(2)-to-solution weight ratio, and a low solution concentration. In particular, spherical particles, approximately 0.1-0.4microm in size, were obtained when a 10.0wt% CPD solution was used. As a result of dissolution study, almost 90% of the processed CPD had dissolved within 10min. The recovery yield of the CPD powder reached approximately 80% using a membrane filter.

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USP
Cefpodoxime proxetil, United States Pharmacopeia (USP) Reference Standard
Cefpodoxime proxetil, European Pharmacopoeia (EP) Reference Standard
Cefpodoxime proxetil for peak identification, European Pharmacopoeia (EP) Reference Standard
Cefpodoxime proxetil for impurity H identification, European Pharmacopoeia (EP) Reference Standard