Influence of process parameters in the ASES process on particle properties of budesonide for pulmonary delivery

被引:37
作者
Steckel, H [1 ]
Pichert, L [1 ]
Müller, BW [1 ]
机构
[1] Univ Kiel, Dept Pharmaceut & Biopharmaceut, D-24118 Kiel, Germany
关键词
budesonide; supercritical fluid; aerosol solvent extraction system; dry powder inhalation; aerodynamic diameter; micronization;
D O I
10.1016/j.ejpb.2004.01.002
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Budesonide was micronized by precipitation in supercritical carbon dioxide by using the aerosol solvent extraction system at various process conditions. The process is characterised by spraying an organic solution of budesonide into the supercritical fluid (SCF), precipitation of the drug in the SCF and extraction and recovery of the solvent. The micronized budesonide particles were characterized physicochemically for their morphology, crystallinity, size distribution and for their aerodynamic behaviour. The particle size distribution of the powder products was similar, regardless of the process conditions used for the crystallization. Also, the morphology of the particles did not differ between the batches. However, the aerodynamic properties of the precipitated batches were significantly different between the batches produced and as compared to a jet-milled budesonide powder. In conclusion, the process conditions in the SCF precipitation may influence the aerodynamic properties, although other physico-chemical parameters appear to be similar. (C) 2004 Elsevier B.V. All rights reserved.
引用
收藏
页码:507 / 512
页数:6
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