Particle size in parenteral fat emulsions, what are the true limitations?

被引:47
作者
Koster, VS [1 ]
Kuks, PFM [1 ]
Lange, R [1 ]
Talsma, H [1 ]
机构
[1] UNIV UTRECHT,GRONINGEN UTRECHT INST DRUG EXPLORAT,UTRECHT INST PHARMACEUT SCI,DEPT PHARMACEUT,3508 TB UTRECHT,NETHERLANDS
关键词
particle size; parenteral fat emulsions; adverse reactions;
D O I
10.1016/0378-5173(95)04409-4
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Intravenously administered fat droplets exceeding 5 mu m in diameter are believed to cause adverse reactions, in particular emboli in the lungs. We investigated the fat particle size and particle size distribution of commercially available parenteral fat emulsions. Both laser diffraction and light obscuration were used as a detection technique. With the light obscuration technique a significant number of particles >5 mu m in diameter was detected in all investigated emulsions. The investigated emulsions have been in use for several years, without reports of important adverse reactions in this respect. Therefore, it is concluded that the requirements concerning the particle size limitations in fat emulsions should be reconsidered.
引用
收藏
页码:235 / 238
页数:4
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