Cyr T D, Duhaime R M, Graham S J, Ormsby E D, Lawrence R C, LeBelle M J
Health Canada, Drugs Directorate, Bureau of Drug Research, Ottawa, ON, Canada.
J Pharm Biomed Anal. 1997 Jul;15(11):1709-18. doi: 10.1016/s0731-7085(96)01992-9.
Three American products and one Canadian product were examined for content uniformity and particle size distribution. The results showed that not all products performed equally well. Some of the products exhibited high sprays early in the canister lifetime and all products demonstrated loss of prime. The particle size distributions were determined using the Andersen cascade impactor (USP Induction Port) and the fine particle fraction was determined using the twin impinger. The results showed that three of the four products had similar particle size distribution profiles. Both the Andersen cascade impactor and the twin impinger yielded the same trends in the amount of drug substance delivered to the fine particle fraction.
对三种美国产品和一种加拿大产品进行了含量均匀度和粒度分布检查。结果表明，并非所有产品的表现都同样出色。一些产品在罐使用寿命早期出现高喷雾现象，并且所有产品均出现启动损失。使用安德森级联撞击器（USP进气口）测定粒度分布，使用双联撞击器测定细颗粒分数。结果表明，四种产品中的三种具有相似的粒度分布曲线。安德森级联撞击器和双联撞击器在递送至细颗粒分数的药物量方面呈现相同趋势。
