一种用于研究药物吸入制剂生物等效性的新假说。
A new hypothesis to investigate bioequivalence of pharmaceutical inhalation products.
机构信息
Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
出版信息
Daru. 2019 Jun;27(1):517-524. doi: 10.1007/s40199-019-00250-x. Epub 2019 Mar 7.
BACKGROUND
This short communication reports a new hypothesis regarding bioequivalence of inhalation products which can potentially provide a reliable means to compare pharmaceutical aerosol formulations and inhalers.
METHODS
Available methods regarding the bioequivalence studies, inhaled drugs and advantages of exhaled breath condensate (EBC) samples were reviewed to develop this hypothesis.
RESULTS
It is postulated that two inhalation products providing the same drug concentrations in airway lining fluid (ALF) could be considered bioequivalent. The use of EBC tests which reflect ALF composition can be recommended as an alternative to current testing methods for consideration of bioequivalence.
CONCLUSION
The methods based on EBC analysis can potentially be applied to bioequivalence study of inhalation products and could reflect drug concentration in ALF. However, experimental studies would be necessary to support or refute this hypothesis on the novel application of EBC to bioequivalence in the future. Graphical abstract In vitro (cascade impactor) and In vivo (EBC concentration) corrolation for inhaled drugs.
背景
本简讯报告了一个关于吸入制剂生物等效性的新假设，该假设可能为比较药物气溶胶制剂和吸入器提供一种可靠的方法。
方法
为了提出该假设，我们回顾了关于生物等效性研究、吸入药物和呼气冷凝物（EBC）样本优点的现有方法。
结果
我们推测，能在气道衬液（ALF）中提供相同药物浓度的两种吸入制剂可以被认为是生物等效的。推荐使用反映 ALF 组成的 EBC 测试作为当前生物等效性测试方法的替代方法。
结论
基于 EBC 分析的方法可能可应用于吸入制剂的生物等效性研究，并能反映 ALF 中的药物浓度。然而，未来有必要进行实验研究来支持或反驳 EBC 在生物等效性方面的新应用的这一假设。
吸入药物的体外（级联撞击器）和体内（EBC 浓度）相关性。
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