Abstract
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. Available methods regarding the bioequivalence studies, inhaled drugs and advantages of exhaled breath condensate (EBC) samples were reviewed to develop this hypothesis. 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. 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.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
