Maryam Khoubnasabjafari1, Elaheh Rahimpour2, Morteza Samini3, Vahid Jouyban-Gharamaleki4,5, Lan Chen6,7, Donghao Chen6, Hak-Kim Chan8, Abolghasem Jouyban9. 1. Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 2. Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 3. Research and Development Department, Jaber Ebne Hayyan Pharmaceutical Co., Tehran, Iran. 4. Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 5. Kimia Idea Pardaz Azarbayjan (KIPA) Science Based Company, Tabriz University of Medical Sciences, Tabriz, Iran. 6. Hangzhou Chance Pharmaceuticals, Hangzhou, China. 7. University of Shanghai for Science and Technology, Shanghai, China. 8. Advanced Drug Delivery Group, School of Pharmacy, University of Sydney, Sydney, NSW 2006, Australia. 9. Pharmaceutical Analysis Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran. ajouyban@hotmail.com.
Abstract
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.
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.
Authors: I Horváth; J Hunt; P J Barnes; K Alving; A Antczak; E Baraldi; G Becher; W J C van Beurden; M Corradi; R Dekhuijzen; R A Dweik; T Dwyer; R Effros; S Erzurum; B Gaston; C Gessner; A Greening; L P Ho; J Hohlfeld; Q Jöbsis; D Laskowski; S Loukides; D Marlin; P Montuschi; A C Olin; A E Redington; P Reinhold; E L J van Rensen; I Rubinstein; P Silkoff; K Toren; G Vass; C Vogelberg; H Wirtz Journal: Eur Respir J Date: 2005-09 Impact factor: 16.671
Authors: Matthijs D Kruizinga; Willem A J Birkhoff; Michiel J van Esdonk; Naomi B Klarenbeek; Tomasz Cholewinski; Tessa Nelemans; Melloney J Dröge; Adam F Cohen; Rob G J A Zuiker Journal: Br J Clin Pharmacol Date: 2020-01-03 Impact factor: 4.335