A new hypothesis to investigate bioequivalence of pharmaceutical inhalation products

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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

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Author and article information

Contributors

Abolghasem Jouyban:

ORCID: http://orcid.org/0000-0002-4670-2783

ajouyban@hotmail.com

Journal

Journal ID (nlm-ta): Daru

Journal ID (iso-abbrev): Daru

Title: DARU Journal of Pharmaceutical Sciences

Publisher: Springer International Publishing (Cham )

ISSN (Print): 1560-8115

ISSN (Electronic): 2008-2231

Publication date (Electronic): 7 March 2019

Publication date Collection: June 2019

Volume: 27

Issue: 1

Pages: 517-524

Affiliations

[1 ] ISNI 0000 0001 2174 8913, GRID grid.412888.f, Tuberculosis and Lung Diseases Research Center, , Tabriz University of Medical Sciences, ; Tabriz, Iran

[2 ] ISNI 0000 0001 2174 8913, GRID grid.412888.f, Drug Applied Research Center, , Tabriz University of Medical Sciences, ; Tabriz, Iran

[3 ]Research and Development Department, Jaber Ebne Hayyan Pharmaceutical Co., Tehran, Iran

[4 ] ISNI 0000 0001 2174 8913, GRID grid.412888.f, Liver and Gastrointestinal Diseases Research Center, , Tabriz University of Medical Sciences, ; Tabriz, Iran

[5 ] ISNI 0000 0001 2174 8913, GRID grid.412888.f, Kimia Idea Pardaz Azarbayjan (KIPA) Science Based Company, , Tabriz University of Medical Sciences, ; Tabriz, Iran

[6 ]Hangzhou Chance Pharmaceuticals, Hangzhou, China

[7 ] ISNI 0000 0000 9188 055X, GRID grid.267139.8, University of Shanghai for Science and Technology, ; Shanghai, China

[8 ] ISNI 0000 0004 1936 834X, GRID grid.1013.3, Advanced Drug Delivery Group, School of Pharmacy, , University of Sydney, ; Sydney, NSW 2006 Australia

[9 ] ISNI 0000 0001 2174 8913, GRID grid.412888.f, Pharmaceutical Analysis Research Center and Faculty of Pharmacy, , Tabriz University of Medical Sciences, ; Tabriz, Iran

Author information

Abolghasem Jouyban http://orcid.org/0000-0002-4670-2783

Article

Accession ID: PMC6593033 Pmcid ID: PMC6593033 Pmc-uid ID: 6593033 Publisher ID: 250

DOI: 10.1007/s40199-019-00250-x

PMC ID: 6593033

PubMed ID: 30847847

SO-VID: 0bd485b2-6a96-4b89-90c3-964543072f04

History

Date received : 31 August 2018

Date accepted : 13 February 2019

Custom metadata

Keywords: Inhaled drugs,Bioequivalence,Exhaled breath condensate,Hypothesis

Data availability:

Keywords: Inhaled drugs, Bioequivalence, Exhaled breath condensate, Hypothesis

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