COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS

The aerodynamic properties of the developed generic product Salbutamol metered dose inhaler 100 μg/dose and Salbutamol-Teva metered dose inhaler 100 μg/dose using apparatuses A, C, D and E in accordance with the general article 2.9.18 of the European Pharmacopoeia have been studied. In vitro equival...

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Main Authors: N. A. Lyapunov, E. P. Bezuglaya, V. A. Bovtenko, Yu. M. Stolper
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Series:Разработка и регистрация лекарственных средств
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Online Access:https://www.pharmjournal.ru/jour/article/view/545
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author N. A. Lyapunov
E. P. Bezuglaya
V. A. Bovtenko
Yu. M. Stolper
author_facet N. A. Lyapunov
E. P. Bezuglaya
V. A. Bovtenko
Yu. M. Stolper
author_sort N. A. Lyapunov
collection DOAJ
description The aerodynamic properties of the developed generic product Salbutamol metered dose inhaler 100 μg/dose and Salbutamol-Teva metered dose inhaler 100 μg/dose using apparatuses A, C, D and E in accordance with the general article 2.9.18 of the European Pharmacopoeia have been studied. In vitro equivalence of the generic product and the comparator with regard to such aerodynamic characteristics as the fine particle dose, the particle size distribution, the relative amount of salbutamol passed through the apparatus stages, the mass median aerodynamic diameter (MMAD), and the geometric standard deviation (GSD) has been shown. It is shown that the device A is useful for testing of the respirable fraction, and the apparatuses D and E are suitable for the assessment of the particle size distribution, MMAD and GSD.
format Article
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institution DOAJ
issn 2305-2066
2658-5049
language Russian
publishDate 2019-01-01
publisher LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
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series Разработка и регистрация лекарственных средств
spelling doaj-art-8b2dfed2da0e40a1b635ba1b7c6eec3b2025-08-20T02:54:19ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-01015461545COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERSN. A. Lyapunov0E. P. Bezuglaya1V. A. Bovtenko2Yu. M. Stolper3Institute for Single Crystals of the National Academy of Sciences of UkraineInstitute for Single Crystals of the National Academy of Sciences of UkraineInstitute for Single Crystals of the National Academy of Sciences of UkraineInstitute for Single Crystals of the National Academy of Sciences of UkraineThe aerodynamic properties of the developed generic product Salbutamol metered dose inhaler 100 μg/dose and Salbutamol-Teva metered dose inhaler 100 μg/dose using apparatuses A, C, D and E in accordance with the general article 2.9.18 of the European Pharmacopoeia have been studied. In vitro equivalence of the generic product and the comparator with regard to such aerodynamic characteristics as the fine particle dose, the particle size distribution, the relative amount of salbutamol passed through the apparatus stages, the mass median aerodynamic diameter (MMAD), and the geometric standard deviation (GSD) has been shown. It is shown that the device A is useful for testing of the respirable fraction, and the apparatuses D and E are suitable for the assessment of the particle size distribution, MMAD and GSD.https://www.pharmjournal.ru/jour/article/view/545salbutamolpressurized metered dose inhalerimpingerimpactorfine particle doseparticle size distribution
spellingShingle N. A. Lyapunov
E. P. Bezuglaya
V. A. Bovtenko
Yu. M. Stolper
COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS
Разработка и регистрация лекарственных средств
salbutamol
pressurized metered dose inhaler
impinger
impactor
fine particle dose
particle size distribution
title COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS
title_full COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS
title_fullStr COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS
title_full_unstemmed COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS
title_short COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS
title_sort comparative assessment of aerodynamic properties of salbutamol pressurized metered dose inhalers
topic salbutamol
pressurized metered dose inhaler
impinger
impactor
fine particle dose
particle size distribution
url https://www.pharmjournal.ru/jour/article/view/545
work_keys_str_mv AT nalyapunov comparativeassessmentofaerodynamicpropertiesofsalbutamolpressurizedmetereddoseinhalers
AT epbezuglaya comparativeassessmentofaerodynamicpropertiesofsalbutamolpressurizedmetereddoseinhalers
AT vabovtenko comparativeassessmentofaerodynamicpropertiesofsalbutamolpressurizedmetereddoseinhalers
AT yumstolper comparativeassessmentofaerodynamicpropertiesofsalbutamolpressurizedmetereddoseinhalers