COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS
Abstract
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.
About the Authors
N. A. Lyapunov
Institute for Single Crystals of the National Academy of Sciences of Ukraine
Russian Federation
Russian Federation
E. P. Bezuglaya
Institute for Single Crystals of the National Academy of Sciences of Ukraine
Russian Federation
Russian Federation
V. A. Bovtenko
Institute for Single Crystals of the National Academy of Sciences of Ukraine
Russian Federation
Russian Federation
Yu. M. Stolper
Institute for Single Crystals of the National Academy of Sciences of Ukraine
Russian Federation
Russian Federation
References
1. M. Lippmann. Regional Deposition of Particles in the Human Respiratory Tract / Comprehensive Physiology. 2011. P. 213-232.
2. European Pharmacopoeia. 9th Edition. European Directorate for the Quality of Medicines (EDQM). Council of Europe, 67075 Strasbourg Cedex, France 2016. 4016 p.
3. Н.А. Ляпунов, Е.П. Безуглая, Е.К. Товмасян, Ю.М. Столпер, В.А. Бовтенко, С.Л. Дашутина. Вопросы контроля качества лекарственных средств для ингаляции // Фармаком. 2006. № 4. С. 9-16.
4. EMEA/СHМР/QWP/49313/2005 Corr. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products. London, 21 June 2006.
5. Salbutamol Pressurised Inhalation // British Pharmacopoeia. 2013. V. III.
6. CPMP/EWP/4151/00 Rev. 1. Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence between two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents. London, 22 January 2009.
7. Регистр лекарственных средств России. URL: http://grls.rosminzdrav.ru/ (дата обращения 30.10.2017).
8. Н.А. Ляпунов, Е.П. Безуглая, В.А. Бовтенко, Ю.М. Столпер. Обоснование нового подхода к оценке качества дозированных аэрозолей для ингаляций на этапе их разработки // Научные ведомости Белгородского государственного университета. Сер.: Медицина. Фармация. 2016. № 5(226). Вып. 33. С. 170-179.
9. USP 36-NF 31. The United States Pharmacopeia and National Formulary 2012 - Copyright © 2012 The United States Pharmacopeial Convention 12601 Twinbrook Parkway, Rockville, MD 20852 - Printed in the United States by United Book Press, Inc., Baltimore, MD. 5642 p.
Review
For citations:
Lyapunov N.A., Bezuglaya E.P., Bovtenko V.A., Stolper Yu.M. COMPARATIVE ASSESSMENT OF AERODYNAMIC PROPERTIES OF SALBUTAMOL PRESSURIZED METERED DOSE INHALERS. Drug development & registration. 2018;(1):54-61. (In Russ.)
Views:
787
Email this article 