Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions
Introduction We compared in vitro drug delivery characteristics of two budesonide/formoterol dry powder inhalers, the Bufomix Easyhaler ® and the budesonide/formoterol Turbuhaler ® , at different patient air flow rates, and to test dose delivery from the Easyhaler in stressed conditions exposed to m...
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| Veröffentlicht in: | Pulmonary therapy 2017-06, Vol.3 (1), p.125-138 |
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| creator | Haikarainen, Jussi Selroos, Olof Löytänä, Tero Metsärinne, Sirpa Happonen, Anita Rytilä, Paula |
| description | Introduction
We compared in vitro drug delivery characteristics of two budesonide/formoterol dry powder inhalers, the Bufomix Easyhaler
®
and the budesonide/formoterol Turbuhaler
®
, at different patient air flow rates, and to test dose delivery from the Easyhaler in stressed conditions exposed to moisture, dropping, vibration and freezing/thawing.
Methods
A total of 36 inhalers from two batches of both products (160/4.5 µg strength) were used when comparing the effect of flow rate; six inhalers for each of the three flow rates for uniformity of delivered dose (DD), fine particle dose (FPD), mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD). Consistency of DD, FPD, MMAD and GSD were determined for each inhaler at three different flow rates: 10th, 50th and 90th percentile air flows. Dosing properties as a function of inhaler life were tested. The effects of moisture, dropping, vibration and freezing/thawing on DD and FPD were tested with two to four inhalers per test using all three strengths of Easyhaler: 80/4.5, 160/4.5 and 320/9 µg.
Results
The Easyhaler, 160/4.5 µg, showed statistically significantly better dose consistency (expressed as percentage of labelled dose) at all three inhalation flows compared with the Turbuhaler, 160/4.5 µg, (
p
|
| doi_str_mv | 10.1007/s41030-016-0025-z |
| format | Article |
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We compared in vitro drug delivery characteristics of two budesonide/formoterol dry powder inhalers, the Bufomix Easyhaler
®
and the budesonide/formoterol Turbuhaler
®
, at different patient air flow rates, and to test dose delivery from the Easyhaler in stressed conditions exposed to moisture, dropping, vibration and freezing/thawing.
Methods
A total of 36 inhalers from two batches of both products (160/4.5 µg strength) were used when comparing the effect of flow rate; six inhalers for each of the three flow rates for uniformity of delivered dose (DD), fine particle dose (FPD), mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD). Consistency of DD, FPD, MMAD and GSD were determined for each inhaler at three different flow rates: 10th, 50th and 90th percentile air flows. Dosing properties as a function of inhaler life were tested. The effects of moisture, dropping, vibration and freezing/thawing on DD and FPD were tested with two to four inhalers per test using all three strengths of Easyhaler: 80/4.5, 160/4.5 and 320/9 µg.
Results
The Easyhaler, 160/4.5 µg, showed statistically significantly better dose consistency (expressed as percentage of labelled dose) at all three inhalation flows compared with the Turbuhaler, 160/4.5 µg, (
p
< 0.001 for three flow rates). Exposure to moisture, dropping, vibration and freezing/thawing did not affect DD or FDP. These results were similar to all three tested Easyhaler strengths.
Conclusion
In vitro performance of the Easyhaler indicates reliable dosing. Dose consistency was superior compared with the Turbuhaler at all tested flow rates. Environmental moisture, dropping, vibration and freezing/thawing did not affect the performance.
Funding
Orion Corporation Orion Pharma.</description><identifier>ISSN: 2364-1754</identifier><identifier>EISSN: 2364-1746</identifier><identifier>DOI: 10.1007/s41030-016-0025-z</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Family Medicine ; General Practice ; Inhalers ; Internal Medicine ; Medicine ; Medicine & Public Health ; Original Research ; Pharmacoeconomics and Health Outcomes ; Pharmacotherapy ; Pneumology/Respiratory System ; Quality of Life Research</subject><ispartof>Pulmonary therapy, 2017-06, Vol.3 (1), p.125-138</ispartof><rights>The Author(s) 2017</rights><rights>Pulmonary Therapy is a copyright of Springer, (2017). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c274z-db15ae0c7c7a6269e76e85b3bdd7354f181b312863dc1437f005e77aa58f7b293</citedby><cites>FETCH-LOGICAL-c274z-db15ae0c7c7a6269e76e85b3bdd7354f181b312863dc1437f005e77aa58f7b293</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s41030-016-0025-z$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://doi.org/10.1007/s41030-016-0025-z$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,864,27922,27923,41118,42187,51574</link.rule.ids></links><search><creatorcontrib>Haikarainen, Jussi</creatorcontrib><creatorcontrib>Selroos, Olof</creatorcontrib><creatorcontrib>Löytänä, Tero</creatorcontrib><creatorcontrib>Metsärinne, Sirpa</creatorcontrib><creatorcontrib>Happonen, Anita</creatorcontrib><creatorcontrib>Rytilä, Paula</creatorcontrib><title>Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions</title><title>Pulmonary therapy</title><addtitle>Pulm Ther</addtitle><description>Introduction
We compared in vitro drug delivery characteristics of two budesonide/formoterol dry powder inhalers, the Bufomix Easyhaler
®
and the budesonide/formoterol Turbuhaler
®
, at different patient air flow rates, and to test dose delivery from the Easyhaler in stressed conditions exposed to moisture, dropping, vibration and freezing/thawing.
Methods
A total of 36 inhalers from two batches of both products (160/4.5 µg strength) were used when comparing the effect of flow rate; six inhalers for each of the three flow rates for uniformity of delivered dose (DD), fine particle dose (FPD), mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD). Consistency of DD, FPD, MMAD and GSD were determined for each inhaler at three different flow rates: 10th, 50th and 90th percentile air flows. Dosing properties as a function of inhaler life were tested. The effects of moisture, dropping, vibration and freezing/thawing on DD and FPD were tested with two to four inhalers per test using all three strengths of Easyhaler: 80/4.5, 160/4.5 and 320/9 µg.
Results
The Easyhaler, 160/4.5 µg, showed statistically significantly better dose consistency (expressed as percentage of labelled dose) at all three inhalation flows compared with the Turbuhaler, 160/4.5 µg, (
p
< 0.001 for three flow rates). Exposure to moisture, dropping, vibration and freezing/thawing did not affect DD or FDP. These results were similar to all three tested Easyhaler strengths.
Conclusion
In vitro performance of the Easyhaler indicates reliable dosing. Dose consistency was superior compared with the Turbuhaler at all tested flow rates. Environmental moisture, dropping, vibration and freezing/thawing did not affect the performance.
Funding
Orion Corporation Orion Pharma.</description><subject>Family Medicine</subject><subject>General Practice</subject><subject>Inhalers</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Research</subject><subject>Pharmacoeconomics and Health Outcomes</subject><subject>Pharmacotherapy</subject><subject>Pneumology/Respiratory System</subject><subject>Quality of Life Research</subject><issn>2364-1754</issn><issn>2364-1746</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1kMtKw0AUhgdRsNQ-gLuA67Fzy0ziTkurQkGxdj1MMmc0Jc3UmWTRPpQP4ZOZEhE3rs4P57_Ah9AlJdeUEDWNghJOMKESE8JSfDhBI8alwFQJefqrU3GOJjFuCCE050yobIRWd52F6JvKwnThw9a3EHydzE3cv5sawtfnTfIMwfUv05SQrBsLIVlV2642LdjkBUyNl5WDZOYbW7WVb-IFOnOmjjD5uWO0XsxfZw94-XT_OLtd4pIpccC2oKkBUqpSGclkDkpClha8sFbxVDia0YJTlkluSyq4coSkoJQxaeZUwXI-RldD7y74jw5iqze-C00_qWku-42cSdG76OAqg48xgNO7UG1N2GtK9BGfHvDpHp8-4tOHPsOGTOy9zRuEP83_hr4BmINzRA</recordid><startdate>20170601</startdate><enddate>20170601</enddate><creator>Haikarainen, Jussi</creator><creator>Selroos, Olof</creator><creator>Löytänä, Tero</creator><creator>Metsärinne, Sirpa</creator><creator>Happonen, Anita</creator><creator>Rytilä, Paula</creator><general>Springer Healthcare</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>KB0</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PADUT</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>20170601</creationdate><title>Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions</title><author>Haikarainen, Jussi ; Selroos, Olof ; Löytänä, Tero ; Metsärinne, Sirpa ; Happonen, Anita ; Rytilä, Paula</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c274z-db15ae0c7c7a6269e76e85b3bdd7354f181b312863dc1437f005e77aa58f7b293</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Family Medicine</topic><topic>General Practice</topic><topic>Inhalers</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Research</topic><topic>Pharmacoeconomics and Health Outcomes</topic><topic>Pharmacotherapy</topic><topic>Pneumology/Respiratory System</topic><topic>Quality of Life Research</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Haikarainen, Jussi</creatorcontrib><creatorcontrib>Selroos, Olof</creatorcontrib><creatorcontrib>Löytänä, Tero</creatorcontrib><creatorcontrib>Metsärinne, Sirpa</creatorcontrib><creatorcontrib>Happonen, Anita</creatorcontrib><creatorcontrib>Rytilä, Paula</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Research Library China</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><jtitle>Pulmonary therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Haikarainen, Jussi</au><au>Selroos, Olof</au><au>Löytänä, Tero</au><au>Metsärinne, Sirpa</au><au>Happonen, Anita</au><au>Rytilä, Paula</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions</atitle><jtitle>Pulmonary therapy</jtitle><stitle>Pulm Ther</stitle><date>2017-06-01</date><risdate>2017</risdate><volume>3</volume><issue>1</issue><spage>125</spage><epage>138</epage><pages>125-138</pages><issn>2364-1754</issn><eissn>2364-1746</eissn><abstract>Introduction
We compared in vitro drug delivery characteristics of two budesonide/formoterol dry powder inhalers, the Bufomix Easyhaler
®
and the budesonide/formoterol Turbuhaler
®
, at different patient air flow rates, and to test dose delivery from the Easyhaler in stressed conditions exposed to moisture, dropping, vibration and freezing/thawing.
Methods
A total of 36 inhalers from two batches of both products (160/4.5 µg strength) were used when comparing the effect of flow rate; six inhalers for each of the three flow rates for uniformity of delivered dose (DD), fine particle dose (FPD), mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD). Consistency of DD, FPD, MMAD and GSD were determined for each inhaler at three different flow rates: 10th, 50th and 90th percentile air flows. Dosing properties as a function of inhaler life were tested. The effects of moisture, dropping, vibration and freezing/thawing on DD and FPD were tested with two to four inhalers per test using all three strengths of Easyhaler: 80/4.5, 160/4.5 and 320/9 µg.
Results
The Easyhaler, 160/4.5 µg, showed statistically significantly better dose consistency (expressed as percentage of labelled dose) at all three inhalation flows compared with the Turbuhaler, 160/4.5 µg, (
p
< 0.001 for three flow rates). Exposure to moisture, dropping, vibration and freezing/thawing did not affect DD or FDP. These results were similar to all three tested Easyhaler strengths.
Conclusion
In vitro performance of the Easyhaler indicates reliable dosing. Dose consistency was superior compared with the Turbuhaler at all tested flow rates. Environmental moisture, dropping, vibration and freezing/thawing did not affect the performance.
Funding
Orion Corporation Orion Pharma.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><doi>10.1007/s41030-016-0025-z</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Pulmonary therapy, 2017-06, Vol.3 (1), p.125-138 |
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| language | eng |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Springer Nature OA Free Journals; PubMed Central |
| subjects | Family Medicine General Practice Inhalers Internal Medicine Medicine Medicine & Public Health Original Research Pharmacoeconomics and Health Outcomes Pharmacotherapy Pneumology/Respiratory System Quality of Life Research |
| title | Budesonide/Formoterol Easyhaler®: Performance Under Simulated Real-Life Conditions |
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