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Article: Determination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization

TitleDetermination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronization
Authors
KeywordsDry powder inhalers
Fine particle dose
Relative lung bioavailability
Supercritical fluids
Urinary salbutamol
Issue Date2007
PublisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0724-8741
Citation
Pharmaceutical Research, 2007, v. 24 n. 11, p. 2008-2017 How to Cite?
AbstractPurpose. The relative lung bioavailability of salbutamol sulfate particles produced using supercritical fluids (SEDS™) and delivered by dry powder inhaler (DPI) was compared with the performance of a conventional micronized drug DPI using the same device design (Clickhaler™, Innovata Biomed). Materials and Methods. Twelve healthy volunteers and 11 mild asthmatic patients completed separate four-way randomised cross-over studies, assessing the relative bioavailability of salbutamol sulfate (urinary excretion method), formulated as SEDS™ particles (three batches) and micronized particles (Asmasal™ inhaler, UCB Pharma Ltd). Post-treatment improvements in patient lung function were assessed by measuring FEV1. Physicochemical evaluation of the three SEDS™ batches revealed inter-batch differences in particle size and shape. Results. There was no significant difference in the relative lung bioavailability of salbutamol and its bronchodilator response between the best performing SEDS™ formulation and the Asmasal™ inhaler in volunteers and patients, respectively. SEDS™ salbutamol sulfate showing wafer like morphology gave greater fine particle dose, relative lung bioavailability and enhanced bronchodilation compared to other SEDS™ batches containing elongated particles. Conclusions. Active Pharmaceutical Ingredient (API) manufactured using supercritical fluids and delivered by DPI can provide similar lung bioavailability and clinical effect to the conventional micronized commercial product. Product performance is however notably influenced by inter-batch differences in particle characteristics. © 2007 Springer Science+Business Media, LLC.
Persistent Identifierhttp://hdl.handle.net/10722/132864
ISSN
2015 Impact Factor: 3.26
2015 SCImago Journal Rankings: 1.189
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorRichardson, CHen_HK
dc.contributor.authorDe Matas, Men_HK
dc.contributor.authorHosker, Hen_HK
dc.contributor.authorMukherjee, Ren_HK
dc.contributor.authorWong, Ien_HK
dc.contributor.authorChrystyn, Hen_HK
dc.date.accessioned2011-04-04T07:57:40Z-
dc.date.available2011-04-04T07:57:40Z-
dc.date.issued2007en_HK
dc.identifier.citationPharmaceutical Research, 2007, v. 24 n. 11, p. 2008-2017en_HK
dc.identifier.issn0724-8741en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132864-
dc.description.abstractPurpose. The relative lung bioavailability of salbutamol sulfate particles produced using supercritical fluids (SEDS™) and delivered by dry powder inhaler (DPI) was compared with the performance of a conventional micronized drug DPI using the same device design (Clickhaler™, Innovata Biomed). Materials and Methods. Twelve healthy volunteers and 11 mild asthmatic patients completed separate four-way randomised cross-over studies, assessing the relative bioavailability of salbutamol sulfate (urinary excretion method), formulated as SEDS™ particles (three batches) and micronized particles (Asmasal™ inhaler, UCB Pharma Ltd). Post-treatment improvements in patient lung function were assessed by measuring FEV1. Physicochemical evaluation of the three SEDS™ batches revealed inter-batch differences in particle size and shape. Results. There was no significant difference in the relative lung bioavailability of salbutamol and its bronchodilator response between the best performing SEDS™ formulation and the Asmasal™ inhaler in volunteers and patients, respectively. SEDS™ salbutamol sulfate showing wafer like morphology gave greater fine particle dose, relative lung bioavailability and enhanced bronchodilation compared to other SEDS™ batches containing elongated particles. Conclusions. Active Pharmaceutical Ingredient (API) manufactured using supercritical fluids and delivered by DPI can provide similar lung bioavailability and clinical effect to the conventional micronized commercial product. Product performance is however notably influenced by inter-batch differences in particle characteristics. © 2007 Springer Science+Business Media, LLC.en_HK
dc.languageengen_US
dc.publisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0724-8741en_HK
dc.relation.ispartofPharmaceutical Researchen_HK
dc.subjectDry powder inhalersen_HK
dc.subjectFine particle doseen_HK
dc.subjectRelative lung bioavailabilityen_HK
dc.subjectSupercritical fluidsen_HK
dc.subjectUrinary salbutamolen_HK
dc.titleDetermination of the relative bioavailability of salbutamol to the lungs following inhalation from dry powder inhaler formulations containing drug substance manufactured by supercritical fluids and micronizationen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, I: wongick@hku.hken_HK
dc.identifier.authorityWong, I=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1007/s11095-007-9328-yen_HK
dc.identifier.pmid17510755-
dc.identifier.scopuseid_2-s2.0-34848928443en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-34848928443&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume24en_HK
dc.identifier.issue11en_HK
dc.identifier.spage2008en_HK
dc.identifier.epage2017en_HK
dc.identifier.eissn1573-904X-
dc.identifier.isiWOS:000249802500004-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridRichardson, CH=22136209900en_HK
dc.identifier.scopusauthoridDe Matas, M=22134158300en_HK
dc.identifier.scopusauthoridHosker, H=6701774618en_HK
dc.identifier.scopusauthoridMukherjee, R=22135544100en_HK
dc.identifier.scopusauthoridWong, I=7102513915en_HK
dc.identifier.scopusauthoridChrystyn, H=7005136151en_HK

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