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dc.contributor.authorGrainger, C.I.
dc.contributor.authorSaunders, M.
dc.contributor.authorButtini, F.
dc.contributor.authorTelford, Richard
dc.contributor.authorMerolla, L.L.
dc.contributor.authorMartin, G.P.
dc.contributor.authorJones, S.A.
dc.contributor.authorForbes, B.
dc.date.accessioned2019-10-15T13:45:37Z
dc.date.accessioned2019-10-29T11:06:15Z
dc.date.available2019-10-15T13:45:37Z
dc.date.available2019-10-29T11:06:15Z
dc.date.issued2012-03
dc.identifier.citationGrainger CI, Saunders M, Buttini F et al (2012) Critical characteristics for corticosteroid solution metered dose inhaler bioequivalence. Molecular Pharmaceutics. 9(3): 563-569.en_US
dc.identifier.urihttp://hdl.handle.net/10454/17380
dc.descriptionNoen_US
dc.description.abstractDetermining bioequivalence for solution pressurized metered dose inhalers (pMDI) is difficult because the critical characteristics of such products are poorly defined. The aim of this study was to elucidate the non-aerodynamic properties of the emitted aerosol particles from two solution pMDI products that determine their biopharmaceutical differences after deposition. Novel particle capture and analysis techniques were employed to characterize the physicochemical and biopharmaceutical properties of two beclomethasone dipropionate (BDP) products: QVAR and Sanasthmax. The BDP particles emitted from the Sanasthmax inhaler were discernibly different those emitted from QVAR in terms of size (50% larger, less porous), solid state (less crystalline) and dissolution (20-fold slower). When deposited onto the surface of respiratory epithelial cell layers, QVAR delivered ∼50% more BDP across the cell layer in 60 min than Sanasthmax. Biopharmaceutical performance was not attributable to individual particle properties as these were manifold with summative and/or competing effects. The cell culture dissolution− absorption model revealed the net effect of the particle formed on drug disposition and was predictive of human systemic absorption of BDP delivered by the test inhalers. This illustrates the potential of the technique to detect the effect of formulation on the performance of aerosolized particles and contribute to assessment of bioequivalence.en_US
dc.description.sponsorshipThis work was in part funded by a grant from the Safety and Environmental Assurance Centre, Unilever Colworth, U.K. Particle sizing was performed by Steve Ingham, Institute of Pharmaceutical Science, King’s College London.en_US
dc.language.isoenen_US
dc.relation.isreferencedbyhttps://doi.org/10.1021/mp200415gen_US
dc.subjectAerosol depositionen_US
dc.subjectAerosol formulationen_US
dc.subjectAirway epithelial cellen_US
dc.subjectInhaled corticosteroidsen_US
dc.subjectPressurized metered dose inhalersen_US
dc.titleCritical characteristics for corticosteroid solution metered dose inhaler bioequivalenceen_US
dc.status.refereedYesen_US
dc.date.Accepted2012-01-01
dc.date.application2012-01-01
dc.typeArticleen_US
dc.type.versionNo full-text in the repositoryen_US
dc.date.updated2019-10-15T12:45:37Z
refterms.dateFOA2019-11-12T15:04:19Z


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