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dc.contributor.authorPaluch, Krzysztof J.*
dc.contributor.authorTajber, L.*
dc.contributor.authorAmaro, M.I.*
dc.contributor.authorCorrigan, O.I.*
dc.contributor.authorHealy, A.M.*
dc.date.accessioned2018-01-04T12:24:35Z
dc.date.available2018-01-04T12:24:35Z
dc.date.issued2012-11
dc.identifier.citationPaluch KJ, Tajber L, Amaro MI et al (2012) Impact of process variables on the micromeritic and physicochemical properties of spray-dried microparticles, part II: physicochemical characterisation of spray-dried materials. 64(11): 1583-1591.
dc.identifier.urihttp://hdl.handle.net/10454/14361
dc.descriptionYes
dc.description.abstractObjectives  In this work we investigated the residual organic solvent content and physicochemical properties of spray-dried chlorothiazide sodium (CTZNa) and potassium (CTZK) salts. Methods  The powders were characterised by thermal, X-ray diffraction, infrared and dynamic vapour sorption (DVS) analyses. Solvent levels were investigated by Karl–Fischer titration and gas chromatography. Key findings  Spray-drying from water, methanol (MeOH) and mixes of MeOH and butyl acetate (BA) resulted in amorphous microparticles. The glass transition temperatures of CTZNa and CTZK were ∼192 and ∼159°C, respectively. These materials retained their amorphous nature when stored at 25°C in dry conditions for at least 6 months with no chemical decomposition observed. DVS determined the critical relative humidity of recrystallisation of CTZNa and CTZK to be 57% RH and 58% RH, respectively. The inlet temperature dependant oxidation of MeOH to formaldehyde was observed; the formaldehyde was seen to deposit within the amorphous matrix of spray-dried product. Spray-drying in the open blowing mode coupled with secondary drying resulted in a three-fold reduction in residual BA (below pharmacopoeial permitted daily exposure limit) compared to spray-drying in the closed mode. Conclusions  Experiments showed that recirculation of recovered drying gas increases the risk of deposition of residual solvents in the spray-dried product.
dc.description.sponsorshipThe Irish Research Council for Science and Engineering Technology (IRCSET), the Solid State Pharmaceutical Cluster (SSPC), supported by Science Foundation Ireland under grant number (07/SRC/B1158) and the Irish Drug Delivery Research Network, a Strategic Research Cluster grant (07/SRC/B1154) under the National Development Plan co-funded by EU Structural Funds and Science Foundation Ireland.
dc.language.isoen
dc.rights© 2012 Wiley This is the peer reviewed version of the following article: Paluch KJ, Tajber L, Amaro MI et al (2012) Impact of process variables on the micromeritic and physicochemical properties of spraydried microparticles – Part II. Physicochemical characterisation of spray-dried materials. 64(11): 1583-1591., which has been published in final form at http://dx.doi.org/10.1111/j.2042- 7158.2012.01543.x. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
dc.subjectSpray drying
dc.subjectAmorphous
dc.subjectOrganic solvent
dc.subjectOxidation
dc.subjectCritical relative humidity
dc.subjectRecrystallisation
dc.subjectResidual solvent level
dc.subjectSecondary drying
dc.subjectPermitted daily exposure
dc.titleImpact of process variables on the micromeritic and physicochemical properties of spray-dried microparticles, part II: physicochemical characterisation of spray-dried materials
dc.status.refereedYes
dc.date.Accepted2012-04-17
dc.date.application2012-05-24
dc.typeArticle
dc.type.versionAccepted manuscript
dc.identifier.doihttps://doi.org/10.1111/j.2042-7158.2012.01543.x
dc.rights.licenseUnspecified
refterms.dateFOA2018-07-29T03:01:45Z
dc.openaccess.statusopenAccess


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