Near-infrared monitoring of roller compacted ribbon density: investigating sources of variation contributing to noisy spectral data

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dc.contributor.author Crowley, Mary Ellen
dc.contributor.author Hegarty, Avril
dc.contributor.author McAuliffe, Michael A. P.
dc.contributor.author O'Mahony, Graham E.
dc.contributor.author Kiernan, Luke
dc.contributor.author Hayes, Kevin
dc.contributor.author Crean, Abina M.
dc.date.accessioned 2017-08-18T11:39:52Z
dc.date.available 2017-08-18T11:39:52Z
dc.date.issued 2017-02-16
dc.identifier.citation Crowley, M. E., Hegarty, A., McAuliffe, M. A. P., O'Mahony, G. E., Kiernan, L., Hayes, K. and Crean, A. M. (2017) 'Near-infrared monitoring of roller compacted ribbon density: investigating sources of variation contributing to noisy spectral data', European Journal of Pharmaceutical Sciences, 102, pp. 103-114. doi:10.1016/j.ejps.2017.02.024 en
dc.identifier.volume 102 en
dc.identifier.startpage 103 en
dc.identifier.endpage 114 en
dc.identifier.issn 0928-0987
dc.identifier.uri http://hdl.handle.net/10468/4470
dc.identifier.doi 10.1016/j.ejps.2017.02.024
dc.description.abstract The aim of this study was to highlight how variability in roller compacted ribbon quality can impact on NIR spectral measurement and to propose a simple method of data selection to remove erroneous spectra. The use of NIR spectroscopy for monitoring ribbon envelope density has been previously demonstrated, however to date there has been limited discussion as to how spectral data sets can contain erroneous outliers due to poor sample presentation to the NIR probes. In this study compacted ribbon of variable quality was produced from three separate blends of microcrystalline cellulose (MCC)/lactose/magnesium stearate at 8 Roll Force settings (2–16 kN/cm). The three blends differed only in the storage conditions of MCC prior to blending and compaction. MCC sublots were stored at ambient (41% RH/20 °C), low humidity (11% RH/20 °C) and high humidity (75% RH/40 °C) conditions prior to blending. Ribbon envelope density was measured and ribbon NIR spectral data was acquired at line using a multi-probe spectrometer (MultiEye™ NIR). Initial inspection of the at-line NIR spectral data set showed a large degree of variability which indicated that some form of data cleaning was required. The source of variability in spectral measurements was investigated by subjective visual examination and by statistical analysis. Spectral variability was noted due to the storage conditions of MCC prior to compaction, Roll Force settings and between individual ribbon samples sampled at a set Roll Force/Blend combination. Variability was also caused by ribbon presentation to probes, such as differences in the presentation of broken, curved and flat intact ribbons. Based on the subjective visual examination of data, a Visual Discard method was applied and was found to be particularly successful for blends containing MCC stored at ambient and low humidity. However the Visual Discard method of spectra cleaning is subjective and therefore a non-subjective method capable of screening for erroneous probe readings was developed. For this data set a Trimmed Mean method was applied to set a limit on how data is cleaned from the data set allowing for the removal of a faulty probe reading (25% of data) or a poor sample (33% of data). The 33% Trimmed Mean reduced the impact of spectral variation or misreads between samples or probes and was found to be as successful as the Visual Discard method at cleaning the data set prior to development of the calibration equation. en
dc.description.sponsorship Science Foundation Ireland (Grant number 12/RC/2275; Investigator Award 12/IA/1683); Enterprise Ireland/IDA Ireland (Tc 2013-0015: Pharmaceutical Manufacturing Technology Centre, Ireland) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Elsevier Ltd en
dc.rights © 2017, European Federation for Pharmaceutical Sciences (EUFEPS). Published by Elsevier B.V. This manuscript version is made available under the CC-BY-NC-ND 4.0 license. en
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/ en
dc.subject Near-infrared spectroscopy en
dc.subject NIRS en
dc.subject Roller compaction en
dc.subject Process analytical technology en
dc.subject PAT en
dc.subject Ribbon en
dc.subject Envelop density en
dc.subject Dry granulation en
dc.title Near-infrared monitoring of roller compacted ribbon density: investigating sources of variation contributing to noisy spectral data en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Abina Crean, School Of Pharmacy, University College Cork, Cork, Ireland. +353-21-490-3000 Email: a.crean@ucc.ie en
dc.internal.availability Full text available en
dc.check.info Access to this article is restricted until 12 months after publication by request of the publisher. en
dc.check.date 2018-02-16
dc.date.updated 2017-08-18T11:19:29Z
dc.description.version Accepted Version en
dc.internal.rssid 383927416
dc.contributor.funder Science Foundation Ireland en
dc.contributor.funder Enterprise Ireland en
dc.contributor.funder IDA Ireland en
dc.description.status Peer reviewed en
dc.identifier.journaltitle European Journal of Pharmaceutical Sciences en
dc.internal.copyrightchecked Yes en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress a.crean@ucc.ie en


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© 2017, European Federation for Pharmaceutical Sciences (EUFEPS). Published by Elsevier B.V. This manuscript version is made available under the CC-BY-NC-ND 4.0 license. Except where otherwise noted, this item's license is described as © 2017, European Federation for Pharmaceutical Sciences (EUFEPS). Published by Elsevier B.V. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.
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