Please use this identifier to cite or link to this item: https://doi.org/10.1016/j.ijpharm.2010.06.011
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dc.titleIn-line quantification of micronized drug and excipients in tablets by near infrared (NIR) spectroscopy: Real time monitoring of tabletting process
dc.contributor.authorKarande, A.D.
dc.contributor.authorHeng, P.W.S.
dc.contributor.authorLiew, C.V.
dc.date.accessioned2014-10-29T01:54:29Z
dc.date.available2014-10-29T01:54:29Z
dc.date.issued2010-08
dc.identifier.citationKarande, A.D., Heng, P.W.S., Liew, C.V. (2010-08). In-line quantification of micronized drug and excipients in tablets by near infrared (NIR) spectroscopy: Real time monitoring of tabletting process. International Journal of Pharmaceutics 396 (1-2) : 63-74. ScholarBank@NUS Repository. https://doi.org/10.1016/j.ijpharm.2010.06.011
dc.identifier.issn03785173
dc.identifier.urihttp://scholarbank.nus.edu.sg/handle/10635/106066
dc.description.abstractThe objectives of this study were to assess the utility of near infrared (NIR) spectroscopy for simultaneous in-line quantification of the contents of drug and excipients in tablets and to monitor the tabletting process in real time. Direct compression tablet formulations comprising micronized chlorpheniramine maleate, lactose, microcrystalline cellulose and magnesium stearate were used. A custom built NIR setup was used for in-line spectral acquisition (980-1900. nm with 1. nm resolution) during the tabletting process. Calibration models using dynamic spectral acquisition were prepared and validated using design of experiment approach. During tabletting, stratified sampling of tablets was also carried out to compare the NIR prediction results and subsequent UV analysis results for drug content. The results obtained with calibration and validation statistics confirmed the accuracy of models used to predict contents of tablet components. Stratified sampling results for drug content did not exhibit any significant statistical variation. However, in-line quantification enabled the content analysis of individual tablets in the production batch and detection of content uniformity problems towards the end of the tabletting process. Furthermore, it provided the assurance of in-process content uniformity monitoring of the individual excipients during the tabletting process. © 2010 Elsevier B.V.
dc.description.urihttp://libproxy1.nus.edu.sg/login?url=http://dx.doi.org/10.1016/j.ijpharm.2010.06.011
dc.sourceScopus
dc.subjectContent uniformity
dc.subjectContinuous quality monitoring
dc.subjectIn-line sampling
dc.subjectNear infrared (NIR) spectroscopy
dc.subjectStratified sampling
dc.subjectTabletting
dc.typeArticle
dc.contributor.departmentPHARMACY
dc.description.doi10.1016/j.ijpharm.2010.06.011
dc.description.sourcetitleInternational Journal of Pharmaceutics
dc.description.volume396
dc.description.issue1-2
dc.description.page63-74
dc.description.codenIJPHD
dc.identifier.isiut000280936000009
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