The Critical Role Of Nir Spectroscopy And Statistical Process Control (spc) Strategy Towards Captopril Tablets (25 Mg) Manufacturing Process Understanding: A Case Study

dc.creatorDal Curtivo
dc.creatorCatia Panizzon; Funghi
dc.creatorNathalia Bitencourt; Tavares
dc.creatorGuilherme Diniz; Barbosa
dc.creatorSavio Fujita; Loebenberg
dc.creatorRaimar; Bou-Chacra
dc.creatorNadia Araci
dc.date2015-MAY
dc.date2016-06-07T13:17:22Z
dc.date2016-06-07T13:17:22Z
dc.date.accessioned2018-03-29T01:37:55Z
dc.date.available2018-03-29T01:37:55Z
dc.identifier
dc.identifierThe Critical Role Of Nir Spectroscopy And Statistical Process Control (spc) Strategy Towards Captopril Tablets (25 Mg) Manufacturing Process Understanding: A Case Study. Informa Healthcare, v. 20, p. 345-351 MAY-2015.
dc.identifier1083-7450
dc.identifierWOS:000352705300012
dc.identifier10.3109/10837450.2013.867448
dc.identifierhttp://www.tandfonline.com/doi/abs/10.3109/10837450.2013.867448?journalCode=iphd20#.Vyt8F9IrLcc
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/242305
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1306003
dc.descriptionIn this work, near-infrared spectroscopy (NIRS) method was used to evaluate the uniformity of dosage units of three captopril 25mg tablets commercial batches. The performance of the calibration method was assessed by determination of Q value (0.9986), standard error of estimation (C-set SEE = 1.956), standard error of prediction (V-set SEP = 2.076) as well as the consistency (106.1%). These results indicated the adequacy of the selected model. The method validation revealed the agreement of the reference high pressure liquid chromatography (HPLC) and NIRS methods. The process evaluation using the NIRS method showed that the variability was due to common causes and delivered predictable results consistently. Cp and Cpk values were, respectively, 2.05 and 1.80. These results revealed a non-centered process in relation to the average target (100% w/w), in the specified range (85-115%). The probability of failure was 21:100 million tablets of captopril. The NIRS in combination with the method of multivariate calibration, partial least squares (PLS) regression, allowed the development of methodology for the uniformity of dosage units evaluation of captopril tablets 25 mg. The statistical process control strategy associated with NIRS method as PAT played a critical role in understanding of the sources and degree of variation and its impact on the process. This approach led towards a better process understanding and provided the sound scientific basis for its continuous improvement.
dc.description20
dc.description3
dc.description
dc.description345
dc.description351
dc.descriptionpharmaceutical industry Prati-Donaduzzi
dc.description
dc.description
dc.description
dc.languageen
dc.publisherINFORMA HEALTHCARE
dc.publisher
dc.publisherLONDON
dc.relationPHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY
dc.rightsembargo
dc.sourceWOS
dc.subjectNear-infrared Spectroscopy
dc.subjectValidation
dc.subjectMonitor
dc.subjectPowder
dc.subjectPart
dc.titleThe Critical Role Of Nir Spectroscopy And Statistical Process Control (spc) Strategy Towards Captopril Tablets (25 Mg) Manufacturing Process Understanding: A Case Study
dc.typeArtículos de revistas


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