PAT Applications of NIR Spectroscopy in the Pharmaceutical Industry
暂无分享,去创建一个
Eric Ziemons | Philippe Hubert | Charlotte De Bleye | Pierre‐Yves Sacré | P. Hubert | É. Ziemons | P. Sacré | Charlotte De Bleye | C. D. Bleye
[1] Simon Gaisford,et al. 3D printed drug products: Non‐destructive dose verification using a rapid point‐and‐shoot approach , 2018, International journal of pharmaceutics.
[2] Dongsheng Bu,et al. Comparison of near infrared and microwave resonance sensors for at-line moisture determination in powders and tablets. , 2011, Analytica chimica acta.
[3] M. Blanco,et al. NIR analysis of pharmaceutical samples without reference data: improving the calibration. , 2011, Talanta.
[4] Tibor Casian,et al. Fluidised bed granulation of two APIs: QbD approach and development of a NIR in-line monitoring method , 2019, Asian journal of pharmaceutical sciences.
[5] Lawrence X. Yu. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control , 2008, Pharmaceutical Research.
[6] Marcelo Blanco,et al. Analysis of pharmaceuticals by NIR spectroscopy without a reference method , 2010 .
[7] Klemen Korasa,et al. Overview of PAT process analysers applicable in monitoring of film coating unit operations for manufacturing of solid oral dosage forms , 2018, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[8] Zhenqi Shi,et al. On-line monitoring of blend uniformity in continuous drug product manufacturing process--The impact of powder flow rate and the choice of spectrometer: Dispersive vs. FT. , 2016, Journal of pharmaceutical and biomedical analysis.
[9] Eric Sanchez,et al. Evaluation of Analytical and Sampling Errors in the Prediction of the Active Pharmaceutical Ingredient Concentration in Blends From a Continuous Manufacturing Process , 2017, Journal of Pharmaceutical Innovation.
[10] A L Pomerantsev,et al. Chemometric aided NIR portable instrument for rapid assessment of medicine quality. , 2016, Journal of pharmaceutical and biomedical analysis.
[11] Serena Vickers,et al. Field detection devices for screening the quality of medicines: a systematic review , 2018, BMJ Global Health.
[12] J. Drennen,et al. A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. , 2006, Journal of pharmaceutical sciences.
[13] Hengchang Zang,et al. Near-infrared spectroscopy monitoring and control of the fluidized bed granulation and coating processes-A review. , 2017, International journal of pharmaceutics.
[14] Attila Farkas,et al. Spectroscopic characterization of tablet properties in a continuous powder blending and tableting process , 2018, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[15] Adriluz Sánchez-Paternina,et al. Near infrared spectroscopic transmittance measurements for pharmaceutical powder mixtures. , 2016, Journal of pharmaceutical and biomedical analysis.
[16] Barbara Bakri,et al. Assessment of powder blend uniformity: Comparison of real-time NIR blend monitoring with stratified sampling in combination with HPLC and at-line NIR Chemical Imaging. , 2015, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[17] Jean Paul Remon,et al. Blend uniformity evaluation during continuous mixing in a twin screw granulator by in-line NIR using a moving F-test. , 2016, Analytica chimica acta.
[18] Brahma N. Singh. Product Development, Manufacturing, and Packaging of Solid Dosage Forms Under QbD and PAT Paradigm: DOE Case Studies for Industrial Applications , 2019, AAPS PharmSciTech.
[19] Kim H. Esbensen,et al. Representative process sampling — in practice: Variographic analysis and estimation of total sampling errors (TSE) , 2007 .
[20] Anh Q. Vo,et al. Application of FT-NIR Analysis for In-line and Real-Time Monitoring of Pharmaceutical Hot Melt Extrusion: a Technical Note , 2018, AAPS PharmSciTech.
[21] J. Palmer,et al. Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line , 2018, Journal of Pharmaceutical Innovation.
[22] Lawrence X. Yu,et al. The future of pharmaceutical quality and the path to get there. , 2017, International journal of pharmaceutics.
[23] Lan Sun,et al. Pharmaceutical Raw Material Identification Using Miniature Near-Infrared (MicroNIR) Spectroscopy and Supervised Pattern Recognition Using Support Vector Machine , 2016, Applied spectroscopy.
[24] B. Igne,et al. Development of an In-Line Near-Infrared Method for Blend Content Uniformity Assessment in a Tablet Feed Frame , 2019, Applied spectroscopy.
[25] P Kleinebudde,et al. A comparison of quality control methods for active coating processes. , 2012, International journal of pharmaceutics.
[26] A. Kelly,et al. A novel transflectance near infrared spectroscopy technique for monitoring hot melt extrusion. , 2015, International journal of pharmaceutics.
[27] Jenny M. Vargas,et al. Process analytical technology in continuous manufacturing of a commercial pharmaceutical product. , 2018, International journal of pharmaceutics.
[28] Klemen Korasa,et al. Applicability of near-infrared spectroscopy in the monitoring of film coating and curing process of the prolonged release coated pellets. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[29] R. Marini,et al. Comparing the qualitative performances of handheld NIR and Raman spectrophotometers for the detection of falsified pharmaceutical products. , 2019, Talanta.
[30] T. Tran,et al. An efficient, maintenance free and approved method for spectroscopic control and monitoring of blend uniformity: The moving F-test. , 2015, Journal of pharmaceutical and biomedical analysis.
[31] J Baronsky-Probst,et al. Process design and control of a twin screw hot melt extrusion for continuous pharmaceutical tamper-resistant tablet production. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[32] Simon Gaisford,et al. 3D printed medicines: A new branch of digital healthcare , 2018, International journal of pharmaceutics.
[33] S. Baumgartner,et al. Characterization of physicochemical properties of hydroxypropyl methylcellulose (HPMC) type 2208 and their influence on prolonged drug release from matrix tablets. , 2012, Journal of pharmaceutical and biomedical analysis.
[34] Hiroshi Nakagawa,et al. Operationalizing Maintenance of Calibration Models Based on Near-Infrared Spectroscopy by Knowledge Integration , 2015, Journal of Pharmaceutical Innovation.
[35] A. Kelly,et al. Monitoring ibuprofen-nicotinamide cocrystal formation during solvent free continuous cocrystallization (SFCC) using near infrared spectroscopy as a PAT tool. , 2012, International journal of pharmaceutics.
[36] Victoria Pauli,et al. Real-time monitoring of particle size distribution in a continuous granulation and drying process by near infrared spectroscopy. , 2019, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[37] Fernando J. Muzzio,et al. Sampling practices in powder blending , 1997 .
[38] M. Blanco,et al. Critical evaluation of methods for end-point determination in pharmaceutical blending processes , 2012 .
[39] Ravendra Singh,et al. PAT for pharmaceutical manufacturing process involving solid dosages forms , 2018 .
[40] Rafael Méndez,et al. Variographic analysis: A new methodology for quality assurance of pharmaceutical blending processes , 2019, Comput. Chem. Eng..
[41] Clémence Fauteux-Lefebvre,et al. Using multiple Process Analytical Technology probes to monitor multivitamin blends in a tableting feed frame. , 2017, Talanta.
[42] K. Esbensen,et al. Theory of sampling (TOS) - Fundamental definitions and concepts , 2015 .
[43] J. Drennen,et al. In-line monitoring and optimization of powder flow in a simulated continuous process using transmission near infrared spectroscopy. , 2017, International journal of pharmaceutics.
[44] S. Y. Wong,et al. On-demand continuous-flow production of pharmaceuticals in a compact, reconfigurable system , 2016, Science.
[45] P. K. Aldridge,et al. On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. , 1996, Analytical chemistry.
[46] Lawrence X. Yu,et al. Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production , 2015, Journal of Pharmaceutical Innovation.
[47] C Vervaet,et al. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. , 2011, International journal of pharmaceutics.
[48] James K. Drennen,et al. Development of NIR Methods for Blend Analysis Using Small Quantities of Materials , 2014, Journal of Pharmaceutical Innovation.
[49] Johan Bøtker,et al. Near-infrared chemical imaging (NIR-CI) of 3D printed pharmaceuticals. , 2016, International journal of pharmaceutics.
[50] Pierre-François Chavez,et al. Towards a real time release approach for manufacturing tablets using NIR spectroscopy. , 2014, Journal of pharmaceutical and biomedical analysis.
[51] Mikko Juuti,et al. In-line monitoring of the drug content of powder mixtures and tablets by near-infrared spectroscopy during the continuous direct compression tableting process. , 2013, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[52] James K Drennen,et al. A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity. , 2006, Journal of pharmaceutical sciences.
[53] Ravendra Singh,et al. Residence Time Distribution (RTD)-Based Control System for Continuous Pharmaceutical Manufacturing Process , 2018, Journal of Pharmaceutical Innovation.
[54] D. Bempong,et al. Substandard and falsified medicine screening technologies , 2019, AAPS Open.
[55] M. Melichar,et al. In‐line analysis of a fluid bed pellet coating process using a combination of near infrared and Raman spectroscopy , 2010 .
[56] G. K. Raju,et al. Understanding Pharmaceutical Quality by Design , 2014, The AAPS Journal.
[57] Eva Roblegg,et al. Inline monitoring and a PAT strategy for pharmaceutical hot melt extrusion. , 2013, International journal of pharmaceutics.
[58] A S Rathore,et al. Process analytical technology (PAT) for biopharmaceutical products , 2010, Analytical and bioanalytical chemistry.
[59] R. Gosselin,et al. Monitoring the concentration of flowing pharmaceutical powders in a tableting feed frame , 2017, Pharmaceutical development and technology.
[60] G. Reklaitis,et al. Perspectives on the continuous manufacturing of powder‐based pharmaceutical processes , 2016 .
[61] James K. Drennen,et al. Solid Dosage Form Analysis by near Infrared Spectroscopy: Comparison of Reflectance and Transmittance Measurements Including the Determination of Effective Sample Mass , 2002 .
[62] J. Khinast,et al. How to Measure Coating Thickness of Tablets: Method Comparison of Optical Coherence Tomography, Near-infrared Spectroscopy and Weight-, Height- and Diameter Gain. , 2019, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[63] William Engisch,et al. Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing , 2015, Journal of Pharmaceutical Innovation.
[64] L. Felton. Mechanisms of polymeric film formation. , 2013, International journal of pharmaceutics.
[65] Michel Baron,et al. Comparative static curing versus dynamic curing on tablet coating structures. , 2013, International journal of pharmaceutics.
[66] Gintaras V. Reklaitis,et al. Data reconciliation in the Quality‐by‐Design (QbD) implementation of pharmaceutical continuous tablet manufacturing , 2019, International journal of pharmaceutics.
[67] T Puchert,et al. A new PAT/QbD approach for the determination of blend homogeneity: combination of on-line NIRS analysis with PC Scores Distance Analysis (PC-SDA). , 2011, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[68] Xiaorong He,et al. Assessing powder segregation potential by near infrared (NIR) spectroscopy and correlating segregation tendency to tabletting performance , 2013 .
[69] Fernando J. Muzzio,et al. A review of the Residence Time Distribution (RTD) applications in solid unit operations , 2012 .
[70] Lan Zhang,et al. Application of quality by design in the current drug development , 2016, Asian journal of pharmaceutical sciences.
[71] Dörte Solle,et al. Spectroscopic sensors for in-line bioprocess monitoring in research and pharmaceutical industrial application , 2016, Analytical and Bioanalytical Chemistry.
[72] T. O'Connor,et al. Emerging Technology for Modernizing Pharmaceutical Production: Continuous Manufacturing , 2017 .
[73] Age K. Smilde,et al. Principal Component Analysis , 2003, Encyclopedia of Machine Learning.
[74] Rafael Méndez,et al. Assessment of blend uniformity in a continuous tablet manufacturing process , 2019, International journal of pharmaceutics.
[75] M. Jamrógiewicz. Application of the near-infrared spectroscopy in the pharmaceutical technology. , 2012, Journal of pharmaceutical and biomedical analysis.
[76] Zhenqi Shi,et al. Characterization of Near-Infrared and Raman Spectroscopy for In-Line Monitoring of a Low-Drug Load Formulation in a Continuous Manufacturing Process. , 2019, Analytical chemistry.
[77] Douglas Both,et al. Analytical Method Quality by Design for an On-Line Near-Infrared Method to Monitor Blend Potency and Uniformity , 2014, Journal of Pharmaceutical Innovation.
[78] Kim H. Esbensen,et al. Representative Sampling for reliable data analysis: Theory Of Sampling , 2005 .
[79] P. Kleinebudde,et al. PAT-tools for process control in pharmaceutical film coating applications. , 2013, International journal of pharmaceutics.
[80] C. Anderson,et al. Blending and Characterization of Pharmaceutical Powders , 2018 .
[81] Xinyuan Shi,et al. Monitoring of a pharmaceutical blending process using near infrared chemical imaging , 2012 .
[82] R. Romañach,et al. Near-infrared spectroscopic applications in pharmaceutical particle technology , 2019, Drug development and industrial pharmacy.
[83] R. Gosselin,et al. In-line monitoring of Ibuprofen during and after tablet compression using near-infrared spectroscopy. , 2019, Talanta.
[84] J. Rantanen,et al. The Future of Pharmaceutical Manufacturing Sciences , 2015, Journal of pharmaceutical sciences.
[85] A. Pomerantsev,et al. In-line prediction of drug release profiles for pH-sensitive coated pellets. , 2011, The Analyst.
[86] B. Igne,et al. Effect of Sampling Frequency for Real-Time Tablet Coating Monitoring Using Near Infrared Spectroscopy , 2016, Applied spectroscopy.
[87] Jérôme Mantanus,et al. Design space approach in the optimization of the spray-drying process. , 2012, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[88] Pierre Margot,et al. Profiling of counterfeit medicines by vibrational spectroscopy. , 2011, Forensic science international.
[89] M. Lamas,et al. New approaches to identification and characterization of tioconazole in raw material and in pharmaceutical dosage forms , 2018, Journal of pharmaceutical analysis.
[90] Reza Vatankhah Barenji,et al. Cyber-Physical-based PAT (CPbPAT) framework for Pharma 4.0. , 2019, International journal of pharmaceutics.
[91] Michel Baron,et al. Comprehensive study of dynamic curing effect on tablet coating structure. , 2012, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[92] Ingmar Nopens,et al. Moisture and drug solid-state monitoring during a continuous drying process using empirical and mass balance models. , 2014, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[93] Fernando J. Muzzio,et al. Advanced Control of Continuous Pharmaceutical Tablet Manufacturing Processes , 2016 .
[94] Eric Ziemons,et al. Vibrational spectroscopy in analysis of pharmaceuticals: Critical review of innovative portable and handheld NIR and Raman spectrophotometers , 2019, TrAC Trends in Analytical Chemistry.
[95] Qinglin Su,et al. A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing , 2019, Comput. Chem. Eng..
[96] Victoria Pauli,et al. Process analytical technology for continuous manufacturing tableting processing: A case study , 2019, Journal of pharmaceutical and biomedical analysis.
[97] Yleana M. Colon,et al. Assessment of Robustness for a Near-Infrared Concentration Model for Real-Time Release Testing in a Continuous Manufacturing Process , 2017, Journal of Pharmaceutical Innovation.
[98] T. De Beer,et al. In-line NIR spectroscopy for the understanding of polymer-drug interaction during pharmaceutical hot-melt extrusion. , 2012, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[99] R. Löbenberg,et al. The critical role of NIR spectroscopy and statistical process control (SPC) strategy towards captopril tablets (25 mg) manufacturing process understanding: a case study , 2015, Pharmaceutical development and technology.
[100] Martin Horn,et al. Optimized continuous pharmaceutical manufacturing via model-predictive control. , 2016, International journal of pharmaceutics.
[101] C. De Bleye,et al. Quantitation of active pharmaceutical ingredient through the packaging using Raman handheld spectrophotometers: A comparison study. , 2020, Talanta.
[102] Thomas De Beer,et al. Real-time assessment of critical quality attributes of a continuous granulation process , 2013, Pharmaceutical development and technology.
[103] Fabien Chauchard,et al. Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products , 2016, Analytical and Bioanalytical Chemistry.
[104] Hiroshi Nakagawa,et al. Verification of model development technique for NIR-based real-time monitoring of ingredient concentration during blending. , 2014, International journal of pharmaceutics.
[105] N. Scoutaris,et al. Implementation of transmission NIR as a PAT tool for monitoring drug transformation during HME processing. , 2015, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[106] Jérôme Mantanus,et al. Optimization of a pharmaceutical tablet formulation based on a design space approach and using vibrational spectroscopy as PAT tool. , 2015, International journal of pharmaceutics.
[107] T Puchert,et al. A novel in-line NIR spectroscopy application for the monitoring of tablet film coating in an industrial scale process. , 2012, Talanta.
[108] Michel Baron,et al. Development of a Process Analytical Technology (PAT) for in-line monitoring of film thickness and mass of coating materials during a pan coating operation. , 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[109] Richard A. Crocombe,et al. Portable Spectroscopy , 2018, Applied spectroscopy.
[110] Denita Winstead,et al. Measurement of drug agglomerates in powder blending simulation samples by near infrared chemical imaging. , 2008, International journal of pharmaceutics.
[111] R. Marini,et al. Development, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops. , 2015, Journal of pharmaceutical and biomedical analysis.
[112] Manabu Kano,et al. Estimation of active pharmaceutical ingredients content using locally weighted partial least squares and statistical wavelength selection. , 2011, International journal of pharmaceutics.
[113] M. Blanco,et al. Influence of physical factors on the accuracy of calibration models for NIR spectroscopy. , 2010, Journal of pharmaceutical and biomedical analysis.
[114] Martin Horn,et al. Control of three different continuous pharmaceutical manufacturing processes: Use of soft sensors , 2018, International journal of pharmaceutics.
[115] Carl A Anderson,et al. Characterization of pharmaceutical powder blends by NIR chemical imaging. , 2008, Journal of pharmaceutical sciences.
[116] Fernando Muzzio,et al. Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC). , 2016, International journal of pharmaceutics.
[117] P. Kleinebudde,et al. Continuous manufacturing process monitoring of pharmaceutical solid dosage form: A case study. , 2019, Journal of pharmaceutical and biomedical analysis.
[118] Charlotte Brenier,et al. Fighting falsified medicines: The analytical approach , 2017, Journal of pharmaceutical and biomedical analysis.