Implementation of a fully integrated CM direct compression and coating process at a commercial pharmaceutical facility - Part 2: PAT and RTD results for normal operational conditions batches.

[1]  M. Metzger,et al.  Development and Use of a Residence Time Distribution (RTD) Model Control Strategy for a Continuous Manufacturing Drug Product Pharmaceutical Process , 2022, Pharmaceutics.

[2]  J. Wahlich Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms , 2021, Pharmaceutics.

[3]  Robert Meyer,et al.  A very boring 120 h: 15 million tablets under a continuous state of control , 2021 .

[4]  V. Vanhoorne,et al.  Recent progress in continuous manufacturing of oral solid dosage forms. , 2020, International journal of pharmaceutics.

[5]  Indrajeetsinh K. Yadav,et al.  Mapping key process parameters to the performance of a continuous dry powder blender in a continuous direct compression system , 2020 .

[6]  R. T. Haslam,et al.  Why We Need Continuous Pharmaceutical Manufacturing and How to Make it Happen: A Summary of Thoughts from the International Symposium on Continuous Manufacturing. , 2019, Journal of pharmaceutical sciences.

[7]  V. Vanhoorne,et al.  Evaluation of an in-line NIR spectroscopic method for the determination of the residence time in a tablet press. , 2019, International journal of pharmaceutics.

[8]  Rafael Méndez,et al.  Assessment of blend uniformity in a continuous tablet manufacturing process , 2019, International journal of pharmaceutics.

[9]  Victoria Pauli,et al.  Process analytical technology for continuous manufacturing tableting processing: A case study , 2019, Journal of pharmaceutical and biomedical analysis.

[10]  Eric Ziemons,et al.  Development and validation of an in‐line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press , 2018, Journal of pharmaceutical and biomedical analysis.

[11]  Jenny M. Vargas,et al.  Process analytical technology in continuous manufacturing of a commercial pharmaceutical product. , 2018, International journal of pharmaceutics.

[12]  Salvador García-Muñoz,et al.  A flowsheet model for the development of a continuous process for pharmaceutical tablets: An industrial perspective , 2018 .

[13]  Debasis Mallik,et al.  Process Analytical Tools for Flow Analysis: A Perspective , 2017, Journal of Flow Chemistry.

[14]  Bernhardt L Trout,et al.  Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals. , 2017, Journal of pharmaceutical sciences.

[15]  C Vervaet,et al.  Development of a continuous direct compression platform for low-dose drug products. , 2017, International journal of pharmaceutics.

[16]  Karthik Nagapudi,et al.  Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products. , 2017, Journal of pharmaceutical sciences.

[17]  C Vervaet,et al.  Continuous direct compression as manufacturing platform for sustained release tablets. , 2017, International journal of pharmaceutics.

[18]  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.

[19]  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.

[20]  Fernando J. Muzzio,et al.  Development of a methodology to estimate error in the on-line measurements of blend uniformity in a continuous powder mixing process , 2013 .

[21]  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.

[22]  Aditya U. Vanarase,et al.  Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy , 2010 .

[23]  Stefan Andersson-Engels,et al.  Time-Resolved NIR/Vis Spectroscopy for Analysis of Solids: Pharmaceutical Tablets , 2002 .

[24]  J. Fricke,et al.  Effective Sample Size in Diffuse Reflectance Near-IR Spectrometry. , 1999, Analytical chemistry.

[25]  P. K. Aldridge,et al.  Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part I. System development and control. , 1996, Journal of pharmaceutical and biomedical analysis.

[26]  P. K. Aldridge,et al.  On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. , 1996, Analytical chemistry.

[27]  Lloyd S. Nelson,et al.  Column: Technical Aids: The Shewhart Control Chart--Tests for Special Causes , 1984 .

[28]  A. T. McKay,et al.  Distribution of the Coefficient of Variation and the Extended “T” Distribution , 1932 .