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Research Article

Utility of Multivariate Analysis in Modeling the Effects of Raw Material Properties and Operating Parameters on Granule and Ribbon Properties Prepared in Roller Compaction

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Pages 1022-1035 | Published online: 05 Nov 2008

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Read on this site (9)

Valentyn Mohylyuk. (2022) Effect of roll compaction pressure on the properties of high drug-loaded piracetam granules and tablets. Drug Development and Industrial Pharmacy 48:9, pages 425-437.
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Marcel Prikeržnik & Stanko Srčič. (2021) Multivariate analysis for optimization and validation of the industrial tablet-manufacturing process. Drug Development and Industrial Pharmacy 47:1, pages 61-71.
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M. Razuc, A. Grafia, L. Gallo, M. V. Ramírez-Rigo & R. J. Romañach. (2019) Near-infrared spectroscopic applications in pharmaceutical particle technology. Drug Development and Industrial Pharmacy 45:10, pages 1565-1589.
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Tim Wenzel, Cordula Stillhart, Peter Kleinebudde & Anikó Szepes. (2017) Influence of drug load on dissolution behavior of tablets containing a poorly water-soluble drug: estimation of the percolation threshold. Drug Development and Industrial Pharmacy 43:8, pages 1265-1275.
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Fei Sun, Bing Xu, Yi Zhang, Shengyun Dai, Chan Yang, Xianglong Cui, Xinyuan Shi & Yanjiang Qiao. (2016) Statistical modeling methods to analyze the impacts of multiunit process variability on critical quality attributes of Chinese herbal medicine tablets. Drug Design, Development and Therapy 10, pages 3909-3924.
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Nathan Boersen, David Belair, Garnet E. Peck & Rodolfo Pinal. (2016) A dimensionless variable for the scale up and transfer of a roller compaction formulation. Drug Development and Industrial Pharmacy 42:1, pages 60-69.
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Nathan Boersen, M. Teresa Carvajal, Kenneth R. Morris, Garnet E. Peck & Rodolfo Pinal. (2015) The influence of API concentration on the roller compaction process: modeling and prediction of the post compacted ribbon, granule and tablet properties using multivariate data analysis. Drug Development and Industrial Pharmacy 41:9, pages 1470-1478.
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Ivana M. Savic, Katarina Nikolic, Goran Nikolic, Ivan Savic, Danica Agbaba & Milorad Cakic. (2013) Application of mathematical modeling for the development and optimization formulation with bioactive copper complex. Drug Development and Industrial Pharmacy 39:7, pages 1084-1090.
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Niklas Sandler & Robert Frank Lammens. (2011) Pneumatic dry granulation: potential to improve roller compaction technology in drug manufacture. Expert Opinion on Drug Delivery 8:2, pages 225-236.
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Articles from other publishers (28)

Kalyan V. Vasudevan, Yu Elaine Pu, Hossein Amini, Catherine Guarino, Anjali Agrawal & Ilgaz Akseli. (2022) Using a Model-based Material Sparing Approach for Formulation and Process Development of a Roller Compacted Drug Product. Pharmaceutical Research 39:9, pages 2083-2093.
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Guolin Shi, Longfei Lin, Yuling Liu, Gongsen Chen, Yuting Luo, Yanqiu Wu & Hui Li. (2021) Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets. RSC Advances 11:14, pages 8323-8345.
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Aleša Dular Vovko & Franc Vrečer. (2020) Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing. Acta Pharmaceutica 70:4, pages 443-463.
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Jiaqi Yu, Bing Xu, Kunfeng Zhang, Chenfeng Shi, Zhiqiang Zhang, Jing Fu & Yanjiang Qiao. (2019) Using a Material Library to Understand the Impacts of Raw Material Properties on Ribbon Quality in Roll Compaction. Pharmaceutics 11:12, pages 662.
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Olívia da S. Domingos, Bianca G. V. Alcântara, Mário F. C. Santos, Tatiane C. S. Maiolini, Danielle F. Dias, João L. Baldim, João Henrique G. Lago, Marisi G. Soares & Daniela A. Chagas-Paula. (2019) Anti-Inflammatory Derivatives with Dual Mechanism of Action from the Metabolomic Screening of Poincianella pluviosa. Molecules 24:23, pages 4375.
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Howard J. Stamato & Omar L. Sprockel. 2019. Chemical Engineering in the Pharmaceutical Industry. Chemical Engineering in the Pharmaceutical Industry 81 118 .
Euichaul Oh, Uijung Kim, Beom-Jin Lee & Cheol Moon. (2019) Multivariate Statistical Optimization of Tablet Formulations Incorporating High Doses of a Dry Herbal Extract. Pharmaceutics 11:2, pages 79.
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Ana Patricia Ferreira, John F. Gamble, Michael M. Leane, Hyunsoo Park, Dolapo Olusanmi & Mike Tobyn. (2018) Enhanced Understanding of Pharmaceutical Materials Through Advanced Characterisation and Analysis. AAPS PharmSciTech 19:8, pages 3462-3480.
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Ana Pérez Gago, Gavin Reynolds & Peter Kleinebudde. (2018) Impact of roll compactor scale on ribbon density. Powder Technology 337, pages 92-103.
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F. Stauffer, V. Vanhoorne, G. Pilcer, P-F. Chavez, S. Rome, M.A. Schubert, L. Aerts & T. De Beer. (2018) Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing. European Journal of Pharmaceutics and Biopharmaceutics 127, pages 92-103.
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Ana Patricia Ferreira, Clare Frances Rawlinson-Malone, John Gamble, Sarah Nicholson & Mike Tobyn. 2018. Multivariate Analysis in the Pharmaceutical Industry. Multivariate Analysis in the Pharmaceutical Industry 235 267 .
Per Holm, Morten Allesø, Mette C. Bryder & René Holm. 2017. ICH Quality Guidelines. ICH Quality Guidelines 535 577 .
Nabil Souihi, Gavin Reynolds, Pirjo Tajarobi, Håkan Wikström, Gunnar Haeffler, Mats Josefson & Johan Trygg. (2015) Roll compaction process modeling: Transfer between equipment and impact of process parameters. International Journal of Pharmaceutics 484:1-2, pages 192-206.
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Margot Fonteyne, Ana Correia, Sofie De Plecker, Jurgen Vercruysse, Ilija Ilić, Qi Zhou, Chris Vervaet, Jean Paul Remon, Fernanda Onofre, Vincent Bulone & Thomas De Beer. (2015) Impact of microcrystalline cellulose material attributes: A case study on continuous twin screw granulation. International Journal of Pharmaceutics 478:2, pages 705-717.
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Margot Fonteyne, Henrika Wickström, Elisabeth Peeters, Jurgen Vercruysse, Henrik Ehlers, Björn-Hendrik Peters, Jean Paul Remon, Chris Vervaet, Jarkko Ketolainen, Niklas Sandler, Jukka Rantanen, Kaisa Naelapää & Thomas De Beer. (2014) Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets. European Journal of Pharmaceutics and Biopharmaceutics 87:2, pages 252-263.
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Emanuele Tomba, Massimiliano Barolo & Salvador García-Muñoz. (2014) In-silico product formulation design through latent variable model inversion. Chemical Engineering Research and Design 92:3, pages 534-544.
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Emanuele Tomba, Pierantonio Facco, Fabrizio Bezzo & Massimiliano Barolo. (2013) Latent variable modeling to assist the implementation of Quality-by-Design paradigms in pharmaceutical development and manufacturing: A review. International Journal of Pharmaceutics 457:1, pages 283-297.
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Nabil Souihi, Mats Josefson, Pirjo Tajarobi, Bindhu Gururajan & Johan Trygg. (2013) Design Space Estimation of the Roller Compaction Process. Industrial & Engineering Chemistry Research 52:35, pages 12408-12419.
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Pham V. Quyet, Asim K. Samanta, Celine V. Liew, Lai W. Chan & Paul W.S. Heng. (2013) A Prediction Model for Monitoring Ribbed Roller Compacted Ribbons. Journal of Pharmaceutical Sciences 102:8, pages 2667-2678.
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Fani Boukouvala & Marianthi G. Ierapetritou. (2013) Surrogate-Based Optimization of Expensive Flowsheet Modeling for Continuous Pharmaceutical Manufacturing. Journal of Pharmaceutical Innovation 8:2, pages 131-145.
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Nabil Souihi, Melanie Dumarey, Håkan Wikström, Pirjo Tajarobi, Magnus Fransson, Olof Svensson, Mats Josefson & Johan Trygg. (2013) A quality by design approach to investigate the effect of mannitol and dicalcium phosphate qualities on roll compaction. International Journal of Pharmaceutics 447:1-2, pages 47-61.
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Asim Kumar Samanta, Atul D. Karande, Ka Yun Ng & Paul Wan Sia Heng. (2012) Application of Near-Infrared Spectroscopy in Real-Time Monitoring of Product Attributes of Ribbed Roller Compacted Flakes. AAPS PharmSciTech 14:1, pages 86-100.
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Emanuele Tomba, Marialuisa De Martin, Pierantonio Facco, John Robertson, Simeone Zomer, Fabrizio Bezzo & Massimiliano Barolo. (2013) General procedure to aid the development of continuous pharmaceutical processes using multivariate statistical modeling – An industrial case study. International Journal of Pharmaceutics 444:1-2, pages 25-39.
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Fani Boukouvala, Vasilios Niotis, Rohit Ramachandran, Fernando J. Muzzio & Marianthi G. Ierapetritou. (2012) An integrated approach for dynamic flowsheet modeling and sensitivity analysis of a continuous tablet manufacturing process. Computers & Chemical Engineering 42, pages 30-47.
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Mark A. Polizzi & Salvador García-Muñoz. (2011) A framework for in-silico formulation design using multivariate latent variable regression methods. International Journal of Pharmaceutics 418:2, pages 235-242.
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Zheng Liu, Mark-John Bruwer, John F. MacGregor, Samarth S. S. Rathore, David E. Reed & Marc J. Champagne. (2011) Scale-up of a Pharmaceutical Roller Compaction Process Using a Joint-Y Partial Least Squares Model. Industrial & Engineering Chemistry Research 50:18, pages 10696-10706.
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Omar L. Sprockel & Howard J. Stamato. 2010. Chemical Engineering in the Pharmaceutical Industry. Chemical Engineering in the Pharmaceutical Industry 727 755 .
Josephine L. P. Soh, Nathan Boersen, M. Teresa Carvajal, Kenneth R. Morris, Garnet E. Peck & Rodolfo Pinal. (2007) Importance of Raw Material Attributes for Modeling Ribbon and Granule Properties in Roller Compaction: Multivariate Analysis on Roll Gap and NIR Spectral Slope as Process Critical Control Parameters. Journal of Pharmaceutical Innovation 2:3-4, pages 106-124.
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