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Volumn 438, Issue 1-2, 2012, Pages 307-326

An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction

Author keywords

Continuous processing; Pharmaceutical; Process control; Roller compactor; Simulation

Indexed keywords

ARTICLE; CHEMICAL COMPOSITION; CONTROL STRATEGY; CONTROL SYSTEM; DISSOLUTION; DRUG MANUFACTURE; FLOW RATE; PARTICLE SIZE; PHARMACEUTICAL ENGINEERING; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUALITY CONTROL; TABLET COMPRESSION; TABLET FORMULATION; WEIGHT;

EID: 84867403382     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2012.09.009     Document Type: Article
Times cited : (106)

References (45)
  • 2
    • 0042344952 scopus 로고    scopus 로고
    • Batch and continuous processing in the production of pharmaceutical granules
    • G. Betz, P. Junker-Burgin, and H. Leuenberger Batch and continuous processing in the production of pharmaceutical granules Pharm. Dev. Technol. 8 3 2003 289 297
    • (2003) Pharm. Dev. Technol. , vol.8 , Issue.3 , pp. 289-297
    • Betz, G.1    Junker-Burgin, P.2    Leuenberger, H.3
  • 3
    • 30744467703 scopus 로고    scopus 로고
    • Content uniformity and tablet hardness testing of intact pharmaceutical tablets by near infrared spectroscopy: A contribution to process analytical technologies
    • M. Blanco, and M. Alcalá Content uniformity and tablet hardness testing of intact pharmaceutical tablets by near infrared spectroscopy: a contribution to process analytical technologies Anal. Chim. Acta 557 2006 353 359
    • (2006) Anal. Chim. Acta , vol.557 , pp. 353-359
    • Blanco, M.1    Alcalá, M.2
  • 4
    • 84861574281 scopus 로고    scopus 로고
    • An integrated approach for dynamic flowsheet modeling and sensitivity analysis of a continuous tablet manufacturing process: An integrated approach
    • doi:10.1016/j.compchemeng.2012.02.015 in press
    • Boukouvala, F., Niotis, V., Ramachandran, R., Muzzio, F., Ierapetritou, M. An integrated approach for dynamic flowsheet modeling and sensitivity analysis of a continuous tablet manufacturing process: an integrated approach. Comput. Chem. Eng., in press, http://dx.doi.org/10.1016/j.compchemeng.2012.02. 015.
    • Comput. Chem. Eng.
    • Boukouvala, F.1    Niotis, V.2    Ramachandran, R.3    Muzzio, F.4    Ierapetritou, M.5
  • 6
    • 77958151627 scopus 로고    scopus 로고
    • Future manufacturing approaches in the chemical and pharmaceutical industry
    • S. Buchholz Future manufacturing approaches in the chemical and pharmaceutical industry Chem. Eng. Process 49 2010 993 995
    • (2010) Chem. Eng. Process , vol.49 , pp. 993-995
    • Buchholz, S.1
  • 7
    • 84856524155 scopus 로고    scopus 로고
    • Quality by design approach for formulation development: A case study of dispersible tablets
    • N.A. Charoo, A.A.A. Shamsher, A.S. Zidan, and Z. Rahman Quality by design approach for formulation development: A case study of dispersible tablets Int. J. Pharm. 423 2012 167 178
    • (2012) Int. J. Pharm. , vol.423 , pp. 167-178
    • Charoo, N.A.1    Shamsher, A.A.A.2    Zidan, A.S.3    Rahman, Z.4
  • 9
    • 84875575730 scopus 로고    scopus 로고
    • FDA/CDER U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 19 June 2012
    • FDA/CDER, 2005. OPS process analytical technology - (PAT) initiative, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 19 June 2012. http://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm088828.htm.
    • (2005) OPS Process Analytical Technology - (PAT) Initiative
  • 10
    • 35348960542 scopus 로고    scopus 로고
    • Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control
    • S. Gnoth, M. Jenzsch, R. Simutis, and A. Lübbert Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control J. Biotechnol. 132 2 2007 180 186
    • (2007) J. Biotechnol. , vol.132 , Issue.2 , pp. 180-186
    • Gnoth, S.1    Jenzsch, M.2    Simutis, R.3    Lübbert, A.4
  • 11
    • 77954651347 scopus 로고    scopus 로고
    • Modeling and control of roller compaction for pharmaceutical manufacturing. Part I: Process dynamics and control framework
    • S. Hsu, G.V. Reklaitis, and V. Venkatasubramanian Modeling and control of roller compaction for pharmaceutical manufacturing. Part I: Process dynamics and control framework J. Pharm. Innov. 5 2010 14 23
    • (2010) J. Pharm. Innov. , vol.5 , pp. 14-23
    • Hsu, S.1    Reklaitis, G.V.2    Venkatasubramanian, V.3
  • 12
    • 77954659415 scopus 로고    scopus 로고
    • Modeling and control of roller compaction for pharmaceutical manufacturing. Part II: Control and system design
    • S. Hsu, G.V. Reklaitis, and V. Venkatasubramanian Modeling and control of roller compaction for pharmaceutical manufacturing. Part II: Control and system design J. Pharm. Innov. 5 2010 24 36
    • (2010) J. Pharm. Innov. , vol.5 , pp. 24-36
    • Hsu, S.1    Reklaitis, G.V.2    Venkatasubramanian, V.3
  • 13
    • 0036703616 scopus 로고    scopus 로고
    • An intelligent measurement system for powder flowrate measurement in pneumatic conveying system
    • Z. Huang, B. Wang, and H. Li An intelligent measurement system for powder flowrate measurement in pneumatic conveying system IEEE Trans. Instrum. Meas. 51 4 2002 700 703
    • (2002) IEEE Trans. Instrum. Meas. , vol.51 , Issue.4 , pp. 700-703
    • Huang, Z.1    Wang, B.2    Li, H.3
  • 14
    • 0015004777 scopus 로고
    • Some considerations on powder compression equations
    • K. Kawakita, and K.H. Ludde Some considerations on powder compression equations Powder Technol. 4 1971 61 68
    • (1971) Powder Technol. , vol.4 , pp. 61-68
    • Kawakita, K.1    Ludde, K.H.2
  • 15
    • 79956193954 scopus 로고    scopus 로고
    • Microstructure-based mathematical modelling and spectroscopic imaging of tablet dissolution
    • J.A. Kimber, S.G. Kazarian, and F. Stepánek Microstructure-based mathematical modelling and spectroscopic imaging of tablet dissolution Comput. Chem. Eng. 35 2011 1328 1339
    • (2011) Comput. Chem. Eng. , vol.35 , pp. 1328-1339
    • Kimber, J.A.1    Kazarian, S.G.2    Stepánek, F.3
  • 16
    • 0034699242 scopus 로고    scopus 로고
    • A new model for the hardness of a compacted particle system, applied to tablets of pharmaceutical polymers
    • M. Kuentz, and H. Leuenberger A new model for the hardness of a compacted particle system, applied to tablets of pharmaceutical polymers Powder Technol. 111 2000 143 145
    • (2000) Powder Technol. , vol.111 , pp. 143-145
    • Kuentz, M.1    Leuenberger, H.2
  • 17
    • 78649782930 scopus 로고    scopus 로고
    • Production of pharmaceuticals: Amines from alcohols in a continuous flow fixed bed catalytic reactor
    • G.W. Lamb, F.A. Al Badran, J.M.J. Williams, and S.T. Kolaczkowski Production of pharmaceuticals: Amines from alcohols in a continuous flow fixed bed catalytic reactor Chem. Eng. Res. Des. 88 2010 1533 1540
    • (2010) Chem. Eng. Res. Des. , vol.88 , pp. 1533-1540
    • Lamb, G.W.1    Al Badran, F.A.2    Williams, J.M.J.3    Kolaczkowski, S.T.4
  • 18
    • 33745266376 scopus 로고    scopus 로고
    • The microreactor a systematic and efficient tool for the transition from batch to continuous process?
    • S. Lomel, L. Falk, J.M. Commenge, J.L. Houzelot, and K. Ramdani The microreactor a systematic and efficient tool for the transition from batch to continuous process? Chem. Eng. Res. Des. 84 A5 2006 363 369
    • (2006) Chem. Eng. Res. Des. , vol.84 , Issue.A5 , pp. 363-369
    • Lomel, S.1    Falk, L.2    Commenge, J.M.3    Houzelot, J.L.4    Ramdani, K.5
  • 19
    • 78649763666 scopus 로고    scopus 로고
    • Pharmaceutical processing - Batch or a continuous process: A choice
    • G. Malhotra Pharmaceutical processing - batch or a continuous process: a choice Pharm. Process. 2009 16 17
    • (2009) Pharm. Process. , pp. 16-17
    • Malhotra, G.1
  • 20
    • 58949093775 scopus 로고    scopus 로고
    • Bicomponent aggregation with composition dependent rates and the approach to well-mixed state
    • T. Matsoukas, T. Kim, and K. Lee Bicomponent aggregation with composition dependent rates and the approach to well-mixed state Chem. Eng. Sci. 64 4 2009 787 799
    • (2009) Chem. Eng. Sci. , vol.64 , Issue.4 , pp. 787-799
    • Matsoukas, T.1    Kim, T.2    Lee, K.3
  • 21
    • 22744441634 scopus 로고    scopus 로고
    • Continuous processing in the pharmaceutical industry: Changing the mind set
    • K. Plumb Continuous processing in the pharmaceutical industry: Changing the mind set Chem. Eng. Res. Des. 83 A6 2005 730 738
    • (2005) Chem. Eng. Res. Des. , vol.83 , Issue.A6 , pp. 730-738
    • Plumb, K.1
  • 22
    • 77957333768 scopus 로고    scopus 로고
    • Investigation of the effect of impeller rotation rate, powder flow rate, and cohesion on powder flow behavior in a continuous blender using PEPT
    • P.M. Portillo, A. Vanarase, A. Ingram, J.K. Seville, M.G. Ierapetritou, and F.J. Muzzio Investigation of the effect of impeller rotation rate, powder flow rate, and cohesion on powder flow behavior in a continuous blender using PEPT Chem. Eng. Sci. 65 2010 5658 5668
    • (2010) Chem. Eng. Sci. , vol.65 , pp. 5658-5668
    • Portillo, P.M.1    Vanarase, A.2    Ingram, A.3    Seville, J.K.4    Ierapetritou, M.G.5    Muzzio, F.J.6
  • 24
    • 84864513951 scopus 로고    scopus 로고
    • Model-based design and control of continuous drum granulation processes
    • R. Ramachandran, and A. Chaudhury Model-based design and control of continuous drum granulation processes Chem. Eng. Res. Des. 90 8 2012 1063 1073
    • (2012) Chem. Eng. Res. Des. , vol.90 , Issue.8 , pp. 1063-1073
    • Ramachandran, R.1    Chaudhury, A.2
  • 25
    • 84856256385 scopus 로고    scopus 로고
    • Model-based control loop performance assessment of a continuous direct compaction pharmaceutical processes
    • R. Ramachandran, J. Arjunan, A. Chaudhury, and M. Ierapetritou Model-based control loop performance assessment of a continuous direct compaction pharmaceutical processes J. Pharm. Innov. 6 3 2012 249 263
    • (2012) J. Pharm. Innov. , vol.6 , Issue.3 , pp. 249-263
    • Ramachandran, R.1    Arjunan, J.2    Chaudhury, A.3    Ierapetritou, M.4
  • 26
    • 23244449133 scopus 로고    scopus 로고
    • Characterizing process effects on pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging
    • Y. Roggo, N. Jent, A. Edmond, P. Chalus, and M. Ulmschneider Characterizing process effects on pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging Eur. J. Pharm. Biopharm. 61 2005 100 110
    • (2005) Eur. J. Pharm. Biopharm. , vol.61 , pp. 100-110
    • Roggo, Y.1    Jent, N.2    Edmond, A.3    Chalus, P.4    Ulmschneider, M.5
  • 27
    • 21444450169 scopus 로고    scopus 로고
    • The use of a continuous flow-reactor employing a mixed hydrogen flow stream for the efficient reduction of imines to amines
    • S. Saaby, K.R. Knudsen, M. Ladlow, and S.V. Ley The use of a continuous flow-reactor employing a mixed hydrogen flow stream for the efficient reduction of imines to amines Chem. Commun. 2005 2909 2911
    • (2005) Chem. Commun. , pp. 2909-2911
    • Saaby, S.1    Knudsen, K.R.2    Ladlow, M.3    Ley, S.V.4
  • 30
    • 65949102989 scopus 로고    scopus 로고
    • An efficient and transition metal free protocol for the transfer hydrogenation of ketones as a continuous flow process
    • J. Sedelmeier, S.V. Ley, and I.R. Baxendale An efficient and transition metal free protocol for the transfer hydrogenation of ketones as a continuous flow process Green Chem. 11 2009 683 685
    • (2009) Green Chem. , vol.11 , pp. 683-685
    • Sedelmeier, J.1    Ley, S.V.2    Baxendale, I.R.3
  • 31
    • 84870484299 scopus 로고    scopus 로고
    • A multi-dimensional population balance model approach to continuous powder mixing processes
    • doi:10.1016/j.apt2012.02.001 in press
    • Sen, M., Ramachandran, R. A multi-dimensional population balance model approach to continuous powder mixing processes. Adv. Powder Technol., in press, http://dx.doi.org/10.1016/j.apt2012.02.001.
    • Adv. Powder Technol.
    • Sen, M.1    Ramachandran, R.2
  • 32
    • 84863855475 scopus 로고    scopus 로고
    • Multi-dimensional population balance modeling and experimental validation of continuous powder mixing processes
    • M. Sen, R. Singh, A. Vanarase, J. John, and R. Ramachandran Multi-dimensional population balance modeling and experimental validation of continuous powder mixing processes Chem. Eng. Sci. 80 2012 349 360
    • (2012) Chem. Eng. Sci. , vol.80 , pp. 349-360
    • Sen, M.1    Singh, R.2    Vanarase, A.3    John, J.4    Ramachandran, R.5
  • 35
    • 56949093864 scopus 로고    scopus 로고
    • Model-based computer-aided framework for design of process monitoring and analysis systems
    • R. Singh, K.V. Gernaey, and R. Gani Model-based computer-aided framework for design of process monitoring and analysis systems Comput. Chem. Eng. 33 1 2009 22 42
    • (2009) Comput. Chem. Eng. , vol.33 , Issue.1 , pp. 22-42
    • Singh, R.1    Gernaey, K.V.2    Gani, R.3
  • 36
    • 77954864065 scopus 로고    scopus 로고
    • ICAS-PAT: A software for design, analysis & validation of PAT systems
    • R. Singh, K.V. Gernaey, and R. Gani ICAS-PAT: a software for design, analysis & validation of PAT systems Comput. Chem. Eng. 34 7 2010 1108 1136
    • (2010) Comput. Chem. Eng. , vol.34 , Issue.7 , pp. 1108-1136
    • Singh, R.1    Gernaey, K.V.2    Gani, R.3
  • 37
    • 77954864289 scopus 로고    scopus 로고
    • An ontological knowledge based system for selection of process monitoring and analysis tools
    • R. Singh, K.V. Gernaey, and R. Gani An ontological knowledge based system for selection of process monitoring and analysis tools Comput. Chem. Eng. 34 7 2010 1137 1154
    • (2010) Comput. Chem. Eng. , vol.34 , Issue.7 , pp. 1137-1154
    • Singh, R.1    Gernaey, K.V.2    Gani, R.3
  • 38
    • 34250426642 scopus 로고
    • A method of measuring powder flow rates
    • 10.1007/BF00791750
    • L.M. Sorokin, and A.B. Gugnyak A method of measuring powder flow rates Powder Metall. Met. Ceram. 12 12 1973 1015 1016 10.1007/BF00791750
    • (1973) Powder Metall. Met. Ceram. , vol.12 , Issue.12 , pp. 1015-1016
    • Sorokin, L.M.1    Gugnyak, A.B.2
  • 39
    • 0037191516 scopus 로고    scopus 로고
    • Alternative multiphase reactors for fine chemicals: A world beyond stirred tanks?
    • E.H. Stitt Alternative multiphase reactors for fine chemicals: a world beyond stirred tanks? Chem. Eng. J. 90 2002 47 60
    • (2002) Chem. Eng. J. , vol.90 , pp. 47-60
    • Stitt, E.H.1
  • 40
    • 84875617085 scopus 로고    scopus 로고
    • Next-wave model
    • 19 June 2012
    • Trout, B.L., 2007. Next-wave model. World Pharmaceutical Frontiers, 19 June 2012. http://www.worldpharmaceuticals.net/editorials/015-march09/WPF015- nextwave.pdf.
    • (2007) World Pharmaceutical Frontiers
    • Trout, B.L.1
  • 41
    • 77957344308 scopus 로고    scopus 로고
    • Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy
    • A. Vanarase, M. Alcal, J. Rozo, F. Muzzio, and R. Romaach Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy Chem. Eng. Sci. 65 21 2010 5728 5733
    • (2010) Chem. Eng. Sci. , vol.65 , Issue.21 , pp. 5728-5733
    • Vanarase, A.1    Alcal, M.2    Rozo, J.3    Muzzio, F.4    Romaach, R.5
  • 42
    • 79951675848 scopus 로고    scopus 로고
    • Effect of operating conditions and design parameters in a continuous powder mixer
    • A. Vanarase, and F.J. Muzzio Effect of operating conditions and design parameters in a continuous powder mixer Powder Technol. 208 2011 26 36
    • (2011) Powder Technol. , vol.208 , pp. 26-36
    • Vanarase, A.1    Muzzio, F.J.2
  • 43
    • 78650692565 scopus 로고    scopus 로고
    • Characterizing continuous powder mixing using residence time distribution
    • A. Vanarase, Y. Gao, F.J. Muzzio, and M.G. Ierapetritou Characterizing continuous powder mixing using residence time distribution Chem. Eng. Sci. 66 3 2011 417 425
    • (2011) Chem. Eng. Sci. , vol.66 , Issue.3 , pp. 417-425
    • Vanarase, A.1    Gao, Y.2    Muzzio, F.J.3    Ierapetritou, M.G.4
  • 44
    • 0037704669 scopus 로고    scopus 로고
    • Continuous flow reactors for drug discovery
    • P. Watts, and S.J. Haswell Continuous flow reactors for drug discovery Drug Discov. Today 8 13 2003 586 593
    • (2003) Drug Discov. Today , vol.8 , Issue.13 , pp. 586-593
    • Watts, P.1    Haswell, S.J.2


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