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Original Articles

Modeling, experimental trials, and design space determination for the GEA ConsiGma™ coater

, , &
Pages 475-485 | Received 12 Sep 2017, Accepted 28 Mar 2018, Published online: 08 May 2018

References

  • Teżyk, M.; Milanowski, B.; Ernst, A.; Lulek, J. Recent Progress in Continuous and Semi-Continuous Processing of Solid Oral Dosage Forms: A Review. Drug Dev. Ind. Pharm. 2015, 42, 1–60. DOI: 10.3109/03639045.2015.1122607.
  • Ojakavo, P. Continuous Tablet Film Coating: Technology Landscape and Developing a Commercial Continuous Coating Process. 50th Arden House AAPS Conference, Baltimore, USA, March 15, 2015.
  • Agrawal, A. M.; Pandey, P. Scale Up of Pan Coating Process using Quality by Design Principles. J. Pharm. Sci. 2015, 104(11), 3589–3611. DOI: 10.1002/jps.24582.
  • Lyngberg, O.; Bijnens, L.; Geens, J.; Marchut, A.; Mehrman, S.; Schafer, E. Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing. In Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture, Methods in Pharmacology and Toxicology, pp. 1-42. Chapter 1. Ierapetritou, M., Ramachandran, R., Eds.; Humana Press: New York, 2016.
  • Page, S.; Baumann, K.-H.; Kleinebudde, P. Mathematical Modeling of an Aqueous Film Coating Process in a Bohle Lab-Coater. Part 1: Development of the Model. AAPS PharmSci.-Tech. 2006, 7, E79–E86. DOI: 10.1208/pt070242.
  • Page, S.; Baumann, K.-H.; Kleinebudde, P. Mathematical Modeling of an Aqueous Film Coating Process in a Bohle Lab-Coater. Part 2: Application of the Model. AAPS PharmSci.-Tech. 2006, 7, E87–E94. DOI: 10.1208/pt070243.
  • Chen, W.; Chang, S. Y.; Kiang, S.; Marchut, A.; Lyngberg, O.; Wang, J.; Rao, V.; Desai, D.; Stamato, H.; Early, W. Modeling of Pan Coating Processes: Prediction of Tablet Content Uniformity and Determination of Critical Process Parameters. J. Pharm. Sci. 2010, 99, 3213–3225. DOI: 10.1002/jps.22044.
  • Aliseda, A.; Hopfinger, E.; Lasheras, J. C.; Kremer, D.; Berchielli, A.; Connolly, E. Atomization of Viscous and Non-Newtonian Liquids by a Coaxial, High-Speed Gas Jet. Experiments and Droplet Size Modeling. Int. J. Multiphase Flow 2008, 34, 161–175. DOI: 10.1016/j.ijmultiphaseflow.2007.09.003.
  • Mansour, A.; Chigier, N. Air-Blast Atomization of Non-Newtonian Liquids. J. Non-Newtonian Fluid Mech. 1995, 58(2–3), 161–194. DOI: 10.1016/0377-0257(95)01356-z.
  • Thybo, P.; Hovgaard, L.; Andersen, S. K.; Lindeløv, J. S. Droplet Size Measurements for Spray Dryer Scale-Up. Pharm. Dev. Technol. 2008, 13(2), 93–104. DOI: 10.1080/10837450701830957.
  • Kemp, I. C.; Hartwig, T.; Herdman, R.; Hamilton, P.; Bisten, A.; Bermingham, S. Spray Drying with a Two-Fluid Nozzle to Produce Fine Particles; Atomisation, Scale-Up and Modelling. Drying Technol. 2016, 34(10), 1243–1252. DOI: 10.1080/07373937.2015.1103748 (Original paper presented at IDS’14, Lyon, August 2014).
  • Ebey, G. C. A Thermodynamic Model for Aqueous Tablet Film Coating. Pharm. Technol. 1987, 11(4), 40–50.
  • Am Ende, M. T.; Berchielli, A. A Thermodynamic Model for Organic and Aqueous Tablet Film Coating. Pharm. Dev. Technol. 2005, 10(1), 47–58. DOI: 10.1081/PDT-35915.
  • Uzi, A.; Ostrovski, Y.; Levy, A. Modeling and Simulation of Mono-Layer Coating. Drying Technol. 2015, 33(15–16), 1798–1807. DOI: 10.1080/07373937.2015.1026981.
  • Rieck, C.; Bück, A.; Tsotsas, E. Monte Carlo Modeling of Fluidized Bed Coating and Layering Processes. AIChE J. 2016, 62, 2670–2680. DOI: 10.1002/aic.15237.
  • Kemp, I. C.; Sohet, Q. Scale-up, Optimization and Control of Industrial Batch Fluidized Bed Dryers using Multilevel Theoretical Models. Drying Technol. 2010, 28(5), 710–722. DOI: 10.1080/07373931003799285 (also in Proceedings of 16th IDS, 9–12 November 2008, Hyderabad, India, Vol. B, pp. 714–721).
  • Groenewold, H.; Tsotsas, E. Drying in Fluidized Beds with Immersed Heating Elements. Chem. Eng. Sci. 2007, 62, 481–502. DOI: 10.1016/j.ces.2006.09.017.
  • Perry, R. H.; Green, D. W. (Eds.). Perry’s Chemical Engineers Handbook, 8th ed.; Chapter 5, Heat and Mass Transfer. McGrawHill: New York, 2007.
  • British Standard BS1339. Humidity and Dewpoint. Part 2; Calculation Functions British Standards Institution: Gunnersbury, London, UK, 2007.
  • Colorcon. Colorcon Coating School, 2015—Course Notes; Course Repeated Regularly at Colorcon: Dartford, UK.
  • ICH Q8. ICH Harmonised Tripartite Guideline: Pharmaceutical Development, Q8(R2). ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), 2009. Published online by US Food and Drug Administration at www.fda.gov.
  • van den Ban, S.; Pitt, K. G.; Whiteman, M. Application of a tablet film coating model to define a process-imposed transition boundary for robust film coating. Pharm. Dev. Technol., 2018, 23(2), 176–182. DOI: 10.1080/10837450.2017.1384492.
  • Gu, L.; Liew, C.; Heng, P. Wet Spheronization by Rotary Processing—A Multistage Single-Pot Process for Producing Spheroids. Drug Dev. Ind. Pharm. 2004, 30, 111–123. DOI: 10.1081/ddc-120028706.

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