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Original Articles

Quality by Design in the Secondary Drying Step of a Freeze-Drying Process

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Pages 1307-1316 | Published online: 17 Aug 2012

REFERENCES

  • Franks , F. Freeze-drying of Pharmaceuticals and Biopharmaceuticals ; Royal Society of Chemistry : Cambridge , 2007 .
  • Matejtschuk , P. ; Malik , K. ; Duru , C. ; Bristow , A. Freeze drying of biologicals: Process development to ensure biostability . American Pharmaceutical Review 2009 , 12 , 54 – 58 .
  • Rathore , A.S. ; Winkle , H. Quality by design for biopharmaceuticals . Nature Biotechnology 2009 , 27 , 26 – 34 .
  • Liapis , A.I. ; Pikal , M.J. ; Bruttini , R. Research and development needs and opportunities in freeze drying . Drying Technology 1996 , 14 , 1265 – 1300 .
  • Sadikoglu , H. ; Ozdemir , M. ; Seker , M. Freeze-drying of pharmaceutical products: Research and development needs . Drying Technology 2006 , 24 , 849 – 861 .
  • Tang , X.C. ; Pikal , M.J. Design of freeze-drying processes for pharmaceuticals: Practical advice . Pharmaceutical Research 2004 , 21 , 191 – 200 .
  • Tang , X.C. ; Nail , S.L. ; Pikal , M.J. Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer . Pharmaceutical Research 2005 , 22 , 685 – 700 .
  • Gieseler , H. ; Kramer , T. ; Pikal , M.J. Use of manometric temperature measurement (MTM) and SMART™ freeze dryer technology for development of an optimized freeze-drying cycle . Journal of Pharmaceutical Sciences 2007 , 96 , 3402 – 3418 .
  • Barresi , A.A. ; Velardi , S.A. ; Pisano , R. ; Rasetto , V. ; Vallan , A. ; Galan , M. In-line control of the lyophilization process: A gentle PAT approach using software sensors . International Journal of Refrigeration 2009 , 32 , 1003 – 1014 .
  • Fissore , D. ; Pisano , R. ; Rasetto , V. ; Marchisio , D.L. ; Barresi , A.A. ; Vallan , A. ; Corbellini , S. Applying Process Analytical Technology (PAT) to lyophilization processes . Chimica Oggi-Chemistry Today 2009 , 27 (2, Supplement), vii-xi.
  • Barresi , A.A. ; Pisano , R. ; Rasetto , V. ; Fissore , D. ; Marchisio , D.L. Model-based monitoring and control of industrial freeze-drying processes: Effect of batch non-uniformity . Drying Technology 2010 , 28 , 577 – 590 .
  • Fissore , D. ; Pisano , R. ; Velardi , S.A. ; Barresi , A.A. ; Galan , M. PAT tools for the optimization of the freeze-drying process . Pharmaceutical Engineering 2010 , 29 , 58 – 70 .
  • Pisano , R. ; Fissore , D. ; Velardi , S.A. ; Barresi , A.A. In-line optimization and control of an industrial freeze-drying process for pharmaceuticals . Journal of Pharmaceutical Sciences 2010 , 99 , 4691 – 4709 .
  • Daraoui , N. ; Dufour , P. ; Hammouri , H. ; Hottot , A. Model predictive control during the primary drying stage of lyophilisation . Control Engineering Practice 2010 , 18 , 483 – 494 .
  • Pisano , R. ; Fissore , D. ; Barresi , A.A. Freeze-drying cycle optimization using Model Predictive Control techniques . Industrial Engineering Chemistry Research 2011 , 50 , 7363 – 7379 .
  • Lombraña , J.I. ; De Elvira , C. ; Villaran , M.C. ; Izcara , J. Simulation and design of heating profiles in heat controlled freeze-drying of pharmaceuticals in vials by the application of a sublimation semispherical model . Drying Technology 1993 , 11 , 471 – 487 .
  • Lombraña , J.I. ; De Elvira , C. ; Villaran , M.C. ; Izcara , J.. Simulation and design of heating profiles in heat controlled freeze-drying of pharmaceuticals in vials by the application of a sublimation cylindrical model . Drying Technology 1003 , 11 , 85 – 102 .
  • Sadikoglu , H. ; Liapis , A.I. Mathematical modelling of the primary and secondary drying stages of bulk solution freeze-drying in trays: Parameter estimation and model discrimination by comparison of theoretical results with experimental data . Drying Technology 1997 , 15 , 791 – 810 .
  • Gan , K.H. ; Crosser , O.K. ; Liapis , A.I. ; Bruttini , R. Lyophilisation in vials on trays: Effects of tray side . Drying Technology 2005 , 23 , 341 – 363 .
  • Hottot , A. ; Peczalski , R. ; Vessot , S. ; Andrieu , J. Freeze-drying of pharmaceutical proteins in vials: Modeling of freezing and sublimation steps . Drying Technology 2006 , 24 , 561 – 570 .
  • Velardi , S.A. ; Barresi , A.A. Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions . Chemical Engineering Research and Design 2008 , 86 , 9 – 22 .
  • Brülls , M. ; Rasmuson , A. Ice sublimation in vial lyophilization . Drying Technology 2009 , 27 , 695 – 706 .
  • Sundaram , J. ; Hsu , C.C. ; Shay , Y.M. ; Sane , S.U. Design space development for lyophilization using DOE and process modeling . BioPharm International 2010 , 23 , 26 – 36 .
  • Giordano , A. ; Barresi , A.A. ; Fissore , D. On the use of mathematical models to build the design space for the primary drying phase of a pharmaceutical lyophilization process . Journal of Pharmaceutical Sciences 2011 , 100 , 311 – 324 .
  • Koganti , V.R. ; Shalaev , E.Y. ; Berry , M.R. ; Osterberg , T. ; Youssef , M. ; Hiebert , D.N. ; Kanka , F.A. ; Nolan , M. ; Barrett , R. ; Scalzo , G. ; Fitzpatrick , G. ; Fitzgibbon , N. ; Luthra , S. ; Zhang , L. Investigation of design space for freeze-drying: Use of modeling for primary drying segment of a freeze-drying cycle . AAPS PharmSciTech 2011 , 12 , 854 – 861 .
  • Fissore , D. ; Pisano , R. ; Barresi , A.A. Advanced approach to build the design space for the primary drying of a pharmaceutical freeze-drying process . Journal of Pharmaceutical Sciences 2011 , 100 , 4922 – 4933 .
  • Pikal , M.J. ; Shah , S. ; Roy , M.L. ; Putman , R. The secondary drying stage of freeze drying: Drying kinetics as a function of temperature and pressure. International Journal of Pharmaceutics 1980, 60, 203–217.
  • Pikal , M.J. ; Lang , J.E. Rubber closures as a source of haze in freeze-dried parenterals: Test methodology for closure evaluation . Journal of Parenteral Drug Association 1978 , 32 , 162 – 173 .
  • Last , I.R. ; Prebble , K.A. Suitability of near-infrared methods for the determination of moisture in a freeze-dried injection product containing different amounts of the active ingredient . Journal of Pharmaceutical and Biomedical Analysis 1993 , 2 , 1071 – 1076 .
  • Pikal , M.J. ; Tang , X.C. ; Nail , S.L. Automated Process Control Using Manometric Temperature Measurement. U. S. patent US 6971187 B1, 2005.
  • Mayeresse , Y. Moisture content in freeze-dried product. Cambridge Healthtech Institute's Seventh Annual Pep Talk 2008, San Diego, California, January 7–11, 2008.
  • Pikal , M.J. Heat and mass transfer in low pressure gases: Applications to freeze-drying . In Transport Processes in Pharmaceutical Systems ; Amidon , G.L. , Lee , P.I. , Topp , E.M. , Eds.; Marcel Dekker : New York , 2000 ; 611 – 686 .
  • Pisano , R. ; Fissore , D. ; Barresi , A.A. Heat transfer in freeze-drying apparatus . In Heat Transfer - Book 1 ; dos Santos Bernardes , M.A. , Ed.; InTech - Open Access Publisher : Rijeka , 2011 ; 91 – 114 .
  • Liapis , A.I. ; Bruttini , R. A theory for the primary and secondary drying stages of the freeze-drying of pharmaceutical crystalline and amorphous solutes: Comparison between experimental data and theory . Separation Technology 1994 , 4 , 144 – 155 .
  • Liapis , A.I. ; Bruttini , R. Freeze-drying of pharmaceutical crystalline and amorphous solutes in vials: Dynamic multidimensional models of the primary and secondary drying stages and qualitative features of the moving interface . Drying Technology 1995 , 13 , 43 – 72 .
  • Pikal , M.J. Freeze drying . In Encyclopedia of Pharmaceutical Technology ; Swarbrick , J. , Ed.; Informa Healthcare : New York , 2006 ; 1807 – 1833 .
  • Kessler , W.J. ; Davis , S.J. ; Mulhall , P.A. ; Finson , M.L. System for Monitoring a Drying Process. United States Patent No. 0208191 A1, 2006.
  • Gieseler , H. ; Kessler , W.J. ; Finson , M. ; Davis , S.J. ; Mulhall , P.A. ; Bons , V. ; Debo , D.J. ; Pikal , M.J. Evaluation of Tunable Diode Laser Absorption Spectroscopy for in-process water vapor mass flux measurement during freeze drying . Journal of Pharmaceutical Sciences 2007 , 96 , 1776 – 1793 .
  • Kuu , W.Y. ; Nail , S.L. ; Sacha , G. Rapid determination of vial heat transfer parameters using tunable diode laser absorption spectroscopy (TDLAS) in response to step-changes in pressure set-point during freeze-drying . Journal of Pharmaceutical Sciences 2009 , 98 , 1136 – 1154 .
  • Milton , N. ; Pikal , M.J. ; Roy , M.L. ; Nail , S.L. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilisation . PDA Journal of Pharmaceutical Science and Technology 1997 , 5 , 7 – 16 .
  • Liapis , A.I. ; Sadikoglu , H. Dynamic pressure rise in the drying chamber as a remote sensing method for monitoring the temperature of the product during the primary drying stage of freeze-drying . Drying Technology 1998 , 16 , 1153 – 1171 .
  • Chouvenc , P. ; Vessot , S. ; Andrieu , J. ; Vacus , P. Optimization of the freeze-drying cycle: a new model for pressure rise analysis . Drying Technology 2004 , 22 , 1577 – 1601 .
  • Velardi , S.A. ; Rasetto , V. ; Barresi , A.A. Dynamic parameters estimation method: Advanced manometric temperature measurement approach for freeze-drying monitoring of pharmaceutical . Industrial Engineering Chemistry Research 2008 , 47 , 8445 – 8457 .
  • Fissore , D. ; Pisano , R. ; Barresi , A.A. On the methods based on the Pressure Rise Test for monitoring a freeze-drying process . Drying Technology 2011 , 29 , 73 – 90 .
  • Fissore , D. ; Pisano , R. ; Barresi , A.A. Monitoring of the secondary drying in freeze-drying of pharmaceuticals . Journal of Pharmaceutical Sciences 2011 , 100 , 732 – 742 .
  • Fissore , D. ; Barresi , A.A. ; Pisano , R. Method for Monitoring the Secondary Drying in a Freeze-drying Process. European patent EP 2148158 (B1), 2011.
  • Hancock , B.C. ; Zografi , G. The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids . Pharmaceutical Research 1994 , 11 , 471 – 477 .
  • Barresi , A.A. ; Pisano , R. ; Fissore , D. ; Rasetto , V. ; Velardi , S.A. ; Vallan , A. ; Parvis , M. ; Galan , M. Monitoring of the primary drying of a lyophilization process in vials . Chemical Engineering and Processing 2009 , 48 , 408 – 423 .
  • Patel , S.M. ; Doen , T. ; Pikal , M.J. Determination of end point of primary drying in freeze-drying process control . AAPS PharmSciTech 2010 , 11 , 73 – 84 .

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