A Model-Based Framework to Optimize Pharmaceuticals Freeze Drying

REFERENCES

• Barresi , A.A. ; Ghio , S. ; Fissore , D. ; Pisano , R. Freeze drying of pharmaceutical excipients close to collapse temperature: Influence of the process conditions on process time and product quality . Drying Technology 2009 , 27 , 805 – 816 .
   Web of Science ®Google Scholar
• Barresi , A.A. Overcoming common lyophilization scale-up issues . Pharmaceutical Technology Europe 2011 , 23 , 29 .
   Google Scholar
• Fissore , D. ; Barresi , A.A. Scale-up and process transfer of freeze-drying recipes . Drying Technology 2009 , 29 , 1673 – 1684 .
   Web of Science ®Google Scholar
• Trappler , H.E. Freeze drying, scale-up considerations . In Encyclopedia of Pharmaceutical Technology ; Swarbrick , J. , Ed.; Informa Healthcare : New York , 2006 ; 1834 – 1849 .
   Google Scholar
• US Food and Drug Administration. PAT Guidance for Industry—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance; US FDA: Rockville, MD, 2004 .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• Pisano , R. ; Fissore , D. ; Barresi , A.A. Freeze-drying cycle optimization using model predictive control techniques . Industrial Engineering Chemistry Research 2011 , 50 , 7363 – 7379 .
   Web of Science ®Google Scholar
• Fissore , D. ; Velardi , S.A. ; Barresi , A.A. In-line control of a freeze-drying process in vial . Drying Technology 2008 , 26 , 685 – 694 .
   Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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.
   Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• Pisano , R. ; Fissore , D. ; Barresi , A.A. Heat transfer in freeze-drying apparatus . In Heat Transfer—Book 1 ; dos Santos Bernardes , M.A. , Ed.; InTechOpen : Rijeka , Croatia , 2011 ; 91 – 114 .
   Google Scholar
• 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 .
   Google Scholar
• Goff , J.A. ; Gratch , S. Low-pressure properties of water from −160 to 212°F . Transactions of the American Society of Venting Engineering 1946 , 52 , 95 – 122 .
   Google Scholar
• Wagner , W. ; Saul , A. ; Pruss , A. International equations for the pressure along the melting and along the sublimation curve of ordinary water substance . Journal of Physical and Chemical Reference Data 1994 , 23 , 515 – 525 .
   Web of Science ®Google Scholar
• Marti , J. ; Mauersberger , K. A survey and new measurements of ice vapor pressure at temperatures between 170 and 250 K . Geophysical Research Letters 1993 , 20 , 363 – 366 .
   Web of Science ®Google Scholar
• Kast , W. ; Hohenthanner , C.R. Mass transfer within the gas phase of porous media . International Journal of Heat and Mass Transfer 2000 , 43 , 807 – 823 .
   Web of Science ®Google Scholar
• Pikal , M.J. Use of laboratory data in freeze drying process design: Heat and mass transfer coefficients and the computer simulation of freeze drying . Journal of Parenteral Science & Technology 1985 , 39 , 115 – 139 .
   PubMedGoogle Scholar
• Pikal , M.J. ; Roy , M.L. ; Shah , S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial . Journal of Pharmaceutical Sciences 1984 , 73 , 1224 – 1237 .
   PubMed Web of Science ®Google Scholar
• Kessler , W.J. ; Davis , S.J. ; Mulhall , P.A. ; Finson , M.L. System for Monitoring a Drying Process. U.S. Patent No. 0208191 A1, 2006.
   Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Google Scholar
• 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 .
   Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• Pisano , R. ; Fissore , D. ; Barresi , A.A. Innovation in monitoring food freeze-drying . Drying Technology 2011 , 29 , 1920 – 1931 .
   Web of Science ®Google Scholar
• Corbellini , S. ; Parvis , M. ; Vallan , A. In-process temperature mapping system for industrial freeze dryers . IEEE Transactions on Instrumentation and Measurement 2010 , 59 , 1134 – 1140 .
   Web of Science ®Google Scholar
• Rambhatla , S. ; Ramot , R. ; Bhugra , C. ; Pikal , M.J. Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling. AAPS PharmSciTech 2004, 5, Art. 58.
   Google Scholar
• Vallan , A. A Measurement system for lyophilization process monitoring. In Instrumentation and Measurement Technology Conference—IMTC 2007, Warsaw, Poland, May 1–3, 2007.
   Google Scholar
• Fissore , D. ; Pisano , R. ; Barresi , A.A. A model-based framework to get quality-by-design in freeze-drying of pharmaceuticals. In Proceedings of Freeze Drying of Pharmaceuticals and Biologicals Conference, Garmisch-Partenkirchen, Germany, September 28–October 1, 2010; 460–493.
   Google Scholar
• 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 .
   Web of Science ®Google Scholar
• 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 .
   PubMed Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar
• Velardi , S.A. ; Hammouri , H. ; Barresi , A.A. In-line monitoring of the primary drying phase of the freeze-drying process in vial by means of a Kalman filter based observer . Chemical Engineering Research & Design 2009 , 87 , 1409 – 1019 .
   Web of Science ®Google Scholar
• Velardi , S.A. ; Hammouri , H. ; Barresi , A.A. Development of a high gain observer for in-line monitoring of sublimation in vial freeze-drying . Drying Technology 2010 , 28 , 256 – 268 .
   Web of Science ®Google Scholar
• Bosca , S. ; Fissore , D. Design and validation of an innovative soft-sensor for pharmaceuticals freeze-drying monitoring . Chemical Engineering Science 2011 , 66 , 5127 – 5136 .
   Web of Science ®Google Scholar
• 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 .
   Web of Science ®Google Scholar