Computer-Aided Framework for the Design of Freeze-Drying Cycles: Optimization of the Operating Conditions of the Primary Drying Stage
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[1] J. Andrieu,et al. Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products. , 2005, PDA journal of pharmaceutical science and technology.
[2] Hassan Hammouri,et al. In-line monitoring of the primary drying phase of the freeze-drying process in vial by means of a Kalman filter based observer , 2009 .
[3] Marcus Karel,et al. Loss of structure in freeze-dried carbohydrates solutions: effect of temperature, moisture content and composition , 1976 .
[4] G D Adams,et al. Some implications of structural collapse during freeze-drying using Erwinia caratovora L-asparaginase as a model. , 1993, Journal of chemical technology and biotechnology.
[5] M. Pikal,et al. Use of laboratory data in freeze drying process design: heat and mass transfer coefficients and the computer simulation of freeze drying. , 1985, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.
[6] Thomas A. Jennings,et al. Lyophilization: Introduction and Basic Principles , 1999 .
[7] Sumit Luthra,et al. Investigation of Design Space for Freeze-Drying: Use of Modeling for Primary Drying Segment of a Freeze-Drying Cycle , 2011, AAPS PharmSciTech.
[8] Davide Fissore,et al. Fast freeze-drying cycle design and optimization using a PAT based on the measurement of product temperature. , 2013, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[9] Lisa M. Hardwick,et al. Product mass transfer resistance directly determined during freeze-drying cycle runs using tunable diode laser absorption spectroscopy (TDLAS) and pore diffusion model. , 2011, Pharmaceutical development and technology.
[10] Davide Fissore,et al. Design and validation of an innovative soft-sensor for pharmaceuticals freeze-drying monitoring , 2011 .
[11] Steven L Nail,et al. 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. , 2009, Journal of pharmaceutical sciences.
[12] Antonello Barresi,et al. Dynamic Parameters Estimation Method: Advanced Manometric Temperature Measurement Approach for Freeze-Drying Monitoring of Pharmaceutical Solutions , 2008 .
[13] Hasan Sadikoglu,et al. 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 , 1998 .
[14] S L Nail,et al. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. , 1997, PDA journal of pharmaceutical science and technology.
[15] Davide Fissore,et al. Innovation in Monitoring Food Freeze Drying , 2011 .
[16] Michael J. Pikal,et al. Freeze‐Drying of Proteins. Process, Formulation, and Stability. , 1995 .
[17] Davide Fissore,et al. On the Methods Based on the Pressure Rise Test for Monitoring a Freeze-Drying Process , 2010 .
[18] Julien Andrieu,et al. Freeze-Drying of Pharmaceutical Proteins in Vials: Modeling of Freezing and Sublimation Steps , 2006 .
[19] Davide Fissore,et al. Freeze Drying of Pharmaceutical Excipients Close to Collapse Temperature: Influence of the Process Conditions on Process Time and Product Quality , 2009 .
[20] A. I. Liapis,et al. Research and Development Needs and Opportunities in Freeze Drying , 1996 .
[21] Antonello Barresi,et al. Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions , 2008 .
[22] Davide Fissore,et al. On the use of mathematical models to build the design space for the primary drying phase of a pharmaceutical lyophilization process. , 2011, Journal of pharmaceutical sciences.
[23] Davide Fissore,et al. Quality by design: optimization of a freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of the freezing protocol , 2013, Pharmaceutical development and technology.
[24] J. Mellor,et al. Fundamentals of Freeze-Drying , 1978 .
[25] Steven L. Nail,et al. Effect of Collapse on the Stability of Freeze-Dried Recombinant Factor VIII and α-amylase , 2004 .
[26] F Franks,et al. Freeze-drying of bioproducts: putting principles into practice. , 1998, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[27] Davide Fissore,et al. Freeze-Drying Monitoring Using a New Process Analytical Technology: Toward a “Zero Defect” Process , 2013 .
[28] Stanley E. Charm,et al. Freeze Drying , 1964 .
[29] Anika Ashok,et al. ICH Harmonised Tripartite Guideline , 2009 .
[30] R. Bruttini,et al. Lyophilization in Vials on Trays: Effects of Tray Side , 2005 .
[31] Davide Fissore,et al. Use of soft sensors to monitor a pharmaceuticals freeze-drying process in vials , 2014, Pharmaceutical development and technology.
[32] J. Abraham. The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .
[33] Chung C. Hsu,et al. Lyophilization of protein formulations in vials: investigation of the relationship between resistance to vapor flow during primary drying and small-scale product collapse. , 1999, Journal of pharmaceutical sciences.
[34] Steven J Davis,et al. Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying. , 2007, Journal of pharmaceutical sciences.
[35] Michael J. Pikal,et al. The collapse temperature in freeze drying: Dependence on measurement methodology and rate of water removal from the glassy phase , 1990 .
[36] Davide Fissore,et al. Use of a soft sensor for the fast estimation of dried cake resistance during a freeze-drying cycle. , 2013, International journal of pharmaceutics.
[37] C. J. King,et al. Freeze-drying of aqueous solutions: Maximum allowable operating temperature. , 1972, Cryobiology.
[38] Hassan Hammouri,et al. Development of a High Gain Observer for In-Line Monitoring of Sublimation in Vial Freeze Drying , 2010 .
[39] N. Ho,et al. Lyophilization of pharmaceutical injections: theoretical physical model. , 1979, Journal of pharmaceutical sciences.
[40] Hasan Sadikoglu,et al. 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 , 1997 .
[41] Julien Andrieu,et al. Optimization of the Freeze-Drying Cycle: A New Model for Pressure Rise Analysis , 2004 .
[42] Felix Franks,et al. Freeze-drying of Pharmaceuticals and Biopharmaceuticals , 2007 .
[43] Davide Fissore,et al. Advanced approach to build the design space for the primary drying of a pharmaceutical freeze-drying process. , 2011, Journal of pharmaceutical sciences.
[44] Hasan Sadikoglu,et al. Freeze-Drying of Pharmaceutical Products: Research and Development Needs , 2006 .