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Original Articles

Measuring and predicting pore size distribution of freeze-dried solutions

ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon
Pages 435-447 | Received 29 Aug 2017, Accepted 14 Jan 2018, Published online: 16 Feb 2018

References

  • Franks, F.; Auffret, T. Freeze-Drying of Pharmaceuticals and Biopharmaceuticals; RCS Publishing: Cambridge, UK, 2007.
  • Rey, L.; May, J. Freeze-Drying/Lyophilization of Pharmaceuticals and Biological Products; Marcel Dekker, Inc: New York, USA, 2004.
  • Hottot, A.; Vessot, S.; Andrieu, J. Freeze-Drying of Pharmaceuticals in Vials: Influence of Freezing Protocol and Sample Configuration on Ice Morphology and Freeze-Dried Cake Texture. Chem. Eng. Process. Process Intensification 2007, 46(7), 666–674.
  • Oddone, I.; Fulginiti, D.; Barresi, A. A.; Pisano, R.; Grassini, S. Non-Invasive Temperature Monitoring in Freeze Drying: Control of Freezing as a Case Study. Drying Technol. 2015, 33(13), 1621–1630.
  • Searles, J.; Carpenter, J.; Randolph, T. The Ice Nucleation Temperature Determines the Primary Drying Rate of Lyophilization for Samples Frozen on a Temperature-Controlled Shelf. J. Pharm. Sci. 2001, 90(7), 860–871.
  • Kasper, J. C.; Friess, W. F. The Freezing step in Lyophilization: Physico-Chemical Fundamentals, Freezing Methods and Consequences on Process Performance and Quality Attributes of Biopharmaceuticals. Eur. J. Pharm. Biopharm. 2011, 78(2), 248–263.
  • Oddone, I.; Van Bockstal, P.-J.; De Beer, T.; Pisano, R. Impact of Vacuum-Induced Surface Freezing on Inter- and Intra-Vial Heterogeneity. Eur. J. Pharm. Biopharm. 2016, 103(1), 167–178.
  • Oddone, I.; Barresi, A. A.; Pisano, R. Influence of Controlled Ice Nucleation on the Freeze-Drying of Pharmaceutical Products: The Secondary Drying Step. Int. J. Pharm. 2017, 524(1–2), 134–140.
  • Pisano, R.; Fissore, D.; Barresi, A. A.; Intensification of Freeze-Drying for the Pharmaceutical and Food Industry. In Modern Drying Technology Vol. 5: Process Intensification; Tsotsas, E., Mujumdar, A. S., Eds.; Wiley-VCH Verlag GmbH & Co. KGaA: Weinhein, 2014; Chap. 5, pp. 131–161.
  • Patel, S.; Bhugra, C.; Pikal, M. Reduced Pressure Ice Fog Technique for Controlled ice Nucleation During Freeze-Drying. AAPS Pharm. Sci. Tech. 2009, 10, 1406–1411.
  • Rambhatla, S.; Ramot, R.; Bhugra, C.; Pikal, M. J. Heat and Mass Transfer Scale-Up Issues During Freeze Drying, Part 2: Control and Characterization of the Degree of Supercooling. AAPS Pharm. Sci. Tech. 2004, 5(4), Article number 58.
  • Rampersad, B. M.; Sever, R. R.; Hunek, B.; Gasteyer, T. H. Freeze-Dryer and Method of Controlling the Same. U.S. Patent US824065 B2, 2012.
  • Bursac, R.; Sever, R.; Hunek, B. A Practical Method for Resolving the Nucleation Problem in Lyophilization. Bioprocess Int. 2009, 7(9), 66–72.
  • Konstantinidis, A. K.; Kuu, W.; Otten, L.; Nail, S. L.; Sever, R. R.. Controlled Nucleation in Freeze-Drying: Effects on Pore Size in the Dried Product Layer, Mass Transfer Resistance, and Primary Drying Rate. J. Pharm. Sci. 2011, 100(8), 3453–3470.
  • Kramer, M.; Sennhenn, B.; Lee, G. Freeze-Drying Using Vacuum-Induced Surface Freezing. J. Pharm. Sci. 2002, 91, 433–443.
  • Liu, J.; Viverette, T.; Virgin, M.; Anderson, M.; Dalal, P. A Study of the Impact of Freezing on the Lyophilization of a Concentrated Formulation with a High Fill Depth. Pharm. Dev. Technol. 2005, 10, 261–272.
  • Oddone, I.; Pisano, R.; Bullich, R.; Stewart, P. Vacuum-Induced Nucleation as a Method for Freeze-Drying Cycle Optimization. Ind. Eng. Chem. Res. 2014, 53(47), 18236–18244.
  • 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. J. Pharm. Sci. 2011, 100(1), 311–324.
  • Fissore, D.; Pisano, R.; Barresi, A. A. Advanced Approach to Build the Design Space for the Primary Drying of a Pharmaceutical Freeze-Drying Process. J. Pharm. Sci. 2011, 100(11), 4922–4933.
  • Fissore, D.; Pisano, R.; Barresi, A. A. A Model Based Framework to Optimize Pharmaceuticals Freeze-Drying. Drying Technol. 2012, 30, 946–958.
  • Pisano, R.; Fissore, D.; Barresi, A. A. In-Line and Off-Line Optimization of Freeze-Drying Cycles for Pharmaceutical Products. Drying Technol. 2013, 31(8), 905–919.
  • Fissore, D.; Pisano, R. Computer-Aided Framework for the Design of Freeze-Drying Cycles: Optimization of the Operating Conditions of the Primary Drying Stage. Processes 2015, 3(4), 406–421.
  • Fissore, D.; Pisano, R.; Barresi, A. A. Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-Drying Processes. In Quality by Design for Biopharmaceutical Drug Product Development, Jameel, F., Hershenson, S., Khan, M. A., Martin-Moe, S., Eds.; AAPS Advances in the Pharmaceuticals Sciences Series 18, Springer Science + Business Media: New York, 2015; pp. 565–593.
  • Pisano, R.; Fissore, D.; Barresi, A. A.; Rastelli, M. Quality by Design: Scale-Up of Freeze-Drying Cycles in Pharmaceutical Industry. AAPS Pharm. Sci. Tech. 2013, 14(3), 1137–1149.
  • Fissore, D.; Barresi, A. A. Scale-Up and Process Transfer of Freeze-Drying Recipes. Drying Technol. 2011, 29(14), 1673–1684.
  • Fissore, D.; Pisano, R.; Barresi, A. A. Model-Based Framework for the Analysis of Failure Consequences in a Freeze-Drying Process. Ind. Eng. Chem. Res. 2012, 51(38), 12386–12397.
  • Kuu, W.-Y.; McShane, J.; Wong, J. Determination of Mass Transfer Coefficients During Freeze Drying Using Modeling and Parameter Estimation Techniques. Int. J. Pharm. 1995, 124(2–3), 241–252.
  • Kuu, W. Y.; Hardwick, L. M.; Akers, M. J. Rapid Determination of Dry Layer Resistance to Various Pharmaceutical Formulations During Primary Drying Using Product Temperature Profiles. Int. J. Pharm. 2006, 313(1), 99–113.
  • Bosca, S.; Barresi, A. A.; Fissore, D. Use of a Soft-Sensor for the Fast Estimation of Dried Cake Resistance During a Freeze-Drying Cycle. Int. J. Pharm. 2013, 451, 23–33.
  • Bosca, S.; Barresi, A.; Fissore, D. Design of a Robust Soft-Sensor to Monitor In-Line a Freeze-Drying Process. Drying Technol. 2015, 33(9), 1039–1050.
  • Kuu, W. Y.; Obryan, K. R.; Hardwick, L. M.; Paul, T. W. Product Mass Transfer Resistance Directly Determined During Freeze-Drying Cycle Runs Using Tunable Diode Laser Absorption Spectroscopy (TDLAS) and Pore Diffusion Model. Pharm. Dev. Technol. 2011, 16(4), 343–357.
  • Hottot, A.; Vessot, S.; Andrieu, J. Determination of Mass and Heat Transfer Parameters During Freeze-Drying Cycles of Pharmaceutical Products. PDA J. Pharm. Sci. Technol. 2005, 59(2), 138–153.
  • Fissore, D.; Pisano, R.; Barresi, A. A. On the Methods Based on the Pressure Rise Test for Monitoring a Freeze-Drying Process. Drying Technol. 2011, 29(1), 73–90.
  • Pisano, R.; Barresi, A. A.; Capozzi, L. C.; Novajra, G.; Oddone, I.; Vitale-Brovarone, C. Characterization of the Mass Transfer of Lyophilized Products Based on X-Ray Micro-Computed Tomography Images. Drying Technol. 2017, 35(8), 933–938.
  • Grassini, S.; Pisano, R.; Barresi, A. A.; Angelini, E.; Parvis, M. Frequency Domain Image Analysis for the Characterization of Porous Products. Measurement 2016, 94, 515–522.
  • Kodama, T.; Sawada, H.; Hosomi, H.; Takeuchi, M.; Wakiyama, N.; Yonemochi, E.; Terada, K. Determination for Dry Layer Resistance of Sucrose Under Various Primary Drying Conditions Using a Novel Simulation Program for Designing Pharmaceutical Lyophilization Cycle. Int. J. Pharm. 2013, 452(1–2), 180–187.
  • Pisano, R.; Capozzi, L. Prediction of Product Morphology of Lyophilized Drugs in the Case of Vacuum Induced Surface Freezing. Chem. Eng. Res. Des. 2017, 125, 119–129.
  • Parvis, M.; Grassini, S.; Angelini, E.; Pisano, R.; Barresi, A. A. Characterization of Freeze-Dried Pharmaceutical Product Structures by an FFT-Imaging Approach. In Proceedings of IEEE International Symposium on Medical Measurements and Applications “MeMeA 2014”, Lisbon, Portugal, June 11–12, 2014; 302–307.
  • Grassini, S.; Angelini, E.; Pisano, R.; Barresi, A.; Parvis M. Wavelet Image Decomposition for Characterization of Freeze-Dried Pharmaceutical Product Structures. In Proceedings of IEEE International Instrumentation and Measurements Technology Conference “I2MTC 2015”, Pisa, Italy, May 11–14, 2015; 2072–2077.
  • Shapiro, L. G.; Stockman, G. C. Computer Vision; Prentice-Hall: New Jersey, 2001.
  • Pham, D. L.; Xu, C.; Prince, J. L. Current Methods in Medical Image Segmentation. Annu. Rev. Biomed. Eng. 2000, 2(2000), 315–337.
  • Forghani, M.; Forouzanfar, M.; Teshnehlab, M. Parameter Optimization of Improved Fuzzy c-Means Clustering Algorithm for Brain MR Image Segmentation. Eng. Appl. Artif. Intell. 2010, 23(2), 160–168.
  • Bomben, J. L.; King, C. J. Heat and Mass Transport in the Freezing of Apple Tissue. Int. J. Food Sci. Technol. 1982, 17(5), 615–632.
  • Kochs, M.; Korber, C. H.; Heschel, I.; Nunner, B. The Influence of the Freezing Process on Vapour Transport During Sublimation in Vacuum Freeze-Drying. Int. J. Heat Mass Transfer 1991, 34(9), 2395–2408.
  • Kurz, W.; Fisher, D. J. Fundamentals of Solidification; Trans Tech Publications: Switzerland, 1992.
  • Nakagawa, K.; Hottot, A.; Vessot, S.; Andrieu, J. Modeling of Freezing Step During Freeze-Drying of Drugs in Vials. AIChE J. 2007, 53(5), 1362–1372.
  • Arsiccio, A.; Barresi, A. A.; Pisano, R. Prediction of Ice Crystal Size Distribution after Freezing of Pharmaceutical Solutions. Cryst. Growth Des. 2017, 17(9), 4573–4581.
  • Schladitz, K. Quantitative Micro-CT. J. Microsc. 2011, 243(2), 111–117.
  • Gull, S. F.; Skilling, J. Maximum Entropy Method in Image Processing. IEE Proc. F Radar Signal Process. 1984, 131(6), 646–659.
  • Sahoo, P. K.; Arora, G. Image Thresholding Using Two-Dimensional Tsallis – Havrda – Charvát. Pattern Recognition Lett. 2006, 27(6), 520–528.
  • Sparavigna, A. C. Tsallis Entropy in Bi-Level and Multi-Level Image Thresholding. Int. J. Sci. 2015, 4(1), 40–49.
  • Gierahn, T. M.; Loginov, D.; Love, J. C. Crossword: A Fully Automated Algorithm for the Segmentation and Quality Control of Protein Microarray Images. J. Proteome Res. 2014, 13(2), 362–371.
  • Zigomitros, A.; Patsakis, C. Cross Format Embedding of Metadata in Images Using QR Codes. In Intelligent Interactive Multimedia Systems and Services. Smart Innovation, Systems and Technologies; Tsihrintzis, G. A., Virvou, M., Jain, L. C., Howlett, R. J., Eds.; Springer: Berlin, 2011; pp. 113–121.
  • Bosca, S.; Barresi, A. A.; Fissore, D. Use of Soft Sensors to Monitor a Pharmaceuticals Freeze-Drying Process in Vials. Pharm. Dev. Technol. 2014, 19(2), 148–159.
  • 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 Pharm. Sci. Tech. 2004, 5(4), 1–9.

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