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Drying Technology
An International Journal
Volume 36, 2018 - Issue 2
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REVIEW ARTICLE

A review on experimental determination and optimization of physical quality factors during pharmaceuticals freeze-drying cycles

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Pages 129-145 | Received 24 Mar 2017, Accepted 07 Jun 2017, Published online: 21 Jul 2017

References

  • Andrieu, J.; Vessot, S. Control of some physical quality factors during freeze-drying of pharmaceuticals in vial in modern drying technology, Volume 3. Chapter 3. Quality in Drying; Editor Wiley-VCH, 2011; 51–90.
  • Pikal, M.J. Freeze-drying. In Encyclopaedia of Pharmaceutical Technology; Dekker, M. Ed.; 1992, Vol. 6, 275–303.
  • Barresi, A.; Fissore, D. In line product quality control of pharmaceuticals in freeze-drying. Modern Drying Technology. In Product Quality and Formulation; Tsotsas, E.; Mujumdar, A.S. Eds., Vol. 3, Verlag GmbH & Co. KGaA: Weinheim, 2011, 91–154.
  • Bogdani, E.; Vessot, S.; Andrieu, J. Optimization of freeze-drying cycles of pharmaceutical organic co-solvent based formulations using the design space methodology. Drying Technology 2012, 30, 1297–1306.
  • Pisano, R.; Fissore, D.; Barresi, A. Non-invasive monitoring of a freeze-drying process for TBA/water co-solvent based formulations. Industrial & Engineering Chemical Research 2016, 55(19), 5670–5680.
  • Chouvenc, P.; Vessot, S.; Andrieu J. Experimental study of the impact of annealing on ice structure and mass transfer parameters during freeze-drying of a pharmaceutical formulation. PDA Journal of Pharmaceutical Science and Technology 2006, 60(2), 95–103.
  • Hottot, A.; Vessot, S.; Andrieu, J.A direct characterization method of the ice morphology. Relationship between mean crystals size and primary drying times of freeze-drying processes. Drying Technology 2004, 22, 2009–2021.
  • Nakagawa, K.; Hottot, A.; Vessot, S.; Andrieu, J. Influence of controlled nucleation by ultrasounds on ice morphology of frozen formulations for pharmaceutical proteins freeze-drying. Chemical Engineering and Processing 2006, 45, 783–91.
  • Nakagawa, K.; Hottot, A.; Vessot, S.; Andrieu, J. Modelling of freezing step during freeze-drying of drugs in vials. AIChE Journal 2007, 53(5), 1362–1372.
  • Goshima, H.; Do, G.; Nakagawa, K. Impact of ice morphology of the frozen formulation in a vial on the design space for the primary drying of freeze-drying process. Journal of Pharmaceutical Sciences 2016, 105(6), 1920–1933.
  • Grassini, S.; Pisano, R.; Barresi, A.A.; Angelini, E.; Parvis, M. Frequency domain image analysis of porous products. Measurement 2016, 94, 515–522.
  • 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(7), 1577–1601.
  • 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, 51(1), 7–16.
  • Pisano, R.; Fissore, D.; Barresi, A. In-Line and off-Line optimization of freeze-drying cycles for pharmaceutical products. Drying Technology 2013, 31(8), 905–919.
  • 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 and Technology 1985, 39(3), 115–139.
  • Patapoff, T.; Overcashier, D.E.; Hsu, C.C. Lyophilisation of proteins formulations in vials: investigation of the relationship between resistance to water vapour flow during primary drying and small-scale product collapse. Journal of Pharmaceutical Sciences 1999, 88(7), 688–695.
  • Chouvenc, P.; Vessot, S.; Andrieu, J.; Vacus, P. Optimization of the freeze-drying cycle: characterization of annealing effects by the pressure rise analysis method. Proceedings IDS 2004, Vol. A, 359–365.
  • Oddone, I.; Fulginiti, D.; Barresi, A.; Grassini, S.; Pisano, R. Non-invasive temperature monitoring in freeze-drying control of freezing as a case study. Drying Technology 2015, 33(13), 1621–1630.
  • Bosca, S.; Barresi, A.; Fissore, D. Fast freeze-drying cycle design and optimization using PAT based on the measurement of product temperature. European Journal of Pharmaceutics and Biopharmaceutics 2013, 85(2), 253–262.
  • Schneid, S.; Gieseler, H. Evaluation of a new wireless temperature remote interrogation system (TEMPRIS) to measure temperature during freeze-drying. AAP Pharmaceutical Science and Technology 2008, 9(3), 729–739.
  • Hottot, A.; Vessot, S.; Andrieu, J. Determination of mass and heat transfer parameters during freeze-drying cycle of pharmaceutical products. PDA Journal of Pharmaceutical Science and Technology 2005, 59, 138–153.
  • Korpus, C.; Pikal, M.; Froess, W. Heat transfer analysis of an optimized flexible holder system for freeze-drying in dual chamber cartridges using different state-of-the-art PAT tools. Journal of Pharmaceutical Sciences 2016, 105(11), 3304–3313.
  • Hottot, A.; Andrieu, J.; Vessot S.; Shalaev, E.; Gatlin, L.A.; Ricketts, S. Experimental study and modelling of freeze-drying in syringe configuration. Part I Freezing step. Drying Technology 2009, 27(1), 40–48.
  • Hottot, A.; Andrieu, J.; Hoang, V.; Shalaev, E.Y.; Gatlin, L.A.; Rickett, S. Experimental study and modelling of freeze-drying in syringe configuration. Part II Mass and heat transfer parameters and sublimation end-points. Drying Technology 2009, 27(1), 49–58.
  • Bosca, S.; Fissore, D. Monitoring of pharmaceuticals freeze-drying processes by model-based process analytical technology tools. Chemical Engineering and Technology 2014, 37(2), 240–248.
  • Bosca, S.; Barresi, A.; Fissore, D. Use of soft sensors to monitor a pharmaceutical freeze-drying process in vial. Pharmaceutical Development and Technology 2014, 19(2), 148–159.
  • Kasper, J.C.; Friess, W. The freezing step in lyophilization: Physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. European Journal of Pharmaceutics and Biopharmaceutics 2011, 78, 248–263.
  • Pisano, R.; Fissore, D.; Barresi, A.A.; Brayard, P.; Chouvenc, P.; Woinet, B. Quality by design: optimization of freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of freezing protocol. Pharmaceutical Development and Technology. Pharmaceutical Development and Technology 2013, 18(1), 280–295.
  • Searles, J.A.; Carpenter, J.F.; Randolph, T. The ice nucleation temperature determines the primary drying rate of lyophilisation for samples frozen on a temperature-controlled shelf. Journal of Pharmaceutical Sciences 2001, 90(7), 860–869.
  • 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. Chemical Engineering and Processing 2006, 46, 666–674.
  • Searles, J.A.; Carpenter, J.J.; Randolph, T. Annealing to optimize the primary drying rate, reduce freeze-induced drying rate heterogeneity, and determine Tg’ in pharmaceutical lyophilization. Journal of Pharmaceutical Silences 2001, 90(7), 872–887.
  • Rambhatla, S.; Ramot, R.; Bhugra, C.; Pikal, M.J. Heat and mass transfer scale-up issues during freeze-drying: II. Control and characterization of degree of supercooling. AAPS Pharmaceutical Science and Technology 2004, 5(4), 1–8.
  • Hottot, A.; Nakagawa, K.; Andrieu, J. Effect of ultrasound-controlled nucleation on structural and morphological properties of freeze-dried mannitol solution. Chemical Engineering Research and Design 2008, 86, 193–200.
  • Morris, J., Morris, G.J.; Taylor, R.; Zhai, S.; Slater, N.K.H. The effect of controlled nucleation on ice structure, drying rate, and protein recovery in vials in a modified freeze-dryer. Cryobiology 2004, 49, 308–309.
  • Saclier, M.; Peczalski, R.; Andrieu, J. Modelling of nucleation initiated by ultrasounds for ice morphology control. Ultrasonic Sonochemistry 2010, 17(1), 98–105.
  • Hottot, A.; Peczalski, R.; Vessot, S.; Andrieu, J. Freeze-drying of pharmaceutical proteins in vials: Modelling of freezing and sublimation steps. Drying Technology 2006, 24, 561–70.
  • Bogdani, E.; Vessot, S.; Andrieu J. Experimental and modelling study during freeze-drying of aqueous Tert-butanol based formulations in vials. Drying Technology, IDS 2012 Special Issue, 2013, 31, 1772–1779.
  • Hottot, A.; Andrieu, J.; Vessot, S. Sublimation kinetics during freeze-drying of pharmaceutical protein formulation. Drying Technology 2007, 25, 1–6.
  • Daoussi, R.; Vessot, S.; Andrieu, J.; Monnier, O. Sublimation kinetics and sublimation end-point during freeze-drying of pharmaceutical active principle with organic co-solvent formulations. Chemical Engineering Research and Design 2009, 87, 899–907.
  • Kuu, W.Y., Hardwick, L.S.; Akers, M.J. Correlation of laboratory and production freeze drying cycles. International Journal of Pharmaceutics 2005, 302, 56–67.
  • Roy, M.L.; Pikal, M.J. Process control in freeze-drying: Determination of the end point of sublimation drying by an electronic moisture sensor. Journal of Parenteral Science and Technology 1989, 43(2), 60–66.
  • Bardat, A.; Biguet, J.; Chatenet, E.; Courteille, F. Moisture measurement: A new method for monitoring freeze-drying cycles. Journal of Parenteral Science and Technology 1993, 47(6), 293–299.
  • Pisano, R.; Fissore D.; Barresi, A. In line and off-line optimization of freeze-drying cycles for pharmaceuticals products. Drying Technology 2013, 31, 905–919.
  • Bosca, S.; Barresi, A.; Fissore, D. On the use of model-based tools to optimize in-line a pharmaceutical drying process. Drying Technology 2016, 34(15), 1831–1842.
  • Nail, S.L. Methodology for in process determination of residual water in freeze-drying products”. International Symposium on biological product freeze-drying and formulation, Bethesda, USA 1990: Development. Biology Standards 1991, 74, 137–151.

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