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Research ArticleResearch

Split-Cakes, Still Delicious

Philippe Lam and Thomas W. Patapoff
PDA Journal of Pharmaceutical Science and Technology January 2019, 73 (1) 16-29; DOI: https://doi.org/10.5731/pdajpst.2018.008813
Philippe Lam
1Pharmaceutical Processing and Technology Development, Genentech, Inc.; and
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  • For correspondence: lam.philippe@gene.com
Thomas W. Patapoff
2Early Stage Pharmaceutical Development, Genentech, Inc.
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References

  1. 1.↵
    1. Roy M. L.,
    2. Pikal M. J.
    Process Control in Freeze Drying: Determination of the End Point of Sublimation Drying by an Electronic Moisture Sensor. PDA J. Pharm. Sci. Technol. 1989, 43 (2), 60–66.
    OpenUrlAbstract/FREE Full Text
  2. 2.↵
    1. Lam P.,
    2. Patapoff T. W.
    An Improved Method for Visualizing the Morphology of Lyophilized Product Cakes. PDA J. Pharm. Sci. Technol. 2011, 65 (4), 425–430.
    OpenUrlAbstract/FREE Full Text
  3. 3.↵
    1. Searles J. A.,
    2. Carpenter J. F.,
    3. Randolph T. W.
    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.
    OpenUrlCrossRefPubMedWeb of Science
  4. 4.↵
    1. Vekilov P. G.
    Phase Diagrams and Kinetics of Phase Transitions in Protein Solutions. J. Phys. Condens. Matter 2012, 24 (19), 193101–193117.
    OpenUrlPubMed
  5. 5.↵
    1. Worster M. G.,
    2. Wettlaufer J. S.
    Natural Convection, Solute Trapping, and Channel Formation During Solidification of Saltwater. J. Phys. Chem. 1997, 101 (32), 6132–6136.
    OpenUrl
  6. 6.↵
    1. Bloxham W. H.,
    2. Hennek J. W.,
    3. Kumar A. A.,
    4. Whitesides G. M.
    Fractionating Polymer Microspheres as Highly Accurate Density Standards. Anal. Chem. 2015, 87 (14), 7485–7491.
    OpenUrl
  7. 7.↵
    1. Hare D. E.,
    2. Sorensen C. M.
    The Density of Supercooled Water. II. Bulk Samples Cooled to the Homogeneous Nucleation Limit. J. Chem. Phys. 1987, 87 (8), 4840–4845.
    OpenUrlCrossRefWeb of Science
  8. 8.↵
    1. Ditter D.,
    2. Mahler H. C.,
    3. Roehl H.,
    4. Wahl M.,
    5. Huwyler J.,
    6. Nieto A.,
    7. Allmendinger A.
    Characterization of Surface Properties of Glass Vials Used as Primary Packaging Material for Parenterals. Eur. J. Pharm. Biopharm. 2018, 125, 58–67.
    OpenUrl
  9. 9.↵
    1. Knight C. A.,
    2. De Vries A. L.,
    3. Oolman L. D.
    Fish Antifreeze Protein and the Freezing and Recrystallization of Ice. Nature 1984, 308, 295–296.
    OpenUrlCrossRefPubMedWeb of Science
  10. 10.↵
    1. Kasuga J.,
    2. Fukushi Y.,
    3. Kuwabara C.,
    4. Wang D.,
    5. Nishioka A.,
    6. Fujikawa E.,
    7. Arakawa K.,
    8. Fujikawa S.
    Analysis of Supercooling-Facilitating (Anti-Ice Nucleation) Activity of Flavonol Glycosides. Cryobiology 2009, 60 (2), 240–243.
    OpenUrl
  11. 11.↵
    1. Rosa M.,
    2. Tiago J. M.,
    3. Singh S. K.,
    4. Geraldes V.,
    5. Rodrigues M. A.
    Improving Heat Transfer at the Bottom of Vials for Consistent Freeze Drying with Unidirectional Structured Ice. AAPS PharmSciTech 2016, 17 (5), 1049–1059.
    OpenUrl
  12. 12.↵
    1. Yen Y. C.
    Natural Convection Heat Transfer in Water Near its Density Maximum, Monograph 90-4, U.S. Army Corps of Engineers Cold Regions Research & Engineering Laboratory; NTIS Springfield, VA, 1990, pp. 88–90.
  13. 13.↵
    1. Liu J.,
    2. Viverette T.,
    3. Virgin M.,
    4. Anderson M.,
    5. Dalal P.
    A Study of the Impact of Freezing on the Lyophilization of a Concentrated Formulation with High Fill Depth. Pharm. Dev. Technol. 2005, 10 (2), 261–272.
    OpenUrlPubMed
  14. 14.↵
    1. Patel S. M.,
    2. Nail S. L.,
    3. Pikal M. J.,
    4. Guidobler R.,
    5. Winter G.,
    6. Hawe A.,
    7. Davagnino J.,
    8. Gupta S. R.
    Lyophilized Drug Product Cake Appearance: What Is Acceptable? J. Pharm. Sci. 2017, 106 (7), 1706–1721.
    OpenUrl
  15. 15.↵
    1. Hsu C. C.,
    2. Nguyen H. M.,
    3. Yeung D. A.,
    4. Brooks D. A.,
    5. Koe G. S.,
    6. Bewley T. A.,
    7. Pearlman R.
    Surface Denaturation at Solid-Void Interface—A Possible Pathway by Which Opalescent Participates Form During the Storage of Lyophilized Tissue-Type Plasminogen Activator at High Temperatures. Pharm. Res. 1995, 12 (1), 69–77.
    OpenUrlPubMed
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PDA Journal of Pharmaceutical Science and Technology: 73 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 1
January/February 2019
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Split-Cakes, Still Delicious
Philippe Lam, Thomas W. Patapoff
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 16-29; DOI: 10.5731/pdajpst.2018.008813

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Split-Cakes, Still Delicious
Philippe Lam, Thomas W. Patapoff
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 16-29; DOI: 10.5731/pdajpst.2018.008813
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Keywords

  • Lyophilization
  • cake structure
  • spherulitic ice crystal
  • lamellar ice crystal
  • Split-cake

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