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Research ArticleResearch

Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance

Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle and Cathy Zhao
PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 674-687; DOI: https://doi.org/10.5731/pdajpst.2020.011627
Liang Fang
1West Pharmaceutical Services, Inc.; 530 Herman O. West Drive, Exton, PA 19341; and
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Galen Huaiqiu Shi
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46265
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  • For correspondence: galen_shi@lilly.com
Coralie ADÈle Richard
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46265
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Xia Dong
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46265
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Justin C. Thomas
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46265
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Michael C. Victor
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46265
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Tingting Wang
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46265
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Sharon Shinkle
2Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46265
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Cathy Zhao
1West Pharmaceutical Services, Inc.; 530 Herman O. West Drive, Exton, PA 19341; and
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References

  1. 1.↵
    1. Bittner B.,
    2. Richter W.,
    3. Schmidt J.
    Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs 2018, 32 (5), 425–440.
    OpenUrl
  2. 2.↵
    1. Anderson K. C.,
    2. Landgren O.,
    3. Arend R. C.,
    4. Chou J.,
    5. Jacobs I. A.
    Humanistic and Economic Impact of Subcutaneous versus Intravenous Administration of Oncology Biologics. Future Oncol. 2019, 15 (28), 3267–3281.
    OpenUrl
  3. 3.↵
    1. Shire S. J.,
    2. Shahrokh Z.,
    3. Liu J.
    Challenges in the Development of High Protein Concentration Formulations. J. Pharm. Sci. 2004, 93 (6), 1390–1402.
    OpenUrlCrossRefPubMedWeb of Science
  4. 4.↵
    1. Dounce S. M.
    The Changing Paradigm in Primary Packaging of Therapeutic Proteins. Pharm. Commerce [Online], November 13, 2017 https://www.pharmaceuticalcommerce.com/manufacturing-and-packaging/changing-paradigm-primary-packaging-therapeutic-proteins/ (accessed November 17, 2020).
  5. 5.↵
    1. Schoenknecht T.,
    2. Romacker M.
    Prefilled Syringes: Why New Developments Are Important in Injectable Delivery Today. Prefilled Syringes: Innovations that Meet the Growing Demand, ONDrugDelivery Ltd: East Sussex, UK, 2005, pp 9–11.
  6. 6.↵
    1. Overcashier D. E.,
    2. Chan E. K.,
    3. Hsu C. C.
    Technical Considerations in the Development of Prefilled Syringes for Protein Products. Am. Pharm. Rev. 2006, 9 (7), 77–83.
    OpenUrl
  7. 7.↵
    1. Bee J. S.,
    2. Frey V. V.,
    3. Javed U.,
    4. Chung J.,
    5. Corcoran M. L.,
    6. Roussel P. S.,
    7. Krause S. O.,
    8. Cash P. W.,
    9. Bishop S. M.,
    10. Dimitrova M. N.
    Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 494–503.
    OpenUrlAbstract/FREE Full Text
  8. 8.↵
    1. Dixit N.,
    2. Maloney K. M.,
    3. Kalonia D. S.
    Effect of Processing Parameters on the Physical Stability of Silicone Coatings. AAPS PharmSciTech 2012, 13 (4), 1116–1119.
    OpenUrlPubMed
  9. 9.↵
    1. Bee J. S.,
    2. Randolph T. W.,
    3. Carpenter J. F.,
    4. Bishop S. M.,
    5. Dimitrova M. N.
    Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals. J. Pharm. Sci. 2011, 100 (10), 4158–4170.
    OpenUrl
  10. 10.↵
    1. Gerhardt A.,
    2. Mcgraw N. R.,
    3. Schwartz D. K.,
    4. Bee J. S.,
    5. Carpenter J. F.,
    6. Randolph T. W.
    Protein Aggregation and Particle Formation in Prefilled Glass Syringes. J. Pharm. Sci. 2014, 103 (6), 1601–1612.
    OpenUrl
  11. 11.↵
    1. Mehta S. B.,
    2. Lewus R.,
    3. Bee J. S.,
    4. Randolph T. W.,
    5. Carpenter J. F.
    Gelation of a Monoclonal Antibody at the Silicone Oil–Water Interface and Subsequent Rupture of the Interfacial Gel Results in Aggregation and Particle Formation. J. Pharm. Sci. 2015, 104 (4), 1282–1290.
    OpenUrl
  12. 12.↵
    1. Shi G. H.,
    2. Gopalrathnam G.,
    3. Shinkle S. L.,
    4. Dong X.,
    5. Hofer J. D.,
    6. Jensen E. C.,
    7. Rajagopalan N.
    Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System. PDA J Pharm Sci Technol 2018, 72 (1), 50–61.
    OpenUrlAbstract/FREE Full Text
  13. 13.↵
    1. Hansen C. M.
    Hansen Solubility Parameters: A User’s Handbook, 2nd ed.; CRC Press/Taylor & Francis Group: Boca Raton, FL, 2007; p 6.
  14. 14.↵
    HSPiP Software and 10K Chemical Database, Version 5.0.04. https://www.hansen-solubility.com/HSPiP (accessed Apr 23, 2020).
  15. 15.↵
    1. Abbott S.,
    2. Hansen C. M.,
    3. Yamamoto H.,
    4. Valpey R. S.
    , III. Insoluble Solubility Parameters (HSP for Pigment Surfaces). In Hansen Solubility Parameters in Practice, 5th ed. [Online]; Hansen-Solubility.com; Chapter 10. https://pirika.com/ENG/HSP/E-Book/Chap10.html (accessed November 17, 2020).
  16. 16.↵
    1. Burgess J.
    Metal Ions in Solution; Ellis Horwood: New York, 1978.
  17. 17.↵
    1. Rosen M. J.,
    2. Hua X. Y.
    Dynamic Surface Tension of Aqueous Solutions: 2. Parameters at 1 s and at Meso-Equilibrium. J. Colloid Interface Sci. 1990, 139 (2), 397–407.
    OpenUrl
  18. 18.↵
    1. Jacobson B.
    The Stribeck Memorial Lecture. Tribol. Int.l 2003, 36 (11), 781–789.
    OpenUrl
  19. 19.↵
    1. Niinomi M.
    1. Yan Y.
    Tribology and Tribo-Corrosion Testing and Analysis of Metallic Biomaterials. In Metals for Biomedical Devices, 2nd ed.; Niinomi M., Ed.; Woodhead Publishing, 2019; p 213.
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PDA Journal of Pharmaceutical Science and Technology: 74 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
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Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle, Cathy Zhao
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 674-687; DOI: 10.5731/pdajpst.2020.011627

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Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
Liang Fang, Galen Huaiqiu Shi, Coralie ADÈle Richard, Xia Dong, Justin C. Thomas, Michael C. Victor, Tingting Wang, Sharon Shinkle, Cathy Zhao
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 674-687; DOI: 10.5731/pdajpst.2020.011627
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Keywords

  • prefilled syringe
  • Autoinjector
  • Glide force
  • Injection time
  • Hansen solubility parameters
  • Interfacial tension
  • Contact angle
  • Silicone oil
  • Drug formulation

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