Advancing injection force modeling and viscosity-dependent injectability evaluation for prefilled syringes
[Display omitted] The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient’s capability. This research describes an advanced mathematic injection force model that consisting hydrodynamic force and friction force. The hydrodyn...
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| Published in | European journal of pharmaceutics and biopharmaceutics Vol. 197; p. 114221 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier B.V
01.04.2024
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| Online Access | Get full text |
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| Abstract | [Display omitted]
The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient’s capability. This research describes an advanced mathematic injection force model that consisting hydrodynamic force and friction force. The hydrodynamic force follows the basic law of Hagen-Poiseuille but refines the modeling approach by delving into specific properties of drug viscosity (Newtonian and Shear-thinning) and syringe shape constant, while the friction force was accounted from empty barrel injection force. Additionally, we take actual temperature of injection into consideration, providing more accurate predication. The results show that the derivation of the needle dimension constant and the rheological behavior of the protein solutions are critical parameters. Also, the counter pressure generated by the tissue has been considered in actual administration to address the issue of the inaccuracies of current injection force evaluation preformed in air, especially when the viscosity of the injected drug solution is below 9.0 cP (injecting with 1 mL L PFS staked with 29G ½ inch needle). Human factor studies on patients’ capability against medication viscosity filled the gap in design space of PFS drug product and available viscosity data in very early phase. |
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| AbstractList | The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient's capability. This research describes an advanced mathematic injection force model that consisting hydrodynamic force and friction force. The hydrodynamic force follows the basic law of Hagen-Poiseuille but refines the modeling approach by delving into specific properties of drug viscosity (Newtonian and Shear-thinning) and syringe shape constant, while the friction force was accounted from empty barrel injection force. Additionally, we take actual temperature of injection into consideration, providing more accurate predication. The results show that the derivation of the needle dimension constant and the rheological behavior of the protein solutions are critical parameters. Also, the counter pressure generated by the tissue has been considered in actual administration to address the issue of the inaccuracies of current injection force evaluation preformed in air, especially when the viscosity of the injected drug solution is below 9.0 cP (injecting with 1 mL L PFS staked with 29G ½ inch needle). Human factor studies on patients' capability against medication viscosity filled the gap in design space of PFS drug product and available viscosity data in very early phase. The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient's capability. This research describes an advanced mathematic injection force model that consisting hydrodynamic force and friction force. The hydrodynamic force follows the basic law of Hagen-Poiseuille but refines the modeling approach by delving into specific properties of drug viscosity (Newtonian and Shear-thinning) and syringe shape constant, while the friction force was accounted from empty barrel injection force. Additionally, we take actual temperature of injection into consideration, providing more accurate predication. The results show that the derivation of the needle dimension constant and the rheological behavior of the protein solutions are critical parameters. Also, the counter pressure generated by the tissue has been considered in actual administration to address the issue of the inaccuracies of current injection force evaluation preformed in air, especially when the viscosity of the injected drug solution is below 9.0 cP (injecting with 1 mL L PFS staked with 29G ½ inch needle). Human factor studies on patients' capability against medication viscosity filled the gap in design space of PFS drug product and available viscosity data in very early phase. [Display omitted] The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient’s capability. This research describes an advanced mathematic injection force model that consisting hydrodynamic force and friction force. The hydrodynamic force follows the basic law of Hagen-Poiseuille but refines the modeling approach by delving into specific properties of drug viscosity (Newtonian and Shear-thinning) and syringe shape constant, while the friction force was accounted from empty barrel injection force. Additionally, we take actual temperature of injection into consideration, providing more accurate predication. The results show that the derivation of the needle dimension constant and the rheological behavior of the protein solutions are critical parameters. Also, the counter pressure generated by the tissue has been considered in actual administration to address the issue of the inaccuracies of current injection force evaluation preformed in air, especially when the viscosity of the injected drug solution is below 9.0 cP (injecting with 1 mL L PFS staked with 29G ½ inch needle). Human factor studies on patients’ capability against medication viscosity filled the gap in design space of PFS drug product and available viscosity data in very early phase. |
| ArticleNumber | 114221 |
| Author | Wu, Linke Zhao, Zhixin Zhuang, Guisheng Li, Hui Liu, Chengyu Wang, Yunyun Zhou, Weichang Chen, Quanmin Guo, Jeremy |
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| Cites_doi | 10.3233/IES-2011-0423 10.1007/s41030-021-00146-9 10.1007/978-3-319-90603-4_9 10.1002/aic.12334 10.1016/j.matdes.2020.109008 10.5731/pdajpst.2011.00785 10.1517/17425247.2014.923400 10.1177/001872088903100605 10.1002/jps.23647 10.1208/s12249-011-9625-y 10.1007/s10404-012-1029-0 10.1016/j.xphs.2019.10.033 10.1002/jps.23297 10.1093/rheumatology/38.6.521 10.1016/S0003-6870(02)00073-X 10.1016/j.ejpb.2014.01.009 10.1016/j.compfluid.2014.09.031 10.1080/10408398.2017.1325836 10.1016/S0920-4105(96)00072-1 10.1007/s10891-017-1676-9 10.1016/j.ijpharm.2015.07.054 10.3109/10837450.2014.982825 10.1002/1097-4628(20010307)79:10<1787::AID-APP70>3.0.CO;2-2 10.1016/j.ijpharm.2021.120530 10.1007/s11095-014-1611-0 10.1016/j.ejpb.2010.08.002 10.1007/s40261-023-01284-5 |
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| Keywords | Shear-thinning Tissue counter pressure Injection force Prefilled syringes (PFS) Newtonian Monoclonal antibody Human factor |
| Language | English |
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The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient’s... The development of PFS requires a detailed understanding of the forces occurring during the drug administration process and patient's capability. This research... |
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| SubjectTerms | Human factor Injection force Monoclonal antibody Newtonian Prefilled syringes (PFS) Shear-thinning Tissue counter pressure |
| Title | Advancing injection force modeling and viscosity-dependent injectability evaluation for prefilled syringes |
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