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Advancing injection force modeling and viscosity-dependent injectability evaluation for prefilled syringes
European Journal of Pharmaceutics and Biopharmaceutics ( IF 4.4 ) Pub Date : 2024-02-18 , DOI: 10.1016/j.ejpb.2024.114221 Linke Wu 1 , Hui Li 1 , Yunyun Wang 1 , Chengyu Liu 1 , Zhixin Zhao 1 , Guisheng Zhuang 1 , Quanmin Chen 1 , Weichang Zhou 1 , Jeremy Guo 1
European Journal of Pharmaceutics and Biopharmaceutics ( IF 4.4 ) Pub Date : 2024-02-18 , DOI: 10.1016/j.ejpb.2024.114221 Linke Wu 1 , Hui Li 1 , Yunyun Wang 1 , Chengyu Liu 1 , Zhixin Zhao 1 , Guisheng Zhuang 1 , Quanmin Chen 1 , Weichang Zhou 1 , Jeremy Guo 1
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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.
中文翻译：
推进预充式注射器的注射力建模和粘度依赖性注射性评估
PFS 的开发需要详细了解给药过程中发生的力量和患者的能力。这项研究描述了一种由流体动力和摩擦力组成的高级数学注射力模型。流体动力遵循哈根-泊肃叶基本定律，但通过深入研究药物粘度（牛顿和剪切稀化）和注射器形状常数的特定属性来完善建模方法，而摩擦力则由空筒注射力考虑。此外，我们还考虑了实际注射温度，提供更准确的预测。结果表明，针尺寸常数的推导和蛋白质溶液的流变行为是关键参数。此外，在实际给药中还考虑了组织产生的反压，以解决目前空气中注射力评估不准确的问题，特别是当注射药液粘度低于9.0 cP（注射1 mL L PFS 用 29G ½ 英寸针固定）。关于患者抵抗药物粘度能力的人为因素研究填补了 PFS 药品设计空间和早期阶段可用粘度数据的空白。
更新日期：2024-02-18
中文翻译：
推进预充式注射器的注射力建模和粘度依赖性注射性评估
PFS 的开发需要详细了解给药过程中发生的力量和患者的能力。这项研究描述了一种由流体动力和摩擦力组成的高级数学注射力模型。流体动力遵循哈根-泊肃叶基本定律，但通过深入研究药物粘度（牛顿和剪切稀化）和注射器形状常数的特定属性来完善建模方法，而摩擦力则由空筒注射力考虑。此外，我们还考虑了实际注射温度，提供更准确的预测。结果表明，针尺寸常数的推导和蛋白质溶液的流变行为是关键参数。此外，在实际给药中还考虑了组织产生的反压，以解决目前空气中注射力评估不准确的问题，特别是当注射药液粘度低于9.0 cP（注射1 mL L PFS 用 29G ½ 英寸针固定）。关于患者抵抗药物粘度能力的人为因素研究填补了 PFS 药品设计空间和早期阶段可用粘度数据的空白。
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