ENHANZE® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase 20
ENHANZE® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase 20
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DOI：
10.1080/10717544.2018.1551442
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发表时间：
2019-01-01
期刊：
影响因子：
6
通讯作者：
LaBarre, Michael J.
中科院分区：
文献类型：
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作者：
Locke, Kenneth W.;Maneval, Daniel C.;LaBarre, Michael J.
ENHANZE（（R））药物递送技术基于专有的重组人透明质酸酶PH 20酶（rHuPH 20; Halozyme Therapeutics，Inc.）其促进共同施用的治疗剂的皮下（SC）递送。rHuPH 20通过降解糖胺聚糖透明质酸（HA）发挥作用，HA在抵抗SC空间中的大量流体流动中发挥作用，限制大体积SC药物递送、分散和吸收。rHuPH 20与伴侣疗法的共同施用可以克服与现有SC治疗制剂相关的施用时间和体积障碍，并且与静脉内制剂相比，已经显示出减轻患者和医疗保健提供者的负担。rHuPH 20（作为HYLENEX（R）重组体）目前已被FDA批准用于皮下液体给药，以实现水合作用，增加其他注射药物的分散和吸收，并用于皮下尿路造影，以改善不透射线药物的再吸收。rHuPH 20还与两种抗癌疗法曲妥珠单抗（即赫赛汀SC）和利妥昔单抗（即RITUXAN HYCELA（（R））/RITUXAN（（R））SC/MabThera（（R））SC）共同配制，并与人免疫球蛋白顺序给药以治疗原发性免疫缺陷（即HyQvia（（R））/HYQVIA（R）。本文综述了rHuPH 20的药理学特性、目前已批准的治疗方法及其未来发展的潜力。
ENHANZE((R)) drug delivery technology is based on the proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20; Halozyme Therapeutics, Inc.) that facilitates the subcutaneous (SC) delivery of co-administered therapeutics. rHuPH20 works by degrading the glycosaminoglycan hyaluronan (HA), which plays a role in resistance to bulk fluid flow in the SC space, limiting large volume SC drug delivery, dispersion, and absorption. Co-administration of rHuPH20 with partner therapies can overcome administration time and volume barriers associated with existing SC therapeutic formulations, and has been shown to reduce the burden on patients and healthcare providers compared with intravenous formulations. rHuPH20 (as HYLENEX (R) recombinant) is currently FDA-approved for subcutaneous fluid administration for achieving hydration, to increase the dispersion and absorption of other injected drugs, and in subcutaneous urography for improving resorption of radiopaque agents. rHuPH20 is also co-formulated with two anticancer therapies, trastuzumab (i.e. Herceptin((R)) SC) and rituximab (i.e. RITUXAN HYCELA((R))/RITUXAN((R)) SC/MabThera((R)) SC) and dosed sequentially with human immunoglobin to treat primary immunodeficiency (i.e. HyQvia((R))/HYQVIA((R))). This article reviews pharmaceutical properties of rHuPH20, its current applications with approved therapeutics, and the potential for future developments.