a Halozyme Therapeutics, Inc. , San Diego , CA , USA.
Drug Deliv. 2019 Dec;26(1):98-106. doi: 10.1080/10717544.2018.1551442.
ENHANZE 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 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 SC) and rituximab (i.e. RITUXAN HYCELA/RITUXAN SC/MabThera SC) and dosed sequentially with human immunoglobin to treat primary immunodeficiency (i.e. HyQvia/HYQVIA). This article reviews pharmaceutical properties of rHuPH20, its current applications with approved therapeutics, and the potential for future developments.
ENHANZE 药物输送技术基于专有的重组人透明质酸酶 PH20 酶（rHuPH20；Halozyme Therapeutics，Inc.），该酶有助于联合治疗药物的皮下（SC）输送。rHuPH20 通过降解糖胺聚糖透明质酸（HA）起作用，HA 在 SC 空间中对体积流阻力起作用，限制了 SC 大体积药物输送、分散和吸收。rHuPH20 与联合治疗药物联合使用可以克服与现有 SC 治疗制剂相关的给药时间和体积障碍，并且与静脉制剂相比，已被证明可以减轻患者和医疗保健提供者的负担。rHuPH20（作为 HYLENEX 重组）目前已获得 FDA 批准用于皮下液体给药以实现水化，以增加其他注射药物的分散和吸收，并用于皮下尿路造影术以改善不透射线剂的吸收。rHuPH20 还与两种抗癌疗法曲妥珠单抗（即 Herceptin SC）和利妥昔单抗（即 RITUXAN HYCELA/RITUXAN SC/MabThera SC）联合配制，并与人免疫球蛋白序贯给药以治疗原发性免疫缺陷（即 HyQvia/HYQVIA）。本文综述了 rHuPH20 的药物特性、其与已批准治疗药物的当前应用以及未来发展的潜力。
