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L-脯氨酸稳定的人免疫球蛋白:静脉注射用 Privigen®10% 和皮下注射用 Hizentra®20%。

L-proline-stabilized human IgG: Privigen® 10% for intravenous use and Hizentra® 20% for subcutaneous use.

机构信息

Immunology R & D, CSL Behring LLC, 1020 First Ave, PO Box 61501, King of Prussia, PA 19406-0901, USA.

出版信息

Immunotherapy. 2011 Feb;3(2):163-76. doi: 10.2217/imt.10.108.

Abstract

Liquid IgG preparations are preferred over lyophilized preparations because reconstitution is not required. Formation of dimers and aggregates in liquid preparations increases adverse effects and limits the shelf life of most liquid IgG products. Improved understanding of the binding interactions in IgG dimers and aggregates led to the selection of L-proline at pH 4.8 as an excipient that would minimize their formation. CSL Behring has developed the L-proline-stabilized products Privigen®, a 10% IgG solution for intravenous use; and Hizentra®, a 20% solution for subcutaneous use. The former has the longest shelf life of any liquid IgG in the USA--36 months, and the latter is the most concentrated IgG available. These improvements, which translate into improved convenience for pharmacies and patients, were achieved with no compromise in safety, efficacy or tolerability of the products.

摘要

液体 IgG 制剂优于冻干制剂,因为不需要复溶。液体制剂中二聚体和聚集体的形成会增加不良反应,并限制大多数液体 IgG 产品的货架寿命。对 IgG 二聚体和聚集体中结合相互作用的深入了解导致选择 L-脯氨酸作为在 pH4.8 时的赋形剂,以最小化其形成。CSL Behring 开发了 L-脯氨酸稳定的产品 Privigen®,一种用于静脉注射的 10% IgG 溶液;和 Hizentra®,一种用于皮下注射的 20%溶液。前者是美国任何液体 IgG 中货架寿命最长的--36 个月,后者是最浓缩的 IgG。这些改进为药房和患者提供了更好的便利性,同时在产品的安全性、疗效和耐受性方面没有任何妥协。

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