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雾化给药作为治疗呼吸系统疾病单抗药物的一种输送方法。

Nebulization as a delivery method for mAbs in respiratory diseases.

机构信息

Université François Rabelais, EA6305 , Tours F-37032 , France.

出版信息

Expert Opin Drug Deliv. 2015 Jun;12(6):1027-39. doi: 10.1517/17425247.2015.999039. Epub 2015 Jan 5.

Abstract

INTRODUCTION

The pulmonary route is not invasive and can be used to target drugs directly to the lungs, limiting the exposure of secondary organs. It is, thus, an attractive alternative to the intravenous route, for the delivery of mAbs, which display limited transfer from blood into the lungs.

AREAS COVERED

This review provides an overview of the pharmacological properties of antibody-based treatments, describes those for respiratory diseases and discusses preclinical/clinical results of aerosolized antibody-based therapeutics. The advantages and limitations of aerosol devices and the formulation for the administration of aerosolized mAbs are also detailed.

EXPERT OPINION

Overall, the inhalation of mAbs for therapeutic purposes is both appropriate and feasible. The size and structure of the biotherapeutic molecule are important properties to be taken into account when trying to achieve long-term retention. Mesh nebulizers currently appear to be the most appropriate devices for the safe delivery of large amounts of active mAb into the lungs. mAbs should be formulated so as to prevent their degradation and possible immunogenicity. General guidelines can be given for mAb aerosolization, but the formulation and device combination should be adapted for each therapeutic and clinical application.

摘要

简介

肺部给药途径是非侵入性的,可以将药物直接靶向肺部,从而限制了次级器官的暴露。因此,与静脉途径相比,肺部给药途径对于输送抗体药物具有吸引力,因为抗体药物从血液向肺部的转移有限。

涵盖领域

本文综述了基于抗体的治疗药物的药理学特性,描述了用于治疗呼吸系统疾病的抗体药物,并讨论了雾化抗体治疗药物的临床前/临床结果。还详细介绍了雾化器装置和用于雾化 mAb 给药的制剂的优缺点。

专家意见

总体而言,将 mAb 用于治疗目的是合理且可行的。在试图实现长期保留时,生物治疗分子的大小和结构是需要考虑的重要特性。网孔式雾化器目前似乎是将大量活性 mAb 安全输送到肺部的最适合的装置。应将 mAb 配制成防止其降解和可能的免疫原性。可以为 mAb 的雾化提供一般指南,但制剂和装置的组合应根据每种治疗和临床应用进行调整。

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