ABSTRACT

Introduction

Monoclonal antibodies (mAbs) should be administered by inhalation rather than parenterally to improve their efficiency in lung diseases. However, the pulmonary administration of mAbs in terms of aerosol technology and the formulation for inhalation is difficult.

Areas covered

The feasible or suitable strategies for overcoming the barriers associated with administering mAbs are described.

Expert opinion

Providing mAbs via inhalation to individuals with lung disorders is still difficult. However, inhalation is a desirable method for mAb delivery. Inhaled mAb production needs to be well thought out. The illness, the patient group(s), the therapeutic molecule selected, its interaction with the biological barriers in the lungs, the formulation, excipients, and administration systems must all be thoroughly investigated. Therefore, to create inhaled mAbs that are stable and efficacious, it will be essential to examine the problems linked to instability and protein aggregation thoroughly. More excipients will also need to be manufactured, expanding the range of formulation design choices. Another crucial requirement is for novel carriers for topical delivery to the lungs since carriers might significantly enhance proteins’ stability and pharmacokinetic profile.

中文翻译：

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克服与吸入单克隆抗体治疗肺部疾病相关的生物障碍的策略

摘要

介绍

单克隆抗体 (mAb) 应通过吸入而不是肠胃外给药，以提高其治疗肺部疾病的效率。然而，单克隆抗体的肺部给药在气雾剂技术和吸入制剂方面存在困难。

覆盖领域

描述了克服与施用单克隆抗体相关的障碍的可行或合适的策略。

专家意见

通过吸入向肺部疾病患者提供单克隆抗体仍然很困难。然而，吸入是单克隆抗体递送的理想方法。吸入单克隆抗体的生产需要经过深思熟虑。疾病、患者群体、选择的治疗分子、其与肺部生物屏障的相互作用、配方、赋形剂和给药系统都必须进行彻底的研究。因此，为了创造稳定有效的吸入单克隆抗体，必须彻底检查与不稳定性和蛋白质聚集相关的问题。还需要生产更多的赋形剂，扩大配方设计选择的范围。另一个关键要求是用于局部递送至肺部的新型载体，因为载体可能显着增强蛋白质的稳定性和药代动力学特征。