Advanced Formulations/Drug Delivery Systems for Subcutaneous Delivery of Protein-Based Biotherapeutics.
用于皮下递送蛋白类生物治疗药物的先进制剂/药物递送系统
📄 英文摘要 English Abstract
Multiple advanced formulations and drug delivery systems (DDSs) have been developed to deliver protein-based biotherapeutics via the subcutaneous (SC) route. These formulations/DDSs include high-concentration solution, co-formulation of two or more proteins, large volume injection, protein cluster/complex, suspension, nanoparticle, microparticle, and hydrogel. These advanced systems provide clinical benefits related to efficacy and safety, but meanwhile, have more complicated formulations and manufacturing processes compared to conventional solution formulations. To develop a fit-for-purpose formulation/DDS for SC delivery, scientists need to consider multiple factors, such as the primary indication, targeted site, immunogenicity, compatibility, biopharmaceutics, patient compliance, etc. Next, they need to develop appropriate formulation (s) and manufacturing processes using the QbD principle and have a control strategy. This paper aims to provide a comprehensive review of advanced formulations/DDSs recently developed for SC delivery of proteins, as well as some knowledge gaps and potential strategies to narrow them through future research.
📄 中文摘要 Chinese Abstract
📋 英文结构化总结 English Structured Summary
摘要整理
Background:
Multiple advanced formulations and drug delivery systems (DDSs) have been developed to deliver protein-based biotherapeutics via the subcutaneous (SC) route. These formulations/DDSs include high-concentration solution, co-formulation of two or more proteins, large volume injection, protein cluster/complex, suspension, nanoparticle, microparticle, and hydrogel. These advanced systems provide clinical benefits related to efficacy and safety, but meanwhile, have more complicated formulations and manufacturing processes compared to conventional solution formulations. To develop a fit-for-purpose formulation/DDS for SC delivery, scientists need to consider multiple factors, such as the primary indication, targeted site, immunogenicity, compatibility, biopharmaceutics, patient compliance, etc. Next, they need to develop appropriate formulation (s) and manufacturing processes using the QbD principle and have a control strategy.
Methods:
N/A - Review article
Results:
This paper aims to provide a comprehensive review of advanced formulations/DDSs recently developed for SC delivery of proteins, as well as some knowledge gaps and potential strategies to narrow them through future research.
Data Summary:
These formulations/DDSs include high-concentration solution, co-formulation of two or more proteins, large volume injection, protein cluster/complex, suspension, nanoparticle, microparticle, and hydrogel.
Conclusions:
These advanced systems provide clinical benefits related to efficacy and safety, but meanwhile, have more complicated formulations and manufacturing processes compared to conventional solution formulations.
Practical Significance:
To develop a fit-for-purpose formulation/DDS for SC delivery, scientists need to consider multiple factors, such as the primary indication, targeted site, immunogenicity, compatibility, biopharmaceutics, patient compliance, etc.
📋 中文结构化总结 Chinese Structured Summary
背景:
目前已开发出多种先进制剂和药物递送系统（DDS），用于通过皮下（SC）途径递送蛋白质类生物治疗药物。这些制剂/药物递送系统包括高浓度溶液、两种或多种蛋白质的共制剂、大容量注射、蛋白质聚集体/复合物、混悬液、纳米颗粒、微颗粒和水凝胶。这些先进系统在疗效和安全性方面具有临床优势，但与此同时，与传统溶液型制剂相比，其处方和生产工艺更为复杂。为了开发出适用于皮下递送的合适制剂/药物递送系统，科研人员需要考虑多种因素，如主要适应症、靶向部位、免疫原性、相容性、生物药剂学特性、患者依从性等。随后，他们需要基于质量源于设计（QbD）原则开发合适的制剂和生产工艺，并建立控制策略。
方法:
不适用——综述类文章
结果:
本文旨在对近期开发的用于蛋白质皮下递送的先进制剂/药物递送系统进行全面综述，并指出当前存在的知识空白以及通过未来研究缩小这些空白的潜在策略。
数据概要:
这些制剂/药物递送系统包括高浓度溶液、两种或多种蛋白质的共制剂、大容量注射、蛋白质聚集体/复合物、混悬液、纳米颗粒、微颗粒和水凝胶。
结论:
这些先进系统在疗效和安全性方面具有临床优势，但与此同时，与传统溶液型制剂相比，其处方和生产工艺更为复杂。
实际意义:
为了开发出适用于皮下递送的合适制剂/药物递送系统，科研人员需要考虑多种因素，如主要适应症、靶向部位、免疫原性、相容性、生物药剂学特性、患者依从性等。