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.
Methods:
N/A - Review article
Results:
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.
Data Summary:
No quantitative results or key statistics are provided in the abstract. The text lists the following formulation types: high-concentration solution, co-formulation of two or more proteins, large volume injection, protein cluster/complex, suspension, nanoparticle, microparticle, and hydrogel.
Conclusions:
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.
Practical Significance:
These advanced systems provide clinical benefits related to efficacy and safety, and scientists need to consider factors like primary indication, targeted site, immunogenicity, compatibility, biopharmaceutics, and patient compliance to develop a fit-for-purpose formulation/DDS for SC delivery.
📋 中文结构化总结 Chinese Structured Summary
背景:
多种先进制剂和药物递送系统（DDS）已被开发出来，用于通过皮下（SC）途径递送基于蛋白质的生物治疗药物。这些制剂/DDS包括高浓度溶液、两种或多种蛋白质的共制剂、大容量注射、蛋白质簇/复合物、混悬液、纳米颗粒、微粒和水凝胶。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，与传统溶液制剂相比，其配方和制造工艺更为复杂。
方法:
不适用——综述文章
结果:
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，与传统溶液制剂相比，其配方和制造工艺更为复杂。为了开发适用于皮下递送的合适制剂/DDS，科学家需要考虑多种因素，如主要适应症、靶部位、免疫原性、相容性、生物药剂学、患者依从性等。
数据摘要:
摘要中未提供定量结果或关键统计数据。文中列举了以下制剂类型：高浓度溶液、两种或多种蛋白质的共制剂、大容量注射、蛋白质簇/复合物、混悬液、纳米颗粒、微粒和水凝胶。
结论:
本文旨在对近期开发的用于蛋白质皮下递送的先进制剂/DDS进行全面综述，并指出一些知识空白以及通过未来研究缩小这些空白的潜在策略。
实际意义:
这些先进系统在疗效和安全性方面具有临床优势，科学家需要考虑主要适应症、靶部位、免疫原性、相容性、生物药剂学和患者依从性等因素，以开发适用于皮下递送的合适制剂/DDS。