ABSTRACT

Introduction

Several new biopharmaceutical dosage forms have developed over time, such as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review summarizes major pharmaceutical dosage forms and their advantages, disadvantages, and countermeasures against the shortcomings of each formulation. The appropriate combination of active pharmaceutical ingredients, excipients, and containers should be selected for the safe and less burdensome administration to the patients. Finally, we note certain opinions on the future development of not only therapeutic proteins but also gene therapeutics.

Areas covered

This review is to discuss the challenges of the development of dosage forms to improve pharmaceutical stability and how they can be overcome.

Expert opinion

Silicone oil-free syringes are highly preferable for minimizing subvisible particles in the drug. It can be proposed that materials with less protein adsorption property are preferable for the suppression of protein aggregation. It is required to minimize adverse effects of biopharmaceuticals through proper quality control of the drug in a container, based on the understating of physicochemical stability of the protein in solution, the physicochemical properties of the container, and their combinations.

中文翻译：

---

开发用于输送生物制剂的注射器和小瓶：当前的挑战和创新的解决方案

摘要

介绍

随着时间的推移，已经开发了几种新的生物药物剂型，例如冻干小瓶，液体小瓶和液体预填充注射器制剂。这篇综述总结了主要的药物剂型及其优点，缺点和针对每种制剂缺点的对策。为了安全和减轻患者负担，应选择活性药物成分，赋形剂和容器的适当组合。最后，我们注意到有关治疗性蛋白质和基因治疗性药物未来发展的某些观点。

覆盖区域

这篇综述旨在讨论开发剂型以改善药物稳定性的挑战以及如何克服这些挑战。

专家意见

为了减少药物中的亚可见颗粒，高度不含硅油的注射器是非常可取的。可以提出具有较低蛋白质吸附性能的材料对于抑制蛋白质聚集是优选的。基于对溶液中蛋白质的物理化学稳定性的低估，容器的物理化学特性及其组合，需要通过对容器中的药物进行适当的质量控制来最大程度地减少生物药物的不利影响。