Development of syringes and vials for delivery of biologics: current challenges and innovative solutions

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.

Automated summary

This review discusses the challenges in developing dosage forms to improve pharmaceutical stability and how to overcome them. Expert opinions suggest that silicone oil-free syringes are preferred to minimize subvisible particles in the drug. Materials with low protein adsorption properties are recommended to prevent protein aggregation, and minimizing adverse effects of biopharmaceuticals requires proper quality control of the drug in its container, based on understanding the physicochemical stability of the protein in solution, the properties of the container, and their combinations.