Clinical Applications of 3D Printed Drug Products
摘要
Common challenges in pharmaceutical formulation development and clinical manufacturing include manual labor and a lack of flexibility to formulate a wide range of release characteristics that can be provided in an adaptive fashion. For instance, in Phase I clinical trials for oral delivery, thousands of capsules are manufactured with a single release profile. While the release rate in these dosage forms can be reproducible, they cannot be flexibly manipulated in a controlled manner without a significant change to the formulation or manufacturing process. In this chapter, 3D printing as an automated and versatile manufacturing technique will be explored for the purposes of small- to mid-scale pharmaceutical manufacturing, specifically focusing on oral delivery and microneedles. Unique benefits facilitated by 3D printing will be highlighted, the current technology gaps will be discussed, and future benefits will be explored.