Bridging the gap between fundamental research and product development of long acting injectable PLGA microspheres
Xun Li, Zhanpeng Zhang, A S Harris, Lin Yang
Abstract
INTRODUCTION: Long-acting Injectable PLGA microspheres have gained more and more interest and attention in the field of life cycle management of pharmaceutical products due to their biocompatibility and biodegradability. So far, a multitude of trial-and-error experiments at lab scale have been used for establishing the correlation relationship between critical process parameters, critical material attributes and critical quality attributes. However, few published studies have elaborated on the development of PLGA microspheres from an industrial perspective. AREAS COVERED: In this review, the scale-up feasibility of translational technologies of PLGA microspheres manufacturing has been evaluated. Additionally, state-of-the-art of technologies and facilities in PLGA development have been summarized. Meanwhile, the industrial knowledge matrix of PLGA microspheres development and research is establishing which provides comprehensive insight for understanding properties of PLGA microspheres as controlled/sustained release vehicle. EXPERT OPINION: There is still big gap between fundamental research in academic institute and product development in pharmaceuticals. Therefore, the difference and connection between them should be identified gradually for better understanding of PLGA microspheres development.