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.
Article highlights
Upscaling strategy and methodology of translational approaches for PLGA microspheres development
Gap assessment between academic research and industrial development
State-of-art technologies with different emulsification mechanism
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.