Bridging the gap between fundamental research and product development of long acting injectable PLGA microspheres

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.

KEYWORDS:

• PLGA microspheres development
• gap bridging
• industrial perspective
• Scale-up methodology
• State-of-the-art technologies

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.

Additional information

Funding

This paper was not funded.