Current trends in PLGA based long-acting injectable products: The industry perspective

ABSTRACT

Introduction

Poly(lactic-co-glycolic acid) (PLGA) has been used in many long-acting drug formulations, which have been approved by the US Food and Drug Administration (FDA). PLGA has unique physicochemical properties, which results in complexities in the formulation, characterization, and evaluation of generic products. To address the challenges of generic development of PLGA-based products, the FDA has established an extensive research program to investigate novel methods and tools to aid product development and regulatory review.

Areas covered

This review article intends to provide a comprehensive review on physicochemical properties of PLGA polymer, characterization, formulation, analytical aspects, manufacturing conditions on product performance, in-vitro release testing, and bioequivalence. Current research on formulation development was done as per QbD in vitro release testing methods, regulatory research outcomes, and bioequivalence.

Expert opinion

The development of PLGA-based long-acting injectables is promising and challenging when considering the numerous interrelated delivery-related factors. Achieving a successful formulation requires a thorough understanding of the critical interactions between polymer/drug properties, release profiles over time, up-to-date knowledge on regulatory guidance, and elucidation of the impact of multiple in vivo conditions to methodically evaluate the eventual clinical efficacy.

KEYWORDS:

• PLGA
• Long-acting injectable
• USFDA
• QbD

Article highlights

• The importance of PLGA based long-acting injectables (LAI) delivery systems over conventional dosage forms are discussed

• Synthesis of PLGA polymer and QbD based elements to be considered during PLGA based LAI delivery systems are discussed.

• Manufacturing techniques involved in the preparation of PLGA based LAIs are discussed.

• In vitro release mechanisms and the establishment of bioequivalence is discussed.

• Regulatory guidance, challenges, and the future of PLGA based LAIs development are discussed.

This box summarizes key points contained in the article.

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.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.