Journal
EXPERT OPINION ON DRUG DELIVERY
Volume 19, Issue 5, Pages 559-576Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/17425247.2022.2075845
Keywords
PLGA; Long-acting injectable; USFDA; QbD
Categories
Ask authors/readers for more resources
This review provides a comprehensive overview of the physicochemical properties, formulation development, manufacturing conditions, in-vitro release testing, and bioequivalence of PLGA-based products. The development of PLGA-based long-acting injectables has great potential and challenges, requiring 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 on eventual clinical efficacy.
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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available