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- W4229456474 abstract "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.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.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." @default.
- W4229456474 created "2022-05-11" @default.
- W4229456474 creator A5067980345 @default.
- W4229456474 date "2022-05-04" @default.
- W4229456474 modified "2023-10-16" @default.
- W4229456474 title "Current trends in PLGA based long-acting injectable products: The industry perspective" @default.
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- W4229456474 doi "https://doi.org/10.1080/17425247.2022.2075845" @default.
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