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- W4220785098 abstract "Poly(lactic-co-glycolic acid) (PLGA) is one of the preferred polymeric inactive ingredients for long-acting parenteral drug products that are constituted of complex formulations. Despite over 30 years of use, there are still many challenges faced by researchers in formulation-related aspects pertaining to drug loading and release. Until now, PLGA-based complex generic drug products have not been successfully developed. The complexity in developing these generic drug products is not just due to their complex formulation, but also to the manufacturing process of the listed reference drugs that involve PLGA. The composition and product attributes of commercial PLGA formulations vary with the drugs and their intended applications. The lack of standard compendial methods for in vitro release studies hinders generic pharmaceutical companies in their efforts to develop PLGA-based complex generic drug products. In this review, we discuss the challenges faced in developing PLGA-based long-acting injectable/implantable (LAI) drug products; hurdles that are associated with drug loading and release that are dictated by the physicochemical properties of PLGA and product manufacturing processes. Approaches to overcome these challenges and hurdles are highlighted specifically with respect to drug encapsulation and release." @default.
- W4220785098 created "2022-04-03" @default.
- W4220785098 creator A5008157013 @default.
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- W4220785098 creator A5041468266 @default.
- W4220785098 creator A5061411213 @default.
- W4220785098 creator A5078077536 @default.
- W4220785098 date "2022-03-11" @default.
- W4220785098 modified "2023-10-05" @default.
- W4220785098 title "Challenges and Complications of Poly(lactic-co-glycolic acid)-Based Long-Acting Drug Product Development" @default.
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