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Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development


Lim, Yi Wen and Tan, Wen Siang and Ho, Kok Lian and Mariatulqabtiah, Abdul Razak and Abu Kasim, Noor Hayaty and Abd. Rahman, Noorsaadah and Wong, Tin Wui and Chee, Chin Fei Chee (2022) Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development. Pharmaceutics, 14 (3). art. no. 614. pp. 1-21. ISSN 1999-4923


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.

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Additional Metadata

Item Type: Article
Divisions: Faculty of Biotechnology and Biomolecular Sciences
Faculty of Medicine and Health Science
Institute of Bioscience
DOI Number: https://doi.org/10.3390/pharmaceutics14030614
Publisher: MDPI
Keywords: Poly(lactide-co-glycolide); Drug delivery; Sustained release; PLGA microspheres; Long acting injectable/implantable; Complex generic drug products
Depositing User: Ms. Nur Faseha Mohd Kadim
Date Deposited: 21 Sep 2023 08:05
Last Modified: 21 Sep 2023 08:05
Altmetrics: http://www.altmetric.com/details.php?domain=psasir.upm.edu.my&doi=10.3390/pharmaceutics14030614
URI: http://psasir.upm.edu.my/id/eprint/100651
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