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Pharmaceutics
Volume 14
Issue 3
10.3390/pharmaceutics14030614
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Review

Challenges and Complications of Poly(lactic-co-glycolic acid)-Based Long-Acting Drug Product Development

by
Yi Wen Lim
1,
Wen Siang Tan
1,2,
Kok Lian Ho
3,
Abdul Razak Mariatulqabtiah
2,4,
Noor Hayaty Abu Kasim
5,
Noorsaadah Abd. Rahman
6,
Tin Wui Wong
7,* and
Chin Fei Chee
8,*
1
Department of Microbiology, Faculty of Biotechnology and Biomolecular Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia
2
Laboratory of Vaccines and Biomolecules, Institute of Bioscience, Universiti Putra Malaysia, Serdang 43400, Malaysia
3
Department of Pathology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia
4
Department of Cell and Molecular Biology, Faculty of Biotechnology and Biomolecular Sciences, Universiti Putra Malaysia, Serdang 43400, Malaysia
5
Faculty of Dentistry, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur 50300, Malaysia
6
Institute for Advanced Studies, Universiti Malaya, Kuala Lumpur 50603, Malaysia
7
Non-Destructive Biomedical and Pharmaceutical Research Centre, Smart Manufacturing Research Institute, Universiti Teknologi MARA, Puncak Alam 42300, Malaysia
8
Nanotechnology and Catalysis Research Centre, Universiti Malaya, Kuala Lumpur 50603, Malaysia
*
Authors to whom correspondence should be addressed.
Pharmaceutics 2022, 14(3), 614; https://doi.org/10.3390/pharmaceutics14030614
Submission received: 13 January 2022 / Accepted: 19 February 2022 / Published: 11 March 2022
(This article belongs to the Special Issue Special Issue in Honor of Professor Carla Caramella)
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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.
Keywords: poly(lactide-co-glycolide); drug delivery; sustained release; PLGA microspheres; long acting injectable/implantable; complex generic drug products poly(lactide-co-glycolide); drug delivery; sustained release; PLGA microspheres; long acting injectable/implantable; complex generic drug products

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MDPI and ACS Style

Lim, Y.W.; Tan, W.S.; Ho, K.L.; Mariatulqabtiah, A.R.; Abu Kasim, N.H.; Abd. Rahman, N.; Wong, T.W.; Chee, C.F. Challenges and Complications of Poly(lactic-co-glycolic acid)-Based Long-Acting Drug Product Development. Pharmaceutics 2022, 14, 614. https://doi.org/10.3390/pharmaceutics14030614

AMA Style

Lim YW, Tan WS, Ho KL, Mariatulqabtiah AR, Abu Kasim NH, Abd. Rahman N, Wong TW, Chee CF. Challenges and Complications of Poly(lactic-co-glycolic acid)-Based Long-Acting Drug Product Development. Pharmaceutics. 2022; 14(3):614. https://doi.org/10.3390/pharmaceutics14030614

Chicago/Turabian Style

Lim, Yi Wen, Wen Siang Tan, Kok Lian Ho, Abdul Razak Mariatulqabtiah, Noor Hayaty Abu Kasim, Noorsaadah Abd. Rahman, Tin Wui Wong, and Chin Fei Chee. 2022. "Challenges and Complications of Poly(lactic-co-glycolic acid)-Based Long-Acting Drug Product Development" Pharmaceutics 14, no. 3: 614. https://doi.org/10.3390/pharmaceutics14030614

APA Style

Lim, Y. W., Tan, W. S., Ho, K. L., Mariatulqabtiah, A. R., Abu Kasim, N. H., Abd. Rahman, N., Wong, T. W., & Chee, C. F. (2022). Challenges and Complications of Poly(lactic-co-glycolic acid)-Based Long-Acting Drug Product Development. Pharmaceutics, 14(3), 614. https://doi.org/10.3390/pharmaceutics14030614

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