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

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 pertain...

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Main Authors: Lim, Yi Wen, Tan, Wen Siang, Ho, Kok Lian, Mariatulqabtiah, Abdul Razak, Abu Kasim, Noor Hayaty, Abd. Rahman, Noorsaadah, Wong, Tin Wui, Chee, Chin Fei Chee
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Published: MDPI 2022
Online Access:http://psasir.upm.edu.my/id/eprint/100651/
https://www.mdpi.com/1999-4923/14/3/614
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spelling my.upm.eprints.1006512023-09-21T08:05:33Z http://psasir.upm.edu.my/id/eprint/100651/ Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development Lim, Yi Wen Tan, Wen Siang Ho, Kok Lian Mariatulqabtiah, Abdul Razak Abu Kasim, Noor Hayaty Abd. Rahman, Noorsaadah Wong, Tin Wui Chee, Chin Fei Chee 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. MDPI 2022-03 Article PeerReviewed 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 https://www.mdpi.com/1999-4923/14/3/614 10.3390/pharmaceutics14030614
institution Universiti Putra Malaysia
building UPM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Putra Malaysia
content_source UPM Institutional Repository
url_provider http://psasir.upm.edu.my/
description 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.
format Article
author Lim, Yi Wen
Tan, Wen Siang
Ho, Kok Lian
Mariatulqabtiah, Abdul Razak
Abu Kasim, Noor Hayaty
Abd. Rahman, Noorsaadah
Wong, Tin Wui
Chee, Chin Fei Chee
spellingShingle Lim, Yi Wen
Tan, Wen Siang
Ho, Kok Lian
Mariatulqabtiah, Abdul Razak
Abu Kasim, Noor Hayaty
Abd. Rahman, Noorsaadah
Wong, Tin Wui
Chee, Chin Fei Chee
Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development
author_facet Lim, Yi Wen
Tan, Wen Siang
Ho, Kok Lian
Mariatulqabtiah, Abdul Razak
Abu Kasim, Noor Hayaty
Abd. Rahman, Noorsaadah
Wong, Tin Wui
Chee, Chin Fei Chee
author_sort Lim, Yi Wen
title Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development
title_short Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development
title_full Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development
title_fullStr Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development
title_full_unstemmed Challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development
title_sort challenges and complications of poly (lactic-co-glycolic acid)-based long-acting drug product development
publisher MDPI
publishDate 2022
url http://psasir.upm.edu.my/id/eprint/100651/
https://www.mdpi.com/1999-4923/14/3/614
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score 13.211869

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