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.
Highlights
Equivalent Q1/Q2 as the reference listed drug (RLD) does not mean that generic Poly(lactic-co-glycolic acid) (PLGA)-based long-acting injectable/implantable (LAI) drug products have the same in vitro or in vivo pharmacokinetic profiles as RLD, owing to the sameness potentially being derived from the test methods of differing protocols [16]
PLGA- and polylactic acid (PLA)-based polymers have been exploited for the delivery of a broad class of APIs, including small-molecule drugs, proteins, peptides, and nucleic acids, covering a wide range of treatments listing from cancers, endocrine disorders, psychiatric illnesses, to periodontal diseases [25]
Realising the challenges faced in developing generic PLGA-based long-acting drug products, both the pharmaceutical industry and drug regulatory authorities are required to work together closely to overcome these problems
Summary
25 PLGA-based long-acting drug products, all in the injectable or implantable forms, have been approved by the FDA (Table 1) [6]. These PLGA-based LAI drug products are relatively expensive for most patients [2]. Pharmaceutics 2022, 14, 614 off-patent or non-exclusive, no generic version of these drug products is available in the market [7,8] This situation suggests that it is difficult to develop generic PLGA-based long-acting drug products that involve complex formulations and manufacturing processes. It is difficult for the generic pharmaceutical industry to replicate existing PLGA-based LAI drug products
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