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      Quality by design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery

      , , , , , ,  
      International Journal of Pharmaceutics
      Elsevier BV

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          Abstract

          <p class="first" id="d6794608e125">Adopting the Quality by Design (QbD) approach in the drug development process has transformed from "nice-to-do" into a crucial and required part of the development, ensuring the quality of pharmaceutical products throughout their whole life cycles. This review is discussing the implementation of the QbD thinking into the production of long-acting injectable (LAI) PLGA/PLA-based microspheres for the therapeutic peptide and protein drug delivery. Various key elements of the QbD approaches are initially elaborated using Bydureon®, a commercial product of LAI PLGA/PLA-based microspheres, as a classical example. Subsequently, the factors influencing the release patterns and the stability of the peptide and protein drugs are discussed. This is followed by a summary of the state-of-the-art of manufacturing LAI PLGA/PLA-based microspheres and the related critical process parameters (CPPs). Finally, a landscape of generic product development of LAI PLGA/PLA-based microspheres is reviewed including some major challenges in the field. </p>

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          Author and article information

          Contributors
          Journal
          International Journal of Pharmaceutics
          International Journal of Pharmaceutics
          Elsevier BV
          03785173
          July 2020
          July 2020
          : 585
          : 119441
          Article
          10.1016/j.ijpharm.2020.119441
          32442645
          4124ef27-901c-4954-a536-589a7ca33f47
          © 2020

          https://www.elsevier.com/tdm/userlicense/1.0/

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