<p>Pharmaceutical packaging plays a crucial role in maintaining product quality, ensuring safety, and enhancing patient usability. However, the application of Quality by Design (QbD) principles in packaging development remains limited, particularly in defining critical quality attributes (CQAs). A framework proposes, unlike existing QbD applications that focus on formulation and product stability, to evaluate packaging material attributes, addressing emerging challenges like patient-centric functionality and sustainability through risk-based and AI-enhanced methodologies. This approach aims to ensure regulatory compliance and enhance patient adherence through user-friendly designs and supports sustainability goals. Future research in pharmaceutical product development needs to collaborate with industry stakeholders and adopt cross-functional approaches to integrate packaging early in the product lifecycle.</p> Graphical Abstract <p></p>

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Implementing Quality by Design to Address Emerging Challenges and Future Trends of Pharmaceutical Packaging Development

  • Azhoma Gumala,
  • Nurul Febrina,
  • Adhitya Jessica,
  • Uswatul Hasanah

摘要

Pharmaceutical packaging plays a crucial role in maintaining product quality, ensuring safety, and enhancing patient usability. However, the application of Quality by Design (QbD) principles in packaging development remains limited, particularly in defining critical quality attributes (CQAs). A framework proposes, unlike existing QbD applications that focus on formulation and product stability, to evaluate packaging material attributes, addressing emerging challenges like patient-centric functionality and sustainability through risk-based and AI-enhanced methodologies. This approach aims to ensure regulatory compliance and enhance patient adherence through user-friendly designs and supports sustainability goals. Future research in pharmaceutical product development needs to collaborate with industry stakeholders and adopt cross-functional approaches to integrate packaging early in the product lifecycle.

Graphical Abstract