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The journey of nanocrystals from laboratory innovation to clinical application marks a groundbreaking advancement in drug delivery and therapeutic development. By enhancing drug solubility, bioavailability, and targeted delivery, nanocrystals provide effective solutions to persistent pharmacological challenges. However, the journey from lab-scale synthesis to clinical utilization is complex, requiring rigorous optimization and adaptation at every stage. This chapter explores the essential methodologies and technological innovations enabling this translation, including scalable synthesis, surface engineering, and advanced formulation strategies designed to retain nanocrystal stability and bioactivity. Critical regulatory and industrial challenges, such as compliance with Good Manufacturing Practices (GMP), quality control, and formulation reproducibility, are thoroughly examined, along with innovative strategies that address these barriers. The text also highlights successful case studies where nanocrystal-based drugs have achieved clinical success, providing insights into the translational hurdles they overcame. By detailing both the scientific and regulatory milestones necessary for clinical integration, this chapter offers a roadmap for researchers aiming to advance nanocrystal-based therapies from bench to bedside, illuminating the pathways for future innovations that bridge nanotechnology and medicine.

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Translating Nanocrystals from Lab Scale to Clinical Applications

  • 章节

  • 发表日期：

    2026年

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  • Niveditha Manne,
  • Vishal Labhade,
  • Vaibhav Dhumal,
  • Pooja Khade,
  • Sourabh Tapekar,
  • Bhavana Gajare,
  • Anitha Sriram,
  • Anish Dhuri,
  • Ankur Sharma,
  • Pankaj Kumar Singh

摘要

The journey of nanocrystals from laboratory innovation to clinical application marks a groundbreaking advancement in drug delivery and therapeutic development. By enhancing drug solubility, bioavailability, and targeted delivery, nanocrystals provide effective solutions to persistent pharmacological challenges. However, the journey from lab-scale synthesis to clinical utilization is complex, requiring rigorous optimization and adaptation at every stage. This chapter explores the essential methodologies and technological innovations enabling this translation, including scalable synthesis, surface engineering, and advanced formulation strategies designed to retain nanocrystal stability and bioactivity. Critical regulatory and industrial challenges, such as compliance with Good Manufacturing Practices (GMP), quality control, and formulation reproducibility, are thoroughly examined, along with innovative strategies that address these barriers. The text also highlights successful case studies where nanocrystal-based drugs have achieved clinical success, providing insights into the translational hurdles they overcame. By detailing both the scientific and regulatory milestones necessary for clinical integration, this chapter offers a roadmap for researchers aiming to advance nanocrystal-based therapies from bench to bedside, illuminating the pathways for future innovations that bridge nanotechnology and medicine.