Navigating translational research in nanomedicine: A strategic guide to formulation and manufacturing.

in International journal of pharmaceutics by Xinyue Zhang, Ho Wan Chan, Zitong Shao, Qiyun Wang, Stephanie Chow, Shing Fung Chow

TLDR

  • Nanomedicines have great potential but face significant challenges in getting from research to market, due to manufacturing issues and translational gaps.

Abstract

Over the past two decades, extensive research has focused on both the fundamental and applied aspects of nanomedicine, driven by the compelling advantages that nanoparticles offer over their bulk counterparts. Despite this intensive research effort, fewer than 100 nanomedicines have been approved by the U.S. Food and Drug Administration and the European Medicines Agency since 1989. This disparity highlights a substantial gap in translational research, reflecting the disconnect between the prolific research in nanomedicine and the limited number of products that successfully reach and sustain themselves in the market. For instance, the nanomedicine DepoCyt, which received FDA approval in 1999 for the treatment of lymphomatous meningitis, was discontinued in 2017 due to persistent manufacturing issues. To address similar translational challenges, this review aims to identify and analyse issues related to the formulation design and manufacturing of nanomedicines. It provides an overview of the most prevalent manufacturing technologies and excipients used in nanomedicine production, followed by a critical evaluation of their clinical translatability. Furthermore, the review presents strategies for the rational formulation design and optimization of nanomedicine manufacturing, adhering to the principles of quality-by-design and quality risk management.

Overview

  • The study aims to identify and analyze issues related to the formulation design and manufacturing of nanomedicines.
  • It provides an overview of the most prevalent manufacturing technologies and excipients used in nanomedicine production.
  • The review aims to address the translational challenges in nanomedicine development, highlighting the gap between research and product commercialization.

Comparative Analysis & Findings

  • The review highlights the limited number of nanomedicines approved by regulatory agencies, despite extensive research in the field.
  • The manufacturing issues with DepoCyt, a nanomedicine approved in 1999, led to its discontinuation in 2017, exemplifying the translational challenges.
  • The study provides evidence of the disconnect between nanomedicine research and product development, emphasizing the need for optimal formulation design and manufacturing strategies.

Implications and Future Directions

  • The review highlights the importance of quality-by-design and quality risk management principles for nanomedicine manufacturing and formulation design.
  • The study suggests strategies for rational formulation design and optimization of nanomedicine manufacturing to address translational challenges.
  • Future research directions could focus on addressing the remaining translational gaps in nanomedicine development and exploring novel manufacturing technologies and excipients.
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