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Designing of core–shell nanoconstructs has become a priority research goal nowadays with its very specific applications in biomedical fields. Basically, the optimization of the developed nanoconstructs is still in the developmental stage due to lack of in-depth understandings on the design and production of nanomaterials. Particle size distribution, shape, surface charge, and microstructures along with the stability of ligand-gated structures are important factors for their in vitro and in vivo performance. Particularly in cancer treatment, the involvement of nanotechnologies for the purpose of diagnosis followed by therapeutic (healing) purposes is considered as a most innovative and effective approach to compensate the limitations of conventional or existing chemotherapy such as non-efficacious (toxicity), undesirable drug distribution along with their unpredictable release. Core–shell nanoconstructs are made up of nanoparticles with specific ligands and are engineered with anticancer drugs to cross the main biological barriers and simultaneously to target the cancerous cells through intravenous route in order to obtain better therapeutic effect with reduced side effect. In-depth study of stability of these developed nanoconstructs in complex media, protein, and cell interaction will be required for their successful transformation to the preclinical and clinical prospects. Tailor-made nanoconstructs designed with explicit and accurate ligands help to invade cancer cells in a foreseeable manner by effectively delivering the drugs. So, nanoconstructs offer numerous benefits in cancer treatment; however, they possess numerous challenges, including the issues of nanotoxicity. To deal such formidable tasks, methods derived from artificial intelligence (AI) are being explored. Regulators also struggle with nanotoxicology and biological response. Regulatory agencies like US-FDA, MHRA, and the European Medicines Agency (EMA) also do not provide more specific direction. In this chapter, an overview of the development with commercialization, clinical applications, and the regulatory status as well as challenges to market authorization of nanoconstructs especially for cancer treatment is presented. This chapter emphasizes the chemotherapeutic linked to core–shell nanoconstructs.

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Clinical Applications and Commercialization Challenges of Core–Shell Nanoconstructs

  • 章节

  • 发表日期：

    2025年

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  • Snigdha Das Mandal,
  • Surjyanarayan Mandal,
  • Amitkumar K. Patel

摘要

Designing of core–shell nanoconstructs has become a priority research goal nowadays with its very specific applications in biomedical fields. Basically, the optimization of the developed nanoconstructs is still in the developmental stage due to lack of in-depth understandings on the design and production of nanomaterials. Particle size distribution, shape, surface charge, and microstructures along with the stability of ligand-gated structures are important factors for their in vitro and in vivo performance. Particularly in cancer treatment, the involvement of nanotechnologies for the purpose of diagnosis followed by therapeutic (healing) purposes is considered as a most innovative and effective approach to compensate the limitations of conventional or existing chemotherapy such as non-efficacious (toxicity), undesirable drug distribution along with their unpredictable release. Core–shell nanoconstructs are made up of nanoparticles with specific ligands and are engineered with anticancer drugs to cross the main biological barriers and simultaneously to target the cancerous cells through intravenous route in order to obtain better therapeutic effect with reduced side effect. In-depth study of stability of these developed nanoconstructs in complex media, protein, and cell interaction will be required for their successful transformation to the preclinical and clinical prospects. Tailor-made nanoconstructs designed with explicit and accurate ligands help to invade cancer cells in a foreseeable manner by effectively delivering the drugs. So, nanoconstructs offer numerous benefits in cancer treatment; however, they possess numerous challenges, including the issues of nanotoxicity. To deal such formidable tasks, methods derived from artificial intelligence (AI) are being explored. Regulators also struggle with nanotoxicology and biological response. Regulatory agencies like US-FDA, MHRA, and the European Medicines Agency (EMA) also do not provide more specific direction. In this chapter, an overview of the development with commercialization, clinical applications, and the regulatory status as well as challenges to market authorization of nanoconstructs especially for cancer treatment is presented. This chapter emphasizes the chemotherapeutic linked to core–shell nanoconstructs.