Challenges in Development of Nanoparticle-Based Therapeutics
TL;DR: Challenges likely to be encountered during the development and approval of nanoparticle-based therapeutics are summarized, and potential strategies for drug developers and regulatory agencies to accelerate the growth of this important field are discussed.
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Abstract: In recent years, nanotechnology has been increasingly applied to the area of drug development. Nanoparticle-based therapeutics can confer the ability to overcome biological barriers, effectively deliver hydrophobic drugs and biologics, and preferentially target sites of disease. However, despite these potential advantages, only a relatively small number of nanoparticle-based medicines have been approved for clinical use, with numerous challenges and hurdles at different stages of development. The complexity of nanoparticles as multi-component three dimensional constructs requires careful design and engineering, detailed orthogonal analysis methods, and reproducible scale-up and manufacturing process to achieve a consistent product with the intended physicochemical characteristics, biological behaviors, and pharmacological profiles. The safety and efficacy of nanomedicines can be influenced by minor variations in multiple parameters and need to be carefully examined in preclinical and clinical studies, particularly in context of the biodistribution, targeting to intended sites, and potential immune toxicities. Overall, nanomedicines may present additional development and regulatory considerations compared with conventional medicines, and while there is generally a lack of regulatory standards in the examination of nanoparticle-based medicines as a unique category of therapeutic agents, efforts are being made in this direction. This review summarizes challenges likely to be encountered during the development and approval of nanoparticle-based therapeutics, and discusses potential strategies for drug developers and regulatory agencies to accelerate the growth of this important field.
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From Bench to Bulk: Exploring In-Line Homogenization for Scale-Up and Continuous Production of Vesicular Systems
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References
Toxic Potential of Materials at the Nanolevel
TL;DR: The establishment of principles and test procedures to ensure safe manufacture and use of nanomaterials in the marketplace is urgently required and achievable.
•Journal Article
Long-Circulating and Target-Specific Nanoparticles: Theory to Practice
TL;DR: The surface mechanisms, which affords red blood cells long-circulatory lives and the ability of specific microorganisms to evade macrophage recognition, are explored and the rational approaches in the design as well as the biological performance of such constructs are assessed.
3.6K
Regulation of transport pathways in tumor vessels: Role of tumor type and microenvironment
Susan K. Hobbs,Wayne L. Monsky,Fan Yuan,W. G. Roberts,Linda G. Griffith,Vladimir P. Torchilin,Rakesh K. Jain +6 more
TL;DR: Delivery may be less efficient in cranial tumors than in subcutaneous tumors, delivery may be reduced during tumor regression induced by hormonal ablation, and permeability to a molecule is independent of pore cutoff size as long as the diameter of the molecule is much less than the pore diameter.
2.5K
Polymer conjugates as anticancer nanomedicines
TL;DR: There is growing optimism that ever more sophisticated polymer-based vectors will be a signficant addition to the armoury currently used for cancer therapy.
1.9K
•Journal Article
Vascular Permeability in a Human Tumor Xenograft: Molecular Size Dependence and Cutoff Size
Fan Yuan,Marc Dellian,Dai Fukumura,Michael Leunig,David A. Berk,Vladimir P. Torchilin,Rakesh K. Jain +6 more
TL;DR: Tumor vessels in the model found that tumor vessels in this model were permeable to liposomes of up to 400 nm in diameter, suggesting that the cutoff size of the pores is between 400 and 600nm in diameter.
1.8K