Facilitating the translation of nanomedicines to a clinical product: challenges and opportunities - PubMed

Affiliations

• PMID: 29406263
• DOI: 10.1016/j.drudis.2018.01.047

Review

Facilitating the translation of nanomedicines to a clinical product: challenges and opportunities

Vibhuti Agrahari et al. Drug Discov Today. 2018 May.

Abstract

There are numerous hurdles hindering the clinical translation of nanomedicines. The major challenges are: reproducible manufacturing and scale-up, availability of appropriate characterization methods, instability under in vivo environments, safety issues, poor understanding of the disease heterogeneity and patient preselection strategies, regulatory barriers and inadequate understanding of the biophysical and chemical interactions of nanoformulations. Thus, a better understanding of key physicochemical attributes and their characterization methods, in vivo behavior and the in-vitro-in-vivo characterization cascade of stability, safety and efficacy testing is needed to accelerate nanomedicine translation. Technologies such as quality-by-design, process analytical techniques and microfluidics could significantly accelerate the translation of nanomedicines. However, these approaches require further learning and an adequate regulatory background. Overall, to achieve an efficient clinical translation, collaboration among academia, industry and regulatory bodies is required to ensure safe and effective nanomedicine products. This review discusses the challenges and opportunities to facilitate the translation of nanomedicines to a commercial product.

Similar articles

• Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success.

  Coty JB, Vauthier C. Coty JB, et al. J Control Release. 2018 Apr 10;275:254-268. doi: 10.1016/j.jconrel.2018.02.013. Epub 2018 Feb 15. J Control Release. 2018. PMID: 29454063 Review.

• Challenges associated and approaches for successful translation of nanomedicines into commercial products.

  Agrahari V, Hiremath P. Agrahari V, et al. Nanomedicine (Lond). 2017 Apr;12(8):819-823. doi: 10.2217/nnm-2017-0039. Epub 2017 Mar 24. Nanomedicine (Lond). 2017. PMID: 28338401 Review. No abstract available.

• Current hurdles to the translation of nanomedicines from bench to the clinic.

  Đorđević S, Gonzalez MM, Conejos-Sánchez I, Carreira B, Pozzi S, Acúrcio RC, Satchi-Fainaro R, Florindo HF, Vicent MJ. Đorđević S, et al. Drug Deliv Transl Res. 2022 Mar;12(3):500-525. doi: 10.1007/s13346-021-01024-2. Epub 2021 Jul 23. Drug Deliv Transl Res. 2022. PMID: 34302274 Free PMC article. Review.

• Regulatory Considerations, Challenges and Risk-based Approach in Nanomedicine Development.

  Csóka I, Ismail R, Jójárt-Laczkovich O, Pallagi E. Csóka I, et al. Curr Med Chem. 2021;28(36):7461-7476. doi: 10.2174/0929867328666210406115529. Curr Med Chem. 2021. PMID: 33823761

• Nanomedicines and nanocarriers in clinical trials: surfing through regulatory requirements and physico-chemical critical quality attributes.

  Dri DA, Rinaldi F, Carafa M, Marianecci C. Dri DA, et al. Drug Deliv Transl Res. 2023 Mar;13(3):757-769. doi: 10.1007/s13346-022-01262-y. Epub 2022 Nov 30. Drug Deliv Transl Res. 2023. PMID: 36450964 Free PMC article. Review.

Cited by

• Nanoparticles in Clinical Translation for Cancer Therapy.

  Mundekkad D, Cho WC. Mundekkad D, et al. Int J Mol Sci. 2022 Feb 1;23(3):1685. doi: 10.3390/ijms23031685. Int J Mol Sci. 2022. PMID: 35163607 Free PMC article. Review.

• Drug delivery nanocarriers and recent advances ventured to improve therapeutic efficacy against osteosarcoma: an overview.

  Desai SA, Manjappa A, Khulbe P. Desai SA, et al. J Egypt Natl Canc Inst. 2021 Feb 8;33(1):4. doi: 10.1186/s43046-021-00059-3. J Egypt Natl Canc Inst. 2021. PMID: 33555490 Review.

• An Elucidative Review to Analytically Sieve the Viability of Nanomedicine Market.

  Kad A, Pundir A, Arya SK, Bhardwaj N, Khatri M. Kad A, et al. J Pharm Innov. 2022;17(1):249-265. doi: 10.1007/s12247-020-09495-5. Epub 2020 Sep 21. J Pharm Innov. 2022. PMID: 32983280 Free PMC article. Review.

• Nano based drug delivery systems: recent developments and future prospects.

  Patra JK, Das G, Fraceto LF, Campos EVR, Rodriguez-Torres MDP, Acosta-Torres LS, Diaz-Torres LA, Grillo R, Swamy MK, Sharma S, Habtemariam S, Shin HS. Patra JK, et al. J Nanobiotechnology. 2018 Sep 19;16(1):71. doi: 10.1186/s12951-018-0392-8. J Nanobiotechnology. 2018. PMID: 30231877 Free PMC article. Review.

• Nanotechnology as a Platform for the Development of Injectable Parenteral Formulations: A Comprehensive Review of the Know-Hows and State of the Art.

  Shetab Boushehri MA, Dietrich D, Lamprecht A. Shetab Boushehri MA, et al. Pharmaceutics. 2020 Jun 3;12(6):510. doi: 10.3390/pharmaceutics12060510. Pharmaceutics. 2020. PMID: 32503171 Free PMC article. Review.

Publication types

MeSH terms

LinkOut - more resources

• Full Text Sources

  • Elsevier Science

• Other Literature Sources

  • The Lens - Patent Citations Database
  • scite Smart Citations