TY - JOUR
T1 - Current trends and challenges in the clinical translation of nanoparticulate nanomedicines
T2 - Pathways for translational development and commercialization
AU - Hua, Susan
AU - de Matos, Maria B.C.
AU - Metselaar, Josbert M.
AU - Storm, Gert
PY - 2018/7/17
Y1 - 2018/7/17
N2 - The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.
AB - The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.
KW - Biological
KW - Challenges
KW - Clinical translation
KW - Commercialization
KW - Drug delivery systems
KW - Nanomedicine
KW - Nanoparticles
KW - Regulations
UR - http://www.scopus.com/inward/record.url?scp=85050118384&partnerID=8YFLogxK
U2 - 10.3389/fphar.2018.00790
DO - 10.3389/fphar.2018.00790
M3 - Review article
AN - SCOPUS:85050118384
SN - 1663-9812
VL - 9
JO - Frontiers in pharmacology
JF - Frontiers in pharmacology
IS - JUL
M1 - 790
ER -