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Small review: safety evaluation in clinical transformation of nanodrugs

wallpapers News 2020-12-23

with the rapid development of nanotechnology a series of functional nano drugs emerge as the times require. The rapid accumulation of relevant knowledge can predict that mankind will usher in the spring of nano drug transformation research. However in order to realize the clinical application of nanodrugs safety evaluation safety issues involved in the design use of nanodrugs are important considerations for clinical transformation. In the latest review (small 2020 2000673) Professor Meng Huan of UCLA Dr. Liu Xiangsheng Dr. ZEV Wainberg of cancer center summarized prospectively analyzed the safety evaluation of tumor nanodrugs based on the traditional nano safety research drawing on the experience of liposome clinical transformation research combining with their own research results.

articles first take three successful cases of liposomes as entry points namely Doxil (doxorubicin liposome; approved in 1995) onivyde (irinotecan liposome; approved in 2015) vyxeos (cytarabine / daunorubicin liposome; approved in 2017) focusing on the safety issues involved. In short the safety / toxicology data of liposome encapsulated chemotherapeutic drugs are significantly different from that of small molecule drugs which are reflected in target organs toxic mechanism clinical adverse events. Then the author summarized the biosafety evaluation of emerging nanomaterials tumor drug carriers focused on the safety data of ind (investigational new drug) or early clinical research (such as auro shell). The authors of

point out that some frontier disciplines such as nanotoxicology provide important theoretical experimental basis for ind oriented safety assessment. This paper outlines the workflow of "nanomaterial characterization high-throughput cell level research pharmacokinetics in vivo ADME toxicity evaluation evaluation management of clinical adverse reaction events". In addition the author also summarized prospectively analyzed the scientific problems to be solved in the safety of nanodrugs. These include: different ADME characteristics toxicological mechanisms between nanodrugs traditional drugs safety consistency efficacy differences caused by differences in nanodrug macro preparation specifications design of ind oriented stardized safety evaluation specifications new nano safety evaluation methods (such as lab-on-a-chip) correlation between toxicological results of experimental animals adverse reactions in human body And differences.

finally the author shared the research experience of the research group in the development of phospholipid coated nano mesoporous silica carrier (silicasome) (Fig. 1). Compared with traditional liposomes silicone liposomes have great advantages in drug loading tumor targeting stability biological safety. For example this system has an excellent performance in reducing the toxic side effects of combined chemotherapy (such as folfirinox). In the past few years the team has designed synthesized optimized mass produced (~ 100g / batch) irinotecan silicone liposomes which have achieved success in the treatment of pancreatic colon cancer models (ACS Nano 2016 10 2702; ACS Nano 2019 13 38). The team also designed verified the adjuvant therapy of silicone liposome by means of transcytosis activation for tumor microenvironment so as to further improve its efficacy biological safety (J. Clin. Invest. 2017 127 2007; theranostics 2019 9 8018). It is worth mentioning that irinotecan silicon carrier has greatly improved the safety of such drugs such as bone marrow toxicity diarrhea is expected to become a "new generation" liposome aiming to carry out more safe effective nano tumor treatment.


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