More then 30 nanomedicine has been approve by FDA and in clinical practice. How they overcome the challenges such as large scale production, toxicity issues, instability in body or storage conditions etc which are the hurdles for commercialization of new experimental nanomedicine. My question is then how the approved nanomedicine overcome the mentioned challenges?
The main issue is nanotoxicity due to insolubility at physiological pH. You overcome this by a thorough preformulation. Everything else is similar with all other APIs (stability, degradation, processability, etc.).
That is true for any formulation. Here it comes the skills and knowledge of the scientist.
By compatibility, path and fate of nano in vivio. If the sources are biologically and the nano-products also have bio-structure like chitosan, alginate, CMC,..etc., they are very safe and compatible. If the sources are metallic, they should be small size, coated, concentrations that do not affect the body, no have any toxicity to the body and easily disposed of with urine. Carbon nanotubes have been found to be compatible with the body and washing out with urine and can be functionalised with appropriate therapeutic substances.
Dear Muhammad Naeem,
The biocompatibility, biodegradability, physiological insolubility in body serum, smart drug delivery, stability in theirs formulation are the most important challenges in nanomedicine.
Off target accumulation of nanomedicine such as in the liver, spleen is a major concern for clinical translation of Nanomedicine.
However, this crisis is prominent for some of the nanedicines not applicable for all.
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