Many drugs fail in development due to safety problems. A study indicates that impurities in the non-active ingredients may sometimes be to blame. According to lead researcher Daniel Weinbuch from Leiden University:
“We found that sugar excipients themselves contain nanometer-sized particles, which can damage proteins and make drugs unsafe. These nanoparticle impurities in sugar could even trigger the immune system itself.”
Obviously, drug companies need to learn about this problem and find sugar manufacturers who can make pure products.
It’s unfortunate that this problem exists, but it also holds out the possibility that some drugs that were previously thought to be unsafe could actually be safe. If so, it would be time to restart the development process.
The academic paper (Nanoparticle Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations) was published in Pharmaceutical Research.
December 15, 2016