By Rady Ananda
To clean up its drugs that are contaminated with genotoxic ingredients (which are also carcinogenic), Big Pharma may deploy lab-created, nanosized, polymer-based scavengers.
But is the cure any safer?
New research explains that:
A variety of chemical compounds, intermediates, and reagents are used during the process of synthesizing active pharmaceutical ingredients (APIs). Some of these chemicals, intermediates, and reagents, as well as byproducts of synthetic processes, can have toxic properties and be present as impurities at low levels in the API or final drug formulation….
The kinetics of acrolein scavenging in the presence of the API iodixanol and the scavenging capacity of resins were demonstrated in this paper.
They found a nanopolymer so efficient it cleans up 97.8% of acrolein without eating the active pharmaceutical components.
Yum… drugs with nanobots.
“Pharmaceutical genotoxic impurities may induce genetic mutations, chromosomal breaks, or chromosomal rearrangements, and have the potential to cause cancer in human,” lead researcher Ecevit Yilmaz told In-PharmaTechnologist. “Therefore, exposure to even low levels of such impurities present in the final API may be of significant toxicological concern.”
Research began in earnest after the European Medicines Agency issued its Guideline on the Limits of Genotoxic Impurities in 2006, which set the limit at 1.5m/day under the Threshold of Toxicological Concern (TTC):
A TTC value of 1.5 μg/day intake of a genotoxic impurity is considered to be associated with an acceptable risk (excess cancer risk of <1 in 100,000 over a lifetime) for most pharmaceuticals.
The US Food and Drug Administration followed suit in 2008.
Some nanopolymer scavengers are more or less selective in their activity, the team discovered, based on polymer structure. “Less cross-linked ones showed an ‘undesired high level of nonspecific binding to the API’,” meaning they readily eat the good properties of the drugs, and who knows what else.
In a 2008 study, mesoporous silica nanoparticles (MSNs) were also found to “restore damaged cell membranes and ameilorate abnormal mitochondrial behavior induced by” genotoxins (like acrolein). “MSNs modified with drug/polymer constructs provide significant neuroprotection to cells damaged by a usually lethal exposure to acrolein.”
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