Varnish chemical migrates into medicine bottles, says study
pharmafile | November 24, 2010 | News story | Manufacturing and Production |Â Â AAPS, HDPE, chemical migration, varnishÂ
A chemical found in the varnish coating of pharmaceutical bottles has been show to migrate into the contents and be deposited on tablets carried within, according to research presented at last week’s American Association for Pharmaceutical Sciences meeting in New Orleans.
While the compound in question is not thought to pose a risk to patients at the levels detected in the study, the findings suggest drugmakers should consider chemical migration carefully when selecting primary and secondary packaging components.
The study was reported at AAPS in a poster by Deanna Williamson, a scientist at contract pharmaceutical development and manufacturing services company Metrics.
While analysing stability data of a particularly potent drug stored inside a plastic (HDPE) bottle Williamson discovered the presence of benzophenone, a compound that is often used in the varnish coating of a bottle’s label.
Williamson said that hardly any material in the world is considered truly impermeable, and the phenomenon of chemical migration into medicines is well established.
However, “in this situation, the active ingredient was an agent that needed to be measured using an especially sensitive analytical method,” she said.
“Someone making a typical over-the-counter (OTC) drug product may not employ the same sensitive level of testing. So it’s probable that the levels of benzophenone present in those products would go undetected during the course of routine stability monitoring.”
Benzophenone itself is not thought to be dangerous – has been routinely detected in food products, including cereals – and in the food industry is thought to originate from carton board as a residue from inks and lacquers used to print on the packaging.
One 2006 study found that 17% of food samples tested positive for the chemical, prompting industry groups in Europe to recommend that use of inks containing benzophenone and a related chemical 4-methylbenzophenone (4-MBP) should not be used for printing of food packaging unless a functional barrier is present that blocks the transfer into the contents.
“These compounds may have been present all along [in pharmaceuticals] but, unless you’re looking past a milligram level, you won’t see them,” said Williamson.
“At a minimum, this research could impact one’s choice of label varnish, especially in potent products.”
Phil Taylor
Related Content
The Association of American Physicians & Surgeons sue FDA to end restrictions on hydroxychloroquine, despite evidence it can be life threatening
The Association of American Physicians & Surgeons have filed a lawsuit against the FDA due …
Pharma outsourcing recovering, but tough times are ahead
There are signs that outsourcing in the pharmaceutical sector is staging a comeback after a …
