Some inactive ingredients commonly found in medications may not be as inactive after all, according to a new study published today. The researchers found evidence in the laboratory that various ingredients, including certain dyes and preservatives, are capable of affecting proteins, receptors, and other parts of our biology, possibly in important and remarkable ways. The findings are not proof that these ingredients can harm people, but they do suggest that more research is needed.
Scientists looked at thousands of inactive ingredients, also known as excipients. They were examined for their potential to interact with or link to any number of molecular targets found in the cells of the body, including those that regulate our levels of important neurotransmitters like dopamine. Once they found something that could plausibly affect the body, they used two different methods in the laboratory to see if each of these excipients affected targets in human cells.
All in all, they identified 38 inactive ingredients that interacted with 44 different molecular targets. These included ingredients intended to be used as food dyes, preservatives, and didisinfectants, such as D&C red no. 28, propyl paraben and benzethonium chloride. meIn some cases, the level of activity they saw from these interactions is what you would expect to see from the active ingredients in some drugs. The team’s findings were published in science.
“We showed, at the molecular level, that some excipients modulate the activities of receptors important to human biology,” study author Brian Shoichet, a pharmaceutical chemist at the University of California, San Francisco, told Gizmodo.
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Although inactive ingredients have been considered inert chemicals that pass through the body without any effect, some research is beginning to question that assumption. Last year, for example, a study he found evidence that many ingredients are capable of triggering common food allergies or other hypersensitivity. This study seems to go further, highlighting various ingredients that can interact with the body in the way that the active ingredients are designed.
An example was thimerosal, a mercury derivative used in some adult vaccines and other medical products as an antimicrobial preservative. They found evidence that it could bind to certain dopamine receptors in the brain and intestine with activity high enough to cause a “plausible thimerosal physiological effect.” At the same time, they emphasized the lack of other evidence so far of any bodily effects of thimerosal, including the discredited link between vaccines and autism.
Last year’s study, as well as this new one, were intended only as proofs of concept, a way to draw attention to something that might be a problem but not necessarily one. Shoichet and his team don’t want anyone to panic or avoid taking medications because of the findings.
“We did not demonstrate that they are toxic, far from it, but it is an area where the field can improve,” Shoichet said. “What opens this document is a new direction of research. Start a conversation.
In fact, it is unlikely that most of the not-so-inactive ingredients that Shoichet’s team discovered could reach the types of molecular targets they identified, since most of the targets were found outside of the digestive system, where the drugs usually end. . Other experiments using the animals demonstrated that most of these chemicals did not reach the bloodstream in concentrations high enough to plausibly affect the body. That said, the situation may change under certain circumstances, such as a medication taken by injection. instead of like a pill (if the same inactive ingredients wereme used in both ways) orr in people taking multiple medications or having a leaky gut which allows drug ingredients leak into the bloodstream at higher concentrations.
The study was conducted in part with funds from the Food and Drug Administration and with the collaboration of the pharmaceutical company Novartis. Shoichet praised the FDA and Novartis for being willing to conduct this expensive study, knowing that the results could cause a headache. The results may eventually lead to some changes in the way their products and other companies’ medications are produced.
“Based on this initial work, we are analyzing the next steps to determine if any excipient that we currently use should be replaced,” co-author Laszlo Urban, the executive dDirector and global head of preclinical security profiles at the Novartis Institute for Biomedical Research, he told Gizmodo by email. “We will continue to be guided by science as we see how to potentially improve our medications. We believe this published research will also be useful to others in the industry. “
Shoichet, meanwhile, hopes people will continue to build on his team’s work.
“It would be great to test the inactive ingredients more extensively than we could afford, we just scratched the surface,” he said.
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