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Medicines have long consisted not only of the active ingredient, but also to a large extent of additives.
After a knee operation, a listener to the SRF consumer magazine “Espresso” has to take a painkiller: 600 milligrams of the active ingredient ibuprofen. So far so pain free. But now the man has a question: “I would like to know what other substances you are taking with the tablets.” Because the active ingredient is probably only a small part of a drug.
Auxiliaries and additives predominate
The man guesses correctly: “Modern medicinal substances are being developed in such a way that fewer and fewer active ingredients are needed,” says Michael Arand, Professor at the Institute of Toxicology and Pharmacology at the University of Zurich
It would not be possible to achieve the volume of a tablet without excipients.
“These are microscopic particles. You wouldn’t be able to reach the volume of a tablet without excipients.”
This is also confirmed by Enea Martinelli, chief pharmacist at the FMI hospitals (Frutigen, Meiringen, Interlaken) and vice-president of the Pharmasuisse association of pharmacists: “So that you can, for example, take five milligrams of an active ingredient at all, you need a kind of packaging around it.”
Starch, Lubricant, Titanium Dioxide
The most common additives include adhesives in the form of starch, such as corn starch. They ensure that a tablet holds together. “Depending on the active ingredient, a film is also needed to correct the taste,” says Enea Martinelli.
If the drug is only to take effect in the intestine, it needs a protective layer so that the active ingredient is not already released in the stomach.
This is done, for example, with very bitter active ingredients. “And if the drug is only to take effect in the intestines, it needs a protective layer so that the active ingredient is not already released in the stomach.”
Michael Arand from the University of Zurich adds: “Substances are also needed that facilitate the industrial production of tablets.” These are lubricants such as magnesium stearate that prevent the tablets from sticking to the surfaces of the machines. A common and controversial additive is the whitening agent titanium dioxide, which is no longer allowed in food. The question of whether the substance should also be banned in medicines is currently being hotly debated in Switzerland and abroad.
Compulsory declaration for three years – actually
If you look at the package inserts for common medicines, you can quickly get the idea that additives do not have to be specified in detail. There is only the Latin note “Excipiens pro compresso obducto” for numerous medicines. Freely translated, this means something like: It simply has everything in it that is needed for production.
This labeling is only permitted until the end of 2024, because excipients and additives in medicines have actually had to be declared since January 1, 2019. One speaks of the so-called full declaration. However, a transitional period of five years applies to pre-existing drugs.