I've googled through internet, and all I found was "what expiration dates mean". I found nothing about the underlying mechanism of expiration.
As drugs are chemicals, why do they expire? Are there chemical reactions that produce other chemicals?
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6Chemicals and food break down.– paparazzoCommented Nov 15, 2017 at 11:57
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1This was already asked at the Chemistry.SE (not that there's anything wrong with asking it here, I thought I'd just point it out) ;-)– paracetamolCommented Nov 15, 2017 at 15:59
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1All things that expire are chemicals. Further more all things are chemicals.Being chemicals or not has no bearing on whether or not things expire. (well not being chemicals means it doesn't exist so renders any question of expiration null)– Frames Catherine WhiteCommented Nov 16, 2017 at 1:55
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@LyndonWhite - energy exists, but I wouldn't necessarily call it a "chemical". Some forms of it come from chemical reactions, but some don't. And a lonely photon flying through the universe isn't really a chemical in my view.– DavorCommented Nov 16, 2017 at 10:10
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Energy (including photons) are not "things" in my mind. (though my bracketted section isn;t clear)– Frames Catherine WhiteCommented Nov 16, 2017 at 13:26
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2 Answers
Drug molecules, even when stored safely inside a tablet\capsule, inside a closed container, upon a high shelf (hopefully), are still exposed to the environment, and are thus exposed to all of the chemical processes and reactions that go about all around us (to name just a few - oxidation, hydrolysis, isomerization, polymerization, and more). Depending on the type of drug molecule and its functional groups, the molecule may undergo all kinds of chemical processes that may change its structure and\or properties.
Therefore, drugs (and foodstuffs, as mentioned in the comment above) degrade and decompose over time, and are thus given an expiration date to indicate that after a certain amount of time, the drug's manufacturer strongly recommends to avoid using the product.
An important remark should follow: the expiration date refers to the entire pharmaceutical product, i.e. the formulation, and not just the active ingredient. It is absolutely possible that the active ingredient will remain stable for a long time, but some inactive ingredient (excipient) in the tablet\capsule\syrup will have undergone some decomposition that may render the product ineffective, or even worse, toxic.
A quick Google search for "drug decomposition" or "drug degradation" yields many useful results for further reading. To name just a few:
Understanding the chemical basis of drug stability and degradation
Drug degradation (Slideshare presentation)
Pharmaceutical degradation (Slideshare presentation)
And here's a non-scientific article addressing the issue from another angle: That Drug Expiration Date May Be More Myth Than Fact (might be an interesting read for you as well)
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1Thank you so much. Why would a drug have inactive ingredient?– asmaniCommented Nov 15, 2017 at 14:09
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8@Asmani To make sure the active ingredient gets where it should (capsules), to decrease concentration of active ingredient, to make the patient tolerate the drug. You could go ahead and ask that as a new question, it is a good one.– NarusanCommented Nov 15, 2017 at 14:25
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6"The non-scientific article" is actually a well researched joy to read. I wanted to add a tidbit – but it's already in there. You might add more from that. // This expiration date is indeed an indicator of well meant and necessary regulation that's gone bad itself, leading to massive waste. Commented Nov 15, 2017 at 14:35
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What do they add in drug tablets when the amount of the drug is too small, like 1 mg Clonazepam?– asmaniCommented Nov 15, 2017 at 18:10
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4@LangLangC That's true. For prescription drugs, it's often the prescription that expires before the drug itself actually expires and this can cause legal complications. For example, where I live, if you have some prescription pain killers left over (say, from a minor surgery when you didn't end up needing to take all of them,) if you have some other need for them come up later, it's illegal to take them after the prescription expiration, even though the drugs themselves may still be fine.– reirabCommented Nov 15, 2017 at 20:54
Beside Don_S's very detailed answer I want to point out a few other things: At least in my country, drugs are not only synthetic chemical drugs. Drugs can also be biological or contain other non synthetic chemical substances. Examples are:
- Early versions of what is now known as "Aspirin" was gained from the plant Meadowsweet.
- Some preventive antivirus drugs contain weak forms of the real virus
- Some of the drugs are or contain a mixture of oils and fats. They can go bad the same as for example butter after some time. Some of them have such a short life time that they are directly produced on demand in the drug store and will expire after few days or weeks.
It is hard to produce under such steril conditions and packaging that it is ensured that it will not get polluted for decades.
Another reason might be that the storage life was tested/is known for a limited amount of time and cannot be guaranteed for a longer timespan.
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Welcome to HealthSE! This looks like a very interesting answer. Please take the tour and read the help-docs to get to know ths site. While this comment doesn't judge your answer (imho it's going somewhere)please be aware of the site policy to provide reliable references to backup an answer, so that anyone can check the validity of it. Commented Nov 15, 2017 at 23:04
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@LangLangC I am sorry I can't provide better sources than Wikipedia because I have my knowledge from non-English printed medical/chemical books and course-material in the laboratory I worked.– H. IddenCommented Nov 18, 2017 at 0:05