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FDA Approves First 3D-Printed Drug Tablet

Posted by Soulskill on from the will-take-seven-hours-per-pill dept.

An anonymous reader writes: The U.S. Food and Drug Administration has for the first time approved a 3D-printed pill for human consumption. The printing technique allows higher and more precise dosages to be layered into a smaller tablet size. This is an early step toward a new method of drug distribution. Right now, pills are made in a factory and shipped to hospitals. With 3D printers, hospitals could simply store a bulk supply of the drug in a pure form, and then print out tablets — containing whatever dosage they desire — as they need them. If patients needs to increase or decrease their dosage, the hospital can do so without changing the appearance of the pills, which could help those with memory impairments.

9 of 64 comments (clear)

  1. Not going to move the needle. by Anonymous Coward · · Score: 4, Insightful

    The technology to create bespoke pills exists already, major barriers to hospitals incorporating compounding pharmacies today include cost, regulations, and liability, none of which are addressed by this technology.

    1. Re:Not going to move the needle. by Penguinisto · · Score: 4, Informative

      Actually, those aren't impossible hurdles.

      cost would likely be way less than some of what a hospital buys (e.g. a CT machine), and it could pay for itself over time like any other machine - amortization is your friend in that department. Liability is handled as well, since hospitals (and even their in-house pharmacies in particular) often have to insure against potential drug-related liabilities anyway (misdiagnosis, mislabeling, adverse drug interactions, improper storage procedures, etc).

      Now *regulations* are gonna be the big hurdle... no idea what the FDA (or non-US equivalents) are going to demand, but if you think about it, there isn't much difference between this technology and what a pharmacy does right now with compounding, save for the 'on a computer' aspect (well, machinery too, but you get the idea).

      --
      Quo usque tandem abutere, Nimbus, patientia nostra?
    2. Re:Not going to move the needle. by Dragonslicer · · Score: 2

      That's just it, it's NOT much different than conventional compounding, so what's the big attraction? It will have the same regulatory problems, the same liabilities, etc. But it WILL cost more and add complexity, so there's that in it's "favor".

      The key question is the reliability and accuracy of this printing method. If there are fewer mistakes with this method than there are with current methods, the liability problem should decrease.

  2. Precision by invictusvoyd · · Score: 2

    The printing technique allows higher and more precise dosages to be layered into a smaller tablet size.

    Are we talking 0.1 mg precision here? because I seriously doubt dosage is calculated in fractions of milligrams . It is usually calculated in mg/kg of body weight. Besides, wont it be slower to print than to stock ? I imagine printing 100 doses .

    1. Re:Precision by Rich0 · · Score: 2

      This article was remarkably sparse on details, but I suspect that this is part of some huge manufacturing process analogous to 3D printing, done on an industrial scale. So, the tablets might be built in layers 10,000 at a time over a timespan of a minute or two, or something like that.

      It seems like this short article is really two shorter articles in one. There is the specific product approval, which I suspect is for large scale manufacture (but I'm not certain of that), and then some general speculation about some in-the-hospital technology.

      Also, the summary speaks of making tablets identical so that patients aren't confused. That seems a bit odd to me since the whole point of making pills look different is so that patients aren't confused. I know somebody who is on numerous medications and when they spill their pill organizer it is quite a task to try to sort things out and get them right again, since pills are hard enough to tell apart as it is.

      You could argue that this technology would let you make 1 super-pill tailored to the individual that they could take once a day and not have to take 14 different medications. That makes sense on paper, but in reality from talking to people who take lots of pills many of them end up tweaking their schedules. They'll take some pills before eating, others after, some at different times, they might split some and take them at multiple times instead of once. While I'm sure there isn't clinical data to back this up, when it comes down to individuals sometimes there is a need for flexibility. True, many patients abuse this flexibility to their detriment, but if these patients were given the choice of a take-it-or-leave-it super pill I suspect most would take it, and the first time they get a stomach ache or a leg cramp or whatever they'd just stop taking it.

    2. Re:Precision by DickBreath · · Score: 2

      > You could argue that this technology would let you make 1 super-pill tailored to the individual

      All the drugs a person needs. Maybe a custom morning pill, and evening pill.

      Next advance: custom print the pills at home using a device you pick up at your pharmacy. Your doctor remotely updates your prescription.

      Next advance: hackers remotely update your prescription.

      --

      I'll see your senator, and I'll raise you two judges.
  3. The real purpose? by mark_reh · · Score: 4, Interesting

    Vicodin used to be hydrocodone/APAP 5/325 until the FDA said that the APAP portion should be lowered to 300 mg. So Vicodin gets reformulated to 5/300 and the price goes up. If I follow FDA guidelines and write a prescription for hydrocodone/APAP 5/300 my patient has a substantial out of pocket cost because the pharmacy has to give them name brand Vicodin. If I write the prescription for 5/325, they can use generic which insurance covers fully, or if they are uninsured costs $5-10.

    I suspect that the repackaging has more to do with maintaining the high price than the performance of the medication when packaged by a 3D printer.

  4. Re:Change the dosage without changing looks... by Dragonslicer · · Score: 2

    I can think of other applications for changing someone's dose without them being aware of it. In fact, you could slip them a custom printed pill that looks just like the rest of the pills in their bottle. Extra Credit: consider the implications of custom 3D printing Drug A in Drug B's clothing. (Pill for Drug A looks like it is a pill for Drug B.)

    Your unstated assumption is that access to these printers is the only thing stopping people from doing illegal things like murdering a patient in a hospital. I am not convinced that your assumption is correct.

  5. Re:Change the dosage without changing looks... by dtml-try+MyNick · · Score: 2

    I work with elder mentally disabled patients and chances in medication can be quite stressful for them. "I ALWAYS have two of those pills, why do I need to take three pills now?" or "This does not look like the medication I usually get, I don't trust this, I'm not taking this!"

    It confuses them and at times it can be quite a struggle to get them accustomed to a new medication schedule. So I can see the advantage of changing the dose without changing the appearance or quantity of the pills.

    However, even though that can be very annoying I'm more worried about me being able to quick and clearly tell the difference in pills and dosage.....

    --
    Life starts at the end of your comfort zone.