back to article Screw your cutesy plastic art tat, the US govt has found a use for 3D printing: DRUGS!

The US Food and Drug Administration (FDA) has granted its first-ever approval for a drug manufactured by 3D printing. The FDA told Aprecia Pharmaceuticals it could move forward [PDF] with the introduction of Spritam, an anti-seizure medication for people with epilepsy. The pill is set to go on sale in the US early next year. …

  1. Graham Marsden
    Thumb Up

    I have to admit...

    ... my first reaction of this was "WTF?" because it seemed to be a definite case of using a sledgehammer (or maybe a piledriver) to crack a nut, but as I read further and the reason for using this method to "print" a tablet, ie fast delivery of amounts of the drug which would normally take multiple tablets, I realised that actually it's a bloody neat idea.

    Well done for some creative thinking guys!

    1. deive

      Re: I have to admit...

      +1! Also some pills are absolutely huge, this could be used just to reduce the size of the bloody things!

      1. Fungus Bob
        Coat

        Re: I have to admit...

        "some pills are absolutely huge"

        Those ones aren't for you, they're for the horse...

    2. Nigel 11

      Re: I have to admit...

      Why is a gram of this drug packaged as a conventional pill so much larger than a 1 gram vitamin C or fish oil capsule? (I take these daily with no difficulty at all swallowing them).

      A good use for 3D printing might be time-release medication. Print a complex microstructure of cells with walls of different thicknesses containing a drug, that will release as a constant rate over 12 or 24 hours inside one's digestive system.

  2. JeffyPoooh
    Pint

    Next step...

    ...Figure out how to go back to something resembling traditional manufacturing, while maintaining the desired characteristics of the product, so that the big spinning machine can spit out 200 tablets a second, instead of "printing out" perhaps one tablet every minute.

    1. Nigel 11

      Re: Next step...

      But just how many do you have to 3D print each day to make the printing process profitable? (If the answer is a large number, increase the price.)

      Most pharmaceuticals have extremely high margin over manufacturing cost during their period on patent. On the flip side, they also have huge development costs to recoup, and the profit has to cover the development cost of a large number of other drugs which fail their clinical trials and never make it to market.

  3. decoherence
    Thumb Up

    William Gibson referred to this sort of thing in his (excellent) 2014 story The Peripheral. I wonder if he knew it was going on or if it's just more evidence of Gibson being a time traveller (I wouldn't be surprised by either case.)

  4. Andrew Tyler 1

    FDA

    Somehow I expect this is related more to milking more profits from a drug that's gone off patent than anything else. Is the 3D printed formulation patented? Almost certainly. Is it *really* so much better than the traditional tablets? It doesn't look like it's an emergency treatment for seizures so how important is this more rapid absorption? This isn't to say that the concept is unsound, and I suppose you gotta start somewhere and may as well make some money while you're doing it. It will only be evil if they start funding research aimed at "discovering" that the previous formulation is somehow dangerous and should be taken off the market, which has been known to happen.

  5. Doctor Syntax Silver badge

    1,000mg of levetiracetam? Might as well round it up to 1gm.

    1. J.G.Harston Silver badge

      Rounding error

      No, because then you lose accuracy. 1000mg is anything between 999.5mg and 1000.5mg. 1g is anything between 0.5g and 1.5g. Three magitudes of possible error. Are you willing to have a possible 50% overdose in your medication?

      1. JeffyPoooh
        Pint

        Re: Rounding error

        A person that knows about significant figures. Nice.

        Have a beer. And cheers.

        1. Nigel 11

          Re: Rounding error

          Except that I doubt whether a 200 mg Ibuprofen tablet is actually within half a milligram of that dose. There wouldn't be any point given that adult human body masses vary by a factor of two or more (depending on your definition of normal adult human). 200mg +/- 10% would be just fine. (Manufacturing accuracy is probably better than that without adding any cost). Scientists quote the amount without gratuitous extra digits, and the error separately. 1 gram or 1000 mg +/- 0.03g or 30mg is fine. 1000.0 mg +/- 30mg would be silly. 1000mg equals one gram and shouldn't imply anything about the error when no error is quoted.

          Drugs for which a 50% extra dose is dangerous are unusual, and require individual prescriptions based on a patient's body mass and/or metabolic variables, also careful ongoing monitoring for toxicity. An ideal drug hits its maximum therapeutic effect at one dose and doesn't become toxic until a much higher dose. Ibuprofen (which I know about) maxes out at around 2400mg per day (a doctor-prescribable dose) and doesn't usually have serious toxicity issues at considerably higher doses ... it's just useless to take more. A greater danger is the long-term effect on your body of the drug doing exactly what it is supposed to do (ie suppressing inflammation).

          Incidentally with many drugs (including Ibuprofen) it's safe to take a doubled first dose for a more rapid effect. That first dose finds your body "empty". When it's time for the next, half the original dose is still not present. The third dose finds a quarter of the first and half of the second ... Don't try this trick ("front-loading") without asking a doctor, or at least carefully checking the literature. There are exceptions.

  6. Stevie

    Bah!

    And given the low rate of production and high cost of manufacture I imagine this new medication will be affordable for all those who need it.

    Oh wait. This is America. Land of "the best health care system in the world".

    Which no-one can afford to access.

    Still, the Koch brothers and Donald Trump should be able to get it. That has to count for something.

    1. Mark 85

      Re: Bah!

      Nah... we got insurance for that. What? It's considered experimental? Nevermind... not covered so "Bah!" applies.

  7. phil dude
    Boffin

    alternatively...

    Dietary restriction (low carb, induced ketosis) was shown effective the 1920's.

    I've not read the clinical trial for this molecule, but I'll wager the dietary approach has fewer side-effects...

    I was very surprised when I read this article.

    P.

    1. Not That Andrew

      Re: alternatively...

      Epilepsy is an incredibly complicated subject. Yes, some may react favouraby to a ketogenic diet, many others don't and others it just makes the condition worse.

  8. i steal your leccy

    BREAKING BAD

    I suppose a 3D printer will be 'de rigueur' for any self respecting Meth Lab owner now?

  9. Anonymous Coward
    Anonymous Coward

    'Print your own Viagra'

    i want a 3D printer now:(

  10. Sleep deprived
    Alert

    Bad taste

    "Additionally, the liquid soluble pills, which disintegrate in 10 seconds, will allow epileptics who have trouble swallowing tablets or dislike the taste of liquid medicines to receive their medications."

    The powder in solution has a better taste?

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