Let me confess that I’ve always found the technology behind 3D printers baffling. It sometimes seems that we have the replicator from Star Trek with us already.
I can just about grasp (I think) the printing of guns and other such devices but how in the name of sanity can a 3D printer print a drug?
The article mentions that, “the pill is made by printing layers until the correct dosage is reached.” But layers of what? Molecules? Or are the constituents of the drug somehow packaged with the printer? (In which case there seems little point in the process, you may as well just purchase the drug itself.)
I’m clearly missing something here. By what magic can the printer come up with the drug? Could any drug be produced with the right instructions? Where do the active constituents come from? It hardly seems credible they could be downloadable, but nothing would surprise me these days.
I don’t think they mean that it’s something users will 3D print at home, just that the company will use 3D printing technology (or something like it) to manufacture it. Then people will buy it like they would any other drugs.
Well, this BBC article suggests to me that you have to have the drug to start off with, but that 3d printing is a different way of producing the pill than the traditional way pills are manufactured, which could lead to the same dose in a smaller, easier-to-swallow pill.
It’s the latter idea you had that’s correct, that the drug is manufactured traditionally and mixed with the feedstock, and I would mostly agree that it is pointless, certainly it isn’t all it has been hyped as.
That said, creating molecules and nanoscale structures atom by atom has been done in labs, and it can do some amazing things. Where it falls short is that it can’t be done at the speed and scale necesarry for it to qualify as a manufacturing process instead of a crafting technique. I don’t think it’s possible to actually predict when such a technique will be invented, since its so hard to create parrallels with anything else humans have done, but it’ll be the end of an era and the beginning of a new one when it does.
Depending on the drug I can see it having a specific point. My ex-wife was epileptic and I was around when she transitioned from a dose of phenobarbital that could sedate a horse thanks to one of the newer, at the time, drugs. Over-medicating came with increasing chances of serious side effects. Under-medicating came with occasional seizures which prevented her from being able to do things like drive. Cutting pills for a custom dose was something her doctor avoided because of the risk of varying the dose each time. There’s less ability to customize dosage when there’s only a couple sizes available.
I can see a customized dosage pill being awesome for situations like that.
See, I get that, but I’m still thinking mostly useless. The reason why is that you’re dealing with two extremely stringent precision requirements and and a contamination issue and they all seem concerning to me. The first is the consistent dosage of the drug within the substrate, especially if it’s being mixed on site by a pharmacy tech. We’re talking about very small amounts of active material, and given that they have varying characteristics when mixing them, you’re going to have to do enormous amounts of testing to ensure there won’t be any sort of settling or other degredation. The second is with regards to the printer they’re using- is it accurate enough to dose the pills correctly without creating massive chunks no one can swallow? What about years from now, when it has printed millions of pills and the head is experiencing wear? Are we sure we can hold the machines in every pharmacy consistently to the same specs as in factories?
And lastly- do we expect pharmacies to have seperate printers for every drug? Because if not the cleaning of the device becomes an unavoidable issue if we want to keep people from getting trace (or not so trace) amounts of potentially dangerous substances.
Pills might not be perfect, but we are talking about working out the kinks for an entirely new process for distributing drugs and I’ve only heard of one potential upside to justify putting people’s lives at risk. Maybe you disagree and think it’s totally worth it, but I can’t help but wonder if perscribing multiple smaller dose pills might not be the more obvious answer to the problem you’re attempting to address.
I have considerable experience in 3-D printing of prototype consumer products and medical instruments since ordering my first 3D part in 1988. Also training in basic physiology. “3-D Printing like Star Trek” as presented to the public in the last 5 years is still pretty much a high tech gimmick.
In the 60’s, one method of dosing LSD was to clip the ends from a book of matches, dip the remaining stubs in a solution of LSD. then the user could dose the drug by chewing on one match stub at a time. A similar thing could be done through 3D printing. An array of liquid “drug dots’ could be printed on a surface giving very fine control of the dosage by the number of dots. If you look at a printed page closely you see dots – think about this size. This finely controlled liquid dispensing is known technology both in chemistry and inkjet printing. Dot layers could be layered with an inert filler to create pills.
I could see that this could be done successfully but the process seems very expensive. Some 3-D printer designs use 2 or more materials for various reasons. Let one of these materials be a sugar base for pills and the second be the drug. Perhaps a pharmacy tech gets a vial of drug solution or adds a solvent to vial already containing a bit of powder(?) to create a low-concentration solution. Between cleaning, priming, and flushing the machine maybe 90% (?) of the solution is lost – wasted. Maybe the vial/print-nozzle is a disposable part of the printer. I do think it could be done but I’m not sure a pharmacist would want the expense, hassle, and responsibility. A dilute liquid that’s taken in large dose accomplishes a similar thing – it’s still up to the pharmacist to get the dosage correct and the patient must take it responsibly.
Personally I think this is some Phd. researcher becoming enamored with a technology but having no clue about product development.
It’s a new materials handling process, that produces materials in a form characteristic of the new process. In this case, that means it has an uneven, but regular structure: the fact that the pill is made up of different little dots, instead of one homogenous mass, seems to be an advantage.
Pharmaceutical chemist Derek Low covers it here(at his blog’s new home)
Basically, this solves the problem of how to make a fast dissolving version of a drug that needs to be given in big horse pill doses (250 - 1000 mg).
And note that the news is for FDA approval. This particular formulation must have gone through years of industry-funded development, and review by the FDA. It ain’t some easily-dismissed idea invented by a grad student who said “I dunno, 3d printers?” on their thesis proposal. It might be a gimmick, but it’s a gimmick that a lot of people think will be profitable, safe, and effective.
Share the scepticism of other posters - Bespoke formulation sounds like a real advance, but is 3-D printing the answer? It’s ball-achingly slow in this context and must be very costly relative to large scale, trad formulation methods. It would work if you had one in your own kitchen for personal formulation use, but that is probably stymied for the time being with regulatory issues.
To the OP - you can never ‘print’ a drug from raw materials using a 3-D printer. It is possible, however, to use continuous flow processing to synthesise something very quickly, which could then be fed into an in-line printer to formulate it (in the case of a drug). Chemistry machines are quite in vogue at the moment wrt future-thinking in the field.
A state of the art example is ibuprofen in 3 minutes starting from bulk chemicals. Doing this right now this takes millions of dollars of equipment and world-leading expertise [Jamison lab, MIT]. The chemistry is simple in principle, but adapting it to a 3-minute drug-producing black box is an enormous technical challenge. Not unreasonable, though, to think that this could become more routine to the point of consumer units in the future.
Call me cynical, but I don’t see how you could set up a flow operation of an API direct to formulation and still have the control to pass specs and prove GMP control. I suppose it could be done with enough testing and history, but at that point I’d expect traditional techniques to be cheaper.
My personal wish was to have enough money to just get my morning handful of pills simply put into a couple capsules … between a couple of my meds that I have to take multiple small dose pills of [because god forbid they make and carry a .5 mg clonidine … so I get to take a .2 and a .3 … or a couple other meds I take multiples of in different dosage sizes to make up my proper dose. sigh] I would kill to take say 2 caps and a 1000 mg metformin instead of 9 pills and a metformin.
I would also love to get my victoza in vial and syringe instead of the damned pen. I am not an idiot, I can actually draw a proper dose and inject myself. I always get the damned feeling I am not actually getting a full dose until I have dosed enough to finally see the damned plunger and see the liquid in the pen going down in an actually large enough amount. At least I can still get insulin in the damned vial - I said screw it when I had 3 different pens in 2 months malfunction in various ways [from 2 different production batches] and started having my doc write me vial and syringe again.
[And I can’t be the only one that brings my own damned meds with me to the hospital and has my husband monitor my glucose and pass me my meds on schedule instead of waiting for someone to get around to bringing it whenever they have a moment. Especially after reading about the place that was sharing freaking pens between patients :eek:]
I’m afraid I cannot add to the discussion although I find it interesting, but I did want to thank Busy for adding “ball-achingly slow” to my vocabulary.
That’s no doubt true at this point in time, but it’s early days. Long term, if flow processing and bespoke formulation continues to develop then it will challenge the whole regulatory framework of how we make and administer pharmaceuticals.
There could be more immediate applications in the developing world - The logistics of distributing medicine in poor and remote areas is seriously challenging. I’ve heard it said (prob in a talk from a flow group) that even if we invented a malaria drug tomorrow, we’d still be faced with a collossal logistical nightmare in actually giving it to people that need it. Rapid, portable, on-site manufacture has to have some relevance in thinking about these problems.
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I’m afraid I cannot add to the discussion although I find it interesting, but I did want to thank Busy for adding “ball-achingly slow” to my vocabulary.
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You’re most welcome
I envision a 3-D printing technology someday, in which we pre-load three source-material tanks full of protons, neutrons, and electrons, respectively, and the proceed to 3-D print anything we want from that.
Building materials from raw supplies of various quarks will be the next step.
it’s not a chemical printer. Just making a matrix of the stuff so it can dissolve quickly. NOTHING new. No different than freeze-dried instant/rapid release orally disintegrating medications that have been around a very long time now, since at least 1993: Zydis - Wikipedia. This is just a new way to get a new patent to charge more for an old drug. In a rational society it wouldn’t even be patentable.
