FDA just approved the first 3D-printed drug

[meshaliuknits]

This buzz has been going around the office. It's really interesting. I'd LOVE to see their submission paperwork.


Graphs, video and sources at the link.

Why it matters that the FDA just approved the first 3D-printed drug

www.washingtonpost.com/news/innovations/wp/2015/08/11/why-it-matters-that-the-fda-just-approved-the-first-3d-printed-drug/

For the first time ever, the FDA has approved a 3D-printed prescription pill for consumer use. This 3D-printed pill, which will sold by Aprecia Pharmaceuticals under the name Spritam, could be used by the more than 3 million adults and children in America who suffer from certain types of seizures caused by epilepsy. This 3D printing innovation could have far-ranging implications for the pharmaceutical industry for several reasons.

First, it means that we could see the 3D printing process used to create drugs that are easier to consume and more effective to use as part of a regular medication schedule. “By combining 3D printing technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,” according to Don Wetherhold, CEO of Aprecia.


As a result of Aprecia’s proprietary 3D printing process known as the ZipDose Technology platform, the physical composition of the Spritam pill can be made more porous than typical pills, meaning that it dissolves almost instantaneously when added to a liquid. It literally melts in your mouth with just a sip of water or other liquid, making it easier to swallow. Aprecia refers to these new 3D-printed pills as “fast-melt,” to differentiate them from tablets and capsules.

Moreover, since the active ingredients are being added via 3D printers, Aprecia Pharmaceuticals has the ability to offer high dosages up to 1,000 mg with the knowledge that every dose will be exactly the same. That implies that we could soon seen the introduction of bespoke medications and drugs that have been customizable for specific patients and users – no more of the one-size-fits all approach to medication. With 3D printing, each dosage can be individually measured and then printed.

Later, that development could potentially lead to the biggest breakthrough of all – a tectonic shift in the way patients and doctors think about medicine. In a 2012 TED Talk, Lee Cronin of the University of Glasgow describes a new approach to 3D printing that could potentially enable patients to print their own medicines at home. What’s needed, he explains, is a universal set of “chemical inks” as well as a way to 3D print the lab instruments and these chemical inks at the same time. In essence, this would let 3D printers catalyze the chemical reactions in order to print drugs at the point of need.

As a result, the pharmaceutical industry could eventually witness a transition from prescriptions to algorithms. Doctors could hand off an algorithm for patients to go print at home on a 3D printer rather than jotting down “take 2 and call me in the morning” on a sheet of paper. These algorithms would include information about the set of chemical inks needed to print the medicine as well as the molecular blueprints.

3D printing might also lead to big shifts in pharmaceutical R&D, making it cheaper because the whole process of testing drugs would become more efficient. While the home 3D printing of drugs may not be possible any time soon, it might be possible to 3D print sample tissues and organs for drug testing purposes. Imagine testing out drugs on 3D human organs instead of on animals or synthetic models. And 3D printing might allow for new types of compounds and medications, based on new geometries and configurations made possible with 3D printing.

Of course, the big wildcard in all this is the approval process of the FDA. Yes, this is the same FDA that sometimes gets blamed for the long process of bringing new drugs to market quickly and efficiently. Add in the “gee whiz” aspect of 3D printing, and it’s easy to see potential regulatory nightmares facing other FDA approvals.

Yet, the FDA seems remarkably open to the idea of 3D printing, even while it acknowledges that the regulatory hurdles could be considerable. Even before it approved the 3D printed pill, the agency had already approved the first 3D printed prosthetic. And, last year, the FDA held a workshop on 3D printing for medical device makers, which can be viewed as an encouraging signal to continue on the same 3D printing path.

Aprecia Pharmaceuticals, the company that pioneered the concept of the 3D-printed pill, has already received more than 50 patents related to pharmaceutical applications for 3D printing, and has promised to bring new neurological drugs to market that are made via 3D printing. As Don Wetherhold, CEO of Aprecia, points out. “This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”

We may never do away with the need for the corner pharmacy to fill prescriptions – but 3D printers could fundamentally change the way patients take certain types of medicine. 3D printers could make possible a world of bespoke medicine in which patients play an active role in bringing their own custom-designed pills to market.

[meshaliuknits]

Aug 31, 2015 15:53:31 GMT -5 pt716 said:

"Later, that development could potentially lead to the biggest breakthrough of all – a tectonic shift in the way patients and doctors think about medicine. In a 2012 TED Talk, Lee Cronin of the University of Glasgow describes a new approach to 3D printing that could potentially enable patients to print their own medicines at home. What’s needed, he explains, is a universal set of “chemical inks” as well as a way to 3D print the lab instruments and these chemical inks at the same time. In essence, this would let 3D printers catalyze the chemical reactions in order to print drugs at the point of need."

This is cool, but I am skeptical about the above. Chemistry is more complicated than "mix some things together." What about the purification steps?

I would assume the "chemical inks" would go through the purification process prior to getting to the 3D printer. It seems plausible that this would be sufficient for tablets. But injectibles? IDK how they would be sterile enough to be OK for injection.


Also, I wonder if drug products susceptible to abuse would be allowed to be printed at home. Depending on how the APIs are combined in the "inks" and how hard they'd be to separate back out, that seems like it could be a good way to start a new business, Breaking Bad style. But that's waaaaaay off in the future.

[meshaliuknits]

Aug 31, 2015 16:07:42 GMT -5 pt716 said:

Aug 31, 2015 16:01:48 GMT -5 meshaliuknits said:

I would assume the "chemical inks" would go through the purification process prior to getting to the 3D printer. It seems plausible that this would be sufficient for tablets. But injectibles? IDK how they would be sterile enough to be OK for injection.


Also, I wonder if drug products susceptible to abuse would be allowed to be printed at home. Depending on how the APIs are combined in the "inks" and how hard they'd be to separate back out, that seems like it could be a good way to start a new business, Breaking Bad style. But that's waaaaaay off in the future.

When he was talking about the printers catalyzing chemical reactions, it sounds like they are talking about basically having a set of reagents and then you would program the printer to mix specific ones to create the drug. Maybe I am reading that wrong.

I think the printing is cool, I just don't know how I feel about the drug synthesis happening at home.

I'm right there with that. I don't trust people to read the instructions on that thing.

I read it that way, too, but I'm wondering if it's gonna be a set of single ingredient reagents, a 1 to 1 thing, or combinations. Two premixed reagents in a single tube or whatever the hell you put 3D printer "ink" in. 

[meshaliuknits]

Aug 31, 2015 16:14:38 GMT -5 mryrcn said:

This is so interesting.

Mesh out of curiosity are you in Emeryville?

I used to work in Emeryville, but I'm a couple of cities over now. Why?

[downtoearth]

I thought this was amazing when I heard about it a monthish ago. I actually ended up talking to a friend with a seizure issue and she scoffed it off. I was surprised and asked her why and she said that canabis oil has been through more studies and has less side effects than this new, super expensive, 3D drug and yet she can't use it bc it's illegal in our state. Plus she says she already spends $2k per month out of pocket on her seizure meds and when she looked into this it was not readily available and likely more expensive.

It's disappointing that treatments are out there and novel, but still not realistic to be used by most people.

[readyin07]

Fascinating. I am a dinosaur so the at home method sounds like something our of a bad sci fi. I can't see 3d printers accessible and without a major margin of error for the common user but who knows. Seems like anything is possible

[LadySusan]

Aug 31, 2015 16:14:01 GMT -5 meshaliuknits said:

Aug 31, 2015 16:07:42 GMT -5 pt716 said:

When he was talking about the printers catalyzing chemical reactions, it sounds like they are talking about basically having a set of reagents and then you would program the printer to mix specific ones to create the drug. Maybe I am reading that wrong.

I think the printing is cool, I just don't know how I feel about the drug synthesis happening at home.

I'm right there with that. I don't trust people to read the instructions on that thing.

I read it that way, too, but I'm wondering if it's gonna be a set of single ingredient reagents, a 1 to 1 thing, or combinations. Two premixed reagents in a single tube or whatever the hell you put 3D printer "ink" in. 

I'm right here with you guys on the chemical synthesis.  Sorry WaPo, that's not how any of this works.

Basically this company figured out a way to make really hole-ey horse pills that melt in your mouth because really solid horse pills are a pain to swallow.  And then they patented it and got the FDA's blessing.  So now this company is going to take their 3D printing technology and go looking for other horse pills that would be improved by this technology.

I don't really see 3DP pill creating machines making their way into people's homes.  Maaaaaybe they would be useful in a compounding pharmacy that makes custom medications.  Compounding is ridiculously expensive and human error is a problem so having a $500,000 robot/printer do it might actually make sense.