Print out starfish-shaped drugs for your child at home
Somewhere in the 2030s: Annie was called by the teacher of her daughter that she had a high fever and went with her to the school doctor. He told the girl that she had the flu, and it would be better for her to go home. He also prescribed some pills; and he was terribly sorry that he could not print them out himself, as they had a slight problem with the 3D printer and were waiting for the repair service.
The teacher also apologized to Annie due to the problem, but she reassured the educator that they also have a 3D printer at home. So, she could print out the necessary drug in the necessary dose in the shape of starfish, the favorite animal of her daughter. Annie just asked the teacher to send her information about the exact drug ingredients to see whether they have everything at home. If not, she could also drive to the nearest pharmacy and let them print out the tablets.
This scene is closer than you think. In August 2015, the FDA approved an epilepsy drug called Spritam that is made by 3D printers. It prints out the powdered drug layer by layer to make it dissolve faster than average pills. In June 2015, the UK’s Daily Mail reported that scientists from University College of London are experimenting with 3D printing drugs in odd shapes; such as dinosaurs or octopuses in order to make it easier for kids to take pills.
FabRx and the promise of point-of-care drug making
Those scientists, namely Professor Abdul Basit and Professor Simon Gaisford saw a huge potential in 3D printing for medicine and pharma; thus they established FabRx in 2014. They believe they will be able to commercialize printed tablets within the next 5-10 years. Alvaro Goyanes, director of development told me that currently the biggest challenge for 3D printing is not the technology itself, but rather the regulatory environment. He said that there are strict regulatory requirements in bringing pharmaceutical products to market; and regulators will need to adapt to and accept printing as a method of manufacture.
Although the technology also needs to be improved and more research is necessary in the field of new materials, 3D printing is a viable method for drug creation already today. Goyanes explained that they are able to print any kind of molecule or active selecting the appropriate technology, such as fused deposition modelling (FDM), powder bed printing or stereolithography (SLA). They are basically extruding extruding a water-soluble polymer mixed with acetaminophen and salts. There is no drug type posing them an invincible barrier. The most demanding molecules will be biologicals that are normally more unstable; in that case it is necessary to avoid high temperatures or other harsh conditions, he added.
Pyramid-shaped, 3D printed pills for more effective drug absorption
I was curious whether the drug creation process through 3D printing effects ingredients in any way; but Goyanes told me that it is exactly what they are trying to avoid. Their ultimate goal is to make the drug creation process predictable, calculable and thus safe from every regulatory point of view. In general, the raw material is placed in the printer, which just manufactures an object (in this case the printlet) with the right dose without changing the main characteristics of the given raw material. In some cases the printing process changes some properties of the drug (e.g. solubility). However, these changes are sometimes beneficially improving the medicines.
Not only the enhancement of the drugs themselves, but also a more effective drug absorption process could be the result of 3D printing. In May, 2015 Gizmodo reported that researchers of FabRx are experimenting with differently sized and shaped pills. They carried out a study, through which it turned out that a pyramid-shaped pill is absorbed by the body the fastest, while a cylinder-shaped pill takes much longer. Goyanes explained that here, the basic idea is that if you increase the surface in contact with the dissolution media, while keeping the volume of the printlet constant; you increase the drug release. This also means that selecting oddly shaped pills, such as unicorns, strawberries or starfish for that matter, is going to modify the surface in contact to the water changing the drug release. Researchers designing formulations have to keep that in mind.
Patients want easily swallowable pills, doctors see 3D printing far from the market yet
With 3D printing, it is also going to be possible to print out the exact doses of drugs. So, you would not have to take a pill two times a day for a week, but it would be enough to take only one during the whole period of your illness. However, the medical community have to figure out first, how patients would react to such an innovation. Is it better to only take one pill since patients will not forget it? Or is it better to swallow the medicine daily, since there is a regularity to the process?
In general, Goyanes believes that patients would not mind to have printlets, if they have the right traits. He assumed that they do not care that much about the technology that prepares their medicines; they want medicines to be easy to swallow and acceptable. FabRx is running panels with volunteers at UCL to evaluate the acceptability of placebo printlets with different shapes, sizes and colors; and the results are very promising, he added. Regarding the medical community, many clinicians consider 3D printing personalized medicines as a desired advance, but far from the market now. They are not used to this technology, because they have never seen a 3D printer working; and sometimes they are reluctant and skeptical, noted the director.
The first printers in less than 5 years in the hospitals for the first in situ trials
The skepticism of the medical community is understandable. At the moment not even the time and cost factors are favorable towards 3D printing. Goyanes told me that the technology is not cheaper than the traditional tableting machine. However, the clear advantage of 3D printing is in the personalization of doses, so as the need for it will increase, this difference will also gradually disappear.
And we do not have to wait so much for it. The team of FabRx plans to place the first printers in less than 5 year in the hospitals for the first in situ trials. They believe the technology will be available everywhere in 5-10 years. As Goyanes explained, the adaptation will be gradual and natural, not from one day to another; always complying with the strict regulation for medicines. But it means, that soon hospitals and community pharmacies (at least the big ones) will have printers. And patients will go there to collect their medications prepared specifically for them.
In the case of that future scenario in which your GP might e-mail your drug prescription to your 3D printer at home, Goyanes responded with caution. He believes that maybe for specific patients with very specific diseases it could be imaginable; but printing at home is definitely more complicated, because the process is not supervised by trained professionals, so it will take more than 10 years to introduce it.
Food for thought for regulatory agencies and governments
For FabRx to be able to commercialize 3D printed drugs on the market, it has to prove to market regulators that 3D printing technology is safe and sound; and a completely viable technology for hospitals and pharmacies. For me, it is already clear that the future is personalized medicine, thus personalized drug-making. So, I hope governments and regulatory agencies will also not go against the waves of technology.
But I believe that agencies with regulatory power have to prepare for the changes by familiarizing appropriately with new technologies and trends. Moreover, they have to introduce the appropriate checks and balances to the system based on their knowledge. Goyanes also believes that in the case of 3D printing, it is very important to have different mechanisms of quality control to avoid dose problems during printing or other issues that could affect the quality of medicines. He added that he does not want to imagine that situation either, in which 3D printing of medicines at the dispensing point is implemented first in countries with lower or no regulation; and after proved safe, years later, being accepted in Europe and the US. I totally agree with him on this.
3D printing drugs could positively impact the way drugs are created and distributed, as well as the efficiency of medical treatments. I truly believe it is the way to go for pharma. But we should keep in mind that safety and the proper regulatory environment comes first. So regulatory actors should act up in order to avoid situations, where DIY solutions come to the foreground.