TheMarketForIdeas

It is around 7 AM, little Jim has just been woken up by his mom. He can distinguish clatter of softly gyrating gears from rain taping at his windowsill. There was no reason to focus more on those everyday sounds especially because he heard the same demand again “Can you come to breakfast, finally?” When he gets to the table, he spots his medicines, like usually, little and “zero” shaped. He has problems with swallowing the bigger ones. While looking at them he could spot little difference between layers. The bluish part is preventing him from epilepsy attacks that he has been suffering for years, the other one is navy blue; he was told that those were vitamins. On social media, he saw some anti-medicine printers posts again. That those are causing Down Syndrome or something, he is not about to read this till the end, in his mind is only one thing: if it was not for the 3D printed heart that his father received after the heart attack, they would have never played football again, never hug again and have no more breakfasts together. 

To be able to judge how far away mankind is from this story, let’s go back to Charles Hull, the creator of additive technology. The idea was firstly born in 1980 under the name of “stereolithography”. This might be considered as an example of a solution that came out before problems were fully framed and maybe without estimating where this technology could lead. But it was only a matter of time until multiple methods of 3D printing and opportunities to use them appeared.

An important step in spreading additive technologies was the year 2006, when two different 3D printers were released as open-source. This breakthrough opened the door for everyone (who was curious or passionate enough) to create his/her own device. Nowadays, additive technologies are used by the army, in architecture, in the construction industry, in culture/art, and are becoming more and more popular in scientific research. In the military, 3D printers are used as a quick-repair system because the technology already allows printing not only for complicated and detailed structures, but also for sturdy ones such as gear teeth. By this process, the army engineering maintenance is able to obtain the part that is needed, much faster, through the use of the 3D printing, instead of waiting for it to come through the supply chain. On the other hand, for artists, 3D printers are a new way to express their vision. Another example is medicine where additive technologies are used to create denture prosthetics that can be personalised. And this is the area where 3D printers can show their true power: personalization. By reducing the effort needed to create personalized products, one can make those cheaper and more accessible. 

The first 3D printed medicine 

Four years have passed since the FDA (United States Food and Drug Administration) approved the first 3D printed drug. The pioneer is Spritam, a medicine used to treat epilepsy. This medicine, a different form of Levetiracetam, was invented by Aprecia Pharmaceuticals. There are reasonable indicators that this idea was not only a marketing move.

To understand the need for 3D printing medicines, it is necessary to look at it from a patient’s point of view. The trouble that the majority of people have with drugs is the right dosage. In the scenario in which a huge quantity of a certain substance is needed, producers have two options. One is to create a big pill, with all the ingredients included. The main advantage would be the fact that a patient would not need to take them multiple times per day, which decreases the chance of forgetting about ingesting one or confusing the number of scheduled pills. As well, children or senior people might have problems with swallowing them because of their size. The problems change when the manufacturer decides to produce a drug in a small size. The technology used by Aprecia Pharmaceuticals opened the gate to the third option. One of the printing methods allows the spreading of the medicine powder in a narrow layer. By repeating this process, the pill is created. According to the manufacturer, the polymer used in these pills, after contact with water, completely dissolves in 11 seconds. This allows swallowing the medicine comfortably if sipped with water. Moreover, the pill will not get stuck in the oesophagus. It is still difficult to state that Spritam has revolutionized the market, but it might encourage other developers to choose the 3D printing direction. Aprecia Pharms has showed the potential of additive technologies. The drug they have developed is gaining popularity by its immense advantage – it is really easy to swallow. As this medicine is still expensive in comparison to Levetiracetam, the “general public” may not be so keen to buy it.

Because 3D printing is a relatively new tool in medicine, there are numerous sceptics with respect to using this technology. It is currently used to make bones, cells, eyeglasses, veins and new developments appear almost daily. Scepticism is commonly attributed to the costs of additive technologies. Mankind is not proficient in this as much as it is, for example, in processing steel. Lack of knowledge and experience in a certain field also carries uncertainty. On the other hand, the huge number of DIY (“do it yourself”) enthusiasts who are trying to build their own versions of 3D printers believe that everything can be created by it. Even though the additive technologies are still being developed and their limitations are not known yet, some constraints have already been encountered.

Professor Simon Gaisford and his team encountered difficulties with printing the drug that was about to help the patients with high blood pressure. After tests, it emerged that one of the substances seemed to… disappear. As researchers announced, it was most probably caused by a reaction between the amlodipine (the substance that was undetectable) and the polymer. Also, the high temperature which is frequently used in additive technologies might affect substances used in printing the drugs.

As one team is working on a drug that reduces high blood pressure, the other one is trying to make that pressure to appear. By printing a… heart. In April 2019 BIOLIFE4D proved that 3D printers were far from their potential by developing a smaller printed version of a heart that had the same cellular structure as a human one. So far, medicine may benefit from 3D printing in the field of creating implants, prosthetics or the reconstruction of the face. Even though humanity still has to wait for the first 3D printed organ transplant, this is already a huge step forward. 

What about home printing? 

Scientists are looking for possibilities to implement additive technologies in pharmacies, to allow some kind of drug personalisation there. The problem with home printing lies in its regulation. It is difficult for all drug companies to change their developing direction towards 3D printing medicines. It would be also a huge loss in control over medicines, if everyone would be allowed to print their own drugs, even if by using only specialized or ratified elements. Thus, companies will be unlikely to give up on producing drugs by themselves. But there might be other ways of using this idea of quickly making personalized medicines. For example, in hospitals doctors and specialists might be able to create perfectly dosed and formed pills to reduce the odds of complications. Of course, there will be a need to test the medicine before giving it to the patient. The other reason of using additive technologies is shown in the picture below which presents the supply chain for drugs in comparison with and without 3D printing. 

The graph is simplified and does not contain each step of medicine in both routes. Still, the idea is to show that the final product can be made right before giving it to the patient, and multiple steps might be unnecessary. Also, shortening the supply chain affects transportation costs decisively. Instead of transporting medicines from a factory, this process can be done directly in the area where the very demand arises. Moreover, the costs of storage are diminished. The shorter supply chain is also more reliable by limiting chances for a mishap to appear. 

Conclusions 

So far, the competition in the field of 3D printing drugs or other medical products is not even in its infancy. But there is nothing to prevent additive technologies from finding their permanent place in medicine. But this will not mean that we could/should consider ourselves self-educated and self-employed physicians of pharmacists. Or should we? 

References: 

Aprecia Pharmaceuticals, LLC: https://www.spritam.com.

Aprecia Pharmaceuticals, LLC, (09/2018) Full prescribing information: Spritam.

1. Lee Ventola, (2014), Medical Applications for 3D Printing: Current and Projected Uses, Pharmacy and Therapeutics.

FDA, A Drug Supply Chain Example: From Supplier to Patient: https://www.fda.gov/media/81739/download.

White, V. (2015), FDA Approves First Ever 3D Printed Drug Product: Spritam, European Pharmaceutical Review.