Technology within 3D printing has seen what could almost be described as an exponential development rate over recent years and particularly within the medical field there is incredible interest in the potential that it has across a wide spectrum of uses and clinical specialities. This acceleration seems almost to be self-perpetuating and is only likely to increase in the near future.

The technique of 3D printing, also known as Additive Manufacturing (AM) is a process that allows the accurate reproduction of 3D objects via computerized technology. In incredibly simple terms this process takes place by sequentially and accurately laying down micro-thin layers of a wide variety of different materials and building the layers up little by little. The result of this robotically engineered activity is the accurate reproduction of a wide range of objects, which can literally consist of animal, vegetable or mineral depending on the material being used. Since the early 2000s 3D printing has made great advances and vast improvements in the technology have resulted in a wide range of developments across the medical field including tissue reproduction, development of sections of organs, and recreation of sections of the skeleton out of non-biological materials.

This use of 3D printing to recreate biological samples and tissues is known as bio-printing and is achieved by the exact same technique of creating layer by layer building blocks in standard 3D printing, however with the use of a gel medium. Living cells are cultured and inserted into the gel, or ‘bio-ink’ and the cell containing bio-ink is printed in the same fashion in order to create a copy cellular structure. Although there are many academic institutions researching and developing processes and technologies within 3D bio-printing, Organovo, a U.S.-based early stage regenerative medicine company was the first company to commercialize the bio-printing technology.

2012 saw the first publicized 3D bio-printed part of a skeleton used in a successful operation to restore an 83-year old ladies jaw following an infection, which resulted in the breakdown of the tissue, by generating titanium-based, articulated jaw and covering it in a bio-coating. The 3D printed device was implanted and has required time to ‘bed in’ but within time will hopefully develop muscular attachment and regrowth of nerves and veins.

Bearing in mind the complexities of 3D bio-printing it’s hardly surprising that developmental companies have looked to 3D print pharmaceuticals in what may well be perceived as a simpler process. And indeed towards the end of 2015 Aprecia Pharmaceuticals announced that it has achieved FDA approval of a newly formulated presentation of the drug levetiracetam, also known under the trade name Spritam.

Levetiracetam is a pharmacological compound, which is used to treat epilepsy, a condition, which can be difficult to control and where dosing precision is important to achieve adequate disease management. Using technology that was developed at MIT through the late 1990s and early 2000s, Aprecia have developed their patented ZipDose technology, which uses aqueous fluids to build up the printed, layered tablet preparations containing the powdered active pharmaceutical ingredient. Due to the methods of creation this has facilitated the production of tablets, which are able to orally deliver much higher, accurate doses of medication in a form that rapidly dissolves in the mouth. The dissolution occurs due to the fact that the bonds that have been created in the printing process between powder and fluid are held within a highly porous structure, thus with the addition of water the bonds break down quickly and the drug is dispersed.

But what does this mean to Pharma? Certainly there is truth in the fact that an easily dispersible tablet has distinct advantages for oral delivery in the young, the elderly and those with dysphagia. And the ability to orally deliver high doses of medication will offer alternative routes of delivery, which previously would not have been an option. Furthermore it’s fair to state that 3D printing of tablets is an innovative achievement with the potential to accelerate personalized medicine and ensure that patients with multi-faceted conditions have the ability to obtain tailor made medical solutions. However, for the wider population and blue-chip global giants where will this newly achieved goal take them? Does it really open the road to mass printed tablets and a seismic shift in production technology?

One thing is for sure, medical institutions and private clinics are not going to have bench-top 3D printers sitting next to the examination room in order to print off a tablet in the same manner as a prescription, certainly not within the near future. Secondly, with the ever-expanding world of generics, orally available preparations are manufactured as patents expire in order to offer financial savings and which often don’t have the bells and whistles that the trade marked presentations carry. Sugar coated acetaminophen carries a higher price tag than an uncoated one, and why pay the difference? On top of this orally disintegrating tablets (ODTs) that ‘melt’ can already be created through traditionally manufactured mechanisms, although given that this type of preparation has limited effectiveness in delivering higher doses of drugs effectively.

The idea has been banded around that in the future patients could print their own medication, and rather than receiving a script they will take home an algorithm and create what they need. But the reality of this has to be a world away. Who would bear the cost? And where would that fit in the FDA approvals system?

Aprecia are stated as currently having the rights to over 50 patents for technologies related to pharmaceutical application of 3D printing and their pipeline is protected to 2033. They are also clear in their statement that they aim to develop technologies that improve adherence and delivery of regularly used high dose drugs in which ODTs have limited application. There’s nothing wrong with a niche market at all, and holding lots of cards in this specific area may well be their key to strong commercial success. But it will be interesting to see how the pharmaceutical Big Boys play their 3D printing developments and whether or not they can step outside what is quite a specific market creating a wider need for this innovation. Only time will tell, but in my mind it still does beg the question, “Where will the 3D printed pill fit”?

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Adele Graham-King
Contributing Editor

Adele is a design consultant who works in product development for medical and healthcare ap- plications. Her background is in pharma, and she has a degree in applied physiology.