With the first FDA-approved, 3D-printed drug now on the shelves at pharmacies around the country (the drug in question is SPRITAM, epilepsy medication tablets produced by Aprecia Pharmaceuticals), it’s clear that the pharmaceutical industry is on the brink of dramatic change.
While 3D printing has been in use in the health care industry for some time, it has played a fairly minor role so far, with its applications limited to the production of items such as custom prosthetics or dental implants. However, now that 3D printing has expanded to pharmaceuticals, the horizon is suddenly looking much more expansive.
Industry experts estimate that over the next decade, health care will grow its share of all investments made in the 3D printing industry from its current level of just 1.6 percent of investments to 21 percent. Furthermore, market research company MarketsandMarkets.com anticipates that medical applications for 3D printing could reach a market value of $2.13 billion by 2020.
How exactly is 3D printing expected to be used in the pharmaceutical industry? Here are three potential applications:
3D printing has the potential to open up a whole new range of possibilities for personalized medicine. The most basic of these possibilities involves using 3D printing techniques to produce personalized oral tablets.
At present, oral tablets are by far the most commonly used drug dosage form. This is due to a number of factors, including ease of manufacture, accurate dosing, and high levels of patient compliance. However, the well-established processes that is currently used to manufacture oral tablets does not allow any room for creating customized dosages.
3D printing, however, could completely change this system. Rather than patients coming into a pharmacy with a doctor’s prescription and being given the same medication that everyone else receives, 3D printing would allow doctors and pharmacists to review patient information to determine the optimal dose of a medication.
Pharmacists could then print medications that are uniquely tailored for each individual patient based on factors like their age, gender, or other medical conditions. This would be of particular benefit to patients who are known to have what is called “pharmacogenetic polymorphism,” meaning that due to genetic factors, they respond differently than the majority of patients when given the same dose of the same drug.
3D printing would also make it possible to produce drugs in entirely new and personalized forms and formulations. For example, complex, multilayer pills could be printed that incorporate multiple active ingredients. In other words, patients would be able to take all the medications they need to manage multiple conditions in the form of a single pill.
Finally, as many proponents of 3D printing in the pharmaceutical industry would say, why stop at pills? The power of 3D printing technologies would enable the creation of virtually limitless novel dosage forms: everything from microcapsules to antibiotic-printed micropatterns to bioactive glass scaffolds. Clearly, basic 3D-printed pills like SPRITAM are just the beginning.
More Intricate Drug Release Possibilities
The “drug release profile” of a particular medication describes how the drug is absorbed and broken down in the body after it is ingested by a patient. At present, the FDA identifies only two basic drug release profiles.
The first is immediate release, where the drug is released into the system directly after it has been administered. The second is modified release, where release of the drug is either delayed (that is, release occurs some time following the initial administration), or extended (the drug is released and made available to the system over a prolonged period after ingestion in order to reduce dosing frequency).
However, due to the increased level of personalization that 3D printing offers, future pharmaceuticals could be created with even more specific, targeted, or complex release profiles. For example, printed drugs could include a binder printed in layers onto a matrix powder bed. This would enable drug release to occur in even more sharply defined stages, thus allowing researchers and physicians to study the different variations and effects of staggered release more closely.
Living Tissue for Use in Drug Development
3D printing could soon change not only how we produce drugs, but how we discover and develop them. Although 3D printing of fully-functioning human organs is still some way off, 3D printing technology has reached the stage where it’s possible to print some living human tissue cells, which can then be used in the early stages of drug trials.
For example, the San Diego-based startup Organovo has developed the capacity to produce human liver tissue via 3D printing. For a period of 42 days, these minute tissue samples will have the same response to a drug as a full-size, fully-functioning human liver would.
This makes them far more valuable test subjects than those researchers currently use in early trials. Petri dishes of cells only share the same properties as a liver for a few days, and animals don’t produce the same consistent reactions to drugs that a human patient would. Using 3D printed tissue, therefore, allows researchers to test new drugs on real human tissue, but at no risk to living patients.