Everyone’s heard that 3D printing is, or will be, a big deal for healthcare. But when you look deeper into it, descriptions are often either a little vague … or a bit difficult to visualize, like this: “Three-dimensional (3D) printing enables the production of anatomically matched and patient-specific devices and constructs with high tunability and complexity.” Hmm. What?
We know that 3D printing has gone from being a gimmick at convention booths to saving lives in the developing world to possibly changing our industry. Forget “beyond the pill” or “around the pill” — 3D printing may soon just be “the pill.” But what does that look like? How does it work? If you’d like to know what’s really going on, with details but in plain English, keep reading.
How Does 3D Printing Work?
Imagine the piping bag a baker uses to decorate the top of a cake. The frosting is squeezed out through a nozzle, which is moved around the top of the cake to create the design. A 3D printer works similarly. But unlike our imaginary baker, it isn’t just using colored icing. 3D printing can be used to create everything from homes to sneakers, from hamburgers to surgical clamps, from bones to organs themselves. Different applications, of course, require different “ingredients.”
Combinations of different types of printing can be used, and if you’re printing a pill, the active pharmaceutical ingredient (API) can be applied using a method very similar to inkjet printing. The inert substrates — the underlying layers — are printed, and then the API can be sprayed on them. But the makeup of the substrates can be changed to alter how the active ingredients are delivered. For instance, a more porous or permeable substrate will change how the pill dissolves and, therefore, how the medication enters the bloodstream.
This is how Spritam (levetiracetam) — the first 3D printed pill, which was approved by the FDA for Aprecia Pharmaceuticals in 2015, to treat epilepsy — works. The printing process creates a pill that conventional manufacturing couldn’t.
Earlier this year in Advanced Drug Delivery, talking about Spritam, scientists from the FDA, Merck, and Texas A&M noted that they “believe that the recent approval of a 3D printed drug product will stimulate continual innovation in pharmaceutical manufacturing technology. FDA encourages the development of advanced manufacturing technologies, including 3D-printing, using science- and risk-based approaches.”
How Could 3D Printing Change Healthcare?
3D printing could change our industry in a variety of ways. The most futuristic scenario is one that includes home printers, where you get a prescription and print your own medicine — but, for a variety of reasons, that’s a long way from reality. In the 80s and 90s, “just-in-time” manufacturing attempted to lower costs and waste while improving speed and efficiency. How much more “just-in-time” might it be to literally create the product at the instant, and in the location, where it’s needed?
Another futuristic idea is that pharmaceutical manufacturers get out of the manufacturing business … and pharmacies become little print shops. Imagine a supply chain where logistical problems like storage and shipping are no longer considerations. Imagine how this could change the world, in developed and developing nations. Imagine a dosage that’s exactly tailored to your gender, age, body mass. Imagine Mom only needing to take one pill, instead of seven.
But perhaps the most practical scenario is that pharma adds 3D printing as another method used in their manufacturing. It’s still exciting to imagine the possibilities when the makeup of a pill can be manipulated so precisely.
And that’s just 3D printing of pills. From devices to equipment, from models to scaffolds, all the way to live cells and tissues and organs, 3D printing can open the door to many things we once thought were impossible, allowing us to create in entirely new ways.
What Are the Problems With 3D Printing?
Keeping ingredients safe — unadulterated, sanitary, at the right temperatures; mixing and printing the ingredients with perfect precision; ensuring that the equipment works right, every time: these are just a few of the hurdles that a 3D-printing revolution in healthcare would need to clear.
The FDA, in their own words, “oversees drug manufacturing in several ways. First, domestic and foreign drug manufacturing plants are routinely inspected for compliance with applicable regulations, including the Current Good Manufacturing Practices. Second, FDA samples and tests drugs from retail stores, distribution warehouses, and manufacturing sites.”
Although Aprecia’s Spritam is an FDA-approved drug that’s 3D printed, the company notes that they have more than 50 patents for the process, and states that “Our products are made in an FDA-inspected facility and are part of the same regulated supply chain as other FDA-approved medicines.”
If you’ve ever set foot in a pharma manufacturing plant, or perused one of the FDA inspection reports that are issued after officials review a site, you know that this oversight is no joke. Manufacturers and regulators go to extraordinary lengths to ensure the consistency and safety of drugs and devices.
How does this change if the equipment to make those products is in a retail pharmacy, or in a patient’s home? Well, Aprecia makes it clear that their manufacturing equipment is “not available to the general public and [does] not actually make active ingredients” — but they do state that they “expect 3D printers to be more commonplace in the manufacture of drugs over the next decade.” Will this be in homes and offices? Maybe. But it’s more likely that companies like Aprecia will create 3D-printed pills in standard FDA-inspected facilities.
But wherever the printer lives, the executive director of the American Institute of the History of Pharmacy noted in The Atlantic that, “Some entity still has to produce the drug — the active ingredient in the printer — and that will continue to be controlled by large manufacturers. Only they can afford the costs of getting a new drug approved by the FDA.”
Wherever tablets are printed, their “ingredients,” and the “recipes” for them, will be managed by the FDA for the foreseeable future.
Want to Learn More About 3D Printing in Pharma?
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