3D-printed medicines: from the first approval to programmable tablets
Printing tablets layer by layer lets designers control how a drug is released. A look at the technology and how far it has come.
In this article
A conventional tablet press compresses powder into a simple solid shape. 3D printing builds a tablet layer by layer instead — and that allows complex shapes and internal structures.
The first approval
In 2015, Aprecia’s Spritam, a treatment for seizures in people with epilepsy, became the first 3D-printed medicine approved by the US FDA.
Programmable release
China’s Triastek has developed Melt Extrusion Deposition (MED), which uses digital design and automated manufacturing to print tablets with complex internal geometries, with real-time process analytical technology monitoring quality as they are made. MED was accepted into the FDA’s Emerging Technology Program in April 2020.
In February 2021, Triastek received FDA clearance to begin clinical investigation of T19, a rheumatoid arthritis product designed to be taken at bedtime and release its drug with a delay, so that blood levels peak in the early morning when symptoms are worst. Its “3D formulation by Design” method aims to cut trial and error in formulation development.
Why it matters
| Capability | Potential use |
|---|---|
| Timed or delayed release | Dosing matched to daily symptom patterns |
| Complex internal structure | Several release profiles in one tablet |
| Digital design | Faster formulation development |
How Spritam works
Spritam contains levetiracetam, an established epilepsy medicine, so the innovation was not the drug but the dosage form. It was made by binder-jet printing, in which thin layers of powder are bound together with drops of liquid, building a porous tablet. The result disintegrates very quickly in the mouth with a sip of liquid, even at high doses. That helps patients who have difficulty swallowing large tablets — a real problem for some people with epilepsy and for many children and older adults.
The main printing methods
| Method | How it works | Typical use |
|---|---|---|
| Binder jetting | Liquid binder printed onto powder layers | Fast-dissolving, high-dose tablets |
| Extrusion-based printing | Molten or paste material laid down in lines | Controlled-release tablets, internal structures |
| Semi-solid extrusion | Gels or pastes printed at low temperature | Personalised doses, chewable forms |
| Light-based printing | Liquid resin cured layer by layer | Research into fine structures |
Personalised doses
Beyond complex release, printing could make it practical to produce small numbers of tablets at a specific dose — for a child’s weight, for an elderly patient taking several medicines, or for a clinical trial testing different strengths. Hospitals and researchers in several countries are exploring printing close to the patient for these reasons. That raises new questions for regulators: how to assure the quality of each printed unit, and who is responsible when printing moves out of a traditional factory.
Why industry is cautious
Printing is slower than a conventional tablet press, which can make hundreds of thousands of tablets an hour, so it is unlikely to replace presses for everyday high-volume products. Its value lies where flexibility, complexity or personalisation matter more than speed. For Pakistani manufacturers, the practical lesson is to watch the formulation ideas it enables — and the quality-by-design and real-time monitoring methods it relies on, which apply to any modern plant.
The regulatory path
Regulators treat a new manufacturing technology carefully, because familiar tests may not show every risk. Programmes such as the FDA’s Emerging Technology Program let companies discuss novel approaches with the agency early, before submitting an application. That dialogue helped bring continuous manufacturing into approved products, and Triastek’s printing technology was accepted into the same programme in 2020.
What to watch
The technology is still at an early commercial stage, and regulators assess each new process carefully. For most manufacturers it is something to follow rather than buy today — but it shows how quickly dosage-form technology is moving.
Learning from the world
Following such developments without leaving Pakistan is part of what the International Pharma Convention and Pharma Asia’s international exhibitors offer. See also continuous manufacturing.
