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 |
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.
