3D drug printing offers benefits like chocolate-flavored pills for children, combined medications for older people, and personalized dosages at pharmacies. While the FDA approved the first 3D-printed drug in 2015, ensuring precise drug measurements is crucial for patient safety.
In a new study, NIST scientist Thomas P. Forbes explores quality control methods to guarantee accurate drug printing, emphasizing “quality by design” approaches for reliable dosage production.
Forbes studied inkjet and similar printers for printing personalized drugs remotely. Similar to home inkjet printers but larger, these printers deposit liquified drug materials into small wells or capsules. The liquid can be processed into tablets, powders, or dissolvable films.
Forbes’ research explores quality control methods for 3D drug printing, testing various techniques without making specific recommendations. His work was discussed in the Taking Measure blog.
When your doctor prescribes a medication, she considers available dosages and chooses what’s best for you. 3D printing allows personalized dosages based on age, health, and genetic profile. It also customizes the medication’s form, for example, liquid instead of capsules.
Research explores polypills, combining multiple drugs into one and creating child-friendly medications shaped like starfish or flavored like chocolate.
3D drug printing could revolutionize vaccine distribution by enabling vaccines to be printed at “point-of-care” locations near where they’re needed. While raw materials would still be produced in more extensive facilities, this approach allows for faster and more flexible distribution during pandemics.
Quality control and precise measurements are crucial in 3D drug printing to ensure correct dosages and ingredients. Research at NIST focuses on developing on-site methods to accurately verify and validate these processes.
First, we ensure the printing ink remains viable during transport to remote locations, checking for degradation or exposure to extreme temperatures to confirm its quality.
To verify printer functionality, we used UV-Vis spectroscopy, employing accessible tabletop and handheld devices. These spectrometers analyze chemical composition by passing UV and visible light through samples, measuring absorption patterns.
Commercial printers often feature LEDs under nozzles that dispense ink drops. A photodiode detects interruptions in light when drops are released, signaling ink depletion or nozzle blockages. Our tests affirmed the reliability of LEDs and photodiodes in detecting ink flow irregularities.
Ensuring the correct drug dosage after printing is challenging and requires a nondestructive method. Research is ongoing to develop this capability, representing a critical next step.
The ultimate goal is establishing voluntary guidelines for quality control and measurement accuracy in 3D drug printing. Collaboration with organizations like the American Society for Testing and Materials and United States Pharmacopeia will likely develop and release these protocols.
This effort aims to prepare for the widespread adoption of 3D drug printing, supporting industry and regulatory agencies with robust measurement science.
Journal reference:
- Thomas P. Forbes, John Greg Gillen et al., Quality by Design Considerations for Drop-on-Demand Point-of-Care Pharmaceutical Manufacturing of Precision Medicine. Molecular Pharmaceutics. DOI: 10.1021/acs.molpharmaceut.4c00032.