Chocolate flavored pills for kids who hate taking medicine. Different molecules combined in a single tablet for the elderly who have difficulty remembering their daily therapies, often many. The drugs of the future? They could be customized and 3D printed in pharmacies or in hospitals and healthcare facilities. The path to implement this new potential system for the production of drugs and treatments on site, using 3D printing, has already been started. In the USA, the National Institute of Standards and Technology (Nist) is working to develop standards and security protocols that would allow this activity. The advantage would be to have ‘printed’ drugs at dosages tailored to each patient and her health needs.
This is not something new: in 2015 the US regulatory body Food and Drug Administration (Fda) had already approved the first 3D printed drug, namely Spritam* (levetiracetam) for epilepsy. Many other manufacturers and pharmaceutical companies are developing their own, experts explain. But widespread adoption of 3D drug printing will require rigorous quality control measures to ensure people receive the correct products and dosages. Because even a small incorrect measurement of a drug ingredient during the printing process could put the patient’s health at risk. In a new paper, NIST researcher Thomas P. Forbes evaluated various approaches to ensuring that 3D drug printers work as intended. Objective: to understand what the best procedures and protocols are to obtain correct dosages and the correct mix of chemical substances.
While there are various methods for printing medications remotely, Forbes focused on one of the most common: inkjet printers and similar systems. They are like the classic ones that we also have at home or in offices, only larger: the printer is equipped with nozzles that deposit the liquefied drug materials, or inks, into tiny wells on a tray or directly into the capsules. Through freeze-drying and other processes, the liquid can be made into a tablet or powder poured into a capsule. It can also be evaporated to a thin film that melts in your mouth. The research identifies and tests several possible methods and techniques for maintaining quality control.
The advantages
What are the advantages of 3D printing drugs? “When your doctor writes a prescription, he knows which drugs are available in certain strengths and he will choose the one he thinks is best for you,” explains Forbes. But some products only have one ‘size’. “3D printing allows you to customize the dosage. You can do this based on the person’s age, health, even immune system or genetic profile. You can also customize the form the medicine takes. Some patients, for example, may prefer a liquid to a capsule. Research has also been conducted on polypills, which combine multiple pills into a single drug. And some scientists have focused on the benefits for children who don’t like taking medicine shaped like a starfish or that taste like chocolate”.
3D printing of drugs also has “the enormous potential to change the distribution of vaccines”, the expert points out, thinking about the possibility of printing them close to where they will then be administered. You would “still have a larger facility to produce the raw materials”, but you could become “much more agile and faster in bringing these vaccines to the public. It would be extremely useful during a pandemic”. The aspect of quality and correct measurements in 3D printing is crucial, he adds: “We will need on-site methods to make and validate the measurements.” The quality control process must proceed in parallel with the journey of the 3D printed drug, step by step.
“It starts with delivering the printing ink to the ‘remote’ location. You have to check that it hasn’t degraded, evaporated or been exposed to abnormal temperatures.” To do this, “we used a technique called ultraviolet-visible spectroscopy (UV-Vis) – he explains – There are now relatively inexpensive tabletop and even portable UV-Vis spectrometers on the market.” Next, you have to check that the printer is working properly. “In our tests, we found that LEDs and photodiodes worked well.” Another step: confirming that you’ve printed the right amount of drug, and this is “tricky. You need a non-destructive way to confirm the correct dosage. We’re working on that right now. That’s the next big step,” assures Forbes. The ultimate goal is “to produce a set of protocols or recommendations. We’ll probably work in collaboration with other groups to make those happen. If 3D printing drugs becomes widely adopted, we want to be ready to support both industry and regulators with a scientific basis for measurement.”
