A Path to 3D-Printed Drugs

The 3D printing grant comes at a time when there is a “dire need for pediatric products,” said Khan. “The science is not well understood for pediatric medications.” Too often children must take medications originally intended for adults. Complications around how they get the drugs involve issues such as dosages, physiological effects, absorption, enzyme and other considerations. 

“How do you get a flexible dose for them, that is a problem. When the medication is not available, what do pharmacists do? They take an adult pill, crush it, and grind it and put it in a liquid. They give it to mom and say take two drops three times a day or half a spoon,” he said. “In some cases, the drug is bad tasting, and the child says, ‘I don’t want it.’” Khan, a former FDA senior scientist who worked on regulations involving pediatric medications, had served as the lead reviewer for the only 3D-printed tablet dosage forms approved by the agency’s Center for Drug Evaluation and Research. 

As officials consider the future of 3D drug printing, it is key that pharmacy school curricula prepare future pharmacists to understand these issues. “The students need to keep pace with advances in technology and recognize the multidisciplinary opportunities to enhance therapeutic outcomes,” Khan said. Unlike many pharmacy schools, Texas A&M has a pediatric therapeutic course, which covers the elements for 3D printing and the NIH grant. The research involves a truly interdisciplinary team approach, with pharmacists, engineers, doctors, molecular biologists and biostatisticians developing the proposals, Khan noted. 

Kuttolamadom noted that it was critical to improve the structure of the tablet because it broke apart easily and dissolved, which was important for elderly patients having a difficult time swallowing. The new process being considered at Texas A&M is known as selective laser, in which the drug is put in a powder form with an added biocompatible polymer, heated, with layers scanned, layer upon layer, he said. 

For children, the pills could be shaped like a star or a teddy bear and have a more desirable flavor than other medications, Kuttolamadom added. He noted that there will be built-in deterrents, however, to ensure that children do not treat the medications as candy. “The mission is around drugs already approved by the FDA and we can mix them in the right amounts that we need and print them in the right dosage sizes that need to fit a particular pediatric patient,” he said. “These can be made in a pharmacy in 30 minutes.” 

The team includes Dr. Ziyaur Rahman, a principal investigator; Dr. Samikkannu Thangavel, associate professor in the School of Pharmacy; Dr. Jennifer Fridley, clinical assistant professor and director of Veterinary Medical Park, School of Veterinary Medicine; and Dr. Quan Zhou, assistant professor, the College of Arts and Sciences. 

Khan said several children’s hospitals have expressed keen interest in the plan and he’s excited about the possibilities ahead, although he has not pinpointed a timetable for when the 3D printed medications may be available for children. “The idea seems to be very good for hospitals in the region and they support it,” Khan said. 

While the FDA has approved at least 200 medical devices made by 3D printing technology over the last decade, the agency said there are still numerous regulatory questions that need to be addressed regarding 3D printing for medications. Among those, the agency said, are “what are the critical factors in 3D-printed design that affect the drug release and mechanisms?” The agency’s Office of Testing and Research is conducting research to better understand next steps for 3D-printed drugs. 

Joseph A. Cantlupe is a freelance writer based in Washington, D.C.