A Path to 3D-Printed Drugs

AACP Article

Researchers at Texas A&M University’s Irma Lerma Rangel School of Pharmacy received a $2.8 million NIH grant to use 3D printers for pediatric medications. 

By Joseph A. Cantlupe 

In some ways, 3D printing is pervasive in our society, evident across sectors ranging from manufacturing to architecture to design and even medicine. But oddly for this multibillion-dollar industry, there’s one area in which it has not made much headway: pharmaceuticals. 

For instance, the Food and Drug Administration (FDA) has approved only one drug, Spiritam, a treatment for epilepsy, using 3D technology, which happened in 2015. In that instance, technology has made it easier for patients to take their medications because the active ingredient disintegrates within seconds after a patient takes a sip of water. 

Despite the lag in approvals, experts see vast potential for 3D technology in pharmacy. Studies show that there could be a paradigm shift in pharmaceutical and clinical pharmacy practice, with a transition from mass production of medicines toward drugs that are personalized for everyone. 3D printing also can result in decreased costs and expedited development times. 

Currently, most drugs are typically manufactured in large quantities “using conventional methods that involve large-scale processes, equipment and long production time,” according to the FDA. The agency said that 3D printing “can offer a tantalizing step toward changing the manufacturing processes to offer personalized medicines.”

Dosage Flexibility 

Since there have been relatively few inroads in developing 3D technologies in pharmaceuticals worldwide, officials at Texas A&M University’s Irma Lerma Rangel School of Pharmacy are excited and intrigued after receiving a five-year, $2.82 million grant from the National Institutes of Health (NIH) to use 3D printing machines for pediatric medications. The university is working to engineer “dose-flexible antiviral medications” designed for pediatric patients that could be used in hospitals. 

Dr. Mansoor A. Khan, acting dean and a Regents Professor of Pharmaceutical Services and a Presidential Impact Fellow, has been working on the program with a multidisciplinary team. Khan and other officials said the NIH grant is the first research project grant of its kind. “Many (drug) products are available for adults, not children,” Khan said in a statement, in part because they are not profitable for drugmakers. “Instead, a prescriber or a pharmacist is forced to manipulate adult dosage forms to prepare pediatric dosages.”

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. 

Testing Different Formats 

The Texas A&M team plans to develop a manufacturing method to meet the changing needs of pediatric patients, said Dr. Mathew Kuttolamadom, co-principal investigator and associate professor at the Department of Engineering Technology and Industrial Distribution. Kuttolamadom has been involved in several projects related to 3D printing, not only in pharmacological programs but also in medical design and engineering. 

After the FDA’s approval of Spiritam in 2015, the process “stalled right off the bat,” he said, referring to the complex nature of applications for 3D printing for medications. He has co-authored several academic papers detailing different aspects of 3D printing. One method is called selective laser sintering, in which it is “solvent free” that is advantageous in the printing process. 

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.” 

 Dr. Mansoor A. Khan     “Many (drug) products are available for adults, not children. Instead, a prescriber or a pharmacist is forced to manipulate adult dosage forms to prepare pediatric dosages.” 

—Dr. Mansoor A. Khan 


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.