School of Pharmacy receives nearly $3 million to advance 3D printed pediatric medications

Researchers from the Texas A&M University Irma Lerma Rangel School of Pharmacy have been awarded a five-year, $2.82 million grant from the National Institutes of Health (NIH) to utilize 3D printing machines for pediatric medications.

Principal investigator, Mansoor A. Khan, PhD, who is vice dean, Regents Professor of pharmaceutical sciences, and a Presidential Impact Fellow, along with multiple principal investigator, Ziyaur Rahman, PhD, professor of pharmaceutical sciences, will work to engineer dose-flexible antiviral products that are readily deployable in hospitals for pediatric medication needs.

The grant, entitled “Dose Flexible Combination 3D-Printed Delivery Systems for Antiviral Therapy in Children” is the first RO1 grant of its kind, according to Dean of the Rangel School of Pharmacy Indra K. Reddy, PhD.

“We are very optimistic that the 3D printing machines can actually be deployed in children’s hospitals with a clear pathway to compound very high quality and validated medications,” Reddy said.

This is the first time a multidisciplinary approach is being taken to deliver 3D printed medications for children. “It requires engineering the design and development of pediatric dosage forms, followed by pharmacokinetics and efficacy studies before deployment in children’s hospitals,” Rahman said.

“Many products are available for adults, not children, as it is not a great and profitable business for firms to make pediatric medications for few cases. Instead, a prescriber or pharmacist is forced to manipulate adult dosage forms to prepare pediatric dosages,” Khan said.

According to Khan, these manipulations can easily lead to instability or other issues of compromised quality.

“Our children deserve better medications, and we are committed to providing it for them with advanced technologies,” he said.

Prior to joining the Rangel School of Pharmacy, Khan worked for the U.S. Food and Drug Administration where he served as lead reviewer for the only 3D printed tablet dosage forms approved by the Center for Drug Evaluation and Research.

“That approved product was for a geriatric purpose. We realized it could be valuable for the pediatric population, too, as they need dosage flexibility because of changing age and growth. We teamed up as pharmacists, engineers, doctors, molecular biologists and biostatisticians to develop this rewarding proposal,” Khan explained.

The project will draw from a pool of investigators from different academic units at Texas A&M University.

Co-investigators include:

• Matthew Kuttolamadom, PhD, associate professor, School of Engineering.
• Samikannu Thangavel, PhD, associate professor, Rangel School of Pharmacy.
• Jennifer Fridley, DVM, clinical assistant professor and director of Veterinary Medical Park, School of Veterinary Medicine.
• Quan Zhou, PhD, assistant professor, College of Arts and Sciences.

Khan and Rahman also have an active two-year NIH—R56 grant on 3D printing of medications.