Texas A&M Researchers Pioneer 3D-Printed Medication to Combat Deadly Infections in Children

Toxoplasmosis, an infection caused by a parasite, is the leading cause of foodborne deaths in the U.S., and if contracted by a pregnant woman, can be transmitted to the fetus. The only commercially available medications to treat pediatric toxoplasmosis are costly, compounded adult tablets, but new 3D-printed medication developed at Texas A&M University may save lives and costs.

It is estimated that over 40 million people in the U.S. — and 1 billion worldwide — are infected with toxoplasmosis, which is caused by the parasite Toxoplasma gondii. Most people with healthy immune systems who become infected show no symptoms; around 10% of patients have mild, flu-like symptoms such as swollen lymph nodes and muscle aches and pains.

Infections can be transmitted to humans by eating raw or undercooked meat or shellfish, or unwashed produce; by exposure to infected cat feces or soil; and congenitally, or the passing of an infection from mother to unborn child. Fetuses and newborns are at particularly high risk of death or severe consequences including hydrocephalus, blindness, deafness, seizures and intellectual disabilities. It is estimated up to 4,400 babies in the U.S. are born with toxoplasmosis each year.

Critical Need For Kids With Toxoplasmosis

Dr. Mansoor A. Khan, Regents Professor of pharmaceutical sciences and interim dean of the Texas A&M Irma Lerma Rangel College of Pharmacy, said there is an acute need for a pediatric product to treat toxoplasmosis. “Adult tablets are manipulated and compounded when pediatric prescriptions are received,” he said. “Such products may have questionable quality as they are not evaluated for content, stability and bioavailability.”

Additionally, he said, the adult products themselves are expensive. “As an example, the adult Daraprim [the standard first treatment for toxoplasmosis] costs around $790 per tablet,” Khan said. “Congenital and acquired toxoplasmosis in pediatric patients is treated with pyrimethamine and sulfadiazine plus leucovorin for 12 months or longer. Since the weight of the child changes with time, a dose flexibility in dosage form is required. Therefore, the need for this combination product, with dose flexibility, is acute and lacks commercial availability.”

Prior to joining Texas A&M, Khan worked for the U.S. Food and Drug Administration where he served as a division director senior biomedical research scientist in the Center for Drug Evaluation and Research.

Khan, along with Dr. Ziyaur Rahman, professor of pharmaceutical sciences, has received $3.1 million dollars from the National Institutes of Health, part of which they are using to 3D print pediatric toxoplasmosis drugs. “This study is expected to lead to the development of a novel dose-flexible pediatric delivery system for pediatric populations for toxoplasmosis,” Khan said.

3D Printing The Future Of Medication

The researchers say the tablets will be created using 3D-printing technology at Reynolds Medical Sciences Building on the Texas A&M campus in College Station. “Tablets will be evaluated for required quality attributes, stability, and pharmacokinetics/pharmacodynamic studies,” Khan said. “After the proof of concept and characterization studies, the 3D printing machines can be deployed in area hospitals.”

Rahman said he hopes the 3D printing of drugs for pediatric patients helps ease some of the burdens on parents. “This approach can be applied to other drugs for pediatric diseases where no pediatric-friendly dose-flexible formulation is commercially available,” he said. A similar 3D-printed approach for an antiviral therapy was funded last year ($2.82 million for five years).

In addition to the National Institutes of Health, the research is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Collaboration Across Campus

The interdisciplinary project includes co-investigators from across the university:

• Jennifer Fridley, clinical assistant professor and director of Veterinary Medical Park, College of Veterinary Medicine and Biomedical Sciences;
• Matthew Kuttolamadom, associate professor, College of Engineering;
• Lamba Omar Sangare, assistant professor, College of Arts and Sciences;
• Dr. Quan Zhou, assistant professor, College of Arts and Sciences.