Texas A&M’s 3D Printed Pediatric Medication: A New Hope for Children with Toxoplasmosis

Toxoplasmosis is one of the world’s most widespread parasitic infections, with over a billion people affected globally, including an estimated 40 million Americans. Discovered in 1908, this infection is caused by the Toxoplasma gondii parasite and has been widely studied because of its unique ability to spread both congenitally and through common sources like undercooked meat or coming into contact with infected soil or cat feces.

Although common, most people with the infection have mild, flu-like, or no symptoms. However, the infection is particularly dangerous for immunocompromised individuals, infants, and those infected in utero, who are at risk of severe complications such as hydrocephalus, seizures, and even blindness. It is estimated up to 4,400 babies in the U.S. are born with toxoplasmosis each year.

Until now, treatment options for pediatric toxoplasmosis have been limited and costly, with Daraprim, the standard adult treatment, priced at around $790 per tablet. For children, these tablets are broken down into smaller doses, affecting their stability, effectiveness, and safety.

Recognizing the urgent need for a safer, more flexible option, researchers at Texas A&M University are pioneering a 3D printed pediatric formulation to address this gap. Spearheaded by Mansoor A. Khan, Regents Professor of pharmaceutical sciences and interim dean of the Texas A&M Irma Lerma Rangel College of Pharmacy, and Ziyaur Rahman, professor of pharmaceutical sciences, this new custom-dose solution is designed to grow with pediatric patients as they age, making long-term treatment easier and more affordable.

This research is funded by a $3.1 million grant from the National Institutes of Health (NIH), with additional support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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.

Texas A&M’s breakthrough leverages 3D printing to make flexible doses that combine pyrimethamine, sulfadiazine, and leucovorin. More specifically, the researchers turned to the university’s Reynolds Medical Sciences Building for on-site drug manufacturing. Although the technology being used hasn’t been fully detailed, they are likely using pharmaceutical-grade extrusion-based 3D printers or powder bed fusion (PBF) systems for custom pediatric medications.

In pharmaceutical 3D printing, extrusion-based systems are often adapted for medical use because they allow for precise control of drug doses by adjusting the drug-polymer blend being extruded. For example, companies like Aprecia Pharmaceuticals, known for its ZipDose technology, use similar methods to make rapidly dissolving tablets with tailored dosages, such as its U.S. Food and Drug Administration (FDA)-approved 3D printed epilepsy medication, Spritam.

Meanwhile, PBF builds tablets layer-by-layer using powder bonding, allowing complex tablets to combine multiple drugs or controlled-release features in a single pill. In research and application, powder bed systems are used to produce personalized multivitamin supplements. For example, researchers at FabRx used this technology to create taste-masked antibiotics tailored to children, making medicine easier to consume.

According to Texas A&M, this technology could soon allow hospitals nationwide to produce pediatric-friendly medications as needed, redefining how treatment for toxoplasmosis can be customized to patient needs.

Rahman said he hopes the 3D printing of drugs for pediatric patients helps ease some of the burdens on parents. In fact, a similar 3D printed approach for an antiviral therapy was funded last year ($2.82 million for five years).

The team hopes it will also reduce family costs while ensuring more reliable, effective doses. This model could also be used for other conditions, offering a framework to produce pediatric medications where no suitable options exist. There is a significant lack of child-friendly medication options for several illnesses, especially rare diseases and infections. As research continues, this development marks a promising step toward more accessible, adaptable medication options for young patients facing life-threatening infections.

“Adult tablets are manipulated and compounded when pediatric prescriptions are received. Such products may have questionable quality as they are not evaluated for content, stability and bioavailability,” said Khan. “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 FDA, where he served as a division director and senior biomedical research scientist in the Center for Drug Evaluation and Research.

Khan also points out that 3D printed medications can be manufactured on-site in hospitals, reducing distribution costs and making it easier to access the right dose of medication at the right time. Moreover, the team is exploring collaborations with other university departments at Texas A&M to expand the applications of this research. For example, veterinary sciences researchers may explore similar treatments for animals suffering from Toxoplasma gondii. Meanwhile, engineering and material sciences faculty could refine the printing process and ensure it meets the high standards necessary for medical applications.

The impact of this research could go well beyond a single disease; it could reshape how we think about medication in general, reduce waste, improve patient outcomes, and potentially transform the accessibility of healthcare worldwide.