Texas A&M researchers 3D print pediatric tablets
Replacing high-cost, adult tablets used to treat toxoplasmosis in children
According to Texas A&M, research from the university promises to replace high-cost, adult tablets used to treat toxoplasmosis in children, with 3D printed medication.
Toxoplasmosis, an infection caused by a parasite, is the leading cause of foodborne deaths in the US, and if contracted by a pregnant woman, it can be transmitted to the fetus. It is estimated that over 40 million people in the US – and 1 billion worldwide – are infected with toxoplasmosis, which is caused by the parasite Toxoplasma gondii. It is estimated up to 4,400 babies in the US are born with toxoplasmosis each year.
“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 Dr. Mansoor A. Khan, Regents Professor of pharmaceutical sciences and interim dean of the Texas A&M Irma Lerma Rangel College of Pharmacy. “As an example, the adult Daraprim [the standard first treatment for toxoplasmosis] costs around $790 per tablet. 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 US 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 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,” said Khan.
The tablets will be created using 3D printing technology at the 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,” said Khan. “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).
