The guidelines target firms using nanomaterials in active ingredients, carriers loaded with active ingredients, and inactive ingredients for finished dosage forms, and provides recommendations for investigational, premarket, and postmarket submissions for these products.
Nanomaterials – used in small and large-molecule pharmaceutical drug products – refer to materials on a scale measured in nanometres, that cannot be seen with a regular microscope.
According to the US Food and Drug Administration (FDA), nanomaterials can differ to identical materials that have not been manufactured at a nanometre scale.
“In some instances, nanomaterials may take on different chemical, physical, or biological properties than their larger-scale counterparts that may impact quality, safety or efficacy,” said the Agency, adding that there is “great diversity” in these drug products.
Further, nanomaterials have enhanced rates of dissolution – and consequently improved bioavailability – and can be passively and/or actively targeted to different sites in the body, said the FDA.
“For example, passive targeting to different organs (e.g., liver) may be accomplished based on size or charge, while active targeting of tumours typically requires attachment of specific molecules to the surface of nanomaterials that are recognized by receptors on cancer cells.”
The FDA is inviting comment of the draft guidance as of today.
Nanoscale technologies and materials have attracted increased interest from research institutions looking to both increase the speed of pharmaceutical drug development and improve drug effectiveness.
In 2015, researchers from the Oncology Department of Tianjin Medical University Cancer Hospital in China developed a nano-carrier which allowed for the layering of three active pharmaceutical ingredients (APIs) to create a multi-drug treatment for pancreatic cancer.
Last year, researchers at North Carolina State University and the University of North Carolina at Chapel Hill developed nanoscale droplets – “nano-terminators” – designed to hold and increase the effectiveness of anticancer drug doxorubicin (dox).
In June, Dutch scientists announced the development of a microgel chip capable of holding single cells for analysis and research for far longer than currently available 3D culturing technologies.