Toxicity data of therapeutic nanoparticles in patent documents

Therapeutic nanoparticle systems have become increasingly important in the pharmaceutical sector during the last decade. Many of these systems are either already on the market or in preclinical or clinical studies. In order to assess the impact of these systems on biological organisms, regulatory agencies and other institutions actively seek to collect data related to the safety and toxicity of these nanoparticles. While toxicity data is to some extent available for nanoparticles already on the market or in clinical trials, there continues to be a significant demand for data on nanoparticles in the early developmental stages. Such data would allow researchers and governmental agencies to assess in advance the possible impact of the next generation of nanoparticle-based drugs. This study shows that patent documents can be a valuable source for the information required.

► Patents as a valuable source for toxicity data on therapeutic nanoparticle systems.
► Statistical assessment of the toxicity information in patent documents.
► Conclusion 1: patent documents as an accessible alternative source for early information on toxicity.
► Conclusion 2: high proportion of the toxicity data provided by patent applicants from academic institutions.