Please be aware that this is a machine translation from French to English. AVICENN is not responsible for incorrect or inaccurate translations but welcomes suggestions for reformulation.

VeilleNanos - Nanos and drugs

Nanos and drugs

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Nanos and drugs

By the AVICENN team – Last updated April 2025

Nanos in drugs: research and applications

Reliable, up-to-date information on nanotechnology research and applications in the pharmaceuticals sector is scarce1See the references listed at the bottom of the page in the “Elsewhere on the web” section for more details.

Almost nothing from ANSM on nanos in drugs

The French National Agency for the Safety of Medicines and Health Products (ANSM) published a report in 2011 on the Biological Evaluation of medical devices containing nanomaterials.

Followed by silence… it took nearly ten years to obtain a new report, composed of information that was unfortunately relatively dated:

  • Article 60 of the law on the modernization of our health system stated that the government would submit a report on nanomaterials in drugs and medical devices to Parliament in the summer of 2017.
  • While the Department of Health announced its upcoming release in July 2018, by mid-2020, we still had no record of the report.
  • Despite its numerous reminders to the Ministry of Health, AVICENN did not manage to get more information, except that the report, carried out by ANSM, was being finalized and in the process of inter-ministerial validation… but this since at least December 2017…
  • In July 2020, AVICENN therefore sent a registered letter to the Prime Minister and the Minister of Solidarity and Health to demand the release of the government report on nanomaterials in drugs and medical devices that should have been made public three years before.
  • The report received on August 3, 2020 has no date or author(s), no details on methodology, has mostly old references and major limitations.

The recommendations of the latest ANSM report are nevertheless interesting and remain more relevant than ever:

  • developments in standardization and regulation for better identification and evaluation of nanomedicines and medical devices
  • modifications of the R-nano register (convergent with the demands of the precautionary and prevention actors)
  • increased involvement of ANSM on the subject
  • etc.

(Un)desired presence of nanoparticles in drugs

E71 in the spotlight

E171, banned in food since 2020, is present in many medicines2– In 2017, Que Choisir revealed that “4,000 drugs contain the dye E171” (composed in part of titanium dioxide nanoparticles).
– In 2018, 60 Millions de Consommateurs brought confirmation through tests of the presence of these nanoparticles in 6 widely used drugs: Efferalgan – Upsa, Spasfon – Teva, Zyrtecset – UCB Pharma, Nurofen – Reckitt Benckiser, Doliprane enfant – Sanofi, Euphytose – Bayer.
– In December 2021, in its exclusive issue on nanoparticles, Kali magazine published a list of the 800 most prescribed drugs that contain titanium dioxide
.
This excipient, composed of titanium dioxide nanoparticles, has no therapeutic purpose; it is used as a colorant and/or opacifier in the film coating of tablets or capsules for its protective properties against UV radiation. It is therefore to be dissociated from “nano-drugs”, which are voluntarily designed on a nano-scale with the aim of crossing physiological barriers and bringing active substances more rapidly and/or more precisely into the body.

Many voices in recent years have been calling for the removal of E171 from medicines.

Thomas Borel, Director of Scientific Affairs at LEEM, the professional organization of drug companies in France, believes that “the excipient E171 ensures the stability of the drug” and that it is therefore “indispensable” for example, to ensure protection and ingestion of the drug3Cf. Why titanium dioxide has been banned from plates, but not toothpastes, Challenges, June 7, 2019 and “Removing E171 from drugs would be extremely burdensome,” Rose Up, August 28, 2019.
That said, brands are now promoting TiO2-free drug coatings4See for example Biogrund’s marketing campaign launched in March 2019:
Challenges of TiO2 free film coatings, March 25, 2019
Titanium dioxide (TiO2) – a critical excipient, 19 March 2019
Replacement of titanium dioxide (TiO2) in tablet film coatings
Are you facing the challenge of replacing TiO₂ in your coating formulations?
and in 2019, Sanofi confirmed that it was considering substituting titanium dioxide in its drugs5See speech by René Labatut, Vice President, Technology Innovation Strategy, Sanofi, at the NanoResp Forum, Drugs and vaccines: what are their nanoparticles for?”, May 20, 2019. In May 2018, the TiO2 nanoparticle management plan implemented by Sanofi had been the subject of a presentation at the SOFHYT forum on emerging risks.. In subsequent years, this led to the effective elimination of E171 from Doliprane, among other drugs.

In February 2025, the European Commission should decide whether to delete – or if not, to extend for a period to be determined – the authorization for the use of titanium dioxide (E171) in medicinal products6cf. recitals 14 to 18 and article 3 of European Regulation 2022/63. Several weeks later, still nothing… : to be continued!

Other nanoparticles of concern in drugs

Titanium dioxide (E171) nanoparticles are not the only problem. The safety of other nanoparticles also present in drugs is questionable – in particular those used as colorants (iron oxides in particular7In December 2022, AVICENN’s report Searching for [nanos] in every day products noted the presence of nanoparticles of titanium dioxide and iron oxides in Bayer’s drug Xarelto) or silica. Will the work carried out by ANSES on the risks of nanos in food quickly shed light on these questions?

Stay tuned…

Elsewhere on the web

– In French :

– In English:

Any questions or comments? This information sheet compiled by AVICENN is intended to be completed and updated. Please feel free to contribute.

Upcoming Nano Agenda

12
Mai
2025
Nanoparticles, all exposed? (University of Bordeaux, online)
On line
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  • Citizen webinar for the general public and the university community.
  • Organizers: Research department Law & Social transformation (DETS), University of Bordeaux
  • Speakers:
    • Marion Tissier-Raffin, Senior Lecturer in Public Law, Centre de recherche et de documentation européennes et internationales (CRDEI), University of Bordeaux
    • Mathilde Detcheverry, General Delegate, Association AVICENN – Veillenanos
    • Didier Morin, University Professor of Neuroscience, UMR CNRS INCIA, University of Bordeaux
  • Website: https://dets.u-bordeaux.fr/animation-scientifique/webinaires-citoyens/saison-2024-2025

13
Mai
2025
5th Joint Symposium on Nanotechnology (BfR & Fraunhofer Nanotechnology Network – Würzburg, Germany)
Würzburg
Conference
  • 5th Joint Symposium on Nanotechnology
  • Organizers: the Fraunhofer Nanotechnology Network, with the support of the Federal Institute for Risk Assessment (BfR)
  • Date: May 13-14, 2025
  • Topics:
    • the application of nanotechnology in various sectors, including digitalization, 2D/3D printing, carbon-based materials and battery materials
    • nano on various regulations (REACh, food contact materials, cosmetics, bioagents, PPPs)
    • adaptation and development of OECD Test Guidelines for nano and advanced materials (Malta Initiative)
    • review on nano-specific NAMs (new approach methodologies)
    • when you’re nano and you know it: dealing with uncertainty regarding the nanomaterial definition in regulatory frameworks
  • Website: www.isc.fraunhofer.de/…2025/5th-symposium-nanotechnology.html

19
Mai
2025
Toxicokinetics: the fate of chemicals in the body (ATC, Paris)
Paris
Training
  • 4-day training :
    • the different routes by which toxic substances can enter the body
    • the importance of toxicokinetics in preventing the toxicity of substances,
    • the absorption, distribution, metabolisation and elimination of xenobiotics
    • the toxicity of nanoparticles
  • Organizer : Association Toxicologie Chimie (ATC)
  • From May, 19 to May, 22
  • Speakers :
    • Frédéric Gaidou (Chemical engineer specialising in Toxicology, ERAMET Group, Paris, President ATC Paris)
    • Sarah Dognin dit Cruissat (Doctor of Pharmacy, nutritionist, toxicochemist, CALMEVA, Lyon)
    • Jean-Dominique Puyt (Veterinary Doctor, Honorary Professor at the École Vétérinaire, Nantes)
    • Isabelle Malissin (Doctor, Hôpital Lariboisière, Paris)
    • Nicole Proust (Research Engineer, Honorary Director of Research at the CNRS, Specialist in Nanotechnologies, Arsenic, Electromagnetic Waves, Palaiseau)
    • Marie-Chantal Canivenc-Lavier ((Nutri-toxicologist, Centre des Sciences du Goût et de l’Alimentation INRA-Dijon)
    • Claude Lesné (Doctor, Honorary Senior Research Engineer at the CNRS)
    • Nicole Proust (Ingénieure Recherche, Directeur de recherche honoraire du CNRS, Spécialiste Nanotechnologies, Arsenic, Ondes électromagnétiques, Palaiseau)
  • Website : https://www.atctoxicologie.fr/notre-formation.html

This sheet was originally created in February 2019


Notes and references

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