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 January 2023

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..

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 particular) or silica. Will the work carried out by ANSES on the risks of nanos in food quickly shed light on these questions?

To be followed upon…

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.

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This sheet was originally created in February 2019


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