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VeilleNanos - Nanos and drugs

Nanos and drugs

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Nanos and drugs

By the AVICENN team – Last added January 2023

What research and what nano applications concerning drugs?

We have little reliable and up-to-date information about nanos research and applications in the drug sectorSee1the references listed at the bottom of the page in the “Elsewhere on the web” section for more details.

Silence radio (ou presque) de l'ANSM sur les nanos dans les médicaments

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

Radio silence afterwards… 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 had provided for the government to submit a report to Parliament in the summer of 2017 on nanomaterials in drugs and medical devices.
  • But whilein July 2018, the Department of Health announced its upcoming release in mid-2020, we still had no record of the report.
  • Despite its numerous reminders to the Ministry of Health, AVICENN had not managed to get more information, except that the report, carried out by the ANSM, would be finalized and in the process of interministerial validation… 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 ago.
  • The report received on August 3, 2020 has no date or author(s), no details on methodology, and has mostly old references and significant limitations.

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

  • 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 the ANSM on the subject
  • etc.

(Un)desired presence of nanoparticles in drugs

The 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 in the capsules of 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 have therefore been raised in recent years 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 drug.3Cf. 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 has confirmed that it is 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 dyes (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?

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Ailleurs sur le web

– In French :

– In English:

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Les prochains RDV nanos

5
Juin
2023
NanoSafe conference 2023 (CEA, Grenoble)
Grenoble
Conference
  • 8th International Conference on Health Issues for a Responsible Approach to Nanomaterials
  • From June 5 to 9, 2023
  • Organizer: French Atomic Energy and Alternative Energies Commission(CEA)
  • Website: www.cea.fr/cea-tech/pns/nanosafe/…
22
Juin
2023
How the world deals with Materials on the Nanoscale – Responsible Use and Challenges (OECD-BMUV, Berlin)
Berlin
Conference
  • International Conference from June 22 to 23, 2023
  • Organizers: OECD, German Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection(BMUV)
  • Website: https: //www.bmuv.de/…
3
Juil.
2023
São Paulo School of Advanced Science on Nanotechnology, Agriculture & Environment (SPSAS NanoAgri&Enviro, São Paulo)
São Paulo
Training
agriculture
environment
applications
nanotechnologies
R&D
  • From July 3 to 15, 2023 in São Paulo
  • Organizer: FABESP
  • Application from November 18 to February 05. Registration fees and travel expenses are covered.
  • Speakers: see the complete program here.

This sheet was originally created in February 2019


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