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VigilNanos - Nanos and drugs

Nanos and drugs

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Nanos and drugs

By AVICENN Team – Last Added May 2022

What research and what nano applications concerning drugs?

We have little reliable and up-to-date information regarding nano research and applications in the pharmaceutical sector1See the references listed at the bottom of the page in the "Elsewhere on the web" section for more details..

Radio silence (or almost) from the ANSM on nanos in drugs

The 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 then… it took almost ten years to obtain a new report, composed of unfortunately relatively dated information:

  • THEarticle 60 of the law on the modernization of our health system had planned for the government to submit a report to Parliament in the summer of 2017 on nanomaterials in medicines and medical devices.
  • But whilein July 2018, the Ministry of Health announced its forthcoming publication, mid-2020, we still had no record of this report.
  • Despite its numerous reminders to the Ministry of Health, AVICENN had not succeeded in obtaining more information, except that the report, produced 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 to the Minister of Solidarity and Health to demand the dissemination of the government report on nanomaterials in medicines and medical devices which should have been made public three years ago.
  • Le report received on August 3, 2020 presents neither date nor author(s), nor precision on the methodology, and contains mostly old references and important limits.

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

  • changes to be made to standardization and regulations for better identification and assessment of nanomedicines and medical devices
  • changes to R-nano register (converging with the requests made by the actors of precaution and prevention)
  • increased involvement of the ANSM on the subject
  • etc.

Presence (undesired) of nanoparticles in drugs

The E71 in the hot seat

E171, banned in food since 2020, is present in many drugs2– In 2017, What to choose revealed that "4 drugs contain the dye E000" (composed in part of titanium dioxide nanoparticles).
– In 2018, 60 Million consumers brought the confirmation by tests of the presence of these nanoparticles in 6 widely used drugs : Efferalgan – Upsa, Spasfon – Teva, Zyrtecset – UCB Pharma, Nurofen – Reckitt Benckiser, Doliprane child – Sanofi, Euphytose – Bayer.
– In December 2021, in its exclusive issue on nanoparticles, the magazine Time published the list of the 800 most prescribed drugs that contain titanium dioxide
.
This excipient, composed of nanoparticles of titanium dioxide, has no therapeutic purpose; it is used as a colorant and/or as an 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”, for their part deliberately designed on a nano scale with the aim of crossing physiological barriers and bringing active substances more quickly and/or more precisely into the body.

Many voices have therefore been raised in recent years to demand the withdrawal of E171 in drugs.

Thomas Borel, director of scientific affairs at LEEM, the professional organization of pharmaceutical companies in France, considers that "the E171 excipient ensures the stability of the drug" and that it is therefore " essential ", for example to ensure protection and ingestion of the drug”3See Why Titanium Dioxide Was Banned From Plates, But Not Toothpaste, Challenges, June 7, 2019 and "Removing E171 from drugs would be extremely cumbersome", Rose Up, August 28, 2019.
That said, brands are now promoting TiO2-free drug coatings4See for example the Biogrund marketing campaign launched in March 2019:
- Challenges of TiO2 free film coatings, March 25 2019
- Titanium dioxide (TiO2) – a critical excipient?, March 19 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 replacing titanium dioxide in its drugs.5See speech by René Labatut, Vice President, Director of Technological Innovation Strategy, Sanofi, at the NanoResp Forum, Medicines and vaccines: what are their nanoparticles used for?, May 20, 2019. In May 2018, Sanofi's TiO2 nanoparticle management plan was presented at the SOFHYT forum on emerging risks..

Other nanoparticles of concern in drugs

Titanium dioxide nanoparticles (E171) are not the only problem. The harmlessness of other nanoparticles also present in drugs is subject to caution – in particular those used as dyes (iron oxides in particular) or silica. The work carried out by ANSES on the risks of nanos in food will they quickly shed light on these questions?

To be continued ...

Elsewhere on the web

- In French :

A question, a remark ? This sheet produced by AVICENN is intended to be supplemented and updated. Please feel free to contribute.

The next nano appointments

13
Dec.
2022
Nanotechnology, bend or mirage? (FCE CFDT, Paris)
Paris
  • "What prevention approaches to limit the risks?" »
  • Health and Work Day on the impact of nanotechnology on health
  • Organizer: Chemistry and Energy Federation (FCE) of the CFDT
  • Speakers: FCE, INRS, AVICENN
  • Website : www.fce.cfdt.fr/…
31
Jan.
2023
Future-proof Approaches for Risk Governance – Lessons Learned from Nanomaterials (NANORIGO, RiskGONE & Gov4Nano, online)
Online
Conference
  • Conference
  • Topic: “future challenges in risk governance of nano- & advanced materials. This includes safe- and sustainable by design (SSbD) and harmonization and standardization”
  • Organizers: NANORIGO, RiskGONE et Gov4Nano, in collaboration with the OECD Working Party on Manufactured Nanomaterials
  • Website : www.eventbrite.com/…
5
June
2023
NanoSafe conference 2023 (CEA, Grenoble)
Grenoble
Conference
  • 8th International Conference on Health Issues for a Responsible Approach to Nanomaterials
  • June 5-9, 2023
  • Organizer: Commissariat for Atomic Energy and Alternative Energies (CEA)
  • Website : www.cea.fr/cea-tech/pns/nanosafe/…  

This listing was originally created in February 2019


Notes & references

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