Seeking: Cooling Actives for Topical Applications

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Overview:

This organization, a global consumer healthcare company, is seeking an alternative to menthol, for use as a cooling and pain relief agent in topical applications. Any alternative must be suitable for EU Medical Device classification.

 

Background:

Recent guidance on the borderline between medical devices and medicinal products (MDCG 2022-5 rev. 1), indicates menthol may be reclassified in this application as the principal mode of action is considered pharmacological, involving interaction with the cold-sensitive receptors in the skin. This organization is seeking alternatives to menthol to ensure topical products maintain the medical device classification, while maintaining equivalent performance.

 

Key Criteria:

  • Alternative cooling actives or technologies must be suitable for a topically applied product and ensure Medical Device classification.
  • Performance of alternative actives or technologies ideally similar to menthol performance.
  • Herbal remedies are not in scope.
  • A commercial, or close to commercial solution is desirable, however solutions in the research & development stage are also of interest.

 

Possible Solution Areas:
This client is open to a wide range of solutions, specifically those that utilize a principal mode of cooling other than a pharmacological interaction with the cold-sensitive receptors in the skin. Solutions may be an ingredient, a combination of ingredients, a technology or a combination of ingredient(s) and technology.

 

Desired outcome of the solution:
Identify an alternative for the use of menthol as a cooling active in topical applications offering similar cooling performance

 

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