Home Cosmetic Science Talk Formulating Lube Osmolality

  • Lube Osmolality

    Posted by Chemist5000 on May 30, 2017 at 2:50 pm

    How do you formulate and consider the osmolality of the product? I am being asked to reformulate various vaginal lubricants (sexual purposes). I have done research on the topic but only come up with “medical” type of information nothing really for formulation.  I have not been able to find a list of chemicals with their osmoles/kg.  

    I understand lubes are medical devices and need a 510K from the FDA.I am learning about this too.  I know the FDA upper limit is 1200 osm/kg.  From what I am told one of our products was over 5000 osm/kg.  

    Not sure where to go with this?  Do I need to reformulate?  If so what parameters should I look for? Is this the same requirement for anal lubes? Thanks! 

    Chemist5000 replied 6 years, 10 months ago 2 Members · 2 Replies
  • 2 Replies
  • johnb

    Member
    May 31, 2017 at 3:07 pm

    I don’t think osmolality is of much concern to lube makers - see my recent comment in your vagina thread.

  • Chemist5000

    Member
    May 31, 2017 at 3:11 pm

    @johnb   it is a concern for the FDA though we have been dinged by this.  There are lube makers that do have products with very high osmolality.  I don’t have much knowledge on the subject matter.  I am not sure exactly what the FDA stance is on osmolality beside letting us (my job) know our product is too high.  Not sure if this is a deal breaker with the 510k or not. 

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