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Lube Osmolality
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!
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