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Need help with personal lubricant formula! :)
Hi There, I’m working to formulate a lubricant. Can someone please tell me if I’m way off with these proportions? I’m very new at this, any advice, criticism is much appreciated. Thank you!
Phase A
Distilled Water (aqua) 84.70
Hyaluronic Acid (sodium hyaluronate) 2.00
Hydroxyethylcellulose 10.00
Xantham Gum 0.50
Agar 0.50
Phase B
Sodium Benzoate 1.00
Citric Acid 0.30
Potassium Sorbate 1.00
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12 Replies
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Have you made a bench sample of this formula yet? If so, how did that turn out?
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@globalwidget I haven’t yet, this is purely on paper at this point!
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you might wanna add some aloe vera and perhaps silicone for slip. Is this for moisturization or for intimacy ?
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You may want to keep the pH toward 4.5-5.5 range for the vagina. Lots of lubes have glycerin but it is not the best since it can cause yeast infections.
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@Chemist5000 It is for intimacy, I considered aloe vera but assumed that the HEC would do a similar job. I would be into that addition though.
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It will the most expensive lube in the World with this much of hyaluronic acid
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Keep in mind, that if you sell these products in the US (Personal Lubricants), according to FDA regulations, personal lubricants are classified as medical devices and require agency approval before going on the market. -
I’ve formulated 3 commercial personal lubricants. What is the molecular weight of the Hyaluronic Acid you are using? If it’s a higher molecular weight HA, you’ll wind up with a solid gel with the HA alone. You might consider dropping that down to 0.5 - 0.7% depending on the molecular weight.
Your HEC is way out too high, particularly if you are using a higher molecular HA.
As Mark Fuller mentioned above, personal lubricants for intimacy are regulated as FDA 510K medical devices and must undergo the same testing used for condoms … it’s an expensive undertaking maybe $150,000 or so.
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@MarkBroussard @Microformulation @ngarayeva001 Thank you that’s very helpful, I’ll adjust the HA, and I was already considering subbing out the HEC for Aloe so I might just do that. I won’t be distributing this product so no need for FDA approval, I was aware of that. Thank you!
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@Marley, Maybe use CMC as the gum instead of its derivatives? CMC is very different from those you are using.
@MarkBroussard I didn’t realise it was so regulated? Is the name or the ingredients regulated to cost $150,000
They actually use it in the porn industry replacing condensated milk as the Vagina’s we’re getting too many yeast infections.
Maybe you could call it something else, like lubricating body gel?? -
the name game is how lots of manufacturers of personal “gels” get around the 510K
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The cost is primarily in all the testing required to submit the FDA 510K application to get market approval. The ingredients are quite inexpensive.
Yes, about 2015 the FDA really started cracking down on personal lubricant regulations and several companies had to pull products from the US market. The KY Jelly product line was sold by its owner rather than deal with the 510K submission/regulations.
There are still quite a few small brands flying under the radar without 510K approved status, but that’s just a matter of the FDA paying attention to them or not. You can try calling it by another name, but if your marketing focuses on lubrication for intimate use then you may have regulatory issues to deal with.
Since these products are intended to be used inside a body cavity probably better to err on the safe side.
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