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5% Lidocaine Gel
Hi all -
I am fairly new to formulating. And my questions may be basic, but here goes —
I am trying to formulate a 5% Lidocaine topical gel for the purpose of numbing for tattoo application. According to my research (and exact details seem hard to find), I can use Lidocaine HCI in the oil phase, which consists of Jojoba oil (clear), at a 250ml of oil to 2.5mg of Lidocaine HCI. The oil dissolves the Lidocaine on a magnetic stirrer with heat applied.
The water phase is distilled water (250ml) and i tried adding hyaluronic acid (5%) and Aloe concentrate (5%) which turns my mix white. I could do without that though, and tried it for testing.
I used a homogenizer and added the oil phase to water phase at 10000rpm. It turned out like a cream, but had a slight oily layer, so not sure if i have a process issue.
I also have Carbomer 940 (because i don’t know better), and tried to add that to test.
My ideal outcome would be a clear get, with 5% Lidocaine, similar to OTC creams.
Any input is welcome, and am happy to answer question. Just go easy on me…lol
Thanks!
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2 Replies
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This would be an OTC Drug in the US. You will find more information in the US Pharmacopeia or other Pharmacy sources. I would be hesitant to make this product as a Cosmetic product as it needs to comply with the monograph and it would need to be registered as an OTC. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=dcc5a175-97a0-4e5f-a74d-1a7059d0bfff
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What @Microformulation Mark said, plus 5% is OK for Canada, over the limit for USA. As for a clear gel, lidocaine HCl is soluble in water not oil, regardless of what you read. No carbomer gel will be clear with jojoba oil or any other oil incorporated within. Try dissolving the lidocaine HCl into water after hydrating carbomer but before neutralizing it and see how that works.
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