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Acne Cream with Salicylic Acid
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grapefruit22 said:They mentioned in the brochure that the emulsifier passed stability tests at elevated temperature in the presence of electrolytes without affecting the viscosity, but there is no information on what formulation was tested. They use acrylic thickeners in some other available formulations. Can you use Sepimax Zen?Sorry, I can’t use Sepimax Zen, as it’s not natural
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MarkBroussard said:@Stephanie
What preservative are you using … you only list preservative? Depending on the composition, the preservative may be the culprit in the reduction of viscosity.
(1) Add the SA directly to your oil phase. As mentioned by @ngarayeva001 it is oil soluble, so you don’t need the premix you are preparing. Note: why are you using both Sodium Phytate and NaOH … you only need one base to raise the pH. Unless you’re using Sodium Phytate as a chelating agent?
(2) Prepare the emulsion without the addition of the preservative. If the emulsion will not form or breaks, then you know that you need to choose a different emulsifier that works with SA. If the emulsion does form, but thins or breaks when you add the preservative, then you need to choose a different preservative.
Hi, the preservative I’m using is benzoic acid, sorbic acid.
(1) Yes, sodium phytate is as chelating agent. Will try the method by putting SA in oil
(2) I have done the base (without EO, extract and SA) before, using the same preservative, it’s stable, thus is not preservative issue. Might be SA with the emulsifier.Thank you for the advice.
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@Stephanie Could you make a sample at pH of 5, and another at a pH of 6? I believe the acidity might be modifying the structure of the emulsion. Check how they behave in the oven.
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ketchito said:@Stephanie Could you make a sample at pH of 5, and another at a pH of 6? I believe the acidity might be modifying the structure of the emulsion. Check how they behave in the oven.
Hi Ketchito, but I think salicylic acid won’t be active at those pH as it’s effective at quite low pH. But will try it out if have time. Thank you
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@Stephanie - You may want to read this study on the efficacy of salicylic acid when neutralized. It may be more effective than you think.
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If cream product was made with SA being used as an exfoliant in the OTC range. Wouldn’t you want to do an assay just to make sure your proposed amount in the final product? No acne or blemish claims being made…
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back to the regulatory point
The intent is evident and documented above - in US this product as a drug.
In addition to the monograph, please comply with appropriate 21cfr 201 regulations from registration to CGMP.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201 -
PhilGeis said:back to the regulatory point
The intent is evident and documented above - in US this product as a drug.
In addition to the monograph, please comply with appropriate 21cfr 201 regulations from registration to CGMP.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201People will disregard your citations, try to play the system, and skirt the OTC intended use.I went through an FDA Audit on this issue years ago. Believe me, the FDA Inspector sided with @PhilGeis and they were neither fooled nor amused.
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