Microformulation
Forum Replies Created
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Would be an OTC and an unauthorized drug in the US.
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It is a good layperson reference for those who want to know more about the raw materials in their Cosmetics. The entries are brief, accurate and avoid any fearmongering.
However, there are much deeper references available.
https://chemistscorner.com/top-10-book-cosmetic-science-book-resources/
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Dr. Axe, no. Cosmetics and Toiletries yes. Dr. Oz, no again. Handbook of Cosmetic and Science, yes. There is a prevailing direction in these examples.
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It really doesn’t, but you are not the first to make that assumption. It has been suggested as a marketing tool only but really has no bonafide Scientific benefit.
Honestly, Dr. Axe is not very popular not given much credence by the majority of Cosmetic Chemists. He is generally lumped in with Dr. Oz, Davis “Avocado” Wolfe, Goop and other such Pseudoscience.
In my practice, we qualify sources by Journal citations, credentials and published forum. Any sources would be appropriate to present at a graduate level dissertation.
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What are the candidates that you would consider? There are far too many to name in this forum. Preservation is a topic that takes up a large part of any Formulators continued learning.
I will say that first, you need a definition of what is “natural.” Leaving this term undefined is fine in marketing, but it serves no purpose and in fact is a hindrance to the R&D process. Let me state my definition, albeit it is just my attempt to facilitate the R&D Process. “Plant-based and naturally occurring minerals minimally processed.” Before we belabor what minimally processed is, I will direct you to the COSMOS standard which defines the allowed processes. To simplify, you can say that they are processes that are observed in nature. “Why process them at all?” you may ask. Well, crushed leaves and nuts do not work well and as such most materials must be processed, purified or altered in order to effectively utilize them in skincare.
Right now, in my Market Organic acids are common but they have pH restrictions and can also discolor. Combinations of Phenoxyethanol and a glycol combined with a chelant are also popular and endorsed under many standards.
Can I cover them all? NO. You can not expect to learn reams of information in a forum such as this. You must set a high bar for your sources of information and study extensively. Essentially, if you found it in a google search, you should be suspicious. Blogs are not credentialed. Blogs mean you have a pc and an internet connection, often not much else. Until you raise the bar on your sources and study, you are not ready.
When the products failed challenge testing in what way did they fail? They failed a challenge test. Again, a topic to study on your own. They discolored by darkening, not blue. We are not dealing with colloidal silvers here. They were all topical emulsion products. I will be purposefully vague as my NDA’s set barriers in these areas.
Silver citrate showed some interest to me as a preservative because it is likely to be not absorbed into the user’s body, not have any ill effect on contact and not likely to cause environmental toxicity.
Nearly every approved Cosmetic preservative fits these parameters. Again, vet your references and see. Many of the topics you reference are based upon chemophobia and lack scientific foundations. That being said, when following a natural standard and in Formulating overall, you must accept that some products are avoided not so much by Science but due to Marketing bias. An intelligent line knows that your time to initially promote your product to a customer is finite and you do not need to waste it by dispelling their marketing based beliefs. This was different way back in the late 90’s and early 2000’s when I started seeing an increased demand for “natural”, BUT the chemical distributors have really stepped up.
Lastly, a bit of tongue in cheek humor; I’m not a chemist but love pushing myself to understand.
I am not a Veterinarian but I love pushing myself to understand. Boy are my neighbors pissed at me about their cat!
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I don’t have a great deal of faith in these silver citrate preservative systems. A few years ago a whole line originally formulated by a Contract Manufacturer used this in all the client’s products. The products failed challenge testing and failed stability as the Silver discolored into the second 28-day cycle. They had me fix the entire line. It was at the beginning of December so it was a Merry Christmas! If you are trying to meet a natural standard or avoid certain products due to market bias, there is a huge number of candidates I would consider before this product.
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What is the function of the TiO2? If it is for spf there are numerous issues, but most importantly you may not have the proper mixing equipment to adequately disperse the material.
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1-25% is in the monograph but difficult to obtain and as such, I can’t recall any products that go that high. I do recall 20% ZnO with 1% Calamine.
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In Pharmaceutical compounding we made small batches and honestly only when the mass produced OTC was deviated from.
Your issues are thus;
-If you are in the US, it is an OTC product. That means you must follow an OTC monograph and with the Regulatory requirements, it is not a Cosmetic nor is it feasible for a Cosmetic line to Market.
-The USP OTC percentage is 8% and that was a bear to get incorporated if I recall correctly. Why 20%? In Pharmacy Compounding we were able to deviate from the OTC monograph since I prescription was provided, there were Journal citations for the Physician to justify the higher percentage and it properly became a Prescription Drug evolution. Even so, I never made higher than 12% and that was a challenge. In the end, the sensorials were not what I would have liked. -
As @Bill_Toge properly points out, the only definitive way to answer this is through analytical chemistry processes. You can infer the presence through altering the pH or adding electrolytes, but there are other emulsion materials which could react in the same manner.
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@Doreen81Makes a great point about the skin barrier in dogs. It can be significantly less robust in vet settings and care must be taken.
@zaidjeber also makes a great point which I would heed. In Pharmacokinetics (the calculus-based discipline of identifying and controlling absorption across permeable biological membranes) one of the most controllable areas to reduce absorption is by decreasing the primary concentration (or gradient across the membrane) by decreasing the amount of active.
Penetration across a membrane can be presented in a manner similar to osmotic gradients, where the body seeks to maintain equilibrium under homeostasis. The more electrolyte on one side of the barrier, the larger the osmotic force of water becomes in the attempt to equalize the concentrations. A similar analogous condition exists in Pharmacokinetics.
You will be unlikely to find a lasting and effective penetration inhibitor especially in the disparate skin barriers in vet settings. The real opportunity here is in decreasing the level, hence as seen above decreasing the penetration. As @Doreen81 points out, if this can’t be accomplished in such a manner to maintain performance while decreasing toxicity, your active is not an option.
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With the levels that these tinctures go in, the alcohol is usually negligible. Evaporating in a vacuum is overkill and would be difficult to replicate on a Commercial basis.
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I have worked with it as I have come up through Pharmacy Compounding. If you want some guidance on working with it, look at some of the many Formulations that are posted for Pharmacy compounding as well as the USP/NF documents. Remington: The Science and Practice of Pharmacy covers it quite a bit.
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Hydrogen peroxide can be reactive, hence the reason it is avoided.
Alcohol will evaporate after being sprayed on as a sanitizer.
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You may want to contact Formula Botanica as they are in London and have a consultancy.
As for seeing “one skincare formula” they are proud of, there may be limitations. I know my NDA’s are crafted in such a way to limit my ability to point out products in the Marketplace that I worked on. Many lines like to obscure or imply that the owners had more to do in the Formulation so they will limit the visibility of the Formulator. I joke that I would love my web page to look like the side of a racecar, but it is not how it is usually done.
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In the US and many other places, IPA is easier to get and works as well. You have the right ABV though. Several years ago a Microbiologist mentioned that he had observed that the 90% IPA or in your case 190 proof Ethanol did not work as well. He postulated that it had to do with contact time. I will have to see if he published his findings.
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The belief that Polysorbate and other ethoxylated compounds are carcinogens is somewhat outdated and really falls more properly under fear mongering. Before 1,4 Dioxane was identified as a carcinogen, ethoxylated compounds had high levels of 1,4 Dioxane. However, in response to this, there are new processes which greatly reduce the presence to very low ppm ranges. Even the State of California now has an acceptable range under the Prop 65 limitations.
However, like many raw materials, the marketing bias was already out there and it is perpetuated by those with a surface level familiarity with the issue. But, like many raw materials, there is little return in arguing and most importantly there are numerous alternatives. This would be a vastly different response if it was 15 years ago and the alternatives were not available.
PEG-40 Hydrogenated Castor oil also shares the same issue (note that many Cosmetic lines assert no PEG’s) for the same reason as Polysorbate. The most universally accepted alternatives are APG derivatives and I personally like the Poly Sugamulse D6 from Colonial Chemical. http://www.colonialchem.com/poly-sugamulse-d6/
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Firstly, you really don’t sterilize, you are sanitizing. Sterile properties are only maintained or achieved in a sterile manufacturing setting such as a laminar flow hood.
Your first and best measure is to buy packaging components from a reputable supplier, keep the outer packaging secure as long as possible and to try not to stock more than you can use within a reputable period.
Soap, hot water and bleach are out for multiple reasons. In sanitary cGMP manufacturing, spraying surfaces and components with a 70% Isopropyl alcohol solution is quite common.
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Foam height testing. https://chemistscorner.com/cosmeticsciencetalk/discussion/399/shampoo-foam-testing
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I have to agree with Perry and Bob. There is such a gap between the market expectations (based on the performance of the synthetic fixatives) versus what can pragmatically be delivered with “natural” raw materials (plant based materials minimally processed for definition sake), that you have to address the disparity. You can make a solid product, albeit lacking some performance, that you must address this in your marketing. This has become especially significant in recent years as the market is demanding a much narrower margin between “natural” and “synthetic” finished products in such areas as performance and price. If you can bridge this gap with effective marketing, you can be somewhat successful.
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Here is a partial list;
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These are two separate issues.
A Certificate of Analysis (COA) is a document that shows the testing of your finished good as compared to your established specifications in certain subjective and objective areas such as appearance, odor, viscosity, and so on. This requires the appropriate testing equipment and for the most part some background in testing. As such, unless you have the credible talent within your organization, you will need to outsource this to a testing service. The Society of Cosmetic Chemists (SCC) website lists providers of this service under referrals.
Now, a Certificate of Good Manufacturing Practices is issued by your companies Regulatory person and it states that you are following Current Good Manufacturing Practices. At minimum, I would state that this would require a QA/QC Program as well as SOP’s outlining your standard practices and procedures. Many smaller crafters under estimate the sophistication and documentation standards which should be performed in Cosmetic Manufacturing and this is the point where they get bitten. cGMP is a broad topic and I would recommend reading up on it;
https://www.fda.gov/cosmetics/resourcesforyou/industry/ucm388736.htm
https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm2005190.htm
https://www.amazon.com/Good-Manufacturing-Practices-Cosmetic-Handcrafters/dp/0979594545
The last reference is a book written by Marie Gale. Anyone who has worked with cGMP in a Commercial setting may find it a bit simple, but it is certainly a good starting point.
In summary, if the Forum requires this and you don’t have these programs in place, you aren’t ready to sell in that market and you have some homework ahead of you.
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You can get Xanthan Gum in a clear grade (Vanzan-NF C) but I am not sure how it would do with Carbomer, What is the purpose? Why not simply increase the Carbomer?