Microformulation
Forum Replies Created
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Like others, I wouldn’t weigh-in without better measurements. Wt/wt%, not drops is the proper documentation standard.
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The gold standard for reducing TEWL is Petrolatum. Since this is eliminated, I would suggest looking into Moringa Butter. Several years ago Tiffany Oliphant from Floratech did a wonderful presentation on this material as a replacement for Petrolatum,. It comes very near to Petrolatum (still short though) in occlusivity. Some may say it is not “natural” since it is a hydrogenated oil, but all the Natural standards allow hydrogenated oils as hydrogenation can occur in nature. (Without a catalyst of course).
Here is the PowerPoint presentation.
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Several years ago I spoke with Formulators at a French company that was using that combination. I honestly can’t recall the company. They were using that combination to reduce Aw (water activity). They did Aw testing both during the R&D as well as part of QA/QC in production.
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@MarkBroussard And the tallow is extracted through painless liposuction?
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Emily Bazemore ay http://www.ayaricosmetics.com
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Try contacting Emily Bazemore at http://www.ayaricosmetics.com. She is great at these products.
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http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm090816.htm
“Based on the available information included in this report, the
CIR Expert Panel concludes that Glycolic and Lactic Acid, their common
salts and their simple esters, are safe for use in cosmetic products at
concentrations ≤10%, at final formulation pH ≥3.5, when formulated to
avoid increasing sun sensitivity or when directions for use include the
daily use of sun protection. These ingredients are safe for use in salon
products at concentrations ≤30%, at final formulation pH ≥3.0, in
products designed for brief, discontinuous use followed by thorough
rinsing from the skin, when applied by trained professionals, and when
application is accompanied by directions for the daily use of sun
protection.”
Sunburn Alert: This product contains an alpha hydroxy acid (AHA)
that may increase your skin’s sensitivity to the sun and particularly
the possibility of sunburn. Use a sunscreen, wear protective clothing,
and limit sun exposure while using this product and for a week
afterwards.Salicylic Acid is of course covered in an FDA OTC Monograph. As I stated a Regulatory Person (well respected) advised a client of mine that she could not combine Salicylic Acid with Glycolic Acid.
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You need to consult someone with veterinary experience. Pets can be seriously harmed by certain raw materials. Again, this is not an area to blindly go forward. Research!
As Bob rightfully points out, the burden of research rests with you ultimately. I do thik that you have a great deal of research to complete before you even consider adding a flea agent safely.
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Get several quotes from Chemists. I don’t know how easily you are taken aback, but the fee will realistically be in the thousands, not the hundreds. This is fair based upon the time that goes into developing a stable Formulation. Do not under estimate this task.
Some Chemists will take half, some will require the whole fee upfront. Some Chemists will take a deposit and ask for the remainder when you accept the project. These are ALL valid Business practices. Do not think you can get these costs down to any great extent. In my case if someone balks at my fees, it is a predictor that they will not be able to shoulder the larger costs of manufacturing.
Unless you have an extremely interested Dermatologist, you will find that he Dermatologists fees will dwarf the Formulator fees easily.
Lastly, remember Cosmetic can NOT be used to treat a disease. They can NOT be said to elicit a physiological response. Remember, the Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics
as “articles intended to be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the human body…for cleansing,
beautifying, promoting attractiveness, or altering the appearance.” If you target a disease it becomes an OTC drug at minimum and getting a new product approved OTC requires a “New Drug Application.” This process is expensive, in the millions, not the thousands. -
A couple of points;
First you need to be careful in regards to what this “completely unrelated skin problem” is exactly. There isn’t enough information to say exactly BUT be careful that you aren’t using it to treat a disease or it is likely to become an OTC. That complicates and limits your options. Also, do your research and due diligence and ensure that the product will indeed treat the new condition. Use good references and avoid anecdotal evidence (“my mom used it and it cleared up X” or “I used the product and saw that my X got better). Claims substantiation is very important and should be based upon cognizant and qualified credentialed research, not opinion or a “mommy blogger” post.
Next, each Consultant’s prices and fee structure varies. It is hard to say exactly. Contact many providers initially and gauge pricing and fee structures you are comfortable with. Questions more germane are what do the fees cover? Do they cover ownership of the Formula? I know that sounds like a strange point but some Formulators will have a separate charge for this, especially if they are associated with a Contract Manufacturer.
As far as safeguarding the idea, you will execute an NDA at the start of the project. Some Chemists don’t routinely use NDA’s. Some will execute an NDA without payment. Since I am ethically obligated to comply with an NDA and (since despite what we think), there really aren’t very many really novel ideas in the Industry, were I to execute an NDA before being awarded the job, this could rule me out of similar projects. Without payment your idea could actually cost a Consultant money if he/she signs an NDA without remuneration.
Next, very many people are paranoid that there idea will be stolen. Remember, in general nobody else will be as excited regarding your project as you are. In the event that you captured a market share, someone else will knock off your product.
As Chemists we are routinely asked to “reverse engineer” products. You have an obligation to reveal the Ingredient list (not percentages). This is not optional but rather the FDA Labeling requirements. Your Ingredient declaration is the raw materials listed by INCI name in descending order by weight. Anything at or below 1% (you will hear Formulators refer to the “1% line”) can be listed in any order. My preference as I was trained is to list the preservatives, colors, fragrance components and ingredients such as Sodium Hydroxide (a common pH modifier) near the very end.
That said, a Formulator can identify the “1% line” first. In general anything below the 1% line will have either a readily identifiable function (say a preservative for example) or it is “pixie dust”, a term we like to use for an item simply added to make the ingredient declaration more impressive. Raw materials above the 1% line generally have a listed range of use. With some knowledge, experience with the raw materials and some lab time, almost any product can be knocked off.
How do you protect against this? Simply create a solid product that delivers the promised benefits through proper raw material selection. Once you have a product that performs as requested, it all become Marketing. Trying to overcome an established and effective marketing strategy will protect your market share far more than trying to treat the Formulation as “top secret.” In this Industry Marketing is very important. A common truism is a solid product with an effective market strategy will out sell the most over engineered product which is poorly marketed every time.
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Thank you @Bobzchemist. Someone had to say it.
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Is that for home use? Cosmetic Ingredient Review usually recommends limiting the AHA’s to 10% and pH 3.5 or higher for home use products. Also, there is some Regulatory uncertainty about using Salicylic acid (OTC) with Glycolic acid. One of my clients was told this week by a reknown Regulatory expert that it was an unauthorized combination.
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Again, there must be monitoring of humidity as well. Under the guidance the suggested RH is 65%.
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You also have to maintain humidity as well. Also, is this a set-up that could realistically run continuously for three (3) continuous 28 day periods and not deviate from the standards. Do you have monitoring to ensure the consistency and/or alert you when it goes out of spec?
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@bobzchemist I think you said it all. I couldn’t agree more.
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I suppose if you have the Fundamentals already you can gain some value. Working in a Commercial facility will multiply your knowledge ten fold as well. Perhaps I should revise it to don’t try to learn Formulating Solely over the Internet.
That was more addressed to some of the posters we see occasionally who minimize the importance of training and experience. You know the ones “I am not a Chemist and my background is in banking. I want to make a “insert difficult or OTC product here.”” On one hand I know that the Internet has facilitated training, but on the other hand to minimize or ignore your limitations is dangerous and minimizes the values of others. My 2 cents. I will get off my soapbox.
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Why are you using a 350cst Dimethicone? The lower viscosity dimethicones will give more slip and lubricity. 350cst is generally reserved for skin protectant properties, an OTC application.
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As Bob quite correctly points out, this testing is very rarely used as it does not easilly correlate to projected shelf life. It would be a waste of money in almost all Cosmetic settings. The money would be better spent on an Incubator, quantitative measuring equipment (viscosity, pH, Specific Gravity), a Light Chamber and other needed material to follow the PCPC Stability GUIDELINES. Perry did a great webinar on this subject several months ago. There is no mandated stability protocol, but in my experience if you cite the PCPC Guidance, follow them thoroughly and document well, it is generally universally accepted by clients and retailers.
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But again, you will never really know unless you have it tested. In a perfect World this testing would be mandatory. In the case where there is any doubt whatsoever (and be honest and conservative), Preservative Effectiveness Testing MUST be completed.
Preserving with a Glycol utilizes the concept of Water Activity (Aw). Here is a link to an albeit dated outstanding presentation by one of the Industries experts. He covers Water Activity and the Hurdle Concept on pages 22 to 25. The big take away should be Water Activity “Must be measured, not calculated.” http://www.midwestscc.org/blog2/wp-content/uploads/presentations/Jan2012CurrentTrendsinCosmeticPreservation.pdf
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It is not uncommon to have an idealized yet misinformed outlook on terms such as “natural” (no legal definition, dealers choice), “Organic” and what is “toxic.” In most cases it is overly exaggerated and not realistic in the Market place.
As your line grows, you will see that your definition of these terms and concepts will mature. I generally urge my clients to acquaint themselves with their regional Natural Standards (NSF, COSMOS, etc.) and to use this as a yardstick for your raw material selection. You will find that there is by far way too much misinformation and “fear mongering.” Others will argue “this is what the market wants.” Perhaps in 2005 this was still true, but the core clientele now wants a balance between compliance with a Natural Standard, Price and Performance. To put all the emphasis on being “natural” is naive and outdated.
I would definitely use a Consultant. Cosmetic Science is not as simplistic as many neophytes will at first believe. Also, in this Industry you can be a Chemist or a Marketer. In an effective line you will quickly see that you can’t effectively do both. So hire a Chemist to match your well written Product Definition/Standard, let them do their job, do an about face and realize that you are already behind in the marketing. DO NOT TRY TO LEARN FORMULATING OVER THE INTERNET!
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In addition, you are simplifying the process. This is an area where many trained Chemists would think twice going, since it really is one of the more difficult Formulations.
Probably best to hire a Consultant who works in this area. Not for a Beginner.
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I have done numerous of these products BUT I would have to say it is crucial to use a Chemists in the EU. With differing Regulations, Suppliers and general shipping costs to send prototypes from the US to the EU, it is better to use a local provider. Try Colin at Colin’s Consultancy.
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You could also try replacing a portion of your butters with Captex SBE (https://www.ulprospector.com/en/na/PersonalCare/Detail/601/47564/Captex-SBE?st=1&sl=37447693&crit=a2V5d29yZDpbQ2FwdGV4IFNCRV0%3d&ss=2&k=Captex|SBE&t=Captex+SBE),
We have had great results using this with Shea and Cocoa butter on the Production floor to prevent the graininess. -
One way to get this information would be by joining the online community specific to your area. As Bob pointed out, there are numerous LinkedIn groups that fit this bill. Alternatively you could join one of the Cosmetics specific Facebook groups that operate in the EU (Making Skincare, Skincare Entrepreneurs) and pose this question. Many of these Facebook groups are targeted towards the DIY community but they also have Industry insiders who participate. Many of us practice in the US and as such there has been little impetus to source components in your region.
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To also address this, just about any compound can elicit an allergic response. Keep in mind (as many miss, a marketing driven fallacy), whether an ingredient is naturally derived or synthetic has no bearing on its potential allergenicity. (“I can only use natural preservatives since I am allergic to all the synthetic ones.”)
In this case, one of a rare few clients used the product and demonstrated a reaction. It is hotly under debate what was the allergen here (Shea Butter, the fragrance, even the Stevia which incidentally I learned this week can commonly cause this reaction). Could they have formulated the product to be less allergenic? Perhaps.
But in the end (as I have always attested) EOS’s deficiency here was using all the available component labeling space for marketing and missing a simple statement such as “If you react to this product, discontinue and consult with a Medical professional is needed.” I had an EOS in my standards library as a client once wanted to make a similar product and sent it to me. The packaging was devoid of any such warning.
Now EOS will redo their labeling to close this area of liability, settle and likely go on to continue to be a popular brand.