Microformulation
Forum Replies Created
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We determined a usage rate from a Japanese patent that has I believed already expired. There was not a great deal of data available from the supplier. If I recall correctly it was listed as 0.1-1% wt/wt.
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@Belassi Honestly it wasn’t all that difficult to mask, especially once it was incorporated into the Formulation at the the proper usage rate. Much more pungent as the undiluted raw material.
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Good Lord. Read credible references. At the allowable rates it is safe. Don’t feed into chemophobia and scare mongering.
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@Doreen81 I am in total agreement.
I have had potential clients call me several times in the last 3 years. The FDA pays a visit to their “manufacturing site” (in some cases their kitchen which is a no-no) in response to an over reaching claim posted online. (Crafters have a tendency to make these claims) The FDA shows up and as part of their inspection they have the FDA cGMP check list in hand. The Inspector hits them on numerous issues. Then they call me and ask about setting up a cGMP program which is something I don’t do. I do refer them to some sources to start with;
- 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
Now, I would also like to stress that this is not limited to crafters. I have had some “manufacturers” (used loosely) call with the same issue.
Lastly, before Amazon started tightening things up I had my attention called to multiple non compliant products. One that stands out was a seller offering a 70% Glycolic Acid Solution for home use with little to no guidance. Etsy is much worse.
You can not under estimate the complexity of this market. It is not insurmountable, but one shouldn’t jump in, over estimate one’s skills, under estimate the complexity and feel that they are creating a safe product. I believe if you asked many of the Chemists on here they would honestly say that when they first started in a manufacturing environment, it was several years before they developed the skills and knowledge base needed to start their own facility. To do so with some Internet research and no practical experience can be a recipe for disaster.
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Fortunately the product I purchased was already in a hydroglycolic base and was standardized. I do have to agree. It smells like my Labs when they swim in the neighborhood ponds.
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I dealt with this last week for a manufacturer. They didn’t mention a $3000 fee (which I agree will be a barrier for some), but on my first draft of a cGMP Compliance Letter I drafted for them from a template, the documentation was accepted.
This is part of the increased documentation standards they came out with several weeks ago. They now also can require an MSDS.
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I have used Spirulina in the past. It is available from numerous suppliers as Hydroglycolic extract and is touted for skin conditioning as well as other purported claims.
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You say “The products are all natural and require no preservatives.” I hope what you meant was that they are anhydrous and contain no water and therefore do not need a preservative, but perhaps an anti-oxidant. My point is that a product being “natural” does not alleviate the nee for a preservative and perhaps in many cases calls for a closer look at the preservative system.
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If you are using a reputable manufacturer, they can provide a letter of cGMP compliance on letterhead. This is no big issue unless your manufacturer is very informal, in which case you would want to avoid them anyway. Personally, I have no issue with this. Rather than seeing it as being discriminatory to Home Crafters, you should see it as raising the bar and requiring the crafters to manufacture in a safe and credible manner. Amazon has been weeding out the non compliant products slowly. If that is a problem, there is always the entirely unregulated market in Etsy.
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Firstly, that is an overly tight R&D time. While you may feel pressure to meet that goal out of respect to Customer Service, you will likely fail. It is better to over estimate and to over achieve than to fail at an unrealistic deadline.
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I went down this road years ago with a product that is still in Whole Foods in the US. We did end up using a Hops CO2 Extract which we got from a distributor in New Mexico. We used a water soluble malt extract. This was all done since the product was not economical if we shipped whole wort (the unfermented but hopped malt which has been heated and the solid matter drained out).
The Marketing story comes from both an old product (Body on Tap) and the fact that in certain European countries they will rinse their hair occasionally with flat beer. -
I don’t think that is it. Have you had it stability tested?
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You say it “holds it (sic) emulsion well.” You don’t have an emulsifier in the product. Have you had it stability tested? “Well” is subjective and with water/oils and no emulsifier you are likely to see some separation eventually.
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And for the Marketing; Psychology and Abnormal Psychology.
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For me, the Gold standard is either IKA (https://www.ika.com/laboratory-equipment/products/overhead-stirrers/products/) or Caframo (https://www.caframolabsolutions.com/product/overhead-stirrers/). Now being realistic I know that these may be initially out of reach for a growing company. In that case I would set-up an EBay alert to let inform you when appropriate equipment has been listed.
Now, the mixer is only part of the issue as most people can tell you. The blades (the detachable mixing attachments) have different uses for different applications. Again I would look for these used or look at a company like Indco (https://www.indco.com/) for these blades.
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One day you will get an overhead mixer and you will never look back.
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I think you will find that a magnetic stirrer will not be useful for anything except the very lowest viscosity. As you approach lotions and especially creams, it will simply not have enough power.
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This would require ethoxylation of the compounds, something far beyond a simple process. You would need to buy the materials.
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Lotioncrafter repacks and sells one of the Evonik products; http://www.lotioncrafter.com/ceramide-complex.html
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Years ago there was a mad rush on Cosmetic Products which used Myristoyl pentapeptide-17 (I think and I can’t remember the trade name, all my old files are archived). They were no whereas effective and were generally formulated with some oils. I know that Marketing had to walk a very thin line to avoid encroaching on a drug claim and if I recall correctly the FDA had a field day with Warning letters.
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@Doreen81 Exactly. The phenomenon has been recognized and capitalized on since the mid-2000’s. Now we can scare people with it’s weird side effect of sometimes changing the color of the iris.
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Regardless of an assayed SPF value, it isn’t an approved sunscreen active which renders the testing moot.
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@Bill_Toge We had a batchmaster once drop his pen into a smaller tank while the Arde Barinco Drop-in homogenizer was running.
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Ok, this is already being done, but it is not a Cosmetic or even an OTC product. It is a legend drug and requires a prescription. The Prostaglandins for the reduction of intraocular pressure were long known to increase the growth of lashes. One prostaglandin, bimatoprost was approved for just this indication. The other prostaglandins can be used for the same indication but it is rare. First, the MD has to theoretically be able to show that the product is safe and effective in the orphan indication through Journal citations. Secondly, since Latisse is already marketed for that, there has not been evidence to show that any prostaglandin is better than the other and lastly Latisse has lots of marketing and educational support for the patient, why do it?
Ultimately you have identified an opportunity that was already capitalized upon in the early 2000’s.
