Microformulation
Forum Replies Created
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grapefruit22 said:How much do stability tests cost in US?They vary, but I know Microconsult will email you an estimate if you submit the online form. They are affordable and used by many lines.
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@tecnico3vinia Good idea. It is difficult to track Regs across the World and they do vary. It may be a non-issue.
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You would need lots of lab equipment that you likely don’t have. Our stability oven was over 10K when new and we have to get it certified yearly. We test objectively for SG, pH (calibrated and logged), Viscosity (Brookfield calibrated yearly), visual appearance, and other metrics. We observe it across 3 accelerated cycles for changes. The final certificate is signed by a Chemist.Don’t try to half-ass it or buy all that equipment for a rarely executed protocol. Call Microconsult for example out of Texas (https://microconsultinc.com/) and you would be surprised how affordable it is, especially when contrasted to buying the bench equipment. Also, you get a credible and credentialed certificate from a Professional. I consult with a company to evaluate these submissions to buyers, and we look closely at these forms.Don’t do it. Make a sample, FedEx it to a lab, and wait for the test results.
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The buyers I work with would demand a more structured stability test. Unless you have the needed equipment on board, you are best to send it out. It also grants you third-party validation.
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Be sure you read up about the Regulatory aspects since many lubricants require 501(k) clearance as a Class II Medical device in the US. I wouldn’t suggest “assuming it is compliant without doing your due diligence. (Again, I am citing US Regulatory issues).
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People can give recommendations, but these questions are usually answered experimentally on the lab bench.
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Perry said:And there is that whole exaggerated “alcohol is drying to skin” myth.
Compounded by the fact that I have had numerous clients ask to avoid Cetyl Alcohol or other Fatty alcohols based upon, “Alcohol dries the skin.”
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You need an exemption from the ATF to purchase Tax-Free, alcohol. The exemption is pricey and likely not feasible for most DIYers. As such they will either use denatured alcohol or they will purchase from a source that taxes the alcohol. There are several suppliers.Most DIYers can easily use 190 proof Everclear if available. I cringe however when someone recommends using Vodka. The abv is nowhere near what the commercial products are.So you CAN use ethyl alcohol without ATF permission. It will just be more expensive to buy and may take some work to source.
Alcohol does have a great deal of negative bias in the Mommy Bloggers and is practically vilified by many. It can be used safely, and there are times when it is irreplaceable in the Formulation. -
I like the Knowde interface and it does bring up other sources of materials/documents not available on UL Prospector.However, and maybe it is me, I can almost never get a sample via Knowde easily. Samples that would be routinely sent via UL Prospector have to be followed up by several emails and then you “might” get a sample.
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Abdullah said:Microformulation said:You can’t say that neither is better. It isn’t an objective and homogenous response from the patient. Patients respond differently.Asking for an objective rating disregards the realities of Clinical practice.
My question was not about the response or feelings of patients. My point was if in theory or research one works better than another for acne.
The clinical response of patients is by far the best objective measure of efficacy. In my experience, patients will generally rotate through several different products or get augmented with clindamycin.
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Perry said:I think this regulation from the FDA on intended use is relevant.
This was the Regulation the FDA cited in a Warning Letter for a similar product. We were called in afterwards, but the FDA essentially felt that a 2% Sal Acid O/W Emulsion was “intended” as an OTC
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You can’t say that neither is better. It isn’t an objective and homogenous response from the patient. Patients respond differently.Asking for an objective rating disregards the realities of Clinical practice.
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@Microformulation, several popular brands have been selling products with 2% salicylic acid in the US for years, and their labeling does not imply that it is OTC, there is no mention of “acne” in any of them. It is not like in Europe that generally 2% is acceptable, but there is a rule that you cannot suggest a medicinal effect of a product?I will let other Professional Chemists weigh in, but simply NOT mentioning acne but using an OTC active is NOT allowed. THIS IS NOT A LOOPHOLE.Again, a self-professed “newbie” (in the original post) should NOT be attempting an OTC product. Endorsing such is foolish.
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2% would be OTC, not a Cosmetic. Again, try something else. An OTC can not be manufactured by a Cosmetic manufacturer. Trust me, I have dealt with this issue and the FDA’s stance with clients.
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As @Abdullah mentioned, an O/W emulsion can be checked at full strength with a pH meter of the proper type.The last pH strips I owned were in my 6th Grade Chemistry Set.
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Why? Just why would you even try that? Buy the material. The synthesis process that you are referring to is far beyond the capabilities of anyone without specialized training and equipment.
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Your colloidal silver is being converted somehow to AgCl which is poorly soluble and has a black/grey appearance depending upon the concentration. It isn’t bringing any real benefit.Ditch the SF Complete and use a better preservation system.That long list of ingredients may seem “innovative” but knowing raw material costs/MOQ’s, it will be pricy to manufacture.
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2% Salicylic acid? This is an OTC product and not the best Formula for a self-professed newbie. Have you reviewed the Regs? Again, this would be an OTC Drug.
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Basic Pharmaceutical calculations. If you are serious about Formulating, you will need to learn at least the basics.
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I have seen people try to create a supersaturated solution such as this. They generally fail stability due to crystallization.
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Urbanxt said:Unanimous with Allantoin being the issue. Allantoin must be entered into the formula at a recommended percentage of the water content and not the formula content. It dissolves in water, not oil.
It should be used as a final percentage of the FULL Formula, not just the aqueous phase. The goal is to have an effective, safe, and appropriate level in the final retail product.
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Panthenol at 5% is a waste and will have an effect on the stickiness of the final product.Again, it is important to know the pH, especially in regard to the organic acid preservative system. A chelant is also needed.
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These are the types of conclusions one arrives at when the Foundation of their hypothesis is “it seems” and they cite anecdotal experience. That is not how the Scientific method really works.
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I have a triple beam balance and my original Apothecary Scale from Undergrad. They are on a shelf looking impressive but aren’t really suited for Formulating.
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Silymarin is soluble in glycerin and alcohol. That shouldn’t be an issue.At 2.5% they are above even the suppliers recommended range (up to 1%) and I don’t believe they are gaining much function with the higher dose.MARKETING at its best.