Microformulation
Forum Replies Created
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Behentrimonium methosulfate can be derived from rapeseed and canola oil.
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Perry is absolutely correct about the size of the job as well as the way to approach it.
Several sources can provide you with a basic Outline/Table of Contents for a Basic cGMP/QA/QC Manual. One could start with that and use it to assign placemarker SOP Numbers for each section. Then you could start with a Introductory SOP defining the scope, function and background of your SOP Program.
We did this successfully at a plant I worked at. We wrote the Introductory SOP and then assigned Representatives in each work center to sit on the review Committee and develop the initial SOP’s. Six months later we have a working cGMP program and at the 2 1/2 year mark it was refined and comprehensive.
Even once it was finished, the Committee still met annually and revised the SOPs as needed.
Again this is a lucrative area for Consultants as they charge dearly. However if this is an area you MUST improve upon in your facility, the cost could be worthwhile.
Quite important with a cGMP Program is to use it. I have toured plants where they have a cGMP Program but it is for show and not followed. To make this type program effective you must train effectively. SOP’s are often perceived as BS that serves no purpose. If you train them to understand the whys and hows in a clear manner they will work. We empowered people in each work center to understand and follow the SOP’s. When done correctly it will create an effective “culture” of cGMP.
Lastly have checks and balances and ensure QC checks and logs are completed. B in the mindset of “if it wasn’t recorded, it didn’t happen.”
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In you get a RO system, do not scrimp on or neglect the preventative maintenance. I have seen poorly maintained system that were alarming.
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Many companies (Koster Keunen, Blue Sun) make similar products. I beleive the usage rate is 3-5%. I referenced the Croda material because of their outstanding Technical documents they make available.
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Behentrimonium methosulfate is one of your best options if you are seeking a naturally compliant product.
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Try Susan Raffy at Raffy Consulting. http://www.rockstarchemist.com/
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That would be a waste of time. Honestly it is something you can trouble shoot yourself.
What grade of Carbomer did you use?
How did you hydrate the carbomer? Do you have homogenization? If not, what is your highest available shear?
Lubrizol has volumes of helpful documents online that will help when working with carbomers. Also they have many different grades of Carbomers. Carbopol Ulrez 21 is excellent for making clear gels and very easy to work with.
If changing the carbomer doesn’t solve it you can look further. What was the final pH? Did it vary over the 6 month period? Has the viscosity changed?
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Hard to say without the sample in front of me, but if I had to guess I would have to suspect the carbomer as the issue. I have seen that “tapioca” pudding-like fish eye formation in the past. I am sure many of us have also in Production.
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I am sure the above lines have either made arrangements or could be fighting the patent. In the end. we are not attorneys. I would not infringe upon the patent myself without the go ahead from a patent attorney or a Regulatory Expert. I have consulted someone who is the likely the most experienced in Cosmetics and he has advised against infringing on the patent. I have to side 100% plus with Bob Zonis on this one.
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Check with Doug Schoon at Schoon Scientific. He has established himself in that niche.
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It was L-Ascorbic acid and Ferulic acid. I am unsure of the overall Formulation. I sent them on to a Regulatory Expert and they pulled their products. They were cold emails to my website.
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In the last 5 years I have encountered two (2) lines that were contacted via Registered Mail with a Cease and Desist on their Vitamin C/Ferulic acid combinations. In both cases they folded rather than deal with L’Oreal’s company Counsel.
In the end I would run it buy a Regulatory Expert first. Attorneys we are not.
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I have seen several and formulated several Vitamin C Serums. They are NOT all sourced through the same manufacturer but use similar concepts in the Formulation.
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Be sure to consult with a Regulatory person or a Patent Attorney before making an Ascobic Acid/Ferullic acid product.
http://www.google.com/patents/US7179841
In my experience this is a case where L’Oreal WILL pursue patent infringement if you sell the final product. Lotioncrafter now warns that the FA/Ascorbic acid kit they sell is only for personal use. They were contacted by L’Oreal in the past.
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@nasrins I wouldn’t use Litmus papers. A calibrated STABILITY Incubator is needed and you do need to do viscosities. These are all required if you want to do credible stability test.
The pH meter has the sensitivity to identify small creeps in pH and the accuracy is at the level one would need for a validated test.
Changes in viscosity are CRUCIAL in identifying stability issues in emulsions.
A Stability Incubator is calibrated in RH and temperature. Mine is done by an outside provider who also does all the calibrations on my scales.
Informal tests are helpful but hardly at the level of confidence one would need. When in doubt send it out for third party validation.
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If you are talking about a Vitamin C Serum, use the Cosmetic grade. Try not to go too crazy and try to match some high percentage of Vitamin C Net (what I call chasing the Perricone Dragon). Vitamin C derivatives plateau out and the higher percentages offer more topical side effects with blunted additional effect.
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It can also be used at low levels to decrease the shininess (matte) of some emulsion bases, especially silicones.
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No, if I recall correctly you actually have to use a carbonate (Magnesium carbonate in this case) in an aqueous solution, then mill and dry the product. It also has to be assayed in a validated laboratory. After all that you get Magnesium ascorbate, a compound almost never used in skin care but more predominant in oral dosage forms. In the end it is more than a simple reaction as outlined in your question. Just buy some Magnesium Ascorbyl Phosphate (MAP) from Lotioncrafter and other such retail sites. In wholesale I know Charkit, Caribbean Naturals, and Uniproma sell MAP.
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Regardless since “natural” has no legal definition, I think the claim “100% natural” is a marketing term, not one for Cosmetic Scientists.
In the end the only way to assess efficacy is to use the product properly and then perform micro testing.
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Even with the low pH you are just delaying the breakdown, not preventing it.
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At 30% L-ascorbic acid the increased irritation would certainly offset any additional benefit. As MarkBroussard rightfully pointed out, it won’t be a 30% L-ascorbic acid lotion for very long.
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Marketing is certainly the key term here. The word “perceived” before benefit in my statement was not unintentional.