PhilGeis
Forum Replies Created
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I am familiar with surfactant and benzyl alcohol interactions to greater efficacy. Above discusses shampoo application constrained to Ecocert .
Don’t see any of the organic acids as primary preservatives - DHA is the least compatible with primary that I’d use (isothiazolinones/ FA-releasers).
General concerns for stability.Maybe cost but it’s been too long since I’ve needed to compare.
Above has limited aplications of DHA for which I’ve been respoinsible to some color cosmetics.
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As you suggested, aquagaurd 9093 system is weak in its design even with happy <51> data. Shampoo contaimination is almost always Gram negative and as you noted the acid system is weak v. Gran neg’s. MIC data are pretty useless - we want to kill not just discourage.
Right - there is that odor. Still need something for the Gram neg’s and Ecocert doesn’t offer other options. Could you drop the level? I’d not go less than 0.25 - benzoate/surfactant and benzyl alcohol/benzoate interactions some describe as synergistic may be enough.
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Think I’d forget DHA. Too much of a contrivance that it;s “natural.” That carries Ecocert BS too far.
Try Benzyl alcohol (min 0.5)/Na Benzoate (min 0.25)/Chelator. In the presence of surfactants, benzoate activity is extended to a higher pH- that is not the case with sorbate. Think you’ll also have better stability with benzoate.
Nonioncs can impact benzoate but PET (CTFA) to determine/confirm efficacy. And pick a good package orifice, that system will not support much dilution. -
What is your preservaitve “policy” - what will you not use?
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Packaging and articles from the far east (esp. China) are often of lesser quality - esp micro- than those obtained from NA. Quality is expensive, and elimination of effort in the regard facilitates the cheaper price you enjoy.
You should assess the micro quality of what you’re getting now.
“Sanitizing in 100 ml glass bulk” will be a challenge - gamma can discolor glass and you’ll need to ensure aeration step effectively eliminates remnant ETO.
You might also cost out packaging already “sanitized” or of a specified micro quality - shifting the burden to your supplier. Might be cheaper than treatment bulk containers yourself - if that’s necessary.
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Benzoate and sorbate are not very robuist even at favorable pH - what is your pH? Prefer benzoate and benzyl alcohol and chelator as a combination but not so much in anything that might get diluted - e.g. shampoo, conditioner. What is the product type and packaging?
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Guess was incorrect. ‘”Company” not currently in the pharma biz.
Per level - If you’re marketing in EU, you’ll want to keep the free formaldehyde less than 500 ppm or suffer labeling as contains formaldehyde*. Experience - this drives to 2000-2500 ppm range for most formalehyde releasers, including DMDM Hydantoin.
*Annex IV - “All finished products containing formaldehyde or substances in this Annex and which release
formaldehyde must be labelled with the warning “contains formaldehyde” where the
concentration of formaldehyde in the finished product exceeds 0.05%.” -
I worked for a large, global company - to qualify systems and test, we conducted tests on products recovered after consuner use from each of the major geographies. I’ve worked with other companies who targeted 1000 recovered samples - not for every product but for systems and to qualify their preservative test.
I understand your general concern - but encourage that folks err on the side of microbiological safety within the safety-in-use parameters of preservatives. Think your success speaks very well of your GMP’s and manuf hygiene, esp. if your using <51>.. -
DRBOB@VERDIENT.BIZ said:
We have used DMDMH alone in a myriad of systems ie creams lotions gels etc with products having micro-integrity for 3+ years via OTC/USP preservation testing. Unnecessary Overloading of a preservation system can lead to skin problems such as contact dermatitis and so on.Preservative as rule of thumb should be < 1.0% wt/wt.Preservation should be designed to be broadly effective (esp. if qualified using <51>) and within parameters of safety in use - not by “rule of thumb”.
The primary purpose of presrvation is to protect consumers in use - how much in-use testing have you done?
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Ask here - or ask the FDA.
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DRBOB@VERDIENT.BIZ said:you may not need another DMDMH is broad spectrum.Only problem is formaldehyde releaser
You will need another and IPBC is a good reco. One should design a preservative system that should be broadly effective and then confirm with a PET. Do not use PET to minimize a system - quantitatively or qualitatively.
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amitvedakar said:What about THIS.
This is an advertisement - these folks have a patent on the stuff. Here’s the technical report: https://pubmed.ncbi.nlm.nih.gov/32089252/. It’s in an obscure journal (cite score ~1) likely because it’s a pretty weak study and a “me too” report. Many plant extracts have been reported to lighten skin. To your apparent point - yes, extracts can have some cosmetic activity.
This report:
The stuff probably has an effect - but no idea if its more than technical as in vivo efficacy described is not compelling and ingredient safety is more than irritation. There’s no analysis of litchi “standardized” material.In testing - there is no positive control that calibrates efficacy in either study. Forearm study had skin darkening on its own (more so that litchi lightening) and the base (no litchi) showed efficacy. Why was skin darkening and would an effect been observed without the darkening? What would a commerical product have achieved?
The facial study was uncontrolled and no idea how grading was accomplished - was skin darkening here too? Why no control base formula (that itself previously showed efficacy, and why no calibration to a relevant commercial product? -
In addition to above - can be extracts very inconsistent in composition from batch to batch and can include pesticides.
Broader market expansion of supply is problematic - it’s driven invasive species into naive regions. UN Industrial Development Organization also complained that subsistence farmers converted to cash crops - essential oils, plant extracts - they and their families starved during market declines.One should also ask - why plant extracts? For this, encourage you sign up for the debate Perry has scheduled on the subject.
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Unclear if you said you would market products - but if you’re limited to what you can do at home - do not market. You are responsible for the product safety (chemcial, microbiological) - an affirmative, data-based effort. You’re not going to generate necessary data at home.
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Think the “bug food” concept is largely fiction. Bugs can matabolize most of the ingredients in cosmetics, and cepacia, for one, can grow to large numbers in distilled water.
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Sure - a formaldehyde releaser with parabens (and EDTA) was the classic combination late last century - tho typically methyl and propyl parabens. Try 2500 DMDM H with methyl propyl 2000/1000 ppm.
If you’re marketing in EU be aware of free formaldehyde limits. -
Change control
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Isopropyl or ethyl (~70% and not booze, just alcohol) - rinse, spritz or wipe depending in equipment. Do not rinse with any water - that merely adds bugs.
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With Pharma - you neither need nor can you effetively achieve/maintain sterility. But appreciate your desire for quality.
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Look for data re. “Euxyl 9010” (90% phenoxy/10% ehg). EU directive allows to 1% Phenoxyethanol - suggest starting ~5000 ppm.
Think this leaves a gap re. fungi - might consdier IPBC or organic acid. -
Think you can develop your own technical defense re. principles established in 22716. Avoid PET defining your risk - if you must generate data - try some in-use testing..
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Hey Matt - not aware of data but prob less effective exposure if addition is after clay is in formulation. But that also leaves previous formulation protected only by GMP’s/time/temp etc. and demands late addition doesn’t run afoul other formula interactions.
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Benzoic and maybe other organic acids reportedly absorbed by clays and may have issues with EDTA as preservative adjunct.
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Accepotance criteria in what context? Might consider ISO 29621 for micro risk. https://www.iso.org/obp/ui/#iso:std:iso:29621:ed-2:v1:en
“Reasonably archaic”. Please don’t be casual re. GMP’s. Per the Drective:
To ensure their safety, cosmetic products placed on the
market should be produced according to good manufacturing practice. -
Good point from Dr. Pratt, but think 50 gram net weight may be too much for the exemption. Perhaps follow the Olay regenerist line labeling - those are ~50 grams.
“The PDP of a “boudoir-type” or decorative cosmetic container, e.g., cartridge, pill box, compact or special variety, and those containing 1/4 oz or less may be a tear-away tag or tape affixed to the container [21 CFR 701.13(e)(1)]. It may also be the display panel of a card to which the immediate container is affixed [21 CFR 701.13(e)(2)].”