PhilGeis
Forum Replies Created
-
preservative free
-
One USP 51 by itself is not enough - you should ensure the preservative system is stable.
“Safety” by whatever tests or rational must be established. It can not be presumed, one must have an affirmative justification.
Per 21 CFR
A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the following conspicuous statement on the PDP:Warning - The safety of this product has not been determined.
-
Methyl and propyl is a classic combination - with EDTA and a preservative targeting Gram negative bacteria,
-
Abdullah said:@PhilGeis may i ask why you are not offering that it will be effective?
Also what ratio of phenoxyethanol and methylparaben do you recommend?
Efficacy can not be presumed. One must demonstrate by challenge testing. I’m not recommending the stuff - my answer was in response. If one must use a paraben in a shampoo, use methyl.
-
Shampoo - then methyl parabens. But I’m not offering that it will be effective. This you must determine.
-
Right - Perry! Not!
sorry for the confusion. -
Don’t hold your breath for lactic acid as an antibacterial hand wash - a drug product in US. The linked product is lactic acid solution at pH 2. Their suggestion that it could replace isothiazolinones is very, very doubtful.
They mention EPA registration but offer the stuff as a hand sanitizer. Not aware FDA’s OTC monograph for consumer antiseptic handwash products include lactics acid as an approved active. They need a new drug approval to market it as such in the US and you will need one too.
-
abierose said:It’s pretty crazy that so many people were involved in this scheme over DECADES and no one ever blew the whistle! Even crazier is the fact that the companies paying this entity, none of them ever had another independent lab test their product(s)…?
True - suppose they were exploiting small to medium sized companies and those without their own auditing systems that likely couldn’t afford multiple clinicals and i bet AMA was a low cost supplier.
Major company clinical research study monitors would have caught the fraud. -
It’s just too useful at 10 ppm.
-
Think so - 10 ppm is pretty low, about the low end of what you find in fruit.
https://www.cfs.gov.hk/english/whatsnew/whatsnew_fa/files/formaldehyde.pdf -
Prob ok - what is perfume % in formula.
-
Right chemicalmatt - Germall 115 loss is a sad reality - by any name.
-
Think the raw material - not in finished product. Don’t remember if 2000 was unique but experience with Glydant at 2000-25000 ppm was 100-200 free. As efficacy of releasers is based on the released formaldehyde, 10 ppm is not an effective level for the stuff. Not aware that the parent molecule per se has efficacy.
So doesn’t seem reasonable - but would sure be good if true.
-
For those few like me who were close to it - we were aghast!!!! For normal people, it was taken in stride, barely noticed.
-
In execution, these (with EP 5.1.3. EFFICACY OF ANTIMICROBIAL
PRESERVATION) are about the same. There are major differences in success criteria. You can go with any but, as none has been validated for cosmetics, suggest you defer to ISO 11930 criteria. -
Pharma - that fungus WAS thought to be A. niger until 2007.
-
“Broad spectrum” is marketing hype - do not rely on supplier data and claims. Octopirox (Piroctone olamine) is primarily a substantive antifungal in context of dandruff treatment.
If you can’t access PET (and that is a problem as you are responsible for the microbiological safety of your products), use systems found in major marketer products of the same type. You’ll not find much/any Octopirox there.
-
No those are separate species of fungus.
-
Have you PET generated data for its preservation effect?. There are many materials on positive lists that are pretty useless as preservative. It’s pretty insoluble in water - tho it reportedly can be dispersed surfactant solutions.
Caprylhydroxamic acid and glyceryl caprylate are pretty poor preservatives for comparison.Anti-dandruff is a drug claim in US and Piroctone olamine is not an approved active. Don’t think it is in EU.
-
Aspergillus niger exists - and is not the fungus used in the PET challenge test. That is A. brasiliensis.
We are exposed constantly to mycotoxins in grain and nuts and products made from them. Risk assessment of topical exposure via a cosmetic is not going to be an issue. -
You need a preservative system in addition to your active - Piroctone olamine.
Assume you’re developing an antidandruff shampoo. This would be a drug product in some countries - have you addressed drug product regulations in your country?
-
Not much information on specifics - that they work is enough for their suppliers and customers. Likely they have multiple killing functions, one as vitalys said re membranes.
-
To your original question - all those effects can result from contamination with any bug.
As Pharma said - immunocompromised folks are at risk to microbes like these. The risk is serious as some folks have died from infections they got from contaminated cosmetics. Healthy folks can get limited infection but some infections from contaminated mascara resulted in blindness.