Which product tests should I have done?

Hi... quick question:  Which tests do I need for my moisturizer?

I am starting a company that makes a moisturizer for the body, specifically for obese persons who have folds of skin that get very little air all day -- so I am concerned about bacteria, yeast, etc. between those folds.  

I am also on a very, very tiny budget.  A formulator quoted $15k, and that is simply impossible.

The FDA requires nothing -- but what tests are both within reason and "average" for moisturizers?  

Any discussion & answers are greatly appreciated!!

Sheila

Comments

  • PerryPerry Administrator, Professional Chemist
    The tests needed depend on the specific claims you are making.  

    But you'll need Stability testing and microbial testing for sure.

    Any claim you make, you have to be able to prove.
  • Thanks, Perry.  
  • You will also need safety testing on skin HRIPT with at least 50 panelists which runs about 1500USD:USP 51 microbial challenge--500$.Figure an additional 500 for moisturizer (TEML etc).Total is about 2500USD.
  • Dr. Bob... any idea if a lab would be willing to do HRIPT on people's belly, so it tells me something about the actual area where my product is used?  
    Or -- would that detract from the value of the testing?
    Thanks.
  • I don't know as have never requested such but worth a try.It may be considerably more expensive but could generate specific mildness claims for that area but if you do it; get Dermatologist signature for only 350$ more.
  • Do I need eye testing? It's a body lotion. Thanks. 
  • A body lotion is usually not marketed for facial application but that doesn't mean it can't be, so if you promote it as such I would do an in-vitro Het Cam test - keep in mind this could be overkill unless you specifically claim "safe for use around the eyes". Net/net don't think it is necessary.
  • Thank you!
    Lab in Boca is saying stability testing is not required for a non-OTC. I'm assuming "OTC" means an over the counter drug. 
  • MicroformulationMicroformulation Member, Professional Chemist
    Stability Testing is NOT required in Cosmetics, however, it is HIGHLY recommended. First, it will identify issues with your emulsion. I am sure everyone can relay stories where an emulsion was unstable in testing which predicted a real time issue. Secondly, many vendors as you grow your line will require proof of stability testing.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • Thank you, Microformulation. 
    It's hard to want to produce a first rate quality product on a near nothing budget. But it's worse to lug around big debt!
    Any advice is 100% welcome. 

    Thanks,
    sheila 
  • How could a company possibly attempt to market a product w/o stability testing?? I would certainly do that as cost is minimal---preservation USP 51--400$----Conduct an o/n patch test for irritation on yourself and colleagues. Once you get going do a formal HP with 50 subjects.
  • MicroformulationMicroformulation Member, Professional Chemist
    I agree 100%. I am a big proponent of this testing. However, sadly I have seen it treated as option far too often.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • They want $1500 for stability testing in a glass jar. $3000 to do it in the product's actual packaging. 
    Can you recommend a better lab?
  • Sounds expensive to me @ $3,000. Surely you can set up an accelerated stability test yourself? You would require an oven to maintain 45 C and monitor the products for 3 months with a range of basic tests.

    In our company we do the accelerated stability test plus another set of samples for real time testing. Generally, in my opinion, it is not an excat science, but does identify problems with the product and packaging.
    Dr. Mike Thair
    Cofounder & Chief Formulator
    Indochine Natural
  • Accelerated stability you can do for two year shelf life: do four weeks at 50C and monitor ph viscosity color odor phase stability.also do 6 cycles of freeze/thaw and hold a sample at ambient temp 21C and monitor after 6-months --1 and 2 years.We do this routinely on all products we market and we have marketed hundreds without a recall.For us it is a verifiable science.All you need is a freezer and oven.You should do preservation USP 51--400USD and when you can do RIPT for safety(as i explained above) or at least run occulsive patch test for primary skin irritation.
  • @DRBOB@VERDIENT.BIZ if I may ask, how many hours is one freeze/ thaw cycle?
  • Total hours 24----12 hours overnight in freezer.Take out and stand w/o shaking at ambient RT.Should come back to normal within 12 hours (if stable usually comes back in 6--8.
  • @DRBOB@VERDIENT.BIZ what I understood from my readings over the internet that one freeze/ thaw cycle goes like this:
    24 hrs freeze at -10C followed by 24 hrs thaw at RT, followed by 24 hrs at 45C, then 24 hrs at RT, so one freeze/ thaw cycle takes 4 days, that means 6 cycles of freeze/ thaw will take 24 days.

    Now my questions are:
    1. is what I have read is the "ideal" freeze/ thaw cycle? 
    2. is what you have suggested is the practical freeze/ thaw cycle that you follow in your practice?
  • I follow the practical cycle as outlined--your number 2-----The so called ideal makes me laugh.
  • @DRBOB@VERDIENT.BIZ thank you so much ;-)
  • Mikethair - I can't begin to imagine keeping my kitchen oven on for three months. 
  • svensven Member
    could i ask how would you test shampoo and conditioners? Skin patch testing for irritability and stability testing seems standard but what else can be done to test further. 
  • You can conduct Half Head studies if you have access to a salon for Lather wet/dry comb softness etc versus a commercial blinded benchmark. Don"t forget USP 51 for preservation.
  • PerryPerry Administrator, Professional Chemist
    You can also do tress combing and feel tests on real human hair tresses.
  • First step, approach your local hair salons for tresses. I did this and was given (free) a large amount of different tresses designed for hair extensions, which are proving invaluable to test the development of a hair straightening system. For shampoo, test it on yourself and family members then enlist a panel of people with different hair types who are open to trying new products.
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
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