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CDU: What is the potential impact of heat-treated probiotic formulations on cosmetic product manufacturers?
AA: A heat-treated probiotic would be an oxymoron. A probiotic has an internationally recognized definition of being alive, being administered to a target species such as a human or dog in adequate amounts and demonstrating a health benefit, which means a clinical trial against a placebo. They’re alive, so if it’s heat treated, it’s no longer alive.
Then it becomes a postbiotic, or a paraprobiotic, and there’s an international definition from the same group that has published a position paper on the definition of a probiotic. There is disagreement among some researchers on the true definition of a postbiotic: there is one for prebiotic, and for symbiotic, pre and probiotic together, but a postbiotic or a paraprobiotic would be a non-viable cell, or an extract of that cell and demonstrating a health benefit.
If there is no clinical trial commercializing it in humans for a topical or cosmetic personal care product, then a controlled clinical trial would be needed to study the data in humans seeking to demonstrate a health benefit.
Just because he’s dead, and he was a probiotic, doesn’t mean he’s a postbiotic. The element that is always important, and is very rare, is the existence of a clinical trial against adequate control.
In the context of cosmetics, it’s of great value to a company that wants to have or impart efficacy to their product, to have trials that elevate a post biotic ingredient and, ideally, to be able to measure what’s in it.
For shelf stability, it’s still there a year later because most cosmetics have an expiration date. When you add something dead and you don’t know what it really is, how do you measure it? And one of the really cool innovations of probiotic development is the ability to keep the cell, which is like a circle, and still very much intact.
Then, you get little donuts and you can see them through a technique called flow cytometry, which is a measuring tool or device used when you have blood tests. You have your differential, the different types of white blood cells, and it separates or sorts them.
Here you can use the addition of dyes [if they are] live cells and dead cells. You can see dead cells as an intact cell and therefore you can measure them over time in a product.
When you add it, you know exactly how much you’re adding, not just from what you started with, but from the number of cells there, because a flow cytometer counts them in trillions – you get a numerical value.
CDU: How is the stability of a cosmetic formulation that incorporates these types of additives maintained?
AA: In the seminar I gave during In-Cosmetics Global, I discussed how internationally every country or continent has rules on what is the maximum allowed limit of organisms that grow or can be grown in the cosmetic.
An antimicrobial, antibacterial and/or anti-mold agent is added to virtually every cosmetic. You put your finger or eyelash on it, hold it in your hand, open it and open it again, and so the bugs can get inside.
To control that people add preservatives. But if preservatives kill microbes, how would you put a live microbe into a cosmetic that needs to be preserved?
Well, that’s a different story. One of the benefits of using a postbiotic in that you don’t have to deal with liveliness. If there’s an antimicrobial in there to preserve the whole product, or the whole formulation, you can still have a postbiotic because it’s dead.
It won’t be killed by the antimicrobial. Knowing the amount being added and being able to measure it over time is critical, and this is a developing art form.
CDU: What is the biggest challenge in incorporating these types of postbiotics into cosmetic formulations?
I think your biggest challenge for any postbiotic is, if this ingredient works in a test tube in a skin culture in humans, when you have a simple cream, that means if I add it to my eye care or eye serum with other active ingredients, which will still work the same way? No. Everyone likes to say it’s synergistic, but no one has ever demonstrated it in humans.
It’s a wish because it’s an expensive undertaking. The ultimate, next-generation or true commitment to efficacy is to take finished products and evaluate them against placebo in the right target population of people with, say, red or acne-prone skin, or with sunburn or very fair skin. .
Then you can see how it performs with objective and subjective measurements to prove that this product exerts and has an efficacy effect in that population. But this is an investment that is very rarely undertaken.
With the advent of artificial intelligence and machine learning and what’s called decentralized clinical trials, where you do it remotely, you don’t have to come to a clinic, there are groups that are doing studies with hundreds of people for up to of several weeks, for less than $100,000.
There is no higher marketing weapon or bat signal than an independent placebo-controlled clinical trial of finished products.
CDU: Have any contraindications to the formulation with postbiotics ever been identified?
AA: I’m still in a younger stage. I’m sure with any topical product, there are those people who have an adverse reaction.
I have yet to see any published reports of a serious adverse event, defined by the FDA as overnight hospitalization. There are people like with certain foods, where they get an upset stomach, or develop hives, or go into anaphylactic shock – it’s not for them. But nothing happened.
That’s one of the benefits of having a dead organism is that it doesn’t run the risk in that wrong individual of developing as an infection.
CDU: Is it more cost-effective for a manufacturer or brand to consider formulation with a postbiotic?
AA: I think it always depends on the benefit and the cost. Having worked at an average level in the cosmetic industry, there are numerous ingredients that are very expensive and the quantities that are used are quite small due to the cost or what they have proven to be effective.
Like any new ingredient, it becomes a corporate decision and there is almost always some element of internal experimentation. Let’s try a prototype and see what happens.
There are very few products that have dramatic effects where people say, oh my gosh, my psoriasis cleared up or my acne is gone or my dandruff is gone. It’s very rare.
There is a spectrum of changes and improvements, and if the cosmetic products have really worked to the extent that they are represented. we would be in a very different world. We would be anti-aging; we wouldn’t need cosmetic surgery or cosmetic surgery if it actually worked in the ways described.
I think the most succinct way to answer that is, one, there’s the novelty element of a new type of ingredient like a postbiotic, and there’s a lot of consumer awareness for anything with a biotic suffix. Especially pro, constitutes a positive.
Two, if it’s not alive, it’s easy to formulate, much easier. Three, if that postbiotic has evidence behind it in humans, with an outcome that is relevant to the consumer, satisfying an unmet or unmet need, that’s very attractive.
And then four, when you put those together into a finished product, what’s the total cost of the goods that work with a high probability that the product will deliver results for a good percentage of people who use it?
CDU: What is the most exciting thing about Skinbac for you?
AA: I think the emergence of unpublished data on its effects in chronic inflammatory skin conditions such as psoriasis is very fascinating. As we know, there are numerous ingredients or products that are used for chronic skin conditions like rosacea and chronic inflammatory skin conditions like acne, atopic dermatitis and eczema or psoriasis, which are over the counter. They are not drug monographs and make soft statements.
They also have consumers who enjoy significant benefits. So, I think Skinbac’s anti-inflammatory effects coupled with the ability to keep that cell intact and measure it in a quantitative way, collectively or in combination, appeals to me.
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