PhilGeis
Forum Replies Created
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checked for microbial contamination?.
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IN US - drugs get to the market by the New drug Approval (NDA) takes >5 years, ANDA - generic drugs or the OTC process.
Actives per se are not approved - they have to be in a drug product context. A new drug with a new active would most likely need to satisfy NDA process and show safety and efficacy to obtain approval for prescription/Rx application. But the NDA could be designed to generate OTC sale - but that’s rare. Some OTC drugs started out as Rx and were “switched” to OTC.The OTC process was set up in ’72 to control thousands+ of drugs/patent medicines sold over the counter. Slowly weeded out a lot of bogus stuff that couldn’t show safety and efficacy - e.g. Preparation H once used “yeast extract” as its active. More recently and after 40 years of discussion Agency is finally moving against “antimicrobial soaps”.
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What is the active in this “natural” sunscreen.
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Should be soluble in aq alcohol (~10%) solution. pH should be around neutral to sl alkaline.
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You may be oversimplifying.
How do you expect to ensure the product works? It is not sufficient to formulate with an active - enough active has to be deposited with enough coverage to be effective.
Assume you’re not in the US. -
Deposition is the objective - from solution or suspension. Do not know why a solution is required to achieve a homogenous product.
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As the objective is to deposit the stuff on the scalp - are you sure you want a solution?
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This is an antiperspirant as well as a deodorant. In US, it is a drug.
What is “oil lock powder”?
Doubt you need EHG.
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https://meterpharma.com/learn/water-activity-and-pharmaceuticals/
Prob not so accessible.
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Try them together.
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Do ingredients in your formula hold the pH steady or is pH readily adjusted?
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@DeepTitan
Antiaging is marketing claim in Western world. Can you provide some links the ancient Chinese concept -
Guess I can see it happening in a country that desires to directly control thought and a population unsophisticated in the hyperbole (or worse) of cosmetic marketing.
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@DeedeeUkulele
Please note Glucosamine instability @37C in the cited article appears to be in context of come concentration of ammonia and phosphate buffered to an (in abstract) pH. Can’t access the paper itself - any idea what these other specifcs were? -
Foods? Weak materials with a lower bare of efficacy and regulatory and safety bars even greater.
The best - maybe only - Lanxess and prob more so Arxada.
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Sure - Schulke, (former Dow) Microbial Control, Lonza, Emerald Kamala.
To new classes - no. For perspective, a major effort was mounted a 4 or 5 years back organized by Green Chemical and Commerce Counsel (“3G”) and funded by the major companies - P&G, Unilever, etc. to find new preservatives. It was a complete bust - nothing identified worked. Here’s the very political report observing how well industry played together, completely ignoring the total failure of the effort.
https://www.sciencedirect.com/science/article/abs/pii/S2352554120305696I was contracted couple of years backas technical review by a major company for submissions responding to a similar search. Again nothing new of substance.
Development of novel solutions/chemicals clearly need critical financial and technical mass not found in academic and startup entities.
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Geogards are hardly benchmarks.
Two major companies, Lanxess and Arxada, have respectively acquired multiple former preservative development companies with the nominal objective of novel development.
It really takes companies of size to address adequately efficacy, (most importantly) safety and regulatory demands (e.g. EU cosmetic directive) of novel development.
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Are you buffered?
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Can you get Aw?
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What is the effective water %? Can you get an Aw?
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As Pharma noted, it can be both the microbe and its products. You may also find pink with less-common contaminants Chromobacter and contaminating fungi - esp. yeastlike fungi Rhodotorula.
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Yes you can leave it at 3.8. But why did you think you needed to increase it and to what pH?
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what pH do you want to establish?
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No. Recall it’s not that effective in product.
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9010 is not enough - you should add something for fungi.