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How To Maximize The Bioactive Efficacy Of Your Formula

Written by Mindy Goldstein


Bio-actives in your formula drive the claims that you will be able to make in your advertising copy. In order to build a successful product that gives your customer the desired results, your goal is to make sure you are delivering the highest efficacy from your formulations. A highly effective skincare product results from a combination of a high-quality formulation combined with an optimized selection of bio-actives that work together without conflict of modes of action.

Most small to mid-sized companies don’t have the luxury of having their own in-house biological group. Therefore, the choice of bioactive ingredients may fall on the formulating chemist. Most chemists are visited by many raw material vendors inundating them with pages of information on their latest and greatest new bioactive ingredients.

How do you go about choosing which ingredient or combination of ingredients to use to support the claims you want to make on your new product(s)?

1 – Start by understanding the underlying mechanism of the skin issue that you are looking to correct.

  • For example, if you are looking at skin lightening, learn about the process in the skin that synthesizes melanin. Learn what signal molecules and enzymes are involved in or control the melanin pathway from initiation of the melanin pathway to formation of the melanosomes, maturation of the melanosomes and transfer of the melanosomes from the melanocytes to the keratinocytes.

2 – Identify the raw materials that work on the problem you are targeting.

  • There are usually many suppliers that offer ingredients that target the problem you are working on. Lay out all of the technical files for each bioactive material you are interested in using.

3 – Focus on the modes of action of each of the ingredients you have chosen as possible actives.

  • The mode of action for the bioactive is best identified in the In vitro studies. It is important to understand which process in the pathway each bioactive works on. Then you can choose one bioactive that works on each part of the pathway. It is important to make sure that two bio-actives are not targeting the same mode of action. Using two actives that target the same site of action will compete against each other for the active site, which will result in lower efficacy than you would expect. Using actives that work on different modes of action can result in higher than expected efficacy of your product.

4 – Ingredient compatibility

  • Investigate the compatibility of the ingredients that you have chosen with the base that you are planning to use in your formula. Look at the solubility, pH and temperature recommendation on how and when your bio-actives should be added to your formulation. It is very important to make sure that each of the bio-actives are soluble in the inappropriate phase of the formulation. For optimal efficacy, the bio-active must be solubilized to achieve the greatest efficacy of your product.

5 – Stability testing

  • As with any product that you are looking to launch, you need to run formula stability testing on the product to make sure that your product has an acceptable shelf life. Accelerated stability studies can usually approximate the stability of the product held two years at ambient temperature. Accelerated temperature stability testing should be carried out at 40°C or 45°C for three months plus three cycles of freeze-thaw testing, as well as stability testing in the final package. It is also recommended to check the stability of the product exposed to natural light at ambient temperature.

6 – Clinical testing

  • The final determination of whether a formulation delivers the claims that you wish to make are determined through clinical efficacy testing. Many of the government and non-government agencies that review claims are requiring well-controlled clinical studies on at least 30 people, preferably against a placebo formula.

Making the first sale of your new formula is the start of the growth of your products. The consumer will interact first with the aesthetics of the formula so this is very important. That said if your product doesn’t deliver the performance over time that they expect based on the claims you made, then they would never buy it a second time.  The success of your product comes from continued repurchase and assuring the best efficacy that you can achieve plays a very important part in the product’s success.

About the author

Mindy GoldsteinDr. Mindy Goldstein is the owner of Mindy S. Goldstein, Ph.D. Consulting. Prior to her consulting firm, she was Vice President of R&D and Product Development at Atlantic Coast Brands. Dr. Goldstein received her B.S. with honors in Biochemistry, M.S. in Pathology and Ph.D. in Basic Medical Sciences from New York University in the area of UV and gamma radiation damage to DNA and DNA repair. She has been credited with more than eleven publications in scientific journals, and books and has been awarded patents in the area of raw materials, encapsulation and controlled release. Dr. Goldstein has been in the cosmetic industry since 1987. Dr. Goldstein has been consulting within the personal care and nutraceutical industries since 2015.

Previously, Dr. Goldstein served as Executive Director, Research & Development, for The Estee Lauder Companies where her responsibilities included; supplier contact for REACH activities, internal commercialization of new treatment actives for all of the Estee Lauder brands, troubleshooting formulation issues with active materials, encapsulation technology and identifying new platform technologies.

She has previously held Directors positions in R & D at Bath & Body Works, Lipo Chemicals and Collaborative Laboratories. She is an active member of the Society of Cosmetic Chemists, currently serving as Vice President-Elect.




"Content provided by Mindy S. Goldstein, PhD Consulting. Examples, images, and references are provided for informational purposes only. The information is the opinion of the author and its appearance in this blog is not considered an endorsement by the SCC.  SCC makes no representation, express or implied, regarding the accuracy, adequacy, validity, reliability, availability or completeness of any information contained therein."