The Anatomy of a Formula—Antiperspirant Sticks, Soft Solids and Gels

By: Eric S. Abrutyn, TPC2 Advisors Ltd., Inc.

Posted: May 4, 2009, from the May 2009 issue of Cosmetics & Toiletries.

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Use of an AP active not listed in the FDA monograph requires the submission of a New Drug Application (NDA), which can take 5–7 years for approval and cost up to US $10 million-and regardless, there is no guarantee that an NDA will be approved. Applications can be denied or delayed if there is insufficient safety or efficacy data, in which case, the applicant would be required to provide more data or modify the product to meet the FDA’s requirements. Additionally, even if the application is approved, the use of the new active may have missed its window of opportunity on the market.

Pilot plant scale-up and manufacturing of AP products must be conducted according to drug regulations and this scale-up to full production and stability testing can delay the launch of a product to market up to 18 months from the initiation of project.

All these barriers have affected AP innovation so that, as noted, there has been little change in AP formulating over the past 10 years; thus there is a high probability of minimal change in the foreseeable future.

Trends in APs
Although limited AP innovation currently is taking place, there is room for it in the market, especially in relation to consumer-perceivable improvements. Consumers seek brands that offer extended protection against body odor and perspiration. Therefore, the AP industry is formulating products with “long-lasting” claims, which involve the duration of the fragrance. With the emergence of niche markets, AP manufacturers have begun to target niche-market consumers globally such as organic lines in Europe; non-whitening formulas in Asia; eco-friendly lines in Latin America; and clinical strength/prescription-like, over-the-counter products. For years, the primary focus of AP products has been on minimizing wetness, with the secondary focus being on odor protection. More recently, the trend has been to focus first on odor protection and then on wetness protection. One possible reasons for this change are efforts by marketing to meet consumer demand for differentiation in the available product offerings and the successful consumer response to “deo-cologne” deodorant sprays.

Finally, with the “natural” movement, APs are going “green.” Since the AP product category is regulated in the United States and other countries as a drug, there is limited opportunity to develop natural AP actives. Therefore, the “natural” push has primarily focused on deodorancy claims with innuendos that include natural extracts in an antiperspirant, somehow making the product “natural.”