Looking over-the-counter Cosmeceuticals and other pharmaceutical aerosol challenges... By Montfort A. Johnsen, Ph.D. technicAl eDitor The pharmaceutical segment of the U.S. aerosol industry, excluding asthma inhalers, is unusually small. Arrid XX Ultra Clear Antiperspirant/ Deodorant claims maximum strength protection in a clear spray and an "ultra fresh scent." 14 Spray August 2015 These antiperspirants, antiseptic sprays and athlete’s foot sprays make up only about 1.5% of the 3.8 billion aerosols sold in 2014. If sunscreens and tanning sprays were added, the figure jumps to 3.75%; still quite small and with good growth potential. In contrast, non-aerosol pharmaceutical lotions, gels and sticks have established huge sales volumes, but their growth rate has begun to slow somewhat. Over the last fifty years, there has been some confusion as to exactly what constitutes a pharmaceutical product. On Nov. 13, 1987, John Taylor, Associate Commissioner for Regulatory Affairs, U.S. Food & Drug Administration (FDA), stated that, “A product claiming a physiological effect on the body is a drug—even if (the effect) is temporary.” The key word is “claiming”—on the label or in other advertising. Even placing the words “aluminum chlorohydrate” in the ingredient listing of an underarm aerosol product, with no pharmaceutical claims, will serve to identify it as an antiperspirant subject to special efficacy testing and labeling. The definition has merit since it does not address the ability of individual product ingredients to affect the functionality or structure of the body. For example, after 10–20 minutes, pure water can wrinkle the skin of one’s fingertips and change it to a much lighter color. Common solvents may cause defatting, exfoliation or other physiological changes. On the other hand, the industry has had to carefully develop label claims for many personal care products that can only suggest their special properties, like skin moisturization or de-wrinkling, without characterizing them as pharmaceuticals. A phrase might be, “Product will temporarily improve the appearance of outward signs of aging, such as wrinkles or fine lines, by covering them up.” They have also invented useful terms, such as “cosmeceutical” and “neutraceutical” to help define them. These names have never been recognized by the FDA. The agency did publish new rules in June 2004 to better control label and marketing claims, but some confusion still exists. Lastly, other nations have different regulations. An antiperspirant product in the U.S. can be considered a personal care product in several other countries. Ingredients Pharmaceutical formulations usually follow general standards for aerosol products. There will be one or two active ingredients, perhaps some excipients to make them more effective, a solvent, a corrosion inhibitor, a preservative and a propellant. FDA regulations anticipate that each active therapeutic ingredient will be added to +/-10% of the label claims and that they will still be at 90% or more of each claim after three years at ambient temperature. The venerable Arrhenius calculation, based on assays on warmed test packs, is used to predict the three-year result after less than a year of storage. Where significant deterioration is detected, one approach is to fill the active product to about 8% over label. This permits it to lose 18% of its initial assay in three years and still retain 90% of the label promise. If the drug product disintegrates even more rapidly, the product label must carry a message such as, “Do not use after (date).” The Arrhenius equation is less reliable than its wide use and acceptance would suggest. Product development laboratories should always retain stability test packs for the full three years, not only for drug assays, but for weight loss, corrosion, Ostwald ripening (enlargement) of any solids and other tests. Active ingredients associated with stability problems include urea (produces biuret), Sulfathiazole Sodium 1-Hydrate, Sulcimide and Benzoyl Peroxide. There are a huge number of vitamins, botanicals, aquatics and their synthetic derivatives used in pharmaceutical products. They sometimes augment the benefits of the drug substances, but also convey special, desirable properties to the formulation or enhance the skin. Nearly all aerosol antiperspirants Continued on p. 16
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