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The Global Hand Sanitizer Market size was valued at $919 million in 2016 and is expected to reach $1,755 million by 2023 (1). These figures however were calculated before the current health crisis and should be substantially higher in the future.<\/p>\n
A hand sanitizer is an antiseptic solution used to reduce the concentration of microorganisms on skin. Over-the-counter antiseptics are classified by the FDA as washes and rubs and are regulated as OTC drugs by the FDA (2). They must be registered and produced in FDA approved facilities. Disinfecting cleansers are meant for treating hard, inanimate surfaces. They are regulated and must be registered with the Environmental Protection Agency (EPA).<\/p>\n
According to the EPA (Environmental Protection Agency), the following are standard definitions of clean, sanitize, and disinfect (3).<\/p>\n
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Hand sanitizers are included in the OTC category Antiseptic Hand Wash or Healthcare Personnel Hand Wash category for products \u201cdesigned for frequent use\u201d and intended to \u201creduce the number of transient micro-organisms on intact skin.\u201d This category also includes antimicrobial hand washes, which serve the same purpose as hand sanitizers and differ only in that they require water for use.<\/p>\n
The 1994 tentative final monograph lists topical antimicrobial ingredients based on scientific data submitted to the FDA advisory review panel to determine their safety and efficacy. The ingredients were placed into 3 categories (4)<\/p>\n
The only category I GRASE actives are Ethanol 60-95% and PVP-Iodine 5-10%. Note, PVP-Iodine is brown in color and will stain the skin a light brown color. Category III actives include Triclosan, Triclocarban, Benzalkonium chloride, Benzethonium chloride and Parachlorometaxylenol. All potential active ingredients for skin antiseptics, were placed into Category III because the FDA has concluded that they lack either safety or efficacy data sufficient for GRASE classification in hand sanitizers. The monograph currently is only tentative, and manufacturers can market hand sanitizers based on Category III ingredients. However, they are required by the FDA to submit further safety and\/or efficacy data to prevent these ingredients from being excluded in the Final Monograph as GRASE active ingredients.<\/p>\n
Consumer antiseptic hand sanitizers are available as gels, non-aerosol foams, wipes and sprays. The most popular forms are gels followed by non-aerosol foams however the fastest growing form is foam.<\/p>\n
The most common type of commercial hand sanitizers are gel formulations which use 60-70% Ethanol thickened with ~.4% Acrylates\/C10-30 Alkyl Acrylate Crosspolymer neutralized using ~.2% Aminomethyl Propanol (AMP). Other suitable thickeners include Carbomer, Acrylates\/Vinyl Isodecanoate Crosspolymer, Polyacrylate Crosspolymer-11, Polyacrylate Crosspolymer-6, Polyquaternium 37, Hydroxypropylcellulose, and Hydroxypropyl Guar. Non-aerosol foam formulations are designed to be dispensed using pump foamer packages and are comprised of 60-70% Ethanol and 2-5% surfactant. Choice of the surfactant however is very critical since most will not produce a stable foam due to the high alcohol content. The best types of surfactants for this application are silicone based copolyols however there are numerous patents covering this application.<\/p>\n