Ethanol’s use as a solvent may have varying concentrations depending on the formula and use. Ethanol in concentrations ranging from 60-90% may be used as a disinfectant. Ethanol ≥ 10% may be used as an antimicrobial preservative in compounded preparations. Topical ethanol can also be used to enhance penetration. Ethanol and its various diluted solutions are commonly used in pharmaceutical formulations and cosmetics as a solvent, but also for its antimicrobial effects. High concentrations of topical ethanol may cause dehydration of the stratum corneum and excessive ingestion can lead to alcohol intoxication symptoms and severe GI distress.įunctionally used as an antimicrobial preservative, disinfectant, skin penetrant, and solvent. It is important to note that ethanol is not an effective sporicidal nor anti-viral. Ethanol also has a solvent effect on oily, wax-coated skin around sebaceous glands. Ethanol works by denaturing cellular proteins of microorganisms, which lowers surface tension and facilitates their removal. At concentrations above 80% ethanol loses its bactericidal activity, going from good to low activity. It is naturally produced by yeasts when they ferment sugars.Įthanol should be stored in air-tight containers at controlled room temperature and protected from light.Įthanol has considerably good bactericidal activity at concentrations ranging from 20-70%, acting quickly with very little residual lasting effect. Ethanol is miscible with all organic solvents (ether, chloroform, glycerin) including water. We suggest referring to the PCCA formula database for reference to similar formulas to determine the ideal solvent.Įthanol (ethyl alcohol) is a clear, colorless, mobile, volatile, and flammable liquid with a burning taste. When to choose alcohol as the preferred solvent (over Propylene Glycol USP or Diethylene Glycol Monoethyl Ether NF) in your compounded formulation primarily depends on the API being used and desired characteristics compatible with the vehicle. Another alternative to reduce the evaporation process is storage of the preparation in the refrigerator. When alcohol is a component of the formulation, it is important to note that the preparation should be stored in an air-tight container to reduce exposure to air and causing evaporation, which can over time cause your compound to increase in potency. Therefore, ethanol would be the only option for oral compounded preparations. Isopropyl alcohol is not appropriate for use in oral preparations.īoth ethanol and isopropyl alcohol can be used as disinfectants and were commonly used in compounding hand sanitizers during the shortage.Įthanol can be consumed, where isopropyl or denatured alcohol cannot. Isopropyl alcohol is not as readily used in compounding, but when used it is often as a solvent or disinfectant in a topical formulation. The uses in compounding have a wide range: solvent, stock solution, topical vehicle, penetration enhancer, preservative, to disinfectant. Topically ethanol may also be used as a penetration enhancer.Įthanol and Ethanol dehydrated have been utilized in over 1000 PCCA formulas. It is primarily used as a solvent, however, it also acts as an antimicrobial preservative at concentrations of 10% or greater. ” Alcohols are commonly used in compounded preparations and their characteristics will determine which one is appropriate.Įthanol and aqueous ethanol solutions are used in pharmaceutical formulations and cosmetics. A hydroxyl group is an oxygen molecule bonded with hydrogen, written as -OH. The definition of alcohol is: “ An organic molecule that contains a hydroxyl group bonded to a saturated carbon atom. By Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development Fabiana Banov, RPh, MS, PCCA Senior Formulation Pharmacist Emily Kay Hanners, B.S.
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