Paul DeLeo Coauthors Journal Article on Exposure to Antimicrobial Agent in Hand Soap
Paul DeLeo, Ph.D., of Integral Consulting Inc. has coauthored a paper in the August 2021 issue of the journal Regulatory Toxicology and Pharmacology titled “Systemic Absorption of Benzalkonium Chloride after Maximal Use of a Consumer Antiseptic Wash Product.”
The study, sponsored by Lonza Specialty Ingredients (LSI) and Henkel Corporation, was conducted to satisfy data requirements from the U.S. Food and Drug Administration (FDA) for antimicrobial consumer wash products. It followed the FDA guidance for maximal usage trials for topically applied active ingredients in over-the-counter drug products, and it is one of the first examples of a pharmacokinetic trial being conducted under the guidance for a drug product where the frequency and duration of dosing is at the discretion of the user rather than product labelling (i.e., use as needed). Other coauthors are Victoria Tu of LSI and Janice Fuls of Henkel Corporation.
The paper shows the results of an in vivo pharmacokinetic study for the active ingredient in antimicrobial hand soap, which found that systemic exposure to benzalkonium chloride was low even under exaggerated use conditions.
An in vivo pharmacokinetic study was conducted using consumer antiseptic wash containing 0.13% benzalkonium chloride (BAC) to assess the effect of dermal absorption on long-term systemic exposure to BAC. The objective of the study was to determine blood levels of BAC under maximal use conditions. Subjects were enlisted to wash their hands 60 s with soap containing 0.13% BAC 30 times per day over an 8–9 h time period for 5 consecutive days. The test product with the highest absorption potential was selected based on market share and results from in vitro permeation testing. Blood plasma was collected from subjects on 32 occasions over the 6-day study period. Plasma samples were analyzed for the C12 and C14 homologs of BAC using LC-MS/MS with a lower limit of quantitation (LLOQ) of 106.9 and 32.6 ng/L, respectively. For the 32 subjects, C12 homolog was detected above the LLOQ in only four of 1,024 plasma samples at 117.8–191.7 ng/L, and C14 homolog was detected in only one sample at 59.5 ng/L. Consequently, systemic exposure to BAC in antimicrobial soap is very low and below the level of concern identified by the U.S. Food and Drug Administration (500 ng/L) even under maximal use conditions.
DeLeo, P., V. Tu, and J. Fuls. 2021. Systemic absorption of benzalkonium chloride after maximal use of a consumer antiseptic wash product. Regul. Toxicol. Pharm. 124, Article 104978. https://doi.org/10.1016/j.yrtph.2021.104978
For more information, contact Dr. DeLeo at firstname.lastname@example.org.