{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T23:44:02Z","timestamp":1783035842094,"version":"3.54.6"},"reference-count":43,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,3,11]],"date-time":"2024-03-11T00:00:00Z","timestamp":1710115200000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Sialorrhea or drooling is a common problem in children and adults with neurodevelopmental disorders. It can negatively impact the quality of life due to its physical and psychological manifestations. Providers commonly prescribe atropine eye drops for topical administration to the oral mucosa, as an off\u2010label treatment to manage sialorrhea. However, the off\u2010label use of atropine eye drops can be associated with medication and dosing errors and systemic side effects. To address these limitations of treatment, we developed a mucoadhesive topical oral gel formulation of atropine as an alternative route to off\u2010label administration of atropine eye drops. In this clinical pharmacokinetic (PK) study, we evaluated the safety and PK of atropine gel (0.01% w\/w) formulation after single\u2010dose administration to the oral mucosa in 10 healthy volunteers. The PK data showed that after topical administration to the oral mucosa, atropine followed a two\u2010compartment PK profile. The maximum plasma concentration and area under the curve extrapolated to infinite time were 0.14\u2009ng\/mL and 0.74\u2009h\u00b7ng\u00b7mL<jats:sup>\u22121<\/jats:sup>, respectively. The absorption rate constant calculated by the compartmental analysis was 0.4\u2009h<jats:sup>\u22121<\/jats:sup>. Safety parameters, such as heart rate, blood pressure, and oxygen saturation, did not significantly change before and after administration of the gel formulation, and no adverse events were observed in all participants who received atropine gel. These data indicate that atropine gel formulation has a satisfactory PK profile, is well\u2010tolerated at the dose studied, and can be further considered for clinical development as a drug product to treat sialorrhea.<\/jats:p>","DOI":"10.1111\/cts.13753","type":"journal-article","created":{"date-parts":[[2024,3,11]],"date-time":"2024-03-11T10:03:05Z","timestamp":1710151385000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Clinical pharmacokinetics of atropine oral gel formulation in healthy volunteers"],"prefix":"10.1111","volume":"17","author":[{"given":"Madison","family":"Parrot","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Pediatrics, Spencer Fox Eccles School of Medicine University of Utah  Salt Lake City Utah USA"},{"name":"Department of Molecular Pharmaceutics, Utah Center for Nanomedicine, College of Pharmacy University of Utah  Salt Lake City Utah 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