title: The Effect of Sparkling Water on Intraluminal Formulation Behavior and Systemic Drug Performance.
abstract: In the context of mediating intra- and interindividual variability in systemic drug exposure after oral drug administration, this small-scale, crossover study aimed to investigate the effect of drug intake with sparkling water on fasted state gastric motor function and subsequent (variability in) intraluminal and systemic drug disposition. For this purpose, healthy human volunteers were asked to ingest a conventional paracetamol tablet with either tap or sparkling water, after which antroduodenal motility and intraluminal and systemic drug disposition were monitored as a function of time. Ingestion of sparkling water led to the occurrence of transient pressure events in the upper gastrointestinal tract for all volunteers, although the duration and frequency of the observed effect were subject to variability. Based on systemic drug disposition parameters, drug intake with sparkling water resulted in a trend toward faster and less variable absorption of paracetamol from the gastrointestinal tract. Faster and less variable intragastric tablet disintegration, due to (i) a direct effect (i.e., in vivo dissolution rate) and (ii) an indirect effect (i.e., gastrointestinal motility) of sparkling water, is likely to contribute to this observation.
authors.affiliation: Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Leuven 3000, Belgium.
authors.forename: Jens
authors.initials: J
authors.lastname: Van Den Abeele
authors.affiliation: Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Leuven 3000, Belgium.
authors.forename: Joachim
authors.initials: J
authors.lastname: Brouwers
authors.affiliation: Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Gasthuisberg O&N I, Leuven 3000, Belgium.
authors.forename: Eveline
authors.initials: E
authors.lastname: Deloose
authors.affiliation: Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Gasthuisberg O&N I, Leuven 3000, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Tack
authors.affiliation: Drug Delivery and Disposition, KU Leuven, Gasthuisberg O&N II, Leuven 3000, Belgium. Electronic address: patrick.augustijns@kuleuven.be.
authors.forename: Patrick
authors.initials: P
authors.lastname: Augustijns
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000284:Administration, Oral; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D061545:Carbonated Water / Q000008:administration & dosage*; D018592:Cross-Over Studies; D005260:Female; D005769:Gastrointestinal Motility; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D061545:Carbonated Water; D013607:Tablets; D000082:Acetaminophen
keywords: bioequivalence; biopharmaceutics; clinical pharmacokinetics; disposition; gastrointestinal; oral absorption; oral drug delivery