Determination of Gastric Water Emptying in Fasted and Fed State Conditions Using a Compression-Coated Tablet and Salivary Caffeine Kinetics
Theodora Tzakri,
Lara Rehenbrock,
Stefan Senekowitsch,
Adrian Rump,
Philipp Schick,
Julius Krause,
Marie-Luise Kromrey,
Michael Grimm,
Werner Weitschies
Affiliations
Theodora Tzakri
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Lara Rehenbrock
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Stefan Senekowitsch
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Adrian Rump
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Philipp Schick
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Julius Krause
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Marie-Luise Kromrey
Department of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, Ferdinand-Sauerbruch-Str., 17489 Greifswald, Germany
Michael Grimm
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Werner Weitschies
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport (C_DAT), University of Greifswald, Felix-Hausdorff-Str. 3, 17489 Greifswald, Germany
Because of the importance of gastric emptying for pharmacokinetics, numerous methods have been developed for its determination. One of the methods is the salivary tracer technique, which utilizes an ice capsule containing caffeine as a salivary tracer. Despite the ice capsule’s advantage in labeling ingested fluids with caffeine for subsequent salivary detection, its risk of premature melting before swallowing, and its complicated storage and preparation, limit its application, particularly in special populations (e.g., older people). For this reason, here, a compression-coated tablet was developed and validated against the ice capsule in a cross-over clinical trial. The two dosage forms were administered simultaneously to 12 volunteers in an upright position under fasted and fed state conditions. To distinguish the caffeine concentrations in saliva from each dosage form, regular type of caffeine (12C) was added to the tablet, while for the ice capsule 13C3 labelled caffeine was used. The salivary caffeine concentrations showed no statistically significant differences for the pharmacokinetic parameters tmax and AUC0→60 (p > 0.05). Thus, the new formulation is a useful tool for determining gastric emptying that can also be used in special populations.
