ArticleDrug design, development and therapy2025
Population Pharmacokinetic and Pharmacodynamic Modeling of Enteric-Coated Aspirin Capsule and Tablet Formulations in Healthy Subjects.
Article in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
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Abstract
Purpose: This study aimed to develop a population pharmacokinetic-pharmacodynamic (PK-PD) model to predict the PKs of acetylsalicylic acid (ASA) and salicylic acid (SA), and their effects on thromboxane B2 (TXB2) inhibition following oral administration of two enteric-coated aspirin formulations. Patients and Methods: Data from two Phase I studies in healthy Korean subjects were used to develop the PK-PD model. A nonlinear mixed effect modeling approach was implemented using Monolix Results: The PK of aspirin was well described by a one-compartment model for ASA and a two-compartment model for SA, incorporating pre-systemic metabolism and dual absorption. A turnover model with an Emax function captured the TXB2 inhibition. The capsule formulation showed faster absorption (0.22 h Conclusion: This model adequately described the PK and PD of enteric-coated aspirin and demonstrated comparable TXB2 inhibition between the capsule and tablet formulations, supporting their potential interchangeability in clinical practice.
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