ArticlePharmaceutics2021
On Absorption Modeling and Food Effect Prediction of Rivaroxaban, a BCS II Drug Orally Administered as an Immediate-Release Tablet.
Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed, 4 citations in OpenAlex.
- Development of immediate-release formulation with reliable absorption of rivaroxaban in various meal regimes.Clinical and translational science · 2024Trial
- Enhancement of the Solubility and Dissolution Profile of Rivaroxaban by the Antisolvent Precipitation Technique: A Promising Approach.Polymers · 2026Article
- Transforming Treatment: The Impact of Bariatric Surgery on Oral Drug Absorption.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026Review
- Pharmaceutical Co-Crystal Formulation of Rivaroxaban with Niacinamide: Preparation, Characterization, and In Vitro Release Evaluation.Materials (Basel, Switzerland) · 2026Article
- Food-drug interactions of novel drugs used in cardiologic and diabetic patients - a PRISMA scoping review.Frontiers in pharmacology · 2026Review
- Development of a Universal In Vivo Predictive Dissolution Method for a Borderline BCS III/IV Drug Guided by Modeling and Simulations─Acyclovir as a Case Study.Molecular pharmaceutics · 2025Article
- Formulation Strategy of BCS-II Drugs by Coupling Mechanistic In-Vitro and Nonclinical In-Vivo Data with PBPK: Fundamentals of Absorption-Dissolution to Parameterization of Modelling and Simulation.AAPS PharmSciTech · 2025Review
- From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlusPharmaceuticals (Basel, Switzerland) · 2025Article
- Population pharmacokinetic analysis of rivaroxaban in healthy volunteers and patients with radiofrequency ablation of non-valvular atrial fibrillation in China.Frontiers in pharmacology · 2025Article
- Development and Evaluation of Lactose-Free Single-Unit and Multiple-Unit Preparations of a BCS Class II Drug, Rivaroxaban.Pharmaceutics · 2024Article
- Article
- The development of an innovative method to improve the dissolution performance of rivaroxaban.Heliyon · 2024Article
- Apixaban and rivaroxaban's physiologically-based pharmacokinetic model validation in hospitalized patients: A first step for larger use of a priori modeling approach at bed side.CPT: pharmacometrics & systems pharmacology · 2023Article
- Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study.Clinical and translational science · 2023Article
- Preparation, characterization, and pharmacokinetics of rivaroxaban cocrystals with enhanced in vitro and in vivo properties in beagle dogs.International journal of pharmaceutics: X · 2022Article
- Application of physiologically-based pharmacokinetic model approach to predict pharmacokinetics and drug-drug interaction of rivaroxaban: A case study of rivaroxaban and carbamazepine.CPT: pharmacometrics & systems pharmacology · 2022Article
- Development of Extended-Release Mini-Tablets Containing Metoprolol Supported by Design of Experiments and Physiologically Based Biopharmaceutics Modeling.Pharmaceutics · 2022Article
- Design of Oral Sustained-Release Pellets by Modeling and Simulation Approach to Improve Compliance for Repurposing Sobrerol.Pharmaceutics · 2022Article
- A Combined Pharmacometrics Analysis of Biomarker Distribution Under Treatment With Standard- or Low-Dose Rivaroxaban in Real-World Chinese Patients With Nonvalvular Atrial Fibrillation.Frontiers in pharmacology · 2022Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro-in vivo correlation (IVIVC) models. The bioavailability of Riva upon oral administration of Xarelto IR tablet is reported to exhibit a positive food effect. The PBPK model for Riva was developed and verified using the previously reported in vivo data for oral solution (5 and 10 mg) and Xarelto IR tablet (5 and 10 mg dose strength). Once the PBPK model was established, the in vivo performance of the tablet formulation with the higher dose strength (Xarelto IR tablet 20 mg in fasted and fed state) was predicted using the experimentally obtained data of in vitro permeability, biorelevant solubility and in vitro dynamic dissolution data using United States Pharmacopeia (USP) IV flow-through cell apparatus. In addition, the mathematical IVIVC model was developed using the in vitro dissolution and in vivo profile of 20 mg strength Xarelto IR tablet in fasted condition. Using the developed IVIVC model, the pharmacokinetic (PK) profile of the Xarelto IR tablet in fed condition was predicted and compared with the PK parameters obtained via the PBPK model. A virtual in vivo PK study was designed using a single-dose, 3-treatment cross-over trial in 50 subjects to predict the PK profile of the Xarelto® IR tablet in the fed state. Overall, the results obtained from the IVIVC model were found to be comparable with those from the PBPK model. The outcome from both models pointed to the positive food effect on the in vivo profile of the Riva. The developed models thus can be effectively extended to establish bioequivalence for the marketed and novel complex formulations of Riva such as amorphous solid dispersions.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.