Measuring the Impact of Gastrointestinal Variables on the Systemic Outcome of Two Suspensions of Posaconazole by a PBPK Model

No abstract is available for this paper.

• Publication year

  2018

• Venue

  AAPS Journal

• Publication date

  2018-03-29

• Fields of study

  Medicine, Chemistry

• Identifiers
  DOI 10.1208/s12248-018-0217-6PMID 29600330
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• The artificial membrane insert system as predictive tool for formulation performance evaluation.

  2018cited by this paper
• In Silico Modeling Approach for the Evaluation of Gastrointestinal Dissolution, Supersaturation, and Precipitation of Posaconazole.

  2017cited by this paper
• Dynamic dissolution‐/permeation‐testing of nano‐ and microparticle formulations of fenofibrate

  2017cited by this paper
• Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs.

  2017influential reference
• In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context.

  2017cited by this paper
• Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation‐dependent effect of achlorhydria

  2017cited by this paper
• Mechanistic Fluid Transport Model to Estimate Gastrointestinal Fluid Volume and Its Dynamic Change Over Time

  2017cited by this paper
• Exploring gastrointestinal variables affecting drug and formulation behavior: Methodologies, challenges and opportunities.

  2017cited by this paper
• Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

  2017cited by this paper
• Assessment of Bioequivalence of Weak Base Formulations Under Various Dosing Conditions Using Physiologically Based Pharmacokinetic Simulations in Virtual Populations. Case Examples: Ketoconazole and Posaconazole.

  2017cited by this paper
• Regional Intestinal Permeability of Three Model Drugs in Human.

  2016cited by this paper
• Characterization of Human Duodenal Fluids in Fasted and Fed State Conditions.

  2016cited by this paper
• Gastrointestinal and Systemic Monitoring of Posaconazole in Humans After Fasted and Fed State Administration of a Solid Dispersion.

  2016influential reference
• Segmental-dependent permeability throughout the small intestine following oral drug administration: Single-pass vs. Doluisio approach to in-situ rat perfusion.

  2016cited by this paper
• Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses

  2016cited by this paper
• In-situ intestinal rat perfusions for human Fabs prediction and BCS permeability class determination: Investigation of the single-pass vs. the Doluisio experimental approaches.

  2015cited by this paper
• Supersaturation and Precipitation of Posaconazole Upon Entry in the Upper Small Intestine in Humans.

  2015influential reference
• Evaluation of fasted state human intestinal fluid as apical solvent system in the Caco-2 absorption model and comparison with FaSSIF.

  2015cited by this paper
• The Interdigestive Housekeeper of the Gastrointestinal Tract

  2015cited by this paper
• In Vivo Predictive Dissolution: Comparing the Effect of Bicarbonate and Phosphate Buffer on the Dissolution of Weak Acids and Weak Bases.

  2015cited by this paper
• PBPK models for the prediction of in vivo performance of oral dosage forms.

  2014cited by this paper
• A dynamic system for the simulation of fasting luminal pH-gradients using hydrogen carbonate buffers for dissolution testing of ionisable compounds.

  2014cited by this paper
• Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo.

  2014cited by this paper
• Quantification of gastrointestinal liquid volumes and distribution following a 240 mL dose of water in the fasted state.

  2014influential reference
• In vivo predictive dissolution: transport analysis of the CO2 , bicarbonate in vivo buffer system.

  2014cited by this paper
• The Biopharmaceutics Classification System: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC.

  2014cited by this paper
• A review of drug solubility in human intestinal fluids: implications for the prediction of oral absorption.

  2014cited by this paper
• Gastrointestinal transfer: in vivo evaluation and implementation in in vitro and in silico predictive tools.

  2014cited by this paper
• Intragastric volume changes after intake of a high-caloric, high-fat standard breakfast in healthy human subjects investigated by MRI.

  2014cited by this paper
• Strategies to Address Low Drug Solubility in Discovery and Development

  2013cited by this paper
• In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen

  2012cited by this paper
• pH-Induced Precipitation Behavior of Weakly Basic Compounds: Determination of Extent and Duration of Supersaturation Using Potentiometric Titration and Correlation to Solid State Properties

  2012cited by this paper
• Single-Dose Phase I Study To Evaluate the Pharmacokinetics of Posaconazole in New Tablet and Capsule Formulations Relative to Oral Suspension

  2012cited by this paper
• The migrating motor complex: control mechanisms and its role in health and disease

  2012cited by this paper
• Precipitation in the small intestine may play a more important role in the in vivo performance of poorly soluble weak bases in the fasted state: case example nelfinavir.

  2011cited by this paper
• Effect of pH and Comedication on Gastrointestinal Absorption of Posaconazole

  2011cited by this paper
• Meaningful or redundant complexity – mechanisms behind cyclic changes in gastroduodenal pH in the fasting state

  2011cited by this paper
• Physiological bicarbonate buffers: stabilisation and use as dissolution media for modified release systems.

  2009cited by this paper
• Population-Based Mechanistic Prediction of Oral Drug Absorption

  2009cited by this paper
• Toward an in vivo dissolution methodology: a comparison of phosphate and bicarbonate buffers.

  2009cited by this paper
• Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update

  2008cited by this paper
• Gastric emptying of a non‐digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy

  2008cited by this paper
• Effect of a Nutritional Supplement on Posaconazole Pharmacokinetics following Oral Administration to Healthy Volunteers

  2006cited by this paper
• Intestinal fluid volumes and transit of dosage forms as assessed by magnetic resonance imaging

  2005influential reference
• Drug Bioavailability: Estimation of Solubility, Permeability, Absorption and Bioavailability

  2004cited by this paper
• Predicting the precipitation of poorly soluble weak bases upon entry in the small intestine

  2004cited by this paper
• Use of a Physiologic Bicarbonate Buffer System for Dissolution Characterization of Ionizable Drugs

  2003influential reference
• Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

  2002cited by this paper
• Indirect evidence for cholinergic inhibition of intestinal bicarbonate absorption in humans

  1999cited by this paper
• Human duodenogastric reflux, retroperistalsis, and MMC.

  1998cited by this paper
• Human intestinal permeability.

  1998cited by this paper
• Human duodenogastric reflux, retroperistalsis, and MMC.

  1998cited by this paper
• Human Jejunal Effective Permeability and Its Correlation with Preclinical Drug Absorption Models

  1997cited by this paper
• Regulation of interdigestive gastrointestinal motility and secretion.

  1997cited by this paper
• A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability

  1995cited by this paper
• Cholinergic Regulation of Phase II Interdigestive Pancreatic Secretion in Humans

  1993cited by this paper
• Variability of migrating motor complex in humans

  1992cited by this paper
• Drug release from microparticulates; deconvolution of measurement errors

  1990cited by this paper
• Relationship between interdigestive duodenal motility and fluid transport in humans.

  1990cited by this paper
• The influence of the interdigestive migrating myoelectric complex on the gastric emptying of liquids.

  1990cited by this paper
• The influence of variable gastric emptying and intestinal transit rates on the plasma level curve of cimetidine; an explanation for the double peak phenomenon

  1987cited by this paper
• Investigation of drug absorption from the gastrointestinal tract of man. I. Metoprolol in the stomach, duodenum and jejunum.

  1985cited by this paper
• A comparative study of the gastrointestinal transit of a pellet and tablet formulation

  1984cited by this paper
• A demonstration of bicarbonate production by the normal human stomachin vivo

  1982cited by this paper
• Dissolution kinetics of carboxylic acids I: effect of pH under unbuffered conditions.

  1981cited by this paper
• The secretory component of the interdigestive migrating motor complex in man.

  1979cited by this paper
• The propagation of segmental contractions along the small intestine *

  1972cited by this paper
• Physiological control of gastric acid secretion.

  1971cited by this paper
• Peptic Ulcer

  1971cited by this paper
• The role of the intestine in the regulation of gastric secretion.

  1970cited by this paper
• [The role of the intestine in the regulation of gastric secretion].

  1969cited by this paper
• The influence of volume on gastric emptying

  1954cited by this paper
• Theme: Leveraging Bcs Classification and In-silico Modeling for Product Development Guest Editors: Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets

  year unknowncited by this paper

• PBPK Modeling Addresses Oral Absorption-Mediated Drug Interactions.

  2026cites this paper
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  2025cites this paper
• The role of modeling and simulation to improve the treatment of fungal infections caused by Cryptococcus : A literature review

  2024cites this paper
• Using molecularly dissolved drug concentrations in PBBMs improves the prediction of oral absorption from supersaturating formulations.

  2024cites this paper
• The Effects of Degree and Duration of Supersaturation on In Vivo Absorption Profiles for Highly Permeable Drugs, Dipyridamole and Ketoconazole.

  2023cites this paper
• A Physiologically-Based Pharmacokinetic Model of Ruxolitinib and Posaconazole to Predict CYP3A4-Mediated Drug–Drug Interaction Frequently Observed in Graft versus Host Disease Patients

  2022cites this paper
• Oral biopharmaceutics tools: recent progress from partnership through the Pharmaceutical Education and Research with Regulatory Links collaboration.

  2021cites this paper
• In Vitro Sensitivity Analysis of the Gastrointestinal Dissolution Profile of Weakly Basic Drugs in the Stomach-to-Intestine Fluid Changing System: Explanation for Variable Plasma Exposure after Oral Administration.

  2021cites this paper
• Evaluating the impact of physiological properties of the gastrointestinal tract on drug in vivo performance using Physiologically Based Biopharmaceutics Modeling and virtual clinical trials.

  2021cites this paper
• Amorphous Solid Dispersion Tablets Overcome Acalabrutinib pH Effect in Dogs

  2021cites this paper
• On the usefulness of four in vitro methods in assessing the intraluminal performance of poorly soluble, ionisable compounds in the fasted state

  2021cites this paper
• On the usefulness of four in vitro 1 methods in assessing the intraluminal 2 performance of poorly soluble , ionisable 3 compounds in the fasted state 4 5

  2021cites this paper
• The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development

  2021cites this paper
• Exploring the Impact of Real-Life Dosing Conditions on Intraluminal and Systemic Concentrations of Atazanavir in Parallel with Gastric Motility Recording in Healthy Subjects.

  2020cites this paper
• Physiologically Based Pharmacokinetic Modeling to Understand the Absorption of Risperidone Orodispersible Film

  2020cites this paper
• A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP

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• Biopredictive in vitro testing methods to assess intestinal drug absorption from supersaturating dosage forms

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  2020cites this paper
• Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives

  2020cites this paper
• Novel high-drug-loaded amorphous dispersion tablets of posaconazole; in vivo and in vitro assessment.

  2020cites this paper
• Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012

  2019cites this paper
• Automated small-scale in vitro transfer model as screening tool for the prediction of in vivo-dissolution and precipitation of poorly solubles.

  2019cites this paper