Biorelevant dissolution testing and physiologically based absorption modeling to predict in vivo performance of supersaturating drug delivery systems

Quantifying In Vivo Luminal Drug Solubilization -Supersaturation-Precipitation Profiles to Explain the Performance of Lipid Based Formulations

(2020) Yusuke Tanaka et al.   PHARMACEUTICAL RESEARCH

Mechanisms for oral absorption enhancement of drugs by nanocrystals

(2020) Jiali Liu et al.   JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

(2020) Xavier J.H. Pepin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Biorelevant two-stage in vitro testing for rDCS classification and in PBPK modelling – Case example ritonavir

(2020) Tom Fiolka et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

(2020) Sumit Arora et al.   MOLECULAR PHARMACEUTICS

Combining biorelevant in vitro and in silico tools to investigate the in vivo performance of the amorphous solid dispersion formulation of etravirine in the fed state

(2020) Chara Litou et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Current status and future opportunities for incorporation of dissolution data in pbpk modeling for pharmaceutical development and regulatory applications: orbito consortium commentary

(2020) Masoud Jamei et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Suitability of the z-Factor for Dissolution Simulation of Solid Oral Dosage Forms: Potential Pitfalls and Refinements

(2020) Martin A. Hofsäss et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Molecular dynamics simulations on interindividual variability of intestinal fluids: impact on drug solubilization

(2020) Albin Parrow et al.   MOLECULAR PHARMACEUTICS

Adding a Gastric Step to the Intestinal In Vitro Digestion Model Improves the Prediction of Pharmacokinetic Data in Beagle Dogs of Two Lipid-Based Drug Delivery Systems

(2020) Mette Klitgaard et al.   MOLECULAR PHARMACEUTICS

Application of the Gastrointestinal Simulator (GIS) Coupled with In Silico Modeling to Measure the Impact of Coca-Cola® on the Luminal and Systemic Behavior of Loratadine (BCS Class 2b)

(2020) Bart Hens et al.   Pharmaceutics

The role of pH and dose/solubility ratio on cocrystal dissolution, drug supersaturation and precipitation

(2020) Tatiane Cogo Machado et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

In Vitro Biopredictive Methods: A Workshop Summary Report

(2020) Xavier J.H. Pepin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Impact of differential particle size of fenofibrate nanosuspensions on biopharmaceutical performance using physiologically based absorption modeling in rats

(2020) Divisha Jain et al.   JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY

PBPK Absorption Modeling of Food Effect and Bioequivalence in Fed State for Two Formulations with Crystalline and Amorphous Forms of BCS 2 Class Drug in Generic Drug Development

(2019) Jereb Rebeka et al.   AAPS PHARMSCITECH

A lipolysis-permeation setup for simultaneous study of digestion and absorption in vitro

(2019) Janneke Keemink et al.   MOLECULAR PHARMACEUTICS

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report

(2019) Tycho Heimbach et al.   AAPS Journal

Assessment of Biopharmaceutical Performance of Supersaturating Formulations of Carbamazepine in Rats Using Physiologically Based Pharmacokinetic Modeling

(2019) Samarth D. Thakore et al.   AAPS PHARMSCITECH

Effect of Amorphous Nanoparticle Size on Bioavailability of Anacetrapib in Dogs

(2019) Filippos Kesisoglou et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

PBPK modeling coupled with biorelevant dissolution to forecast the oral performance of amorphous solid dispersion formulations

(2019) Atsushi Kambayashi et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2019) Bart Hens et al.   JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY

Combining biorelevant in vitro and in silico tools to simulate and better understand the in vivo performance of a nano-sized formulation of aprepitant in the fasted and fed states

(2019) Chara Litou et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Mechanisms of increased bioavailability through amorphous solid dispersions: a review

(2019) Andreas Schittny et al.   DRUG DELIVERY

Practical Approach to Modeling the Impact of Amorphous Drug Nanoparticles on the Oral Absorption of Poorly Soluble Drugs

(2019) Aaron M. Stewart et al.   MOLECULAR PHARMACEUTICS

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report

(2018) Andreas Abend et al.   AAPS Journal

Formulation predictive dissolution (fPD) testing to advance oral drug product development: An introduction to the US FDA funded ‘21st Century BA/BE’ project

(2018) Bart Hens et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Investigating the Impact of Drug Crystallinity in Amorphous Tacrolimus Capsules on Pharmacokinetics and Bioequivalence Using Discriminatory In Vitro Dissolution Testing and Physiologically Based Pharmacokinetic Modeling and Simulation

(2018) Hitesh S. Purohit et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Mechanistic Physiologically Based Pharmacokinetic Modeling of the Dissolution and Food Effect of a Biopharmaceutics Classification System IV Compound—The Venetoclax Story

(2018) Arian Emami Riedmaier et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Phase separation of supersaturated solution created from amorphous solid dispersions: Relevance to oral absorption

(2018) Kohsaku Kawakami et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Permeability Behavior of Nanocrystalline Solid Dispersion of Dipyridamole Generated Using NanoCrySP Technology

(2018) Ashish Girdhar et al.   Pharmaceutics

Biopharmaceutic IVIVE – Mechanistic Modelling of Single- and Two-Phase In Vitro Experiments to Obtain Drug-Specific Parameters for Incorporation into PBPK Models

(2018) Shriram M. Pathak et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Mechanistic Study of Belinostat Oral Absorption From Spray-Dried Dispersions

(2018) Aaron Stewart et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

(2018) Manuela Grimstein et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration

(2018) James Butler et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Simultaneous lipolysis/permeation in vitro model, for the estimation of bioavailability of lipid based drug delivery systems

(2017) Hanady Ajine Bibi et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Cocrystals to facilitate delivery of poorly soluble compounds beyond-rule-of-5

(2016) Gislaine Kuminek et al.   ADVANCED DRUG DELIVERY REVIEWS

Polymeric Amorphous Solid Dispersions: A Review of Amorphization, Crystallization, Stabilization, Solid-State Characterization, and Aqueous Solubilization of Biopharmaceutical Classification System Class II Drugs

(2016) Shrawan Baghel et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Absorption Modeling for Amorphous Solid Dispersion Formulations

(2016) Amitava Mitra et al.   MOLECULAR PHARMACEUTICS

Exploiting the Phenomenon of Liquid–Liquid Phase Separation for Enhanced and Sustained Membrane Transport of a Poorly Water-Soluble Drug

(2016) Anura S. Indulkar et al.   MOLECULAR PHARMACEUTICS

Lipidic dispersion to reduce food dependent oral bioavailability of fenofibrate: In vitro, in vivo and in silico assessments

(2015) Joseph P. O’Shea et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Trends in the Precipitation and Crystallization Behavior of Supersaturated Aqueous Solutions of Poorly Water-Soluble Drugs Assessed Using Synchrotron Radiation

(2015) Shweta A. Raina et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

A new in vitro lipid digestion – in vivo absorption model to evaluate the mechanisms of drug absorption from lipid-based formulations

(2015) Matthew F. Crum et al.   PHARMACEUTICAL RESEARCH

The Precipitation Behavior of Poorly Water-Soluble Drugs with an Emphasis on the Digestion of Lipid Based Formulations

(2015) Jamal Khan et al.   PHARMACEUTICAL RESEARCH

Insoluble drug delivery strategies: review of recent advances and business prospects

(2015) Sandeep Kalepu et al.   Acta Pharmaceutica Sinica B

The Design, Operation, and Application of a Dynamic Gastric Model

(2015) M. J. S. Wickham et al.   DISSOLUTION TECHNOLOGIES

Combining in vitro and in silico methods for better prediction of surfactant effects on the absorption of poorly water soluble drugs—a fenofibrate case example

(2014) Ragna Berthelsen et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Insights into Pharmaceutical Nanocrystal Dissolution: A Molecular Dynamics Simulation Study on Aspirin

(2014) Maximilian Greiner et al.   MOLECULAR PHARMACEUTICS

Biopharmaceutical Modeling of Drug Supersaturation During Lipid-Based Formulation Digestion Considering an Absorption Sink

(2014) Cordula Stillhart et al.   PHARMACEUTICAL RESEARCH

In vitro models for the prediction of in vivo performance of oral dosage forms

(2013) Edmund S. Kostewicz et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Analysis of the enhanced oral bioavailability of fenofibrate lipid formulations in fasted humans using an in vitro–in silico–in vivo approach

(2013) Yang Fei et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Toward the Establishment of Standardized In Vitro Tests for Lipid-Based Formulations, Part 1: Method Parameterization and Comparison of In Vitro Digestion Profiles Across a Range of Representative Formulations

(2012) Hywel D. Williams et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Integration of dissolution into physiologically-based pharmacokinetic models III: PK-Sim®

(2012) Stefan Willmann et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

Supersaturating Drug Delivery Systems: Fast is Not Necessarily Good Enough

(2011) Patrick Augustijns et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Mechanism-based prediction of particle size-dependent dissolution and absorption: Cilostazol pharmacokinetics in dogs

(2010) Stefan Willmann et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Forecasting in vivo oral absorption and food effect of micronized and nanosized aprepitant formulations in humans

(2010) Yasushi Shono et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Biorelevant in vitro dissolution testing of products containing micronized or nanosized fenofibrate with a view to predicting plasma profiles

(2010) Daniel Juenemann et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Using polymeric precipitation inhibitors to improve the absorption of poorly water-soluble drugs: A mechanistic basis for utility

(2010) Dallas B. Warren et al.   JOURNAL OF DRUG TARGETING

Precipitation of a Poorly Soluble Model Drug during In Vitro Lipolysis: Characterization and Dissolution of the Precipitate

(2010) Philip J. Sassene et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

A pH-Dilution Method for Estimation of Biorelevant Drug Solubility along the Gastrointestinal Tract: Application to Physiologically Based Pharmacokinetic Modeling

(2010) Yi Gao et al.   MOLECULAR PHARMACEUTICS

Supersaturating Drug Delivery Systems: The Answer to Solubility-Limited Oral Bioavailability?

(2009) Joachim Brouwers et al.   JOURNAL OF PHARMACEUTICAL SCIENCES