Pharmaceutical Education And Research with Regulatory Links: Innovative drug development strategies and regulatory tools tailored to facilitate earlier access to medicines

Informacje na temat projektu

PEARRL

Identyfikator umowy o grant: 674909

DOI

10.3030/674909

Projekt został zamknięty

Data podpisania przez KE 12 Lutego 2016

Data rozpoczęcia 1 Maja 2016

Data zakończenia 31 Sierpnia 2020

Finansowanie w ramach

• EXCELLENT SCIENCE - Marie Skłodowska-Curie Actions

Koszt całkowity

€ 3 856 253,04

Wkład UE

€ 3 856 253,04

Koordynowany przez

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK
Ireland

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

Documents, reports (9)

Publications describing PBPK models adapted for paediatric populations

Publications describing PBPK models adapted for paediatric populations. Two publications are anticipated.

Publications on ‘biorelevant in vitro and pre-clinical performance models’

Publications on ‘biorelevant in vitro and pre-clinical performance models’. Five publications are expected.

Industry score-cards on bio-enabling formulation design

Industry score-cards on bio-enabling formulation design. Three industry score cards are anticipated.

PEARRL Outreach Plan
Peer Reviewed Scientific Publications and Patents
Publications on ‘Bio-enabling formulation approaches’

Publications on ‘Bio-enabling formulation approaches’./ Seven publications are anticipated.

Industry score-card on selecting the most appropriate biophar-maceutics tools

An industry score-card on selecting the most appropriate biopharmaceutics tools

Publications on in silico PBPK models for predict in vivo performance of bio-enabling formulations

Publications illustrating in silico PBPK models for predict in vivo performance of bio-enabling formulations. Five publications are expected.

White paper on ‘Opportunities for Regulatory Bio-waivers using integrated PBPK/PD approaches.

A collaborative white paper on ‘Opportunities for Regulatory Bio-waivers using integrated PBPK/PD approaches.

Websites, patent fillings, videos etc. (5)

PEARRL website

PEARRL website established

Webinar of 'Regulatory Science Apprentice’
InfoPEARRLS published online

InfoPEARRLS – Open-access Digital Media Training Resources. All ESRs will present their research online. The information gathered will then be reformatted and made available for download on the project website.

PEARRLs for Girls
PEARRL Wiki

Other (1)

International Conference

International Conference at end of project

Publikacje

Peer reviewed articles (49)

Gastrointestinal diseases and their impact on drug solubility: Crohn's disease

Autorzy: Angela Effinger, Caitriona M O'Driscoll, Mark McAllister, Nikoletta Fotaki
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 152, 2020, Strona(/y) 105459, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105459

Development and evaluation of a biorelevant medium simulating porcine gastrointestinal fluids

Autorzy: Laura J. Henze, Niklas J. Koehl, Regina Jansen, René Holm, Maria Vertzoni, Phil D. Whitfield, Brendan T. Griffin
Opublikowane w: European Journal of Pharmaceutics and Biopharmaceutics, Numer 154, 2020, Strona(/y) 116-126, ISSN 0939-6411
Wydawca: Elsevier BV
DOI: 10.1016/j.ejpb.2020.06.009

Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions

Autorzy: Marina Statelova, René Holm, Nikoletta Fotaki, Christos Reppas, Maria Vertzoni
Opublikowane w: The AAPS Journal, Numer 22/6, 2020, ISSN 1550-7416
Wydawca: Springer New York
DOI: 10.1208/s12248-020-00504-6

Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions

Autorzy: Christina Pentafragka, Maria Vertzoni, Jennifer Dressman, Mira Symillides, Konstantinos Goumas, Christos Reppas
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 155, 2020, Strona(/y) 105535, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105535

Towards simplified oral lipid-based drug delivery using mono-/di-glycerides as single component excipients

Autorzy: Alexandra-Roxana Ilie, Brendan T. Griffin, Maria Vertzoni, Martin Kuentz, Filip Cuyckens, Koen Wuyts, Ruzica Kolakovic, René Holm
Opublikowane w: Drug Development and Industrial Pharmacy, 2020, Strona(/y) 1-34, ISSN 0363-9045
Wydawca: Marcel Dekker Inc.
DOI: 10.1080/03639045.2020.1843475

Gastrointestinal diseases and their impact on drug solubility: Ulcerative Colitis

Autorzy: Angela Effinger, Caitriona M O'Driscoll, Mark McAllister, Nikoletta Fotaki
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 152, 2020, Strona(/y) 105458, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105458

Novel Biphasic Lipolysis Method To Predict in Vivo Performance of Lipid-Based Formulations

Autorzy: Patrick J. O’Dwyer, Karl J. Box, Niklas J. Koehl, Harriet Bennett-Lenane, Christos Reppas, Rene Holm, Martin Kuentz, Brendan T. Griffin
Opublikowane w: Molecular Pharmaceutics, Numer 17/9, 2020, Strona(/y) 3342-3352, ISSN 1543-8384
Wydawca: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.0c00427

Gastrointestinal diseases and their impact on drug solubility: Celiac disease

Autorzy: Angela Effinger, Caitriona M O'Driscoll, Mark McAllister, Nikoletta Fotaki
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 152, 2020, Strona(/y) 105460, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105460

Characterization of gastrointestinal transit and luminal conditions in pigs using a telemetric motility capsule

Autorzy: Laura J. Henze, Niklas J. Koehl, Harriet Bennett-Lenane, René Holm, Michael Grimm, Felix Schneider, Werner Weitschies, Mirko Koziolek, Brendan T. Griffin
Opublikowane w: European Journal of Pharmaceutical Sciences, 2020, Strona(/y) 105627, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105627

In Vivo Performance of Innovative Polyelectrolyte Matrices for Hot Melt Extrusion of Amorphous Drug Systems

Autorzy: Felix Ditzinger, Rebecca Wieland, Marina Statelova, Maria Vertzoni, René Holm, Martin Kuentz
Opublikowane w: Molecular Pharmaceutics, Numer 17/8, 2020, Strona(/y) 3053-3061, ISSN 1543-8384
Wydawca: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.0c00485

Supersaturated Lipid-Based Formulations to Enhance the Oral Bioavailability of Venetoclax

Autorzy: Niklas J. Koehl, Laura J. Henze, Martin Kuentz, René Holm, Brendan T. Griffin
Opublikowane w: Pharmaceutics, Numer 12/6, 2020, Strona(/y) 564, ISSN 1999-4923
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics12060564

Chase Dosing of Lipid Formulations to Enhance Oral Bioavailability of Nilotinib in Rats

Autorzy: Niklas J. Koehl, René Holm, Martin Kuentz, Brendan T. Griffin
Opublikowane w: Pharmaceutical Research, Numer 37/7, 2020, ISSN 0724-8741
Wydawca: Kluwer Academic/Plenum Publishers
DOI: 10.1007/s11095-020-02841-9

The use of PBPK/PD to establish clinically relevant dissolution specifications for zolpidem immediate release tablets

Autorzy: Rafael L.M. Paraiso, Rachel H. Rose, Nikoletta Fotaki, Mark McAllister, Jennifer B. Dressman
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 155, 2020, Strona(/y) 105534, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105534

Exploring the Impact of Surfactant Type and Digestion: Highly Digestible Surfactants Improve Oral Bioavailability of Nilotinib

Autorzy: Niklas J. Koehl, René Holm, Martin Kuentz, Vincent Jannin, Brendan T. Griffin
Opublikowane w: Molecular Pharmaceutics, Numer 17/9, 2020, Strona(/y) 3202-3213, ISSN 1543-8384
Wydawca: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.0c00305

Exploring gastric emptying rate in mini-pigs: Effect of food type and pre-dosing of metoclopramide

Autorzy: Laura J. Henze, Brendan T. Griffin, Martin Christiansen, Christoffer Bundgaard, Peter Langguth, Rene Holm
Opublikowane w: European Journal of Pharmaceutical Sciences, 2018, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2018.03.017

The pig as a preclinical model for predicting oral bioavailability and in vivo performance of pharmaceutical oral dosage forms: a PEARRL review

Autorzy: Laura J. Henze, Niklas J. Koehl, Joseph P. O'Shea, Edmund S. Kostewicz, René Holm, Brendan T. Griffin
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12912

In vitro methods to assess drug precipitation in the fasted small intestine - a PEARRL review

Autorzy: Patrick J. O'Dwyer, Chara Litou, Karl J. Box, Jennifer B. Dressman, Edmund S. Kostewicz, Martin Kuentz, Christos Reppas
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12951

Food for thought: formulating away the food effect - a PEARRL review

Autorzy: Joseph P. O'Shea, René Holm, Caitriona M. O'Driscoll, Brendan T. Griffin
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12957

Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products - a PEARRL review

Autorzy: Mariana Guimarães, Marina Statelova, René Holm, Christos Reppas, Moira Symilllides, Maria Vertzoni, Nikoletta Fotaki
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12955

Application of the solubility parameter concept to assist with oral delivery of poorly water-soluble drugs - a PEARRL review

Autorzy: Sandra Jankovic, Georgia Tsakiridou, Felix Ditzinger, Niklas J. Koehl, Daniel J. Price, Alexandra-Roxana Ilie, Lida Kalantzi, Kristof Kimpe, René Holm, Anita Nair, Brendan Griffin, Christoph Saal, Martin Kuentz
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12948

Impact of gastrointestinal disease states on oral drug absorption - implications for formulation design - a PEARRL review

Autorzy: Angela Effinger, Caitriona M. O'Driscoll, Mark McAllister, Nikoletta Fotaki
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12928

Approaches to increase mechanistic understanding and aid in the selection of precipitation inhibitors for supersaturating formulations - a PEARRL review

Autorzy: Daniel J. Price, Felix Ditzinger, Niklas J. Koehl, Sandra Jankovic, Georgia Tsakiridou, Anita Nair, René Holm, Martin Kuentz, Jennifer B. Dressman, Christoph Saal
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12927

Effects of medicines used to treat gastrointestinal diseases on the pharmacokinetics of coadministered drugs: a PEARRL Review

Autorzy: Chara Litou, Angela Effinger, Edmund S. Kostewicz, Karl J. Box, Nikoletta Fotaki, Jennifer B. Dressman
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12983

Lipophilicity and hydrophobicity considerations in bio-enabling oral formulations approaches - a PEARRL review

Autorzy: Felix Ditzinger, Daniel J. Price, Alexandra-Roxana Ilie, Niklas J. Köhl, Sandra Jankovic, Georgia Tsakiridou, Simone Aleandri, Lida Kalantzi, René Holm, Anita Nair, Christoph Saal, Brendan Griffin, Martin Kuentz
Opublikowane w: Journal of Pharmacy and Pharmacology, 2018, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12984

Towards a better understanding of solid dispersions in aqueous environment by a fluorescence quenching approach

Autorzy: Simone Aleandri, Sandra Jankovic, Martin Kuentz
Opublikowane w: International Journal of Pharmaceutics, Numer 550/1-2, 2018, Strona(/y) 130-139, ISSN 0378-5173
Wydawca: Elsevier BV
DOI: 10.1016/j.ijpharm.2018.08.029

Modified Polymer Matrix in Pharmaceutical Hot Melt Extrusion by Molecular Interactions with a Carboxylic Coformer

Autorzy: Felix Ditzinger, Uta Scherer, Monica Schönenberger, René Holm, Martin Kuentz
Opublikowane w: Molecular Pharmaceutics, Numer 16/1, 2018, Strona(/y) 141-150, ISSN 1543-8384
Wydawca: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.8b00920

Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review

Autorzy: Ioannis Loisios-Konstantinidis, Rafael L. M. Paraiso, Nikoletta Fotaki, Mark McAllister, Rodrigo Cristofoletti, Jennifer Dressman
Opublikowane w: Journal of Pharmacy and Pharmacology, Numer 71/4, 2019, Strona(/y) 699-723, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.13070

The PEARRL reviews - innovative drug development strategies tailored to facilitate earlier access to new oral medicines

Autorzy: Brendan T. Griffin, Jennifer B. Dressman
Opublikowane w: Journal of Pharmacy and Pharmacology, Numer 71/4, 2019, Strona(/y) 439-440, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.13083

New Insights into Using Lipid Based Suspensions for ‘Brick Dust’ Molecules: Case Study of Nilotinib

Autorzy: Niklas J. Koehl, René Holm, Martin Kuentz, Brendan T. Griffin
Opublikowane w: Pharmaceutical Research, Numer 36/4, 2019, ISSN 0724-8741
Wydawca: Kluwer Academic/Plenum Publishers
DOI: 10.1007/s11095-019-2590-y

Calculation of drug-polymer mixing enthalpy as a new screening method of precipitation inhibitors for supersaturating pharmaceutical formulations

Autorzy: Daniel J. Price, Anita Nair, Martin Kuentz, Jennifer Dressman, Christoph Saal
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 132, 2019, Strona(/y) 142-156, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2019.03.006

Toward the establishment of a standardized pre-clinical porcine model to predict food effects – Case studies on fenofibrate and paracetamol

Autorzy: Laura J. Henze, Niklas J. Koehl, Joseph P. O'Shea, René Holm, Maria Vertzoni, Brendan T. Griffin
Opublikowane w: International Journal of Pharmaceutics: X, Numer 1, 2019, Strona(/y) 100017, ISSN 2590-1567
Wydawca: Elsevier
DOI: 10.1016/j.ijpx.2019.100017

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

Autorzy: Chara Litou, Nikunjkumar Patel, David B. Turner, Edmund Kostewicz, Martin Kuentz, Karl J. Box, Jennifer Dressman
Opublikowane w: European Journal of Pharmaceutical Sciences, 2019, Strona(/y) 105031, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2019.105031

Biphasic drug release testing coupled with diffusing wave spectroscopy for mechanistic understanding of solid dispersion performance

Autorzy: Sandra Jankovic, Patrick J. O'Dwyer, Karl J. Box, Georgios Imanidis, Christos Reppas, Martin Kuentz
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 137, 2019, Strona(/y) 105001, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2019.105001

Opportunities for Successful Stabilization of Poor Glass-Forming Drugs: A Stability-Based Comparison of Mesoporous Silica Versus Hot Melt Extrusion Technologies

Autorzy: Felix Ditzinger, Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Jennifer B. Dressman, Christoph Saal, Martin Kuentz
Opublikowane w: Pharmaceutics, Numer 11/11, 2019, Strona(/y) 577, ISSN 1999-4923
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics11110577

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example: Naproxen

Autorzy: Ioannis Loisios-Konstantinidis, Rodrigo Cristofoletti, Nikoletta Fotaki, David B. Turner, Jennifer Dressman
Opublikowane w: European Journal of Pharmaceutical Sciences, 2019, Strona(/y) 105170, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2019.105170

Incorporation of HPMCAS during loading of glibenclamide onto mesoporous silica improves dissolution and inhibits precipitation

Autorzy: Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Martin Kuentz, Jennifer Dressman, Christoph Saal
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 141, 2020, Strona(/y) 105113, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2019.105113

A Novel Rheological Method to Assess Drug-Polymer Interactions Regarding Miscibility and Crystallization of Drug in Amorphous Solid Dispersions for Oral Drug Delivery

Autorzy: Georgia Tsakiridou, Christos Reppas, Martin Kuentz, Lida Kalantzi
Opublikowane w: Pharmaceutics, Numer 11/12, 2019, Strona(/y) 625, ISSN 1999-4923
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics11120625

The impact of food intake on the luminal environment and performance of oral drug products with a view to in vitro and in silico simulations: a PEARRL review

Autorzy: Christina Pentafragka, Mira Symillides, Mark McAllister, Jennifer Dressman, Maria Vertzoni, Christos Reppas
Opublikowane w: Journal of Pharmacy and Pharmacology, Numer 71/4, 2019, Strona(/y) 557-580, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.12999

In‐vitro–in‐silico investigation of the negative food effect of zolpidem when administered as immediate‐release tablets

Autorzy: Rafael Leal Monteiro Paraiso, Ayahisa Watanabe, Cord J. Andreas, David Turner, Patricia Zane, Jennifer Dressman
Opublikowane w: Journal of Pharmacy and Pharmacology, Numer 71/11, 2019, Strona(/y) 1663-1676, ISSN 0022-3573
Wydawca: Pharmaceutical Press
DOI: 10.1111/jphp.13161

The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group

Autorzy: Mirko Koziolek, Stefano Alcaro, Patrick Augustijns, Abdul W. Basit, Michael Grimm, Bart Hens, Caroline L. Hoad, Philipp Jedamzik, Christine M. Madla, Marc Maliepaard, Luca Marciani, Annalisa Maruca, Neil Parrott, Petr Pávek, Christopher J.H. Porter, Christos Reppas, Diana van Riet-Nales, Jari Rubbens, Marina Statelova, Natalie L. Trevaskis, Kateřina Valentová, Maria Vertzoni, Dubravka Vitali Č
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 134, 2019, Strona(/y) 31-59, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2019.04.003

On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food

Autorzy: Marina Statelova, Konstantinos Goumas, Nikoletta Fotaki, René Holm, Mira Symillides, Christos Reppas, Maria Vertzoni
Opublikowane w: The AAPS Journal, Numer 22/1, 2020, ISSN 1550-7416
Wydawca: Springer New York
DOI: 10.1208/s12248-019-0380-4

Polyelectrolytes in Hot Melt Extrusion: A Combined Solvent-Based and Interacting Additive Technique for Solid Dispersions

Autorzy: Felix Ditzinger, Catherine Dejoie, Dubravka Sisak Jung, Martin Kuentz
Opublikowane w: Pharmaceutics, Numer 11/4, 2019, Strona(/y) 174, ISSN 1999-4923
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics11040174

Disposition of two highly permeable drugs in the upper gastrointestinal lumen of healthy adults after a standard high-calorie, high-fat meal

Autorzy: Christina Pentafragka, Maria Vertzoni, Mira Symillides, Konstantinos Goumas, Christos Reppas
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 149, 2020, Strona(/y) 105351, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105351

On the Usefulness of Two Small-Scale In Vitro Setups in the Evaluation of Luminal Precipitation of Lipophilic Weak Bases in Early Formulation Development

Autorzy: Patrick J. O’Dwyer, Georgios Imanidis, Karl J. Box, Christos Reppas
Opublikowane w: Pharmaceutics, Numer 12/3, 2020, Strona(/y) 272, ISSN 1999-4923
Wydawca: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics12030272

Broadband Diffusing Wave Spectroscopy Reveals Microstructuring of Polymer–Drug System

Autorzy: Sandra Jankovic, Simone Aleandri, Mathias Reufer, Martin Kuentz
Opublikowane w: Crystal Growth & Design, 2020, ISSN 1528-7483
Wydawca: American Chemical Society
DOI: 10.1021/acs.cgd.0c00267

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.

Autorzy: Chara Litou, David B. Turner, Nico Holmstock, Jens Ceulemans, Karl J. Box, Edmund Kostewicz, Martin Kuentz, Rene Holm, Jennifer Dressman
Opublikowane w: European Journal of Pharmaceutical Sciences, 2020, Strona(/y) 105297, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105297

Measuring pH and Buffer Capacity in Fluids Aspirated from the Fasted Upper Gastrointestinal Tract of Healthy Adults

Autorzy: Chara Litou, Dimitrios Psachoulias, Maria Vertzoni, Jennifer Dressman, Christos Reppas
Opublikowane w: Pharmaceutical Research, Numer 37/3, 2020, ISSN 0724-8741
Wydawca: Kluwer Academic/Plenum Publishers
DOI: 10.1007/s11095-019-2731-3

Supersaturated lipid-based drug delivery systems – exploring impact of lipid composition type and drug properties on supersaturability and physical stability

Autorzy: Alexandra-Roxana Ilie, Brendan T. Griffin, Ruzica Kolakovic, Maria Vertzoni, Martin Kuentz, René Holm
Opublikowane w: Drug Development and Industrial Pharmacy, Numer 46/3, 2020, Strona(/y) 356-364, ISSN 0363-9045
Wydawca: Marcel Dekker Inc.
DOI: 10.1080/03639045.2020.1721526

Exploring impact of supersaturated lipid-based drug delivery systems of celecoxib on in vitro permeation across PermeapadⓇ membrane and in vivo absorption

Autorzy: Alexandra-Roxana Ilie, Brendan T. Griffin, Martin Brandl, Annette Bauer-Brandl, Ann-Christin Jacobsen, Maria Vertzoni, Martin Kuentz, Ruzica Kolakovic, René Holm
Opublikowane w: European Journal of Pharmaceutical Sciences, Numer 152, 2020, Strona(/y) 105452, ISSN 0928-0987
Wydawca: Elsevier BV
DOI: 10.1016/j.ejps.2020.105452

Conference proceedings (2)

A Novel In Silico Screening Protocol For The Selection Of Optimized Precipitation Inhibitor Systems For Supersaturable Formulations

Autorzy: Daniel Price, Christoph Saal, Anita Nair, Jennifer Dressman
Opublikowane w: 2017
Wydawca: American Association of Pharmaceutical Scientists (AAPS) Annual meeting

In Vitro Modelling Of Propranolol Immediate Release And Extended Release Formulations Using A Three Chamber Dissolution Apparatus

Autorzy: Patrick O'Dwyer, Karl Box, Robert Taylor, Hayley Watson
Opublikowane w: 2017
Wydawca: American Association of Pharmaceutical Scientists (AAPS) Annual meeting