612
Views
57
CrossRef citations to date
0
Altmetric
Reviews

A biorelevant dissolution stress test device – background and experiences

, &
Pages 1251-1261 | Published online: 26 Oct 2010

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (1)

Martin Culen & Jiri Dohnal. (2014) Advances in dissolution instrumentation and their practical applications. Drug Development and Industrial Pharmacy 40:10, pages 1277-1282.
Read now

Articles from other publishers (56)

Lisa Freerks, Tina Arien, Claire Mackie, Sabine Inghelbrecht & Sandra Klein. (2023) A toolbox for mimicking gastrointestinal conditions in children: Design and evaluation of biorelevant dissolution media for mimicking paediatric gastric- and small intestinal conditions. European Journal of Pharmaceutics and Biopharmaceutics 193, pages 144-157.
Crossref
Gabriela Wyszogrodzka-Gaweł, Olha Shuklinova, Bartek Lisowski, Barbara Wiśniowska & Sebastian Polak. (2023) 3D printing combined with biopredictive dissolution and PBPK/PD modeling optimization and personalization of pharmacotherapy: Are we there yet?. Drug Discovery Today 28:10, pages 103731.
Crossref
Marcela Staniszewska, Michał Romański, Sebastian Polak, Grzegorz Garbacz, Justyna Dobosz, Daria Myslitska, Svitlana Romanova, Jadwiga Paszkowska & Dorota Danielak. (2023) A Rational Approach to Predicting Immediate Release Formulation Behavior in Multiple Gastric Motility Patterns: A Combination of a Biorelevant Apparatus, Design of Experiments, and Machine Learning. Pharmaceutics 15:8, pages 2056.
Crossref
Zahari Vinarov, James Butler, Filippos Kesisoglou, Mirko Koziolek & Patrick Augustijns. (2023) Assessment of food effects during clinical development. International Journal of Pharmaceutics 635, pages 122758.
Crossref
Murui Han, Jin Xu & Yiqing Lin. (2022) Approaches of formulation bridging in support of orally administered drug product development. International Journal of Pharmaceutics 629, pages 122380.
Crossref
Connor O’Farrell, Mark J. H. Simmons, Hannah K. Batchelor & Konstantinos Stamatopoulos. (2022) The Effect of Biorelevant Hydrodynamic Conditions on Drug Dissolution from Extended-Release Tablets in the Dynamic Colon Model. Pharmaceutics 14:10, pages 2193.
Crossref
Nikunjkumar Patel, Shriram M. Pathak & David B. Turner. 2022. Oral Drug Delivery for Modified Release Formulations. Oral Drug Delivery for Modified Release Formulations 355 374 .
Constantinos Markopoulos & Maria Vertzoni. 2022. Oral Drug Delivery for Modified Release Formulations. Oral Drug Delivery for Modified Release Formulations 305 324 .
Mirko Koziolek. 2022. Oral Drug Delivery for Modified Release Formulations. Oral Drug Delivery for Modified Release Formulations 289 303 .
Sandra Klein. 2022. Oral Drug Delivery for Modified Release Formulations. Oral Drug Delivery for Modified Release Formulations 253 271 .
PRASENJIT SARKAR, SAUMYAJYOTI DAS & SUTAPA BISWAS MAJEE. (2022) BIPHASIC DISSOLUTION MODEL: NOVEL STRATEGY FOR DEVELOPING DISCRIMINATORY IN VIVO PREDICTIVE DISSOLUTION MODEL FOR BCS CLASS II DRUGS. International Journal of Pharmacy and Pharmaceutical Sciences, pages 20-27.
Crossref
Suryanarayana Polaka, Kuldeep Rajpoot, Muktika Tekade, Mukesh Chandra Sharma & Rakesh Kumar Tekade. 2022. Pharmacokinetics and Toxicokinetic Considerations. Pharmacokinetics and Toxicokinetic Considerations 263 289 .
Werner Weitschies, Laura Müller, Michael Grimm & Mirko Koziolek. (2021) Ingestible devices for studying the gastrointestinal physiology and their application in oral biopharmaceutics. Advanced Drug Delivery Reviews 176, pages 113853.
Crossref
Ewelina Juszczyk, Kamil Kisło, Paweł Żero, Ewa Tratkiewicz, Maciej Wieczorek, Jadwiga Paszkowska, Grzegorz Banach, Marcela Wiater, Dagmara Hoc, Grzegorz Garbacz, Jaroslaw Sczodrok & Dorota Danielak. (2021) Development and Bio-Predictive Evaluation of Biopharmaceutical Properties of Sustained-Release Tablets with a Novel GPR40 Agonist for a First-in-Human Clinical Trial. Pharmaceutics 13:6, pages 804.
Crossref
Zahari Vinarov, Bertil Abrahamsson, Per Artursson, Hannah Batchelor, Philippe Berben, Andreas Bernkop-Schnürch, James Butler, Jens Ceulemans, Nigel Davies, Didier Dupont, Gøril Eide Flaten, Nikoletta Fotaki, Brendan T. Griffin, Vincent Jannin, Janneke Keemink, Filippos Kesisoglou, Mirko Koziolek, Martin Kuentz, Alan Mackie, Antonio J. Meléndez-Martínez, Mark McAllister, Anette Müllertz, Caitriona M. O'Driscoll, Neil Parrott, Jadwiga Paszkowska, Petr Pavek, Christopher J.H. Porter, Christos Reppas, Cordula Stillhart, Kiyohiko Sugano, Elena Toader, Kateřina Valentová, Maria Vertzoni, Saskia N. De Wildt, Clive G. Wilson & Patrick Augustijns. (2021) Current challenges and future perspectives in oral absorption research: An opinion of the UNGAP network. Advanced Drug Delivery Reviews 171, pages 289-331.
Crossref
Helena Vrbanac, Jurij Trontelj, Špela Kalčič & Igor Legen. (2020) Mechanistic study of model drug release from HPMC matrices in fed gastric media. Journal of Drug Delivery Science and Technology 60, pages 102034.
Crossref
Valentyn Mohylyuk, Seyedreza Goldoozian, Gavin P. Andrews & Andriy Dashevskiy. (2020) IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress. Pharmaceutical Research 37:11.
Crossref
Dorota Danielak, Bartłomiej Milanowski, Krzysztof Wentowski, Maria Nogowska, Michał Kątny, Piotr Rogowski, Łukasz Konwicki, Ewa Puk, Jarosław Pieczuro, Marek Bawiec, Grzegorz Garbacz & Janina Lulek. (2020) Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions. AAPS PharmSciTech 21:5.
Crossref
Bartłomiej Milanowski, Arkadiusz Hejduk, Marek A. Bawiec, Emilia Jakubowska, Agnieszka Urbańska, Anna Wiśniewska, Grzegorz Garbacz & Janina Lulek. (2020) Biorelevant In Vitro Release Testing and In Vivo Study of Extended-Release Niacin Hydrophilic Matrix Tablets. AAPS PharmSciTech 21:3.
Crossref
Helena Vrbanac, Jurij Trontelj, Sandra Berglez, Klemen Kreft, Dejan Krajcar & Igor Legen. (2020) Simulated migrating motor complex and its impact on the release properties of hydrophilic matrix systems. Journal of Drug Delivery Science and Technology 55, pages 101338.
Crossref
Maximilian Sager, Philipp Schick, Magdalena Mischek, Christian Schulze, Mahmoud Hasan, Marie-Luise Kromrey, Hassan Benameur, Martin Wendler, Mladen Vassilev Tzvetkov, Werner Weitschies & Mirko Koziolek. (2019) Comparison of In Vitro and In Vivo Results Using the GastroDuo and the Salivary Tracer Technique: Immediate Release Dosage Forms under Fasting Conditions. Pharmaceutics 11:12, pages 659.
Crossref
Atsushi Kambayashi & Jennifer B. Dressman. (2019) A novel in vivo predictive dissolution testing coupled with a modeling and simulation for hydrogel matrix monolithic extended release oral dosage forms. European Journal of Pharmaceutical Sciences 138, pages 105044.
Crossref
Schneider, Koziolek & Weitschies. (2019) In Vitro and In Vivo Test Methods for the Evaluation of Gastroretentive Dosage Forms. Pharmaceutics 11:8, pages 416.
Crossref
Daniel Zakowiecki, Tobias Hess, Grzegorz Banach, Jadwiga Paszkowska & Grzegorz Garbacz. (2019) Effect of intra- and extragranular addition of highly porous tribasic calcium phosphate on properties of immediate release acyclovir formulation – Comparison with commercial tablets using compendial and biorelevant dissolution methods. Journal of Drug Delivery Science and Technology 51, pages 464-474.
Crossref
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 Čepo & Maura Corsetti. (2019) The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group. European Journal of Pharmaceutical Sciences 134, pages 31-59.
Crossref
Christina Pentafragka, Mira Symillides, Mark McAllister, Jennifer Dressman, Maria Vertzoni & Christos Reppas. (2019) 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 . Journal of Pharmacy and Pharmacology 71:4, pages 557-580.
Crossref
Mirko Koziolek, Michael Grimm, Tabea Bollmann, Kerstin J. Schäfer, Simone M. Blattner, Ralf Lotz, Georg Boeck & Werner Weitschies. (2019) Characterization of the GI transit conditions in Beagle dogs with a telemetric motility capsule. European Journal of Pharmaceutics and Biopharmaceutics 136, pages 221-230.
Crossref
James Butler, Bart Hens, Maria Vertzoni, Joachim Brouwers, Philippe Berben, Jennifer Dressman, Cord J. Andreas, Kerstin Julia Schaefer, James Mann, Mark McAllister, Masoud Jamei, Edmund Kostewicz, Filippos Kesisoglou, Peter Langguth, Mans Minekus, Anette Müllertz, Ronald Schilderink, Mirko Koziolek, Philipp Jedamzik, Werner Weitschies, Christos Reppas & Patrick Augustijns. (2019) In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration. European Journal of Pharmaceutics and Biopharmaceutics 136, pages 70-83.
Crossref
Mirko Koziolek, Edmund Kostewicz & Maria Vertzoni. (2018) Physiological Considerations and In Vitro Strategies for Evaluating the Influence of Food on Drug Release from Extended-Release Formulations. AAPS PharmSciTech 19:7, pages 2885-2897.
Crossref
C.J. Andreas, J. Rosenberger, J. Butler, P. Augustijns, M. McAllister, B. Abrahamsson & J. Dressman. (2018) Introduction to the OrBiTo decision tree to select the most appropriate in vitro methodology for release testing of solid oral dosage forms during development. European Journal of Pharmaceutics and Biopharmaceutics 130, pages 207-213.
Crossref
Frank Karkossa & Sandra Klein. (2018) A Biopredictive In Vitro Comparison of Oral Locally Acting Mesalazine Formulations by a Novel Dissolution Model for Assessing Intraluminal Drug Release in Individual Subjects. Journal of Pharmaceutical Sciences 107:6, pages 1680-1689.
Crossref
Sandra Klein, Nicole Seeger, Raxit Mehta, Shahrzad Missaghi, Relindis Grybos & Ali Rajabi-Siahboomi. (2018) Robustness of barrier membrane coated metoprolol tartrate matrix tablets: Drug release evaluation under physiologically relevant in vitro conditions. International Journal of Pharmaceutics 543:1-2, pages 368-375.
Crossref
Haiyan Grady, David Elder, Gregory K. Webster, Yun Mao, Yiqing Lin, Talia Flanagan, James Mann, Andy Blanchard, Michael J. Cohen, Judy Lin, Filippos Kesisoglou, Andre Hermans, Andreas Abend, Limin Zhang & David Curran. (2018) Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization. Journal of Pharmaceutical Sciences 107:1, pages 34-41.
Crossref
Mark McAllister & Irena Tomaszewska. 2017. Poorly Soluble Drugs. Poorly Soluble Drugs 455 510 .
Sara Cascone, Gaetano Lamberti, Francesco Marra, Giuseppe Titomanlio, Matteo d'Amore & Anna Angela Barba. (2016) Gastrointestinal behavior and ADME phenomena: I. In vitro simulation. Journal of Drug Delivery Science and Technology 35, pages 272-283.
Crossref
Mirko Koziolek, Michael Grimm, Felix Schneider, Philipp Jedamzik, Maximilian Sager, Jens-Peter Kühn, Werner Siegmund & Werner Weitschies. (2016) Navigating the human gastrointestinal tract for oral drug delivery: Uncharted waters and new frontiers. Advanced Drug Delivery Reviews 101, pages 75-88.
Crossref
Daniel Zakowiecki, Krzysztof Cal, Kamil Kaminski, Karolina Adrjanowicz, Lech Swinder, Ewa Kaminska & Grzegorz Garbacz. (2015) The Improvement of the Dissolution Rate of Ziprasidone Free Base from Solid Oral Formulations. AAPS PharmSciTech 16:4, pages 922-933.
Crossref
Piotr Kulinowski, Krzysztof Woyna-Orlewicz, Gerd-Martin Rappen, Dorota Haznar-Garbacz, Władysław P. Węglarz & Przemysław P. Dorożyński. (2015) An understanding of modified release matrix tablets behavior during drug dissolution as the key for prediction of pharmaceutical product performance – case study of multimodal characterization of quetiapine fumarate tablets. International Journal of Pharmaceutics 484:1-2, pages 235-245.
Crossref
Grzegorz Garbacz, Gerd-Martin Rappen, Mirko Koziolek & Werner Weitschies. (2015) Dissolution of mesalazine modified release tablets under standard and bio-relevant test conditions. Journal of Pharmacy and Pharmacology 67:2, pages 199-208.
Crossref
Friederike Eisenächer, Grzegorz Garbacz & Karsten Mäder. (2014) Physiological relevant in vitro evaluation of polymer coats for gastroretentive floating tablets. European Journal of Pharmaceutics and Biopharmaceutics 88:3, pages 778-786.
Crossref
May Almukainzi, Nádia Araci Bou‐Chacra, Roderick B. Walker & Raimar Löbenberg. 2014. Therapeutic Delivery Solutions. Therapeutic Delivery Solutions 335 365 .
Mirko Koziolek, Kristin Görke, Marco Neumann, Grzegorz Garbacz & Werner Weitschies. (2014) Development of a bio-relevant dissolution test device simulating mechanical aspects present in the fed stomach. European Journal of Pharmaceutical Sciences 57, pages 250-256.
Crossref
Grzegorz Garbacz, Dominique Cadé, Hassan Benameur & Werner Weitschies. (2014) Bio-relevant dissolution testing of hard capsules prepared from different shell materials using the dynamic open flow through test apparatus. European Journal of Pharmaceutical Sciences 57, pages 264-272.
Crossref
Edmund S. Kostewicz, Bertil Abrahamsson, Marcus Brewster, Joachim Brouwers, James Butler, Sara Carlert, Paul A. Dickinson, Jennifer Dressman, René Holm, Sandra Klein, James Mann, Mark McAllister, Mans Minekus, Uwe Muenster, Anette Müllertz, Miriam Verwei, Maria Vertzoni, Werner Weitschies & Patrick Augustijns. (2014) In vitro models for the prediction of in vivo performance of oral dosage forms. European Journal of Pharmaceutical Sciences 57, pages 342-366.
Crossref
Hannah K. Batchelor, Nikoletta Fotaki & Sandra Klein. (2014) Paediatric oral biopharmaceutics: Key considerations and current challenges. Advanced Drug Delivery Reviews 73, pages 102-126.
Crossref
Mirko Koziolek, Michael Grimm, Grzegorz Garbacz, Jens-Peter Kühn & Werner Weitschies. (2014) Intragastric Volume Changes after Intake of a High-Caloric, High-Fat Standard Breakfast in Healthy Human Subjects Investigated by MRI. Molecular Pharmaceutics 11:5, pages 1632-1639.
Crossref
Lisa Wilde, Mona Bock, Marieke Wolf, Gunnar Glöckl, Grzegorz Garbacz & Werner Weitschies. (2014) Development of pressure-sensitive dosage forms with a core liquefying at body temperature. European Journal of Pharmaceutics and Biopharmaceutics 86:3, pages 507-513.
Crossref
Grzegorz Garbacz, Anna Kandzi, Mirko Koziolek, Jarosław Mazgalski & Werner Weitschies. (2013) Release Characteristics of Quetiapine Fumarate Extended Release Tablets Under Biorelevant Stress Test Conditions. AAPS PharmSciTech 15:1, pages 230-236.
Crossref
Lisa Wilde, Mona Bock, Gunnar Glöckl, Grzegorz Garbacz & Werner Weitschies. (2014) Development of a pressure-sensitive glyceryl tristearate capsule filled with a drug-containing hydrogel. International Journal of Pharmaceutics 461:1-2, pages 296-300.
Crossref
Mirko Koziolek, Grzegorz Garbacz, Marco Neumann & Werner Weitschies. (2013) Simulating the Postprandial Stomach: Biorelevant Test Methods for the Estimation of Intragastric Drug Dissolution. Molecular Pharmaceutics 10:6, pages 2211-2221.
Crossref
Sandra Klein, Grzegorz Garbacz, Mitja Pišlar, Igor Locatelli, Chong Liu, Werner Weitschies, Werner Siegmund, Aleš Mrhar & Marija Bogataj. (2013) The role of individual gastric emptying of pellets in the prediction of diclofenac in vivo dissolution. Journal of Controlled Release 166:3, pages 286-293.
Crossref
Feng Qian, Jennifer Wang, Ruiling Hartley, Jing Tao, Raja Haddadin, Neil Mathias & Munir Hussain. (2012) Solution Behavior of PVP-VA and HPMC-AS-Based Amorphous Solid Dispersions and Their Bioavailability Implications. Pharmaceutical Research 29:10, pages 2766-2776.
Crossref
Randall J. Mrsny. (2012) Oral drug delivery research in Europe. Journal of Controlled Release 161:2, pages 247-253.
Crossref
Grzegorz Garbacz & Sandra Klein. (2012) Dissolution testing of oral modified-release dosage forms. Journal of Pharmacy and Pharmacology 64:7, pages 944-968.
Crossref
Dorota Haznar-Garbacz, Grzegorz Garbacz, Friederike Eisenächer, Sandra Klein & Werner Weitschies. (2012) A novel liquefied gas based oral controlled release drug delivery system for liquid drug formulations. European Journal of Pharmaceutics and Biopharmaceutics 81:2, pages 334-338.
Crossref
Martin Bergstrand, Erik Söderlind, Ulf G Eriksson, Werner Weitschies & Mats O Karlsson. (2011) A Semi-mechanistic Modeling Strategy to Link In Vitro and In Vivo Drug Release for Modified Release Formulations. Pharmaceutical Research 29:3, pages 695-706.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.