Publications
2020
P. Schick, M. Sager, M. Voelker, W. Weitschies, M. Koziolek. Application of the GastroDuo to study the interplay of drug release and gastric emptying of immediate release Aspirin formulations. Eur. J. Pharm. Biopharm. 151 (2020) 9-17.
2019
M. Sager, P. Schick, M. Mischek, C. Schulze, M. Hasan, M.-L. Kromrey, H. Benameur, M. Wendler, M.V. Tzevtkov, W. Weitschies, M. Koziolek. Comparison of In Vitro and In Vivo Results Using the GastroDuo and the Salivary Tracer Technique: Immediate Release Dosage Forms under Fasting Conditions Pharmaceutics 3 (2019) 1-21.
M. Sager, M. Grimm, P. Aude, P. Schick, S. Merdivan, M. Hasan, M.-L. Kromrey, A. Sivert, H. Benameur, M. Koziolek, M. V. Tzvetkov, W. Weitschies. In Vivo Characterization of EnTRinsicTM Drug Delivery Technology Capsule after Intake in Fed State: A Cross-Validation Approach Using Salivary Tracer Technique in Comparison to MRI J. Control. Release 313 (2019) 24-32.
P. Schick, M. Sager, F. Wegner, M. Wiedmann, E. Schapperer, W. Weitschies, M. Koziolek. The application of the GastroDuo as an in vitro dissolution tool to simulate the gastric emptying of the postprandial stomach. Mol. Pharm. 16 (2019) 4651-4660.
J. Krause, M. Bogdahn, F. Schneider, M. Koziolek, W. Weitschies. Design and characterization of a novel 3D printed pressure-controlled drug delivery system. Eur. J. Pharm. Sci. 140 (2019) 105060.
F. Schneider, M. Koziolek, W. Weitschies. In Vitro and In Vivo Test Methods for the Evaluation of Gastroretentive Dosage Forms. Pharmaceutics. 11 (2019). 1-29.
C. Jede, C. Wagner, H. Kubas, M. Weigandt, C. Weber, M. Lecomte, L. Badolo, M. Koziolek, W. Weitschies. Improved prediction of in vivo supersaturation and precipitation of poorly soluble weakly basic drugs using a biorelevant bicarbonate buffer in a GI transfer model. Mol. Pharm. 16 (2019) 3938-3947.
M. Koziolek, S. Alcaro, P. Augustijns, A. W. Basit, M. Grimm, B. Hens, C. L. Hoad, P. Jedamzik, C. M. Madla, M. Maliepaard, L. Marciani, A. Maruca, N. Parrott, P. Pávek, C. J. H. Porter, C. Reppas, D. van Riet-Nales, J. Rubbens, M. Statelova, N. L. Trevaskis, K. Valentová, M. Vertzoni, D. V. Čepo, M. Corsetti. The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group. Eur. J. Pharm. Sci. 134 (2019) 31–59.
M. Vertzoni, P. Augustijns, M. Grimm, M. Koziolek, G. Lemmens, N. Parrott, C. Pentafragka, C. Reppas, J. Rubbens, J. van Den Αbeele, T. Vanuytsel, W. Weitschies, C. G. Wilson. Impact of regional differences along the gastrointestinal tract of healthy adults on oral drug absorption: An UNGAP review. Eur. J. Pharm. Sci. 134 (2019) 153–175.
C. Jede, C. Wagner, H. Kubas, C. Weber, M. Weigandt, M. Koziolek, W. Weitschies. Application of an automated small-scale in vitro transfer model to predict in vivo precipitation inhibition. Int. J. Pharm. 565 (2019) 458–471
M. Sager, M. Grimm, P. Jedamzik, S. Merdivan, M.-L. Kromrey, M. Hasan, M. Koziolek, M. V. Tzvetkov, W. Weitschies. Combined application of MRI and the salivary tracer technique to determine the in vivo disintegration time of immediate release formulation administered to healthy, fasted subjects. Mol. Pharm. 16 (2019) 1782-1786
M. Grimm, K. Ball, E. Scholz, F. Schneider, A. Sievert, H. Benameur, M.-L. Kromrey, J.-P. Kühn, W. Weitschies. Characterization of the gastrointestinal transit and disintegration behavior of floating and sinking acid-resistant capsules using a novel MRI labeling technique. Eur. J. Pharm. Sci. 129 (2019) 163-172
M. Koziolek, M. Grimm, T. Bollmann, K. J. Schäfer, S. M. Blattner, R. Lotz, G. Boeck, W. Weitschies. Characterization of the GI transit conditions in Beagle dogs with a telemetric motility capsule. Eur. J. Pharm. Biopharm. 136 (2019) 221-230
J. Butler, B. Hens, M. Vertzoni, J. Brouwers, P. Berben, J. Dressman, C. J. Andreas, K. J. Schäfer, J. Mann, M. McAllister, M. Jamei, E. Kostewicz, F. Kesisoglou, P. Langguth, M. Minekus, A. Müllertz, R. Schilderink, M. Koziolek, P. Jedamzik, W. Weitschies, C. Reppas, P. Augustijns. In vitro models for the prediction of in vivo performance of oral dosage forms: recent progress from partnership through the IMI OrBiTo collaboration. Eur. J. Pharm. Biopharm. 136 (2019) 70-83
C. Jede, C. Wagner, H. Kubas, C. Weber, M. Weigandt, M. Koziolek, W. Weitschies. Automated small-scale in vitro transfer model as screening tool for the prediction of in vivo-dissolution and precipitation of poorly solubles. Int. J. Pharm. 556 (2019) 150-158
2018
M. Koziolek, E. Kostewicz, M. Vertzoni. Physiological Considerations and In Vitro Strategies for Evaluating the Influence of Food on Drug Release from Extended-Release Formulations. AAPS PharmSciTech 19 (2018) 2885-2897
M. Koziolek, F. Carrière, C.J.H. Porter. Lipids in the stomach – Implications for the evaluation of food effects on oral drug absorption. Pharm. Res. 35 (2018) 35-55
M. Grimm, M. Koziolek, M. Saleh, F. Schneider, G. Garbacz, J. Kühn, W. Weitschies. Gastric emptying and small bowel water content after administration of grapefruit juice compared to water and iso-caloric solutions of glucose and fructose: a four-way crossover MRI pilot study in healthy subjects, Mol. Pharm. 15 (2018) 548-559
M. Grimm, M. Koziolek, J. Kühn, W. Weitschies. Interindividual and intraindividual variability of fasted state gastric fluid volume and gastric emptying of water.
Eur. J. Pharm. Biopharm. 127 (2018) 309-317
F. Schneider, M. Hoppe, M. Koziolek, W. Weitschies. Influence of Postprandial Intragastric Pressures on Drug Release from Gastroretentive Dosage Forms. AAPS PharmSciTech 19 (2018) 2843-2850
M. Sager, P. Jedamzik, S. Merdivan, M. Grimm, F. Schneider, M.-L. Kromrey, M. Hasan, S. Oswald, J. Kühn, M. Koziolek, W. Weitschies. Low dose caffeine as a salivary tracer for the determination of gastric water emptying in fed and fasted state: A MRI validation study. Eur. J. Pharm. Biopharm. 127 (2018) 443-452
2017
J. van den Abeele, R. Schilderink, F. Schneider, R. Mols, M. Minekus, W. Weitschies, J. Brouwers, J. Tack, P. Augustijns. Gastrointestinal and Systemic Disposition of Diclofenac under Fasted and Fed State Conditions Supporting the Evaluation in in Vitro Predictive Tools. Mol. Pharm. 14 (2017) 4220-4232
F. Schneider, R. Beeck, M. Hoppe, M. Koziolek, W. Weitschies. In vitro simulation of realistic gastric pressure profiles. Eur. J. Pharm. Sci. 30 (2017) 71-77
M. Neumann, F. Schneider, M. Koziolek, G. Garbacz, W. Weitschies. A novel mechanical antrum model for the prediction of the gastroretentive potential of dosage forms.
Int. J. Pharm. 530 (2017) 63-70
T. Hildebrandt, E. Scheuch, W. Weitschies, M. Grimm, F. Schneider, L. Bachmann, I. Vervuert. Measurement of abomasal conditions (pH, pressure and temperature) in healthy and diarrheic dairy calves using a wireless ambulatory capsule.
Livest. Sci. 203 (2017) 41-47
M. Sager, F. Schneider, P. Jedamzik, M. Wiedmann, E. Schremmer, M. Koziolek, W. Weitschies. Effect of Coadministered Water on the in Vivo Performance of Oral Formulations Containing N-Acetylcysteine: An in Vitro Approach Using the Dynamic Open Flow-Through Test Apparatus. Mol. Pharm. 14 (2017) 4272-4280
M. Grimm, E. Scholz, M. Koziolek, J. Kühn, W. Weitschies, Gastric water emptying under fed state clinical trial conditions is as fast as under fasted conditions. Mol. Pharm. 14 (2017) 4262-4271
B. Maciejewski, W. Weitschies, F. Schneider, M. Sznitowska. Gastroresistant gelatin films prepared by addition of cellulose acetate phthalate. Pharmazie 72 (2017) 324-328
B. Hens, M. Corsetti, R. Spiller, L. Marciani, T. Vanuytsel, J. Tack, A. Talattof, G.L. Amidon, M. Koziolek, W. Weitschies, C.G. Wilson, R.J. Bennink, J. Brouwers, P. Augustijns. Exploring gastrointestinal variables affecting drug and formulation behavior: Methodologies, challenges and opportunities. Int. J. Pharm. 519(2017) 79-97
2016
F. Schneider, M. Grimm, M. Koziolek, C. Modeß, A. Dokter, T. Roustom, W. Siegmund, W. Weitschies. Resolving the physiological conditions in bioavailability and bioequivalence studies: Comparison of fasted and fed state. Eur. J. Pharm. Biopharm. 108 (2016) 214-219
M. Koziolek, M. Grimm, F. Schneider, P. Jedamzik, M. Sager, J.P. Kühn, W. Siegmund, W.Weitschies. Navigating the human gastrointestinal tract for oral drug delivery: Uncharted waters and new frontiers. Adv. Drug Deliv. Rev. 101 (2016) 75-88
2015
M. Koziolek, F. Schneider, M. Grimm, C. Modeβ, A. Seekamp, T. Roustom, W. Siegmund, W. Weitschies. Intragastric pH and pressure profiles after intake of the high-caloric, high-fat meal as used for food effect studies. J. Control. Release 220 (2015) 71-81
M. Koziolek, M. Grimm, D. Becker, V. Iordanov, H. Zou, J. Shimizu, C. Wanke, G. Garbacz, W. Weitschies. Investigation of pH and Temperature Profiles in the GI Tract of Fasted Human Subjects Using the Intellicap® System. J. Pharm. Sci. 104 (2015) 2855-2863
2014
M. Koziolek, M. Grimm, G. Garbacz, J.P. Kühn, W. Weitschies. Intragastric volume changes after intake of a high-caloric, high-fat standard breakfast in healthy human subjects investigated by MRI. Mol. Pharm. 11 (2014) 1632-1639
G. Garbacz, B. Kołodziej, M. Koziolek, W. Weitschies, S. Klein. A dynamic system for the simulation of fasting luminal pH-gradients using hydrogen carbonate buffers for dissolution testing of ionisable compounds. Eur. J. Pharm. Sci. 51 (2014) 224-231
M. Koziolek, K. Görke, M. Neumann, G. Garbacz, W. Weitschies. Development of a bio-relevant dissolution test device simulating mechanical aspects present in the fed stomach. Eur. J. Pharm. Sci. 57 (2014) 250-256
G. Garbacz, A. Kandzi, M. Koziolek, J. Mazgalski, W. Weitschies. Release Characteristics of Quetiapine Fumarate Extended Release Tablets Under Biorelevant Stress Test Conditions. AAPS PharmSciTech 15 (2014) 230-236
2013
M. Koziolek, G. Garbacz, M. Neumann, W. Weitschies. Simulating the Postprandial Stomach: Physiological Considerations for Dissolution and Release Testing. Mol. Pharm. 10 (2013) 1610-1622
M. Koziolek, G. Garbacz, M. Neumann, W. Weitschies. Simulating the Postprandial Stomach: Biorelevant Test Methods for the Estimation of Intragastric Drug Dissolution. Mol. Pharm. 10 (2013) 2211-2221