Physiolution GmbH was founded by Prof. Dr. Werner Weitschies and Dr. Grzegorz Garbacz as a spin-off of the University of Greifswald in November 2009. Physiolution GmbH is a highly innovative company focused on investigations of the dissolution behaviour of solid oral dosage forms under bio-relevant test conditions.
The cutting edge test methods utilized by Physiolution GmbH were established by the founders and are based on long experience in the fields of gastro-intestinal tract physiology and biopharmaceutical evaluation of dosage form performance.
The bio-relevant test devices realistically simulate the mechanistic and physico-chemical conditions that act on dosage forms during their gastro-intestinal passage and enable the evaluation of their biopharmaceutical safety and reliability. The applicability of the test devices and test procedures was successfully validated on numerous examples of clinical relevance as well as in the routine analyses of solid oral dosage forms.
In addition, the analytical services of Physiolution GmbH include pharmacopoeial dissolution testing and other pharmacopoeial investigations of solid oral dosage forms and their mechanical stability as well as development and validation of analytical methods and procedures.
Pharmaceutical and analytical
Predictive Dissolution Testing
- Investigation of the dissolution behaviour of solid oral dosage forms under biorelevant test conditions
- Preclinical evaluation of the drug delivery behaviour of solid oral dosage forms
- Biopharmaceutical testing of solid oral dosage forms
- Dissolution testing in accordance with USP and Ph. Eur.
- Investigation of pharmaceutical equivalence of solid oral dosage forms
- Development of dissolution test devices dedicated for special applications
- Development of analytical methods for drug substances
- Development of analytical methods and procedures for pharmaceutical products
- Validation of analytical methods according to the Note For Guidance On Validation conditions (CPMP/ICH)
- bio-relevant dissolution stress test devices
- predictive dissolution testing of modified and immediate release products
- biorelevat dissolution test methods
- pharmacopoeial dissolution test devices
- intrinsic dissolution
- dissolution in hydrogen carbonate buffers
- bio-relevant characterization of targeted dosage forms
- determination of swelling kinetics
- characterization of susceptibility of modified release products towards mechanical stresses of biorelevant intensity
- multichannel fibre optic
- multichannel flow through system
- measurement of fluorescence and luminescence
Analytical HPLC (e.g. normal phase, RP-chromatography)
- isocratic, binary and ternary gradient
- DAD, UV/Vis detection
- Fluorescence detection
- RI detection
- texture analysis
- loss on drying
- crushing force
- uniformity of mass
- disintegration test
- stability testing
- optical microscopy
- SEM microscopy
- M. Grimm, M. Koziolek, M. Saleh, F. Schneider, G. Garbacz, J.P. Kühn, W. Weitschies: Gastric Emptying and Small Bowel Water Content after Administration of Grapefruit Juice Compared to Water and Isocaloric Solutions of Glucose and Fructose: A Four-Way Crossover MRI Pilot Study in Healthy Subjects.
- D. Haznar-Garbacz, E. Kaminska, D. Zakowiecki, M. Lachmann, K. Kaminski, G. Garbacz, P. Dorożyński, P. Kulinowski: Melts of Octaacetyl Sucrose as Oral-Modified Release Dosage Forms for Delivery of Poorly Soluble Compound in Stable Amorphous Form.
- 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.
- P. Kulinowski, K. Woyna-Orlewicz, J. Obrał, G. M. Rappen, D. Haznar-Garbacz, W. P. Węglarz, R. Jachowicz, G: Wyszogrodzka, J. Klaja, P. Dorożyński. Multimodal approach to characterization of hydrophilic matrices manufactured by wet and dry granulation or direct compression methods. Int J Pharm. 499 (2016) 263-270. (PubMed)
- D. Zakowiecki, K. Cal, K. Kaminski, K. Adrjanowicz, L. Swinder, E. Kaminska, G. Garbacz. The Improvement of the Dissolution Rate of Ziprasidone Free Base from Solid Oral Formulations. AAPS PharmSciTech. 16 (2015) 922-933. (PubMed)
- G. Garbacz, G.-M. Rappen M. Koziolek, W. Weitschies. Dissolution of mesalazine modified release tablets under standard and bio-relevant test conditions. J. Pharm. Pharmacol. 67 (2015) 199-208. (PubMed)
- 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. (PubMed)
- P. Kulinowski, K. Woyna-Orlewicz, G.M. Rappen , D. Haznar-Garbacz, W. P. Węglarz, P. Dorożyński. 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. Int J Pharm. 484 (2015) 235-245.(PubMed)
- G. Garbacz, A. Kandzi, M. Koziolek, J. Mazgalski, W. Weitschies. Release Characteristics of Quetiapine Fumarate Extended Release Tablets Under Biorelevant Stress Test Conditions. AAPS Pharm. Sci. Tech. 15 (2014) 230-236. (PubMed)
- 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. (PubMed)
- G. Garbacz, D. Cadé, H. Benameur, W. Weitschies. Bio-relevant dissolution testing of hard capsules prepared from different shell materials using the dynamic open flow through test apparatus. Eur. J.Pharm. Sci. 57 (2014) 264-272. (PubMed)
- 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. (PubMed)
- L. Wilde, M. Bock, M. Wolf, G. Glöckl, G. Garbacz, W. Weitschies. Development of pressure-sensitive dosage forms with a core liquefying at body temperature. Eur. J. Pharm. Biopharm. 86 (2014) 507-513. (PubMed)
- 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. (PubMed)
- F. Eisenächer, G. Garbacz, K. Mäder. Physiological relevant in vitro evaluation of polymer coats for gastroretentive floating tablets. Eur. J. Pharm. Biopharm. 88 (2014) 778-786. (PubMed)
- M. Drechsler, G. Garbacz, R. Thomann, R. Schubert. Development and evaluation of chitosan and chitosan/Kollicoat® Smartseal 30 D film-coated tablets for colon targeting. Eur. J. Pharm. Biopharm 88 (2014) 807-815. (PubMed)
- S.Klein, G. Garbacz, M. Pišlar, I. Locatelli, C. Liu, W. Weitschies, W. Siegmund, A. Mrhar, M. Bogataj. The role of individual gastric emptying of pellets in the prediction of diclofenac in vivo dissolution. J. Control. Release. 66 (2013) 286-293. (PubMed)
- Garbacz, B. Kołodziej, M. Koziolek, W. Weitschies, S. Klein. An automated system for monitoring and regulating the pH of bicarbonate buffers. AAPS Pharm. Sci. Tech. 14 (2013) 517-522. (PubMed)
- Koziolek, G. Garbacz, M. Neumann, W. Weitschies. Simulating the postprandial stomach: physiological considerations for dissolution and release testing. Mol. Pharm. 10 (2013) 1610-1622. (PubMed)
- 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. (PubMed)
- Adrjanowicz, K. Kaminski, P. Wlodarczyk, K. Grzybowska, M. Tarnacka, D. Zakowiecki, G. Garbacz, M. Paluch and S. Jurga. Molecular dynamics of itraconazole at ambient and high pressure. Phys. Chem. Chem. Phys. 15 (2013) 20742-20752. (PubMed)
- Adrjanowicz, K. Kaminski, P. Wlodarczyk, K. Grzybowska, M. Tarnacka, D. Zakowiecki, G. Garbacz, M. Paluch and S. Jurga. Molecular Dynamics of Supercooled Pharmaceutical Agent Posaconazole Studied via Differential Scanning Calorimetry, Dielectric and Mechanical Spectroscopies. Mol. Pharm. 10 (2013) 3934-3945. (PubMed)
- Wilde, M. Bock, G. Glöckl, G. Garbacz, W. Weitschies. Development of a pressure-sensitive glyceryl tristearate capsule filled with a drug-containing hydrogel. Int. J. Pharm. 461 (2013) 296-300. (PubMed)
- Garbacz and S. Klein. Dissolution testing of oral modified-release dosage forms. J. Pharm. Pharmacol. 64 (2012) 944-968. (PubMed)
- Haznar-Garbacz, G. Garbacz, F. Eisenächer, Klein S, W. Weitschies. A novel liquefied gas based oral controlled release drug delivery system for liquid drug formulations. Eur. J. Pharm. Biopharm. 81 (2012) 334-338. (PubMed)
- D. Haznar-Garbacz, G. Garbacz, F. Eisenächer, Klein S, W. Weitschies. An oral-controlled release drug delivery system for liquid and semisolid drug formulations. AAPS Pharm. Sci. Tech. 4 (2011) 1183-1185. (PubMed)
- Garbacz, W. Weitschies, Investigation of dissolution characteristics of four diclofenac sodium extended release tablets using USP apparatus 2 and novel biorelevant dissolution stress test device. Drug. Dev. Ind. Pharm. 36 (2010) 518-530. (PubMed)
- Garbacz, S. Klein, W. Weitschies. Dissolution stress test device – background and experiences. Expert Opin. Drug Deliv. 7 (2010) 1251-61. (PubMed)
- G. Garbacz, H. Blume, W. Weitschies, Investigation of the dissolution characteristics of six different nifedipine 20 mg extended release tablets using USP apparatus 2 and a novel dissolution test apparatus that mimics in vivo physical stress. Dissolution Technologies, 16 (2009) 7‒11.
- G. Garbacz, U. Adam, B. Schug, H. Blume, W. Weitschies, Nifedipin-Retardtabletten mit unterschiedlicher Galenik. Deutsche Apotheker Zeitung 27 (2009) 70‒77.
- M. Anschütz, G. Garbacz, O. Kosch, F. Donath, J. Wiedmann, W. Hoeckh, L. Trahms, B. Schug, W. Weitschies and H. Blume, Characterization of the behavior of alginate based microcapsules in vitro and in vivo. Int. J. Clin. Pharmacol. Ther. 47 (2009):556‒563. (PubMed)
- G. Garbacz, B. Golke, R.-S. Wedemeyer, M. Sjöberg, E. Söderlind, B. Abrahamsson, W. Weitschies, Comparison of dissolution profiles obtained for nifedipine extended release once daily tablets using different dissolution test apparatuses. Eur. J. Pharm. Sci. 38 (2009) 147‒155. (PubMed)
- G. Garbacz, R.S. Wedemeyer, S. Nagel, T. Giessmann, H. Mönnikes, C.G. Wilson, W. Siegmund, W. Weitschies, Irregular absorption profiles observed from diclofenac extended release tablets can be predicted using a dissolution test apparatus that mimics in vivo physical stresses. Eur. J. Pharm. Biopharm. 70 (2008) 421–428. (PubMed)
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