title: Multimodal approach to characterization of hydrophilic matrices manufactured by wet and dry granulation or direct compression methods.
abstract: OBJECTIVE
  The purpose of the research was to investigate the effect of the manufacturing process of the controlled release hydrophilic matrix tablets on their hydration behavior, internal structure and drug release. Direct compression (DC) quetiapine hemifumarate matrices and matrices made of powders obtained by dry granulation (DG) and high shear wet granulation (HS) were prepared. They had the same quantitative composition and they were evaluated using X-ray microtomography, magnetic resonance imaging and biorelevant stress test dissolution.
  
  
  RESULTS
  Principal results concerned matrices after 2 h of hydration: (i) layered structure of the DC and DG hydrated tablets with magnetic resonance image intensity decreasing towards the center of the matrix was observed, while in HS matrices layer of lower intensity appeared in the middle of hydrated part; (ii) the DC and DG tablets retained their core and consequently exhibited higher resistance to the physiological stresses during simulation of small intestinal passage than HS formulation.
  
  
  CONCLUSIONS
  Comparing to DC, HS granulation changed properties of the matrix in terms of hydration pattern and resistance to stress in biorelevant dissolution apparatus. Dry granulation did not change these properties-similar hydration pattern and dissolution in biorelevant conditions were observed for DC and DG matrices.
authors.affiliation: Institute of Technology, The Pedagogical University of Cracow, ul. Podchorążych 2, 30-084 Kraków, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Kulinowski
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Pharmaceutical Faculty, Jagiellonian University, ul. Medyczna 9, 30-688 Kraków, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Woyna-Orlewicz
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Pharmaceutical Faculty, Jagiellonian University, ul. Medyczna 9, 30-688 Kraków, Poland.
authors.forename: Jadwiga
authors.initials: J
authors.lastname: Obrał
authors.affiliation: Physiolution GmbH, Walther-Rathenau-Strasse 49a, 17489 Greifswald, Germany.
authors.forename: Gerd-Martin
authors.initials: GM
authors.lastname: Rappen
authors.affiliation: Department of Pharmaceutical Technology, Pharmaceutical Faculty, Wrocław Medical University, ul. Borowska 211A, 50-556 Wrocław, Poland.
authors.forename: Dorota
authors.initials: D
authors.lastname: Haznar-Garbacz
authors.affiliation: Department of Magnetic Resonance Imaging, Institute of Nuclear Physics PAN, ul. Radzikowskiego 152, 31-342 Kraków, Poland.
authors.forename: Władysław P
authors.initials: WP
authors.lastname: Węglarz
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Pharmaceutical Faculty, Jagiellonian University, ul. Medyczna 9, 30-688 Kraków, Poland.
authors.forename: Renata
authors.initials: R
authors.lastname: Jachowicz
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Pharmaceutical Faculty, Jagiellonian University, ul. Medyczna 9, 30-688 Kraków, Poland.
authors.forename: Gabriela
authors.initials: G
authors.lastname: Wyszogrodzka
authors.affiliation: Department of Well Logging, Oil and Gas Institute-National Research Institute, ul. Bagrowa 1, 30-733, Kraków, Poland.
authors.forename: Jolanta
authors.initials: J
authors.lastname: Klaja
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Pharmaceutical Faculty, Jagiellonian University, ul. Medyczna 9, 30-688 Kraków, Poland. Electronic address: mfdorozy@cyf-kr.edu.pl.
authors.forename: Przemysław P
authors.initials: PP
authors.lastname: Dorożyński
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D003692:Delayed-Action Preparations; D004339:Drug Compounding / Q000379:methods*; D065546:Drug Liberation; D057927:Hydrophobic and Hydrophilic Interactions; D008279:Magnetic Resonance Imaging; D011312:Pressure; D000069348:Quetiapine Fumarate / Q000008:administration & dosage* / Q000737:chemistry; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D055114:X-Ray Microtomography
chemical_list: D003692:Delayed-Action Preparations; D013607:Tablets; D000069348:Quetiapine Fumarate
keywords: Biorelevant stress test dissolution; Direct compression; Dry granulation; High shear granulation; Magnetic Resonance Imaging (MRI); Quetiapine controlled release tablets; X-ray microtomography (μCT, Micro-CT)