title: Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from "Golem": A Novel Apparatus.
abstract: Different batches of atorvastatin, represented by two immediate release formulation designs, were studied using a novel dynamic dissolution apparatus, simulating stomach and small intestine. A universal dissolution method was employed which simulated the physiology of human gastrointestinal tract, including the precise chyme transit behavior and biorelevant conditions. The multicompartmental dissolution data allowed direct observation and qualitative discrimination of the differences resulting from highly pH dependent dissolution behavior of the tested batches. Further evaluation of results was performed using IVIVC/IVIVR development. While satisfactory correlation could not be achieved using a conventional deconvolution based-model, promising results were obtained through the use of a nonconventional approach exploiting the complex compartmental dissolution data.
authors.affiliation: Department of Chemical Drugs, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackého 1-3, 612 42 Brno, Czech Republic ; Department of Internal Medicine, Hematology and Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.
authors.forename: Martin
authors.initials: M
authors.lastname: Čulen
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9 Street, 30-688 Kraków, Poland.
authors.forename: Paweł K
authors.initials: PK
authors.lastname: Tuszyński
authors.affiliation: Department of Pharmacoepidemiology and Pharmacoeconomics and Department of Social Pharmacy, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9 Street, 30-688 Kraków, Poland ; Simcyp (a Certara Company) Limited, Blades Enterprise Centre, John Street, Sheffield S2 4SU, UK.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Polak
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9 Street, 30-688 Kraków, Poland.
authors.forename: Renata
authors.initials: R
authors.lastname: Jachowicz
authors.affiliation: Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9 Street, 30-688 Kraków, Poland.
authors.forename: Aleksander
authors.initials: A
authors.lastname: Mendyk
authors.affiliation: Department of Applied Pharmacy, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackého 1-3, 612 42 Brno, Czech Republic.
authors.forename: Jiří
authors.initials: J
authors.lastname: Dohnal
mesh_terms: D000069059:Atorvastatin / Q000737:chemistry / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D065546:Drug Liberation; D004864:Equipment and Supplies; D041981:Gastrointestinal Tract / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D007421:Intestine, Small / Q000187:drug effects
chemical_list: D000069059:Atorvastatin