Description
JOHN WILEY Oral Drug Delivery For Modified Release Formulations (Hb 2022) by KOSTEWICZ E.S.
ORAL DRUG DELIVERY FOR MODIFIED RELEASE FORMULATIONS Provides pharmaceutical development scientists with a detailed reference guide for the development of MR formulations Oral Drug Delivery for Modified Release Formulations is an up-to-date review of the key aspects of oral absorption from modified-release (MR) dosage forms. This edited volume provides in-depth coverage of the physiological factors that influence drug release and of the design and evaluation of MR formulations. Divided into three sections, the book begins by describing the gastrointestinal tract (GIT) and detailing the conditions and absorption processes occurring in the GIT that determine a formulation's oral bioavailability. The second section explores the design of modified release formulations, covering early drug substance testing, the biopharmaceutics classification system, an array of formulation technologies that can be used for MR dosage forms, and more. The final section focuses on in vitro, in silico, and in vivo evaluation and regulatory considerations for MR formulations. Topics include biorelevant dissolution testing, preclinical evaluation, and physiologically-based pharmacokinetic modelling (PBPK) of in vivo behaviour. Featuring contributions from leading researchers with expertise in the different aspects of MR formulations, this volume: Provides authoritative coverage of physiology, physicochemical determinants, and in-vitro in-vivo correlation (IVIVC)Explains the different types of MR formulations and defines the key terms used in the fieldDiscusses the present status of MR technologies and identifies current gaps in researchIncludes a summary of regulatory guidelines from both the US and the EUShares industrial experiences and perspectives on the evaluation of MR dosage formulationsOral Drug Delivery for Modified Release Formulations is an invaluable reference and guide for researchers, industrial scientists, and graduate students in general areas of drug delivery including pharmaceutics, pharmaceutical sciences, biomedical engineering, polymer and materials science, and chemical and biochemical engineering. Preface and Introduction and overview of MR formulationsPart I Understanding of physiology and anatomy - factors influencing drug release and absorption from MR formulations1. Composition of the GI lumen under fasting and fed conditionsa. Composition of gastric fluids under fasting and fed conditions -Jens Van Den Abeele and Patrick AugustijnsDrug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, O&N II, Herestraat 49 - box 921, 3000 Leuven, Belgiumb. Composition of small intestinal fluids under fasting and fed conditionsEdmund KostewiczInstitute for Pharmaceutical Technology, Goethe University, Max-von-Laure Str. 9, 60439 Frankfurt am Main, Germanyc. Composition of large intestinal fluids under fasting and fed conditionsChristos Reppas and Maria VertzoniDepartment of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.2. Gastrointestinal transit and hydrodynamics under fasting and fed conditionsMirko KoziolekDepartment of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany3. Intestinal Epithelium and Drug TransportersKarelle Menochet*1, Hugues Chanteux*2, Jamie Henshall1, Jean-Marie Nicolas2, Sara Wright1, Judith van Asperen2 and Anna-Lena Ungell21UCB Celltech, Slough, United Kingdom2UCB Biopharma SPRL, Braine-l'Alleud, Belgium4. The interplay between drug release and intestinal gut-wall metabolismAdam S. Darwich1, Oliver J.D. Hatley2, Andres Olivares-Morales1,3, Farzaneh Salem2, Alison Margolskee1, Amin Rostami-Hodjegan1,21Centre for Applied Pharmacokinetic Research, Manchester Pharmacy School, University of Manchester, Manchester M13 9PT, United Kingdom2Certara, Blades Enterprise Centre, Sheffield, S2 4SU, United Kingdom3Roche Pharma Research and Early Development (pRED), Roche Innovation Center Basel, Basel, SwitzerlandPart II Design of MR formulations - considerations, mechanisms and technologies5. Preformulation considerations for design of oral modified-release productsChristel A. S. Bergstroem1 and Rene Holm21 Department of Pharmacy, Uppsala University, Uppsala Biomedical Centre P.O. Box 580, SE-751 23 Uppsala, Sweden.2 Drug Product Development, Janssen Research & Development, Johnson & Johnson, Turnhoutseweg 30, 2430 Beerse, Belgium.6. The Application of Biopharmaceutics Classification Systems to Modified Release FormulationsJames M ButlerBiopharmaceutics, Drug Product Design & DevGlaxoSmithKline R&DWare UK7. Technologies and mechanisms for oral modified release by monolithic and multiparticulate delivery systemsGaia Colombo*, Stavros Politis, Alessandra RossiUniversity of Ferrara44121 FERRARA (Italy)8. Lipid based FormulationsJoseph P. O'Shea, Caitriona M. O'Driscoll, Brendan T. GriffinPharmacodelivery Group, School of Pharmacy, University College Cork, Ireland9. Strategies for MR formulation development: Mesoporous SilicaGeorgios K. Eleftheriadis, Eleni Kontogiannidou, Christina Karavasili, Dimitrios G. FatourosDepartment of Pharmacy, Laboratory of Pharmaceutical Technology, Aristotle University of Thessaloniki, 54124 GR10. Hot melt extrusion technology for modified release (MR) formulation developmentHarpreet Sandhu, Siva Ram Kiran Vaka, Dipen Desai, Paras Jariwala, Aruna Railkar, Wantanee Phuapradit and Navnit ShahParas Jariwala, Aruna Railkar, Wantanee PhuapraditKashiv Pharma LLC, 995 Route 202/206 Bridgewater, NJ 0880711. Gattefosse: Strategies for MR formulation development - LipidsYvonne Rosiaux, Vincent Jannin and Cecile MorinGattefosse SAS - 36 chemin de Genas69804 Saint Priest France12. Evonik: Polymethacrylates for Modified Release FormulationsMiriam Robota, Felix Hofmann and Meike PistnerMeike PistnerEvonik Nutrition & Care GmbH, Darmstadt, Germany13. Capsugel - Strategies for Modified Release oral formulation developmentAurelien Sivert1, Randy Wald2, Chris Craig2, Hassan Benameur1Randy Wald1Capsugel/Lonza R&D, Strasbourg, France 2Capsugel/Lonza R&D, Bend, Oregon USAPart III Evaluation of MR formulations14. Dissolution equipment and hydrodynamic considerations for evaluating MR formulationsSandra KleinDepartment of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany15. The role and application of dissolution media for the investigation of modified release formulationsInstitute for Pharmaceutical Technology, Goethe University, Max-von-Laue Str. 9, 60439 Frankfurt am Main, Germany16. Biorelevant dissolution testing to forecast the in vivo performance of modified release formulationsMirko KoziolekDepartment of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany17. In vitro dissolution tests for considering dissolution in the lower intestineConstantinos Markopoulos, Maria Vertzoni1Faculty of Pharmacy, School of Health Sciences, National & Kapodistrian University of Athens, Greece18. Preclinical evaluation - animal models to evaluate MR formulationsRene HolmDrug Product Development, Janssen Research and Development, Johnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium. E-mail: rholm@its.jnj.com19. In vitro - In vivo correlations for modified release formulationsIvana Tomic1 and Jean-Michel Cardot21Novartis Pharma AG, Technical R&D, Physic Garden 3 - 3.14.49, CH-4002 Base, Switzerland2Universite Clermont Auvergne MEDIS, CHU Clermont-Ferrand, CIC1405, INSERM, F-63000 Clermont-Ferrand, France20. Application of the Simcyp Population-Based PBPK Simulator to the Modelling of MR FormulationsNikunjkumar Patel, Shriram M. Pathak and David B. TurnerSimcyp Ltd (A Certara Company); UK21. PK-Sim (R) for modeling oral drug delivery of modified release formulationsDonato Teutonico, Michael Block, Lars Kuepfer, Juri Solodenko, Thomas Eissing*, Katrin CoboekenMichael Block, Lars Kuepfer, Katrin CoboekenBayer AG, Clinical Pharmacometrics, Germany22. Clinical Evaluation - In vivo bioequivalence assessment of MR formulationsKonstantina Soulele, Panos MacherasLaboratory of Biopharmaceutics and Pharmacokinetics, Faculty of Pharmacy, University of Athens, Athens 15771, Greece23. U.S. Regulatory Considerations for Modified Release ProductsHao Zhu, Ramana S. Uppoor, Mehul MehtaOffice of Clinical Pharmacology, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA24. Regulatory Assessment, European PerspectiveMalin Filler and Anders Lindahl25. Industry perspectives for the evaluation of MR formulationsIrena Tomaszewska and Mark McAllisterPfizer, Medicinal Sciences, Sandwich, UK