Oral Drug Delivery for Modified Release Formulations (eBook, PDF)

Redaktion: Kostewicz, Edmund S.; Roberts, Michael S.; Benson, Heather A. E.; Vertzoni, Maria

• Format: PDF

Produktbeschreibung

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 field * Discusses the present status of MR technologies and identifies current gaps in research * Includes a summary of regulatory guidelines from both the US and the EU * Shares industrial experiences and perspectives on the evaluation of MR dosage formulations Oral 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.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 496
• Erscheinungstermin: 29. März 2022
• Englisch
• ISBN-13: 9781119772705
• Artikelnr.: 63694388

Autorenporträt

Edmund S. Kostewicz, PhD is at the Fraunhofer Institute for Translational Medicine and Pharmacology in Frankfurt, Germany. Maria Vertzoni, PhD is an Assistant Professor of Pharmaceutical Technology and Biopharmaceutics at National and Kapodistrian University of Athens, Greece. Heather A.E. Benson, PhD is an adjunct Associate Professor at the Curtin Medical School, Curtin University, Australia, where she leads the Skin Delivery Research Group. Michael S. Roberts, PhD is a Professor of Therapeutics & Pharmaceutical Science at the University of South Australia, and a Professor of Clinical Pharmacology & Therapeutics at the University of Queensland, Australia.

Inhaltsangabe

Preface and Introduction and overview of MR formulations

Part I Understanding of physiology and anatomy - factors influencing drug release and absorption from MR formulations

1. Composition of the GI lumen under fasting and fed conditions

a. Composition of gastric fluids under fasting and fed conditions -
Jens Van Den Abeele and Patrick Augustijns
Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, O&N II, Herestraat 49 - box 921, 3000 Leuven, Belgium

b. Composition of small intestinal fluids under fasting and fed conditions
Edmund Kostewicz
Institute for Pharmaceutical Technology, Goethe University, Max-von-Laure Str. 9, 60439 Frankfurt am Main, Germany

c. Composition of large intestinal fluids under fasting and fed conditions
Christos Reppas and Maria Vertzoni
Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.

2. Gastrointestinal transit and hydrodynamics under fasting and fed conditions
Mirko Koziolek
Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany

3. Intestinal Epithelium and Drug Transporters
Karelle Ménochet*1, Hugues Chanteux*2, Jamie Henshall1, Jean-Marie Nicolas2, Sara Wright1, Judith van Asperen2 and Anna-Lena Ungell2
1UCB Celltech, Slough, United Kingdom
2UCB Biopharma SPRL, Braine-l'Alleud, Belgium

4. The interplay between drug release and intestinal gut-wall metabolism
Adam S. Darwich1, Oliver J.D. Hatley2, Andrés Olivares-Morales1,3, Farzaneh Salem2, Alison Margolskee1, Amin Rostami-Hodjegan1,2
1Centre for Applied Pharmacokinetic Research, Manchester Pharmacy School, University of Manchester, Manchester M13 9PT, United Kingdom
2Certara, Blades Enterprise Centre, Sheffield, S2 4SU, United Kingdom
3Roche Pharma Research and Early Development (pRED), Roche Innovation Center Basel, Basel, Switzerland

Part II Design of MR formulations - considerations, mechanisms and technologies

5. Preformulation considerations for design of oral modified-release products
Christel A. S. Bergström1 and René Holm2
1 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 Formulations
James M Butler
Biopharmaceutics, Drug Product Design & Dev
GlaxoSmithKline R&D
Ware UK

7. Technologies and mechanisms for oral modified release by monolithic and multiparticulate delivery systems
Gaia Colombo*, Stavros Politis, Alessandra Rossi
University of Ferrara
44121 FERRARA (Italy)

8. Lipid based Formulations
Joseph P. O'Shea, Caitriona M. O'Driscoll, Brendan T. Griffin
Pharmacodelivery Group, School of Pharmacy, University College Cork, Ireland

9. Strategies for MR formulation development: Mesoporous Silica
Georgios K. Eleftheriadis, Eleni Kontogiannidou, Christina Karavasili, Dimitrios G. Fatouros
Department of Pharmacy, Laboratory of Pharmaceutical Technology, Aristotle University of Thessaloniki, 54124 GR

10. Hot melt extrusion technology for modified release (MR) formulation development
Harpreet Sandhu, Siva Ram Kiran Vaka, Dipen Desai, Paras Jariwala, Aruna Railkar, Wantanee Phuapradit and Navnit Shah
Paras Jariwala, Aruna Railkar, Wantanee Phuapradit
Kashiv Pharma LLC, 995 Route 202/206 Bridgewater, NJ 08807

11. Gattefosse: Strategies for MR formulation development - Lipids
Yvonne Rosiaux, Vincent Jannin and Cécile Morin
Gattefossé SAS - 36 chemin de Genas
69804 Saint Priest France