| 000 -LEADER |
|---|
| fixed length control field |
10771cam a2200565 i 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20250319144643.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION |
|---|
| fixed length control field |
m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
|---|
| fixed length control field |
cr ||||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
250319b ||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781119772699 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781119772712 |
| Qualifying information |
electronic publication |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1119772710 |
| Qualifying information |
electronic publication |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1119772702 |
| Qualifying information |
Adobe electronic book |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781119772729 |
| Qualifying information |
electronic book |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1119772729 |
| Qualifying information |
electronic book |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781119772705 |
| Qualifying information |
(electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| Cancelled/invalid ISBN |
9781119772699 |
| Qualifying information |
hardcover |
| 024 7# - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1002/9781119772729 |
| Source of number or code |
doi |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)1257315414 |
| 041 ## - LANGUAGE CODE |
|---|
| Language code of text/sound track or separate title |
eng. |
| 042 ## - AUTHENTICATION CODE |
|---|
| Authentication code |
pcc |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RS199.5 |
| Item number |
.O73 2022 |
| 060 00 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Classification number |
QV 786 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615/.6 |
| Edition number |
23 |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
Oral drug delivery for modified release formulations / |
| Statement of responsibility, etc |
edited by Edmund S Kostewicz, Maria Vertzoni, Heather A E Benson, Michael S Roberts. |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
Hoboken, NJ : |
| Name of publisher, distributor, etc |
John Wiley & Sons, Inc., |
| Date of publication, distribution, etc |
2022. |
| 264 #4 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Date of publication, distribution, etc |
©2022. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
1 online resource (xxiii, 464 pages) : |
| Other physical details |
illustrations (some color) |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent. |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia. |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 0# - CONTENTS |
|---|
| Formatted contents note |
Table of Contents<br/>Preface and Introduction and overview of MR formulations<br/><br/>Part I Understanding of physiology and anatomy – factors influencing drug release and absorption from MR formulations<br/><br/>1. Composition of the GI lumen under fasting and fed conditions<br/><br/>a. Composition of gastric fluids under fasting and fed conditions –<br/>Jens Van Den Abeele and Patrick Augustijns<br/>Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, O&N II, Herestraat 49 – box 921, 3000 Leuven, Belgium<br/><br/>b. Composition of small intestinal fluids under fasting and fed conditions<br/>Edmund Kostewicz<br/>Institute for Pharmaceutical Technology, Goethe University, Max-von-Laure Str. 9, 60439 Frankfurt am Main, Germany<br/><br/>c. Composition of large intestinal fluids under fasting and fed conditions<br/>Christos Reppas and Maria Vertzoni<br/>Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.<br/><br/>2. Gastrointestinal transit and hydrodynamics under fasting and fed conditions<br/>Mirko Koziolek<br/>Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany<br/><br/>3. Intestinal Epithelium and Drug Transporters<br/>Karelle Ménochet*1, Hugues Chanteux*2, Jamie Henshall1, Jean-Marie Nicolas2, Sara Wright1, Judith van Asperen2 and Anna-Lena Ungell2<br/>1UCB Celltech, Slough, United Kingdom<br/>2UCB Biopharma SPRL, Braine-l’Alleud, Belgium<br/><br/>4. The interplay between drug release and intestinal gut-wall metabolism<br/>Adam S. Darwich1, Oliver J.D. Hatley2, Andrés Olivares-Morales1,3, Farzaneh Salem2, Alison Margolskee1, Amin Rostami-Hodjegan1,2<br/>1Centre for Applied Pharmacokinetic Research, Manchester Pharmacy School, University of Manchester, Manchester M13 9PT, United Kingdom<br/>2Certara, Blades Enterprise Centre, Sheffield, S2 4SU, United Kingdom<br/>3Roche Pharma Research and Early Development (pRED), Roche Innovation Center Basel, Basel, Switzerland<br/><br/>Part II Design of MR formulations – considerations, mechanisms and technologies<br/><br/>5. Preformulation considerations for design of oral modified-release products<br/>Christel A. S. Bergström1 and René Holm2<br/>1 Department of Pharmacy, Uppsala University, Uppsala Biomedical Centre P.O. Box 580, SE-751 23 Uppsala, Sweden.<br/>2 Drug Product Development, Janssen Research & Development, Johnson & Johnson, Turnhoutseweg 30, 2430 Beerse, Belgium.<br/><br/>6. The Application of Biopharmaceutics Classification Systems to Modified Release Formulations<br/>James M Butler<br/>Biopharmaceutics, Drug Product Design & Dev<br/>GlaxoSmithKline R&D<br/>Ware UK<br/><br/>7. Technologies and mechanisms for oral modified release by monolithic and multiparticulate delivery systems<br/>Gaia Colombo*, Stavros Politis, Alessandra Rossi<br/>University of Ferrara<br/>44121 FERRARA (Italy)<br/><br/>8. Lipid based Formulations<br/>Joseph P. O’Shea, Caitriona M. O’Driscoll, Brendan T. Griffin<br/>Pharmacodelivery Group, School of Pharmacy, University College Cork, Ireland<br/><br/>9. Strategies for MR formulation development: Mesoporous Silica<br/>Georgios K. Eleftheriadis, Eleni Kontogiannidou, Christina Karavasili, Dimitrios G. Fatouros<br/>Department of Pharmacy, Laboratory of Pharmaceutical Technology, Aristotle University of Thessaloniki, 54124 GR<br/><br/>10. Hot melt extrusion technology for modified release (MR) formulation development<br/>Harpreet Sandhu, Siva Ram Kiran Vaka, Dipen Desai, Paras Jariwala, Aruna Railkar, Wantanee Phuapradit and Navnit Shah<br/>Paras Jariwala, Aruna Railkar, Wantanee Phuapradit<br/>Kashiv Pharma LLC, 995 Route 202/206 Bridgewater, NJ 08807<br/><br/>11. Gattefosse: Strategies for MR formulation development - Lipids<br/>Yvonne Rosiaux, Vincent Jannin and Cécile Morin<br/>Gattefossé SAS – 36 chemin de Genas<br/>69804 Saint Priest France<br/><br/>12. Evonik: Polymethacrylates for Modified Release Formulations<br/>Miriam Robota, Felix Hofmann and Meike Pistner<br/>Meike Pistner<br/>Evonik Nutrition & Care GmbH, Darmstadt, Germany<br/><br/>13. Capsugel – Strategies for Modified Release oral formulation development<br/>Aurélien Sivert1, Randy Wald2, Chris Craig2, Hassan Benameur1<br/>Randy Wald<br/>1Capsugel/Lonza R&D, Strasbourg, France 2Capsugel/Lonza R&D, Bend, Oregon USA<br/><br/>Part III Evaluation of MR formulations<br/><br/>14. Dissolution equipment and hydrodynamic considerations for evaluating MR formulations<br/>Sandra Klein<br/>Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany<br/><br/>15. The role and application of dissolution media for the investigation of modified release formulations<br/>Institute for Pharmaceutical Technology, Goethe University, Max-von-Laue Str. 9, 60439 Frankfurt am Main, Germany<br/><br/>16. Biorelevant dissolution testing to forecast the in vivo performance of modified release formulations<br/>Mirko Koziolek<br/>Department of Biopharmaceutics and Pharmaceutical Technology, Center of Drug Absorption and Transport, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany<br/><br/>17. In vitro dissolution tests for considering dissolution in the lower intestine<br/>Constantinos Markopoulos, Maria Vertzoni<br/>1Faculty of Pharmacy, School of Health Sciences, National & Kapodistrian University of Athens, Greece<br/><br/>18. Preclinical evaluation – animal models to evaluate MR formulations<br/>René Holm<br/>Drug Product Development, Janssen Research and Development, Johnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium. E-mail: rholm@its.jnj.com<br/><br/>19. In vitro – In vivo correlations for modified release formulations<br/>Ivana Tomic1 and Jean-Michel Cardot2<br/>1Novartis Pharma AG, Technical R&D, Physic Garden 3 - 3.14.49, CH-4002 Base, Switzerland<br/>2Université Clermont Auvergne MEDIS, CHU Clermont-Ferrand, CIC1405, INSERM, F-63000 Clermont–Ferrand, France<br/><br/>20. Application of the Simcyp Population-Based PBPK Simulator to the Modelling of MR Formulations<br/>Nikunjkumar Patel, Shriram M. Pathak and David B. Turner<br/>Simcyp Ltd (A Certara Company); UK<br/><br/>21. PK-Sim® for modeling oral drug delivery of modified release formulations<br/>Donato Teutonico, Michael Block, Lars Kuepfer, Juri Solodenko, Thomas Eissing*, Katrin Coboeken<br/>Michael Block, Lars Kuepfer, Katrin Coboeken<br/>Bayer AG, Clinical Pharmacometrics, Germany<br/><br/>22. Clinical Evaluation – In vivo bioequivalence assessment of MR formulations<br/>Konstantina Soulele, Panos Macheras<br/>Laboratory of Biopharmaceutics and Pharmacokinetics, Faculty of Pharmacy, University of Athens, Athens 15771, Greece<br/><br/>23. U.S. Regulatory Considerations for Modified Release Products<br/>Hao Zhu, Ramana S. Uppoor, Mehul Mehta<br/>Office of Clinical Pharmacology, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA<br/><br/>24. Regulatory Assessment, European Perspective<br/>Malin Filler and Anders Lindahl<br/><br/>25. Industry perspectives for the evaluation of MR formulations<br/>Irena Tomaszewska and Mark McAllister<br/>Pfizer, Medicinal Sciences, Sandwich, UK |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
"This book reviews key aspects of oral absorption from modified-release (MR) dosage forms. Divided into three sections that explore the physiological and anatomical factors influencing drug release, the design of MR formulations, and the evaluation of MR formulations. Included are definition of terms used in the field, the present status of MR, types of MR, and current gaps in research. This book will give readers an understanding of physiology, physicochemical determinants, role of dosage formulations, and in-vitro in-vivo correlation (IVIVC)"-- |
| Assigning source |
Provided by publisher. |
| 545 0# - BIOGRAPHICAL OR HISTORICAL DATA |
|---|
| Biographical or historical note |
About the Author<br/>Edmund S. Kostewicz, PhD is at the Fraunhofer Institute for Translational Medicine and Pharmacology in Frankfurt, Germany.<br/><br/>Maria Vertzoni, PhD is an Assistant Professor of Pharmaceutical Technology and Biopharmaceutics at National and Kapodistrian University of Athens, Greece.<br/><br/>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.<br/><br/>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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Controlled release. |
| Authority record control number |
http://id.loc.gov/authorities/subjects/sh85039724. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug delivery systems. |
| Authority record control number |
http://id.loc.gov/authorities/subjects/sh88007108. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Oral medication. |
| Authority record control number |
http://id.loc.gov/authorities/subjects/sh85095244. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Delayed-Action Preparations. |
| Authority record control number |
https://id.nlm.nih.gov/mesh/D003692. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Administration, Oral. |
| Authority record control number |
https://id.nlm.nih.gov/mesh/D000284. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Delivery Systems. |
| Authority record control number |
https://id.nlm.nih.gov/mesh/D016503. |
| 655 #4 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Kostewicz, Edmund S., |
| Authority record control number |
http://id.loc.gov/authorities/names/n2021181675 |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Vertzoni, Maria, |
| Authority record control number |
http://id.loc.gov/authorities/names/n2021181676 |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Benson, Heather A. E., |
| Authority record control number |
http://id.loc.gov/authorities/names/n2011181875 |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Roberts, Michael S., |
| Dates associated with a name |
1949- |
| Authority record control number |
http://id.loc.gov/authorities/names/n98801130 |
| Relator term |
editor. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Link text |
Full text available at Wiley Online Library Click here to view. |
| Uniform Resource Identifier |
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119772729 |
| 942 ## - ADDED ENTRY ELEMENTS |
|---|
| Source of classification or shelving scheme |
|
| Item type |
EBOOK |