Oral biopharmaceutics tools - Time for a new initiative - An introduction to the IMI project OrBiTo

被引：87

作者：

Lennernas, H. ^{[1
]}

Aarons, L. ^{[2
]}

Augustijns, P. ^{[3
]}

Beato, S. ^{[4
]}

Bolger, M. ^{[5
]}

Box, K. ^{[6
]}

Brewster, M. ^{[7
]}

Butler, J. ^{[8
]}

Dressman, J. ^{[9
]}

Holm, R. ^{[10
]}

Frank, K. Julia ^{[11
]}

Kendall, R. ^{[12
]}

Langguth, P. ^{[13
]}

Sydor, J. ^{[14
]}

Lindahl, A. ^{[15
]}

McAllister, M. ^{[16
]}

Muenster, U. ^{[17
,18
]}

Mullertz, A.

Ojala, K. ^{[19
]}

Pepin, X. ^{[20
]}

Reppas, C. ^{[21
]}

Rostami-Hodjegan, A. ^{[22
]}

Verwei, M. ^{[23
]}

Weitschies, W. ^{[24
]}

Wilson, C. ^{[25
]}

Karlsson, C. ^{[26
]}

Abrahamsson, B. ^{[26
]}

机构：

[1] Uppsala Univ, S-75105 Uppsala, Sweden

[2] Univ Manchester, Manchester M13 9PL, Lancs, England

[3] Kathol Univ Leuven, Leuven, Belgium

[4] Novartis, Basel, Switzerland

[5] Simulat Plus, Lancaster, CA USA

[6] Sirius Analyt, Forest Row, E Sussex, England

[7] Johnson & Johnson, Antwerp, Belgium

[8] GSK, Brentford, England

[9] Goethe Univ Frankfurt, Frankfurt, Germany

[10] H Lundbeck & Co AS, Copenhagen, Denmark

[11] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany

[12] Merck, Feltham, Middx, England

[13] Johannes Gutenberg Univ Mainz, Mainz, Germany

[14] AbbVie, Wiesbaden, Germany

[15] Med Prod Agcy, Uppsala, Sweden

[16] Pfizer, Sandwich, Kent, England

[17] Bayer Pharma AG, Berlin, Germany

[18] Univ Copenhagen, DK-1168 Copenhagen, Denmark

[19] Orion Pharma, Espoo, Finland

[20] Sanofi Aventis, Strasbourg, France

[21] Univ Athens, Athens, Greece

[22] Univ Manchester, Simcyp Ltd, Manchester M13 9PL, Lancs, England

[23] TNO, Delft, Netherlands

[24] Ernst Moritz Arndt Univ Greifswald, Greifswald, Germany

[25] Univ Strathclyde, Glasgow G1 1XQ, Lanark, Scotland

[26] AstraZeneca R&D, Gothenburg, Sweden

来源：

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES | 2014年 / 57卷

关键词：

BCS; PBPK; IVIVC; Dissolution; Drug absorption; Permeability; IN-VIVO DISSOLUTION; DRUG DISCOVERY; CACO-2; VITRO; CLASSIFICATION; ABSORPTION; PERMEABILITY; SOLUBILITY; SIMULATION; PREDICTION;

D O I：

10.1016/j.ejps.2013.10.012

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

OrBiTo is a new European project within the IMI programme in the area of oral biopharmaceutics tools that includes world leading scientists from nine European universities, one regulatory agency, one non-profit research organization, four SMEs together with scientists from twelve pharmaceutical companies. The OrBiTo project will address key gaps in our knowledge of gastrointestinal (GI) drug absorption and deliver a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. This will be achieved through novel prospective investigations to define new methodologies as well as refinement of existing tools. Extensive validation of novel and existing biopharmaceutics tools will be performed using active pharmaceutical ingredient (API), formulations and supporting datasets from industry partners. A combination of high quality in vitro or in silico characterizations of API and formulations will be integrated into physiologically based in silica biopharmaceutics models capturing the full complexity of GI drug absorption. This approach gives an unparalleled opportunity to initiate a transformational change in industrial research and development to achieve model-based pharmaceutical product development in accordance with the Quality by Design concept. Benefits include an accelerated and more efficient drug candidate selection, formulation development process, particularly for challenging projects such as low solubility molecules (BCS II and IV), enhanced and modified-release formulations, as well as allowing optimization of clinical product performance for patient benefit. In addition, the tools emerging from OrBiTo are expected to significantly reduce demand for animal experiments in the future as well as reducing the number of human bioequivalence studies required to bridge formulations after manufacturing or composition changes. (C) 2013 Elsevier B.V. All rights reserved.

引用

页码：292 / 299

页数：8

共 33 条

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