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Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo.
Eur J Pharm Sci. 2014 Jun 16; 57:292-9.EJ

Abstract

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 silico 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.

Authors+Show Affiliations

Uppsala University, Sweden.University of Manchester, United Kingdom.Katholische University of Leuven, Belgium.Novartis, Switzerland.Simulations Plus, United States.Sirius Analytical, United Kingdom.Johnson & Johnson, Belgium.GSK, United Kingdom.Goethe University Frankfurt am Main, Germany.H. Lundbeck A/S, Denmark.Boehringer-Ingelheim, Germany.Merck, United Kingdom.Johannes Gutenberg University of Mainz, Germany.AbbVie, Germany.Medical Products Agency, Sweden.Pfizer, United Kingdom.Bayer Pharma AG, Germany.University of Copenhagen, Denmark.Orion Pharma, Finland.Sanofi-Aventis, France.National and Kapodistrian University of Athens, Greece.Simcyp Ltd/University of Manchester, United Kingdom.TNO, Netherlands.University of Greifswald, Germany.University of Strathclyde, United Kingdom.AstraZeneca R&D, Sweden.AstraZeneca R&D, Sweden. Electronic address: Bertil.abrahamsson@astrazeneca.com.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

24189462

Citation

Lennernäs, H, et al. "Oral Biopharmaceutics Tools - Time for a New Initiative - an Introduction to the IMI Project OrBiTo." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 57, 2014, pp. 292-9.
Lennernäs H, Aarons L, Augustijns P, et al. Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo. Eur J Pharm Sci. 2014;57:292-9.
Lennernäs, H., Aarons, L., Augustijns, P., Beato, S., Bolger, M., Box, K., Brewster, M., Butler, J., Dressman, J., Holm, R., Julia Frank, K., Kendall, R., Langguth, P., Sydor, J., Lindahl, A., McAllister, M., Muenster, U., Müllertz, A., Ojala, K., ... Abrahamsson, B. (2014). Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 57, 292-9. https://doi.org/10.1016/j.ejps.2013.10.012
Lennernäs H, et al. Oral Biopharmaceutics Tools - Time for a New Initiative - an Introduction to the IMI Project OrBiTo. Eur J Pharm Sci. 2014 Jun 16;57:292-9. PubMed PMID: 24189462.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo. AU - Lennernäs,H, AU - Aarons,L, AU - Augustijns,P, AU - Beato,S, AU - Bolger,M, AU - Box,K, AU - Brewster,M, AU - Butler,J, AU - Dressman,J, AU - Holm,R, AU - Julia Frank,K, AU - Kendall,R, AU - Langguth,P, AU - Sydor,J, AU - Lindahl,A, AU - McAllister,M, AU - Muenster,U, AU - Müllertz,A, AU - Ojala,K, AU - Pepin,X, AU - Reppas,C, AU - Rostami-Hodjegan,A, AU - Verwei,M, AU - Weitschies,W, AU - Wilson,C, AU - Karlsson,C, AU - Abrahamsson,B, Y1 - 2013/11/01/ PY - 2013/06/19/received PY - 2013/10/22/revised PY - 2013/10/24/accepted PY - 2013/11/6/entrez PY - 2013/11/6/pubmed PY - 2014/12/17/medline KW - BCS KW - Dissolution KW - Drug absorption KW - IVIVC KW - PBPK KW - Permeability SP - 292 EP - 9 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 57 N2 - 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 silico 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. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/24189462/Oral_biopharmaceutics_tools___time_for_a_new_initiative___an_introduction_to_the_IMI_project_OrBiTo_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(13)00419-3 DB - PRIME DP - Unbound Medicine ER -