title: Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo.
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.affiliation: Uppsala University, Sweden.
authors.forename: H
authors.initials: H
authors.lastname: Lennernäs
authors.affiliation: University of Manchester, United Kingdom.
authors.forename: L
authors.initials: L
authors.lastname: Aarons
authors.affiliation: Katholische University of Leuven, Belgium.
authors.forename: P
authors.initials: P
authors.lastname: Augustijns
authors.affiliation: Novartis, Switzerland.
authors.forename: S
authors.initials: S
authors.lastname: Beato
authors.affiliation: Simulations Plus, United States.
authors.forename: M
authors.initials: M
authors.lastname: Bolger
authors.affiliation: Sirius Analytical, United Kingdom.
authors.forename: K
authors.initials: K
authors.lastname: Box
authors.affiliation: Johnson & Johnson, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Brewster
authors.affiliation: GSK, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Butler
authors.affiliation: Goethe University Frankfurt am Main, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Dressman
authors.affiliation: H. Lundbeck A/S, Denmark.
authors.forename: R
authors.initials: R
authors.lastname: Holm
authors.affiliation: Boehringer-Ingelheim, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Julia Frank
authors.affiliation: Merck, United Kingdom.
authors.forename: R
authors.initials: R
authors.lastname: Kendall
authors.affiliation: Johannes Gutenberg University of Mainz, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Langguth
authors.affiliation: AbbVie, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Sydor
authors.affiliation: Medical Products Agency, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Lindahl
authors.affiliation: Pfizer, United Kingdom.
authors.forename: M
authors.initials: M
authors.lastname: McAllister
authors.affiliation: Bayer Pharma AG, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Muenster
authors.affiliation: University of Copenhagen, Denmark.
authors.forename: A
authors.initials: A
authors.lastname: Müllertz
authors.affiliation: Orion Pharma, Finland.
authors.forename: K
authors.initials: K
authors.lastname: Ojala
authors.affiliation: Sanofi-Aventis, France.
authors.forename: X
authors.initials: X
authors.lastname: Pepin
authors.affiliation: National and Kapodistrian University of Athens, Greece.
authors.forename: C
authors.initials: C
authors.lastname: Reppas
authors.affiliation: Simcyp Ltd/University of Manchester, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Rostami-Hodjegan
authors.affiliation: TNO, Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Verwei
authors.affiliation: University of Greifswald, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Weitschies
authors.affiliation: University of Strathclyde, United Kingdom.
authors.forename: C
authors.initials: C
authors.lastname: Wilson
authors.affiliation: AstraZeneca R&D, Sweden.
authors.forename: C
authors.initials: C
authors.lastname: Karlsson
authors.affiliation: AstraZeneca R&D, Sweden. Electronic address: Bertil.abrahamsson@astrazeneca.com.
authors.forename: B
authors.initials: B
authors.lastname: Abrahamsson
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001702:Biopharmaceutics / Q000379:methods*; D002626:Chemistry, Pharmaceutical; D003198:Computer Simulation; D004304:Dosage Forms; D041981:Gastrointestinal Tract / Q000378:metabolism*; D006801:Humans; D007408:Intestinal Absorption; D008954:Models, Biological; D010539:Permeability; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry / Q000378:metabolism*; D010599:Pharmacokinetics; D016730:Program Development; D012995:Solubility
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations
keywords: BCS; Dissolution; Drug absorption; IVIVC; PBPK; Permeability