News & Events
Don’t miss out - last few days to register
for this popular new symposium
Monday 17 - Tuesday 18 Sept 2018
AstraZeneca, Cambridge, UK
Taking a tablet with sparkling water may be a good alternative for a more expensive effervescent tablet. In a study by Jens Van Den Abeele, healthy human volunteers were asked to ingest a conventional paracetamol tablet with either tap or sparkling water, after which antroduodenal motility as well as intraluminal and systemic drug disposition were monitored as a function of time. Ingestion of sparkling water led to the occurrence of transient pressure events in the upper gastrointestinal tract for all volunteers, although the duration and frequency of the observed effect were subject to variability. Based on systemic drug disposition parameters, drug intake with sparkling water resulted in a trend towards faster and less variable absorption of paracetamol from the gastrointestinal tract.
We’re happy to announce the open OrBiTo webinar that will take place on Monday, April 16 – 4 pm (Central European Time).
The webinar will kick off with a brief introduction of the OrBiTo project explaining the work packages, the organization and the obtained results (Dr. Bertil Abrahamsson - AstraZeneca). The second speaker (Philipp Jedamzik – University of Greifswald) will inform you about the biorelevant dissolution model ‘GastroDuo’. A final talk will be given by Dr. Ronald Schilderink (TNO Triskelion) and Dr. Richard Barker (AstraZeneca). Both will present their latest findings related to the TIM advanced gastric model.
This will be an open webinar so feel free to inform your colleagues and let them attend our annual webinar!
Enter the Meeting ID: 507822439 or use the pairing code
Enter the Passcode: 2130
More information can be found on LinkedIn: https://www.linkedin.com/groups/12091380
In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context.
Lennernäs H, Lindahl A, Van Peer A, Ollier C, Flanagan T, Lionberger R, Nordmark A, Yamashita S, Yu L, Amidon GL, Fischer V, Sjögren E, Zane P, McAllister M, Abrahamsson B.
Mol Pharm. 2017 Mar 1. doi: 10.1021/acs.molpharmaceut.6b00824. [Epub ahead of print]
OrBiTo will organise a one day short course about “Recent progress in understanding and predicting oral absorption” at FIP Pharmaceutical Sciences World Congress in Stockholm 21 May. Registration is open to 1 april! More information can be found at the FIP PSWC 2017 webpage.
Below is a brief summary of Orbito achivements July 2015 to June 2016.
- OrBiTo has had its most productive year so far by means of submission of about 40 manuscripts to international high impact pharmaceutical journals with contribution from all work packages (accepted papers listed on www.orbitoprojects.eu).
- There has also been extensive dissemination through presentations by invited and short presentations at international scientific meetings with a dedicated OrBiTo session at the major pharmaceutics conference last year, American Association of Pharmaceutical Sciences (AAPS) annual meeting, a meeting that gathered several thousands of participants.
- There has been focused interactions with European and US regulatory bodies regarding possible future use of predictive tools and approaches developed within OrBiTo for example to reduce number of clinical bioequivalence studies. A paper has been submitted on this topic with contribution both by OrBiTo scientists and leading scientists at regulatory bodies. A series of webinar has also been started where OrBiTo results are presented for scientists at European and US regulatory authorities which has generated very positive feed-back from regulators.
- “Young OrBiTo”, consisting of PhD students and post-docs in the project, has successfully been organising webinar sharing “hot off the press” new science within OrBiTo as well as a poster session at the annual OrBiTo face to face meeting. Finally, three research awards were granted to “Young OrBiTo scientist” at the AAPS annual meeting!
- A brief survey among EFPIA partners has revealed a significant number of examples of early implementation of OrBiTo deliverables in the industrial process. For example, the standardised experimental protocols developed in WP1 and 2 have been implemented in several companies. Enhanced physiological understanding generated in WP3 has been used for refinement of internal in vitro test and in silico modelling approaches. The database generated in WP4 has been used for internal validations and as a source to enhance the learnings from experience. Finally, the output from OrBiTo has also been used to increase knowledge internally and build confidence with stakeholder regarding replacing in vivo studies with in vitro/in silico based predictive tools.
Marcus E. Brewster helped to initiate the Oral Biopharmaceutics Tools project (OrBiTo) and became a key member. Marcus served as coordinator of the work package In Vivo Methods in Oral Drug Absorption and also served on the Executive Committee Board. Marcus passed away unexpectedly 15 September 2014, which was a major loss not only for OrBiTo, but for the whole pharmaceutical sciences community.
In order to honor Marcus, the Editorial Team of the Journal of Pharmaceutical Sciences (JPharmSci®) decided to dedicate a special issue to Dr. Marcus E. Brewster. This has now been published as the September 2016 issue of JPharmSci, and its content can be found on http://www.jpharmsci.org/issue/S0022-3549(16)X0010-X ; this issue includes contributions from many OrBiTo-partners.
In addition, Marcus has been included among the "TRUE GIANTS" in the pharmaceutical sciences website http://www.jpharmsci.org/giants-of-pharmaceutical-sciences
The physiological conditions of the gastrointestinal (GI) tract can largely affect the in vivo performance of orally administered dosage forms during bioavailability and bioequivalence studies. Various parameters within the GI tract such as pH value, pressure activity, temperature, transit times as well as composition of intraluminal contents can influence the liberation and extent of absorption of drug substances.
Work package 3 within the OrBiTo consortium sets as its goal to facilitate model development by providing approaches and data to better understand the in vivo systems and systems biology impacting drug formulation behavior and drug absorption. Thus new and established in vivo tools for better in vivo prediction of the in vivo dosage form behavior can be assessed.
Even today the effects of food on the dosage form in vivo are not well understood. It is obvious that this effect of food on the dosage form can be the result of changed GI conditions. Such effects by co-ingested food can be caused by various reasons such as the delay of gastric emptying, the enhancement of solubility, the binding to food components, or the change of GI pH values and can contribute to the (unwanted) intra- and inter-individual variability of response to drug therapy.
In the present study*, temperature, pH and pressure profiles of nine healthy human volunteers were investigated after ingestion of the SmartPill® under clinical fasting conditions and compared to the same subjects who received the SmartPill® under fed conditions as recommended by the Food and Drug Administration (FDA). Since large non-digestible objects are mainly emptied during phase III of the interdigestive migrating motor complex, the gastric residence time of the SmartPill® was found to be clearly shorter under fasting conditions. Intragastric pH values during the initial 5 min were comparable with mean values of pH 4.2 under fasting and pH 4.6 under fed conditions. Interestingly, the lowest observed intragastric pH values in fasted state were about one pH unit higher than under fed conditions. Highest pressure activity was observed within the stomach, in relation to gastric emptying. In the fasted state, pressure values upon gastric emptying varied strongly between 30 mbar and 304 mbar, whereas in the fed state, values of at least 240 mbar could always be observed. The data showed highly variable gastrointestinal parameters even under clinical fasting conditions which must be considered when evaluating clinical studies and developing biorelevant in vitro test methods.
Figure: Pressure, pH and temperature profile of a subject obtained after fasted state (left) and fed state (right) ingestion of the SmartPill®. GE – gastric emptying, CA – colon arrival.
*Felix Schneider, Michael Grimm, Mirko Koziolek, Christiane Modeß, Anne Dokter, Tarek Roustom, Werner Siegmund and Werner Weitschies: Resolving the physiological conditions in bioavailability and bioequivalence studies: comparison of fasted and fed state. Submitted for publication
Predictive oral biopharmaceutics tools as provided by OrBiTo project gathers significant interest in scientific community according to latest IMI bibliometric report!!
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