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CRYDIS

Driving innovation in pharmaceuticals: integrated studies of physical dissolution properties of crystalline and amorphous forms using enhanced orthogonal monitoring techniques

Total Cost €

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EC-Contrib. €

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Partnership

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Project "CRYDIS" data sheet

The following table provides information about the project.

Coordinator
KOBENHAVNS UNIVERSITET 

Organization address
address: NORREGADE 10
city: KOBENHAVN
postcode: 1165
website: www.ku.dk

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Denmark [DK]
 Project website https://pharmacy.ku.dk/research/pharmaceutical-physical-analytical-chemistry/crydis/
 Total cost 216˙000 €
 EC max contribution 216˙000 € (100%)
 Programme 1. H2020-EU.1.3.3. (Stimulating innovation by means of cross-fertilisation of knowledge)
 Code Call H2020-MSCA-RISE-2014
 Funding Scheme MSCA-RISE
 Starting year 2015
 Duration (year-month-day) from 2015-01-01   to  2018-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    KOBENHAVNS UNIVERSITET DK (KOBENHAVN) coordinator 130˙500.00
2    UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK IE (Cork) participant 31˙500.00
3    PFIZER LIMITED UK (SANDWICH) participant 27˙000.00
4    PARAYTEC LIMITED UK (YORK) participant 18˙000.00
5    PION INC.(UK) LTD UK (FOREST ROW) participant 9˙000.00

Map

 Project objective

The CRYDIS exchange programme will establish and support international and inter-sectoral transfer of knowledge and expertise in pharmaceutical and instrument science between several EU research institutes and industrial companies. It will also enhance understanding of the value of inter-sectoral exchange mechanisms for taking research to market. CRYDIS undertakes innovative, collaborative research on the clinically-important topic of dissolution of drug substance particles in bio-relevant media and the undesired subsequent nucleation and re-precipitation of the drug prior to its absorption. Using innovative advances in UV imaging technology, CRYDIS investigates the utility of novel dissolution assays as key tools to obtain fundamental data on the mechanism and kinetics of undesired nucleation and re-precipitation during or following dissolution, a significant problem for the pharmaceutical industry which struggles to obtain sufficient exposure to poorly soluble drug substances to ensure an effective dose is absorbed by the patient. The key technologies in this proposal offer a step change in capability and functionality, offering the potential to undertake more detailed studies of the dissolution/re-precipitation processes relevant to pharmaceutical materials. Access to this key technology and the further development of its capability offers the potential for breakthroughs in development of process understanding and of robust and widely applicable protocols. Additional value is brought to CRYDIS through close working with synergistic European networks, leveraging a greater knowledge input and impact outreach. Running parallel with the science programme, an innovation management work-package analyses effectiveness of the exchange mechanism in building a shared culture, transferring knowledge and developing understanding of processes that drive a product to market. The outcomes of this will be used to advise and drive potential future exchange activities.

 Deliverables

List of deliverables.
Technical note on new capabilities Documents, reports 2019-10-28 17:20:03
Literature publications for D2.1-D2.4 Documents, reports 2019-10-28 17:20:03
Operating parameters for imaging & variability Demonstrators, pilots, prototypes 2019-10-28 17:20:03
Technical data on nucleation rates Documents, reports 2019-10-28 17:20:03
Screening assay for precipitation inhibitors Demonstrators, pilots, prototypes 2019-10-28 17:20:03
Dissolution testing guidelines for UV/Raman Documents, reports 2019-10-28 17:20:03
Literature publications for D3.1 & D3.2 Documents, reports 2019-10-28 17:20:03
ATR-(FTIR) & turbidity studies Demonstrators, pilots, prototypes 2019-10-28 17:20:02
pH-UV imaging method Demonstrators, pilots, prototypes 2019-10-28 17:20:02
UV imaging data validation Demonstrators, pilots, prototypes 2019-10-28 17:20:02
Technical report on approaches to SDI Documents, reports 2019-10-28 17:20:02
Optimised UV/Raman experiments Demonstrators, pilots, prototypes 2019-10-28 17:20:02
Prototype light microscopy – UV imaging assay Demonstrators, pilots, prototypes 2019-10-28 17:20:02
Technical report on new capabilities Documents, reports 2019-10-28 17:20:02

Take a look to the deliverables list in detail:  detailed list of CRYDIS deliverables.

 Publications

year authors and title journal last update
List of publications.
2017 Peter Madelung, Poul Bertelsen, Jette Jacobsen, Anette Müllertz, Jesper Østergaard
Dissolution enhancement of griseofulvin from griseofulvin-sodium dodecyl sulfate discs investigated by UV imaging
published pages: 516-522, ISSN: 1773-2247, DOI: 10.1016/j.jddst.2017.05.010
Journal of Drug Delivery Science and Technology 39 2019-10-28
2018 Maria Doreth, Korbinian Löbmann, Petra Priemel, Holger Grohganz, Robert Taylor, René Holm, Heidi Lopez de Diego, Thomas Rades
Influence of PVP molecular weight on the microwave assisted in situ amorphization of indomethacin
published pages: 62-69, ISSN: 0939-6411, DOI: 10.1016/j.ejpb.2017.10.001
European Journal of Pharmaceutics and Biopharmaceutics 122 2019-10-28
2018 Jesper Østergaard
UV imaging in pharmaceutical analysis
published pages: 140-148, ISSN: 0731-7085, DOI: 10.1016/j.jpba.2017.07.055
Journal of Pharmaceutical and Biomedical Analysis 147 2019-10-28
2016 Sabrine S. Jensen, Henrik Jensen, David M. Goodall, Jesper Østergaard
Performance characteristics of UV imaging instrumentation for diffusion, dissolution and release testing studies
published pages: 113-123, ISSN: 0731-7085, DOI: 10.1016/j.jpba.2016.08.018
Journal of Pharmaceutical and Biomedical Analysis 131 2019-10-28
2017 Yu Sun, Jesper Østergaard
Application of UV Imaging in Formulation Development
published pages: 929-940, ISSN: 0724-8741, DOI: 10.1007/s11095-016-2047-5
Pharmaceutical Research 34/5 2019-10-28

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