Deliverables
D2.2: Key findings will be collected in a technical publication or commercial technical note relating new technology capabilities to the dissolution properties of co-crystals / salts / multi-component systems and in metastable solid forms (month 24)
Technical report on approaches to SDID21 Production of a technical report on optimal approaches for conducting SDI and interpreting SDI data for compounds susceptible for precipitation month 18
Dissolution testing guidelines for UV/RamanD1.2: Guideline/application note for performing flow-through dissolution testing with simultaneous UV imaging and Raman spectroscopy including step-by-step instructions for dissolution testing of two drug substances undergoing solid form conversions during dissolution, month 15.
Technical data on nucleation ratesD3.1 Technical data on nucleation rates for a range of molecules in a variety of different media (month 30).
Technical note on new capabilitiesD3.2 The key findings will form the basis of a technical note relating new technological capabilities to the precipitation rates of ionisable drugs (month 18).
Literature publications for D2.1-D2.4D2.5: At least three literature publications are anticipated for each objective listed above (O2.1-O2.3), with the first of these expected at month 12.
Literature publications for D3.1 & D3.2D3.3 At least one publication is anticipated for each objective listed above (O5.1-O5.4) at months 10, 22 and 34.
D16 Establishment of the critical operating parameters defining robustness of UV imaging and between lab variability for flowthrough dissolution data month 27
Prototype light microscopy – UV imaging assayD1.5: A prototype light microscopy - UV imaging assay will be developed for precipitation studies month 10.
Optimised UV/Raman experimentsD1.1: Optimized experimental setup for performing through dissolution testing with simultaneous UV imaging and Raman spectroscopy, month 12.
UV imaging data validationD1.7: Validation of UV imaging data by comparison to other microscale dissolution tests and data from Woods apparatus, month 33.
Screening assay for precipitation inhibitorsD2.4: A screening assay will be established for precipitation inhibitors, building on an increased knowledge on mechanisms through which precipitation/re-precipitation can be inhibited (month 30).
ATR-(FTIR) & turbidity studiesD1.4: Feasibility studies on ATR-(FTIR) and turbidity, month 34.
pH-UV imaging methodD1.3: Combined pH - UV imaging method tuned for physiological/ gastrointestinal pH range (pH 1.2, 5.4, 6.8 and 7.4) month 22.
Publications
Author(s):
Yu Sun, Alex Chapman, Susan W. Larsen, Henrik Jensen, Nickolaj J. Petersen, David M. Goodall, Jesper Østergaard
Published in:
Analytical Chemistry, Issue 90/11, 2018, Page(s) 6413-6418, ISSN 0003-2700
Publisher:
American Chemical Society
DOI:
10.1021/acs.analchem.8b00587
Author(s):
Jesper Østergaard
Published in:
Journal of Pharmaceutical and Biomedical Analysis, Issue 147, 2018, Page(s) 140-148, ISSN 0731-7085
Publisher:
Elsevier BV
DOI:
10.1016/j.jpba.2017.07.055
Author(s):
Maria Doreth, Korbinian Löbmann, Petra Priemel, Holger Grohganz, Robert Taylor, René Holm, Heidi Lopez de Diego, Thomas Rades
Published in:
European Journal of Pharmaceutics and Biopharmaceutics, Issue 122, 2018, Page(s) 62-69, ISSN 0939-6411
Publisher:
Elsevier BV
DOI:
10.1016/j.ejpb.2017.10.001
Author(s):
Peter Madelung, Poul Bertelsen, Jette Jacobsen, Anette Müllertz, Jesper Østergaard
Published in:
Journal of Drug Delivery Science and Technology, Issue 39, 2017, Page(s) 516-522, ISSN 1773-2247
Publisher:
Editions de Sante
DOI:
10.1016/j.jddst.2017.05.010
Author(s):
Yu Sun, Jesper Østergaard
Published in:
Pharmaceutical Research, Issue 34/5, 2017, Page(s) 929-940, ISSN 0724-8741
Publisher:
Kluwer Academic/Plenum Publishers
DOI:
10.1007/s11095-016-2047-5
Author(s):
Sabrine S. Jensen, Henrik Jensen, David M. Goodall, Jesper Østergaard
Published in:
Journal of Pharmaceutical and Biomedical Analysis, Issue 131, 2016, Page(s) 113-123, ISSN 0731-7085
Publisher:
Elsevier BV
DOI:
10.1016/j.jpba.2016.08.018
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