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

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Technical report on new capabilities (opens in new window)

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 SDI (opens in new window)

D21 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/Raman (opens in new window)

D1.2: 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 rates (opens in new window)

D3.1 Technical data on nucleation rates for a range of molecules in a variety of different media (month 30).

Technical note on new capabilities (opens in new window)

D3.2 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-D2.4 (opens in new window)

D2.5: 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 & D3.2 (opens in new window)

D3.3 At least one publication is anticipated for each objective listed above (O5.1-O5.4) at months 10, 22 and 34.

Operating parameters for imaging & variability (opens in new window)

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 assay (opens in new window)

D1.5: A prototype light microscopy - UV imaging assay will be developed for precipitation studies month 10.

Optimised UV/Raman experiments (opens in new window)

D1.1: Optimized experimental setup for performing through dissolution testing with simultaneous UV imaging and Raman spectroscopy, month 12.

UV imaging data validation (opens in new window)

D1.7: Validation of UV imaging data by comparison to other microscale dissolution tests and data from Woods apparatus, month 33.

Screening assay for precipitation inhibitors (opens in new window)

D2.4: 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 studies (opens in new window)

D1.4: Feasibility studies on ATR-(FTIR) and turbidity, month 34.

pH-UV imaging method (opens in new window)

D1.3: Combined pH - UV imaging method tuned for physiological/ gastrointestinal pH range (pH 1.2, 5.4, 6.8 and 7.4) month 22.

Publications

UV–vis Imaging of Piroxicam Supersaturation, Precipitation, and Dissolution in a Flow-Through Setup (opens in new window)

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

UV imaging in pharmaceutical analysis (opens in new window)

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

Influence of PVP molecular weight on the microwave assisted in situ amorphization of indomethacin (opens in new window)

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

Dissolution enhancement of griseofulvin from griseofulvin-sodium dodecyl sulfate discs investigated by UV imaging (opens in new window)

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

Application of UV Imaging in Formulation Development (opens in new window)

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

Performance characteristics of UV imaging instrumentation for diffusion, dissolution and release testing studies (opens in new window)

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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