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

Deliverables

Technical report on new capabilities

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

D2.1: 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

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

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

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

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

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

D1.6: Establishment of the critical operating parameters defining robustness of UV imaging and between lab variability for flow-through dissolution data, month 27.

Prototype light microscopy – UV imaging assay

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

Optimised UV/Raman experiments

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

UV imaging data validation

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

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

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

pH-UV imaging method

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.

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Publications

UV–vis Imaging of Piroxicam Supersaturation, Precipitation, and Dissolution in a Flow-Through Setup

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
DOI: 10.1021/acs.analchem.8b00587

UV imaging in pharmaceutical analysis

Author(s): Jesper Østergaard
Published in: Journal of Pharmaceutical and Biomedical Analysis, Issue 147, 2018, Page(s) 140-148, ISSN 0731-7085
DOI: 10.1016/j.jpba.2017.07.055

Influence of PVP molecular weight on the microwave assisted in situ amorphization of indomethacin

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
DOI: 10.1016/j.ejpb.2017.10.001

Dissolution enhancement of griseofulvin from griseofulvin-sodium dodecyl sulfate discs investigated by UV imaging

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
DOI: 10.1016/j.jddst.2017.05.010

Application of UV Imaging in Formulation Development

Author(s): Yu Sun, Jesper Østergaard
Published in: Pharmaceutical Research, Issue 34/5, 2017, Page(s) 929-940, ISSN 0724-8741
DOI: 10.1007/s11095-016-2047-5

Performance characteristics of UV imaging instrumentation for diffusion, dissolution and release testing studies

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
DOI: 10.1016/j.jpba.2016.08.018