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A process analytical technology for characterising the physical properties of crystals

Objective

"An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that has the pharmacological activity. The crystallisation process is a critical step in the API manufacturing process and for delivering “product” in its final form, with some 70 % of products going through a crystallization step at some point in their manufacture. The size and shape of the crystals are important to the quality and safety of the product, and variation during crystal growth can have a significant effect on final product behaviour such as blend homogeneity, drug absorption rates, product robustness, etc. Controlling the final shape and size of crystal is a major challenge to manufacturers, particularly as it is often difficult to measure on line and the crystallisation process is often nonlinear in behaviour. Moreover, API molecules are becoming increasingly complex, tending to reduce aqueous solubility, in turn reducing bioavailability and often leading to difficulties in crystallisation.
The ability to understand the crystallisation process would be a breakthrough for API manufacturers and would allow for control of the crystal phase, in terms of purity, particle size and shape, for high quality, safe products. Moreover, the crystal structure during crystal growth is a direct indicator of process end point and if more closely tracked could lead to leaner process development and process monitoring. Moreover, an understanding of crystallisation is fundamental for reducing the incidences of failure in the development of new molecular entities.
A group of industrial SMEs have come together to outsource the development of a revolutionary imaging-based physical characterisation device that will provide the API industry with real-time information of all crystal physical characteristics in-line in a crystallisation process, thereby allowing this critical of processes for the behaviour of the end-product to be controlled"

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /engineering and technology/materials engineering/crystals

Call for proposal

FP7-SME-2013
See other projects for this call

Funding Scheme

BSG-SME - Research for SMEs

Coordinator

INNOPHARMA LABS LIMITED
Address
Ashfield Crone Lower
Y14 Redcross
Ireland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 521 952,50
Administrative Contact
Luke Kiernan (Mr.)

Participants (9)

TEKNOLOGIAN TUTKIMUSKESKUS VTT

Participation ended

Finland
Address
Tekniikantie 4 A
02044 VTT Espoo
Activity type
Research Organisations
Administrative Contact
Kinga Koski (Ms.)
RITA INVEST OY

Participation ended

Finland
Address
Kaitovayla 1
90570 Oulu
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Raimo Rikola (Mr.)
LABIANA PHARMACEUTICALS SL
Spain
EU contribution
€ 48 199,50
Address
Calle Casanova 27 31
08757 Corbera De Llobregat
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marta Prior Ortega (Ms.)
TOPCHEM PHARMACEUTICALS LIMITED
Ireland
EU contribution
€ 190 225
Address
Ballymote Business Park - Carrownanty
Ballymote Sligo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Donal Coveney (Dr.)
NUTRARESEARCH 2011 SL
Spain
EU contribution
€ 172 545
Address
C/feixa Llarga 105
08907 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ana Gavilan Martin (Ms.)
TEKNOLOGIAN TUTKIMUSKESKUS VTT OY
Finland
EU contribution
€ 7 020
Address
Tekniikantie 21
02150 Espoo
Activity type
Research Organisations
Administrative Contact
Kinga Koski (Ms.)
INSTITIUID TEICNEOLAIOCHTA BHAILE ATHA CLIATH
Ireland
EU contribution
€ 11 200
Address
Grangegorman Lower
D07 H6K8 Dublin
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Pj Cullen (Dr.)
IRIS TECHNOLOGY SOLUTIONS, SOCIEDAD LIMITADA
Spain
EU contribution
€ 12 800
Address
Calle Velazquez, No 94 Primera Planta
28006 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Pradera Carlos (Mr.)
J & M ANALYTIK AG
Germany
EU contribution
€ 189 045
Address
Willy Messerschmitt Strasse 8
73457 Essingen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Harald Nitsche