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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"

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)

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TEKNOLOGIAN TUTKIMUSKESKUS VTT

Finland

RITA INVEST OY

Finland

LABIANA PHARMACEUTICALS SL

Spain

EU Contribution

€ 48 199,50

TOPCHEM PHARMACEUTICALS LIMITED

Ireland

EU Contribution

€ 190 225

NUTRARESEARCH 2011 SL

Spain

EU Contribution

€ 172 545

Teknologian tutkimuskeskus VTT Oy

Finland

EU Contribution

€ 7 020

INSTITIUID TEICNEOLAIOCHTA BHAILE ATHA CLIATH

Ireland

EU Contribution

€ 11 200

IRIS TECHNOLOGY SOLUTIONS, SOCIEDAD LIMITADA

Spain

EU Contribution

€ 12 800

J & M ANALYTIK AG

Germany

EU Contribution

€ 189 045

Project information

Grant agreement ID: 605814

Status

Closed project

  • Start date

    1 January 2014

  • End date

    31 December 2015

Funded under:

FP7-SME

  • Overall budget:

    € 1 513 201,20

  • EU contribution

    € 1 152 987

Coordinated by:

INNOPHARMA LABS LIMITED

Ireland