PARTICLE-PRO
Development of a hybrid process analytical technology to characterise the physical and chemical properties of particles
| Coordinatore | INNOPHARMA LABS LIMITED
Organization address
address: ASHFIELD CRONE LOWER contact info |
| Nazionalità Coordinatore | Ireland [IE] |
| Totale costo | 1˙493˙489 € |
| EC contributo | 1˙149˙786 € |
| Programma | FP7-SME
Specific Programme "Capacities": Research for the benefit of SMEs |
| Code Call | FP7-SME-2012 |
| Funding Scheme | BSG-SME |
| Anno di inizio | 2012 |
| Periodo (anno-mese-giorno) | 2012-12-01 - 2014-11-30 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
INNOPHARMA LABS LIMITED
Organization address
address: ASHFIELD CRONE LOWER contact info |
IE (REDCROSS) | coordinator | 636˙544.71 |
| 2 |
RIKOLA LTD OY
Organization address
address: KAITOVAYLA 1 contact info |
FI (OULU) | participant | 168˙582.00 |
| 3 |
SIGMOID PHARMA LIMITED
Organization address
address: THE INVENT CENTRE, DUBLIN CITY UNIVERSITY contact info |
IE (DUBLIN) | participant | 120˙827.00 |
| 4 |
MANUFACTURAS SERVIPLAST SA
Organization address
address: CL COBALTO 13 contact info |
ES (Hospitalet Llobregat) | participant | 108˙917.00 |
| 5 |
TAKEDA IRELAND LIMITED
Organization address
address: BRAY BUSINESS PARK KILRUDDERY contact info |
IE (BRAY) | participant | 57˙930.00 |
| 6 |
EXENS DEVELOPMENT OY
Organization address
address: KAUPPAKATU 36 contact info |
FI (KAJAANI) | participant | 25˙965.29 |
| 7 |
INNOVACIO I RECERCA INDUSTRIAL I SOSTENIBLE SL
Organization address
address: AVENIDA DEL CANAL OLIMPIC 15 PARC MEDITERRANI DE LA TECNOLOGIA EDIFICIO C4 BLOQUE ANEXO PLANTA BAJA contact info |
ES (Castelldefels) | participant | 12˙800.00 |
| 8 |
DUBLIN INSTITUTE OF TECHNOLOGY
Organization address
address: RATHMINES ROAD LOWER 143-149 contact info |
IE (DUBLIN) | participant | 11˙200.00 |
| 9 |
Teknologian tutkimuskeskus VTT Oy
Organization address
address: Vuorimiehentie 3 contact info |
FI (Espoo) | participant | 7˙020.00 |
| 10 |
TEKNOLOGIAN TUTKIMUSKESKUS VTT
Organization address
address: TEKNIIKANTIE 4 A contact info |
FI (ESPOO) | participant | 0.00 |
Mappa
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Obiettivo del progetto (Objective)
Particles and granules play a key role in process efficacy and final product quality for numerous industries including pharmaceuticals, food, nutritionals and cosmetics. Particle physics governs process variables such as flow, blending, granulation, compression and coating. These variables can have a significant effect on final product behaviour such as blend homogeneity, drug absorption rates, product robustness, etc. The identified key physical parameters include particle/granule size and shape. Similarly the chemistry variation within the products has a critical effect on product quality. The current method of determining the end-point of pharmaceutical processes such as granulation is a combination of off-line or in-line analysis of size and shape characteristics and of moisture content and end product analysis of active content uniformity. The size and shape characteristics are important as they can significantly impact on compression processes. The moisture content is important as it can impact on compression processes and product stability (negatively leading to hydration of the active ingredient). The active content uniformity is important to ensure that each patient receives the correct dosage quantity. The development of one hybrid technology that is capable of assessing these three characteristics in real time will significantly advance pharmaceutical manufacturing control and assure greater product control and patient safety.
This project aims to develop a technology that is a hybrid of imaging-based physical characterization and NIR-Chemical Imaging technologies that will provide physical and chemical granule characterisation in-line in a manufacturing process. The benefits for the pharmaceutical sector are increased granulation process control, increased process quality, increased batch yields, reduced downtime, reduced investigations due to deviation investigations, reduced risk of non-supply of products, greater assurance for regulatory bodies.
Introduzione (Teaser)
Seventy percent of pharmaceuticals are taken in tablet or capsule form. EU-funded research is delivering currently lacking in-line quality control technology that will reduce rejects and enhance quality and safety for patients.