PARTICLE-PRO

Development of a hybrid process analytical technology to characterise the physical and chemical properties of particles

Coordinatore	INNOPHARMA LABS LIMITED    more  Organization address address: ASHFIELD CRONE LOWER city: REDCROSS contact info Titolo: Mr. Nome: Ian Cognome: Jones Email: send email Telefono: 35314853346
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

#	participant	country	role	EC contrib. [€]
1	INNOPHARMA LABS LIMITED  Organization address address: ASHFIELD CRONE LOWER city: REDCROSS contact info Titolo: Mr. Nome: Ian Cognome: Jones Email: send email Telefono: 35314853346	IE (REDCROSS)	coordinator	636˙544.71
2	RIKOLA LTD OY  Organization address address: KAITOVAYLA 1 city: OULU postcode: 90570 contact info Titolo: Mr. Nome: Raimo Cognome: Rikola Email: send email Telefono: +358 40 540 8794	FI (OULU)	participant	168˙582.00
3	SIGMOID PHARMA LIMITED  Organization address address: THE INVENT CENTRE, DUBLIN CITY UNIVERSITY city: DUBLIN postcode: 9 contact info Titolo: Mr. Nome: Tien Cognome: Nghiem Email: send email Telefono: +3531700 7511	IE (DUBLIN)	participant	120˙827.00
4	MANUFACTURAS SERVIPLAST SA  Organization address address: CL COBALTO 13 city: Hospitalet Llobregat postcode: 8907 contact info Titolo: Mr. Nome: Enrique Cognome: Romero Email: send email Telefono: 34933377248	ES (Hospitalet Llobregat)	participant	108˙917.00
5	TAKEDA IRELAND LIMITED  Organization address address: BRAY BUSINESS PARK KILRUDDERY city: BRAY contact info Titolo: Mr. Nome: Brendan Cognome: Donohue Email: send email Telefono: 35312050600	IE (BRAY)	participant	57˙930.00
6	EXENS DEVELOPMENT OY  Organization address address: KAUPPAKATU 36 city: KAJAANI postcode: 87100 contact info Titolo: Mr. Nome: Eero Cognome: Hagrén Email: send email Telefono: +358 8 632040	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 city: Castelldefels postcode: 8860 contact info Titolo: Mr. Nome: Colm Cognome: Digby Email: send email Telefono: 34935542500	ES (Castelldefels)	participant	12˙800.00
8	DUBLIN INSTITUTE OF TECHNOLOGY  Organization address address: RATHMINES ROAD LOWER 143-149 city: DUBLIN postcode: 6 contact info Titolo: Dr. Nome: Pj Cognome: Cullen Email: send email Telefono: 35314027595	IE (DUBLIN)	participant	11˙200.00
9	Teknologian tutkimuskeskus VTT Oy  Organization address address: Vuorimiehentie 3 city: Espoo postcode: 2150 contact info Titolo: Mr. Nome: Janne Cognome: Suhonen Email: send email Telefono: 358207000000	FI (Espoo)	participant	7˙020.00
10	TEKNOLOGIAN TUTKIMUSKESKUS VTT  Organization address address: TEKNIIKANTIE 4 A city: ESPOO postcode: 02044 VTT contact info Titolo: Mr. Nome: Janne Cognome: Suhonen Email: send email Telefono: 358207000000	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.