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Inline/Instant Measurement for PhArma eXtrusion

Deliverables

Project website creation

The project website will be created in order to provide information and access to papers and any other non-confidential documentation related to the IMPAX project. The website will be operational early in the project and will be designed to be the main information repository of the project, indicating its objectives, the technology and all the activities related to its commercialization (including contacts and business developments/progress). The website will be user-friendly and have an easy access, in order to facilitate the communication with the public.

Target of 10 events

Within its dissemination strategy, ColVisTec will proactively promote and publish project results in order to build up a widely recognised and scientific-proven image of the process control and consequently generate end users trust and loyalty in the innovation. ColVisTec will pursue this aim first by organizing workshops addressed to a selected number of relevant stakeholders. Second, it will actively and jointly participate in public conferences, industry seminars, international and national events organised by relevant institutions and R&D centres related to the Pharma sector which will give exposure to key relevant players. Backed by established experience in dealing with polymer and plastic manufactures, ColVisTec holds track record in participating at seminars and industry workshops

Dissemination materials

A set of promotion and dissemination material will be created and used during the project's life cycle: a) Logo, flyer, brochure, folder and poster; b) videos; c) newsletter; d) stakeholders list; e) mass media; f) international dissemination events.

Techno-commercial Pharma case studies

During the performance verification testing in pharma industrial environments, some companies will already access direct experience in implementing ColVisTec's multi-spectra platform in their manufacturing process. These Pharma end users’ validations will be properly documented and presented under the suitable format of Techno-commercial Pharma Case Studies. Confidential information contained in the reports will be kept protected and private for disclosing these case studies to a wider public and enabling their potential support as reliable proofs in the commercialization phase.

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Publications

Investigations Concerning the Residence Time Distribution of Twin-Screw-Extrusion Processes as Indicator for Inherent Mixing

Author(s): Wesholowski J, Berghaus A, Thommes M.
Published in: Pharmaceutics, Issue Oct 26;10(4), 2018, Page(s) Issue 207, ISSN 1999-4923
DOI: 10.3390/pharmaceutics10040207

Scale-Up and In-line Monitoring During Continuous Melt Extrusion of an Amorphous Solid Dispersion

Author(s): Abbe Haser, Brian Haight, Andreas Berghaus, Augie Machado, Charlie Martin, Feng Zhang
Published in: AAPS PharmSciTech, Issue 19/7, 2018, Page(s) 2818-2827, ISSN 1530-9932
DOI: 10.1208/s12249-018-1162-5

In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)

Author(s): Walkiria Schlindwein, Mariana Bezerra, Juan Almeida, Andreas Berghaus, Martin Owen, Gordon Muirhead
Published in: Pharmaceutics, Issue 10/4, 2018, Page(s) 166, ISSN 1999-4923
DOI: 10.3390/pharmaceutics10040166

Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion

Author(s): Jens Wesholowski, Andreas Berghaus, Markus Thommes
Published in: Pharmaceutics, Issue 10/2, 2018, Page(s) 49, ISSN 1999-4923
DOI: 10.3390/pharmaceutics10020049

Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion

Author(s): Wesholowski J, Berghaus A, Prill S, Thommes M.
Published in: Drug Delivery and Translational Research, Issue January 2018; Volume 8, 2018, Page(s) 1595–1603, ISSN 2190-3948

Development and Validation of an in-line API Quantification Method using AQbD Principles based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

Author(s): Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman, Walkiria Schlindwein
Published in: Pharmaceutics, Issue In Press, 2019, Page(s) In Press

Analytical Method Validation of in-line UV-Vis Spectroscopy for Hot Melt Extrusion Process

Author(s): Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman and Walkiria Schlindwein
Published in: 7th QbD Symposium, De Montfort University, Issue 7th March, 2019, 2019