About us | Advertise with us | Contact us
Posted: 19 July 2019 | FPS Food and Pharma Systems | No comments yet
FPS has recently cooperated with pharmaceutical industry experts in research on jet mills’ practices in pharmaceutical industries.
FPS sincerely believes in sharing and constant improvement, at all levels. For this reason, FPS’ President, Eng. Gianola, and the Vice President, Mr Corsini (both experts in milling and micronisation technologies) have worked together with M Nakach PhD (Head of Formulation and Process Development, Biologic Drug Product Development of Sanofi) in a new study.
Jet mills are particularly useful in the pharmaceutical industry where micronisation is used to raise drug activity by increasing particle specific surface or by allowing active substances to reach their site of action by reducing particle size. By increasing the specific surface area (in terms of m2/g) the dissolution rate is improved.
The purpose of the research article was to define a scale-up methodology for sticky Active Pharmaceutical Ingredients (APIs) using Quality by Design (QbD) and a scientific best practices approach. Therefore, a commercial manufacturing process of sticky APIs and its industrialisation has been described.
Particular attention was paid to the cleanability of the system which must be suitable for processing multiple products, avoiding cross-contamination when batch changes are required.
The studies were conducted for sticky Active Pharmaceutical Ingredients on the complete production process that was developed following two industrial Key Performance Indicators (KPIs): high process yield and compliance with Environmental Hygiene and Safety (EHS) regulations.
Finally, an industrial installation was proposed to deliver the product with a high productivity yield, compliant with safety regulation and cleanable in place.
The cooperation with Mr Nakach hasn’t ended, however. In fact, FPS is proud to announce the next edition of a Micronisation Workshop focused on this project, which will be held on 15 October in FPS’ Production Plant (Fiorenzuola d’Arda (PC) Italy), where all the authors will be present and available to discuss the research.
The research was published in the Pharmaceutical Development And Technology Magazine.
Research & Development (R&D)
FPS Food and Pharma Systems
Eng. Gianola, M Nakach PhD, Mr Corsini
By FPS Food and Pharma Systems
Research & Development (R&D)
FPS Food and Pharma Systems
Eng. Gianola, M Nakach PhD, Mr Corsini
All subscriptions include online membership, giving you access to the journal and exclusive content.
By Hannah Balfour (European Pharmaceutical Review)
By Anna Begley (European Pharmaceutical Review)
Your email address will not be published. Required fields are marked *
This site uses Akismet to reduce spam. Learn how your comment data is processed.
Write for us | Advertise with us
European Pharmaceutical Review is published by: Russell Publishing Ltd. Court Lodge Hogtrough Hill Brasted, Kent, TN16 1NU United Kingdom
© Russell Publishing Limited, 2010-2022. All rights reserved.
Website development by e-Motive Media Limited.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
CookieDescriptioncookielawinfo-checkbox-advertising-targetingThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".cookielawinfo-checkbox-analyticsThis cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".cookielawinfo-checkbox-necessaryThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".cookielawinfo-checkbox-performanceThis cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".PHPSESSIDThis cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.viewed_cookie_policyThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.zmember_loggedThis session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.