Pharmaceutical excipients properties and screw feeder performance in continuous processing lines: a Quality by Design (QbD) approach
09 Jun 2023 | Contributor(s):: Santos, Bianca, Carmo, Flavia, Schlindwein, Walkiria, Muirhead, Gordon, Rodrigues, Carlos, Cabral, Lucio, Westrup, Julian, Pitt, Kendal
Screw feeder performance is a critical aspect in continuous manufacturing processes. Pharmaceutical excipients, such as mannitol, microcrystalline cellulose, lactose monohydrate, and anhydrous dibasic calcium phosphate can present problems in ensuring a continuous stable feed rate due to their...
A PAT-based qualification of pharmaceutical excipients produced by batch or continuous processing
09 Jun 2023 | Contributor(s):: Hertrampf A., Müller H., Menezes J.C., Herdling T.
Pharmaceutical excipients have an influence on the main requirements for medicinal products (viz., quality, safety and efficacy) but also on their manufacturability. During product lifecycle it may become necessary to introduce minor changes (e.g., to continuously improve it) or major changes in...