Jet milling industrialization of sticky active pharmaceutical ingredient using quality-by-design approach

24 Jul 2019

FPS has recently cooperated with pharmaceutical industry experts in a research on jet mills' practices in pharmaceutical industries.

FPS sincerely believes on sharing and constant improvement, at all levels. For this reason, the President, Eng. Gianola, and the Vice President, Mr Corsini, both experts in milling and micronization technologies, worked together with M.Nakach Ph.D (Head of formulation and process development - Biologic Drug Product Development of Sanofi). in a research published in the Pharmaceutical Development and Technology Magazine.

Jet milling industrialization of sticky active pharmaceutical ingredient using quality-by-design approach
Jet milling industrialization

JetMills are particularly useful in the pharmaceutical industry where micronization 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 article is 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 industrialization has been described.

Particular attention has been 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 are 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 high productivity yield, compliant with safety regulation and cleanable in place.

The cooperation with Mr M.Nakach Ph.D isn't ended. In fact, FPS is proud to announce the next edition of a Micronization Workshop focused on this project.

It will be held on 15th October in FPS Production Plant (Fiorenzuola d'Arda (PC) Italy) and all the authors will be present and available to discuss about it.

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