Jet milling industrialization of sticky API using QbD

July 10, 2019

FPS has recently cooperated with pharmaceutical industry experts to research best jet mill practices for pharmaceutical. 

FPS strongly believes in knowledge sharing and continuous improvement. For this reason, FPS President, Eng. Gianola, and Vice President, Mr Corsini, both experts in milling and micronization technologies, worked with M. Nakach Ph.D on a research published in the Pharmaceutical Development and Technology Magazine. Mr. Nakach works at Sanofi. He is the Head of formulation and process development for the Biologic Drug Product Development Department.

As you may know JetMills are particularly useful in pharmaceutical when micronization is used to boost drug activity by increasing particle surface or by allowing active substances to reach their target by reducing the particle size. By increasing the specific surface area (in terms of m2/g) the dissolution rate is also 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-practice approach. As a result, a commercial manufacturing process of sticky APIs and their industrialization has been documented. 

Particular attention has been paid to the cleanability of the system which must be suitable for the process of multiple products while avoiding cross-contamination when batch changes are necessary. 

The studies areconducted for sticky Active Pharmaceutical Ingredients on the complete productionprocess that was developed following two industrial Key Performance Indicators (KPIs): high process yield and compliance with Environmental Hygiene and Safety regulations(EHS) . 

Finally, an industrial installationwas proposed to deliver the product with high productivity yield, compliant with safety regulation and clean in place. 

Please note that FPS cooperation with Mr M.Nakach Ph.D is continuing and FPS is proud to announce the next session of the Micronization Workshop Series focused on this project. 

This one-day workshop will be held on 15th October at FPS Production Plant (Fiorenzuola d’Arda (PC) Italy). The three authors of the study will be present and available for discussion. 

Please contact us to receive the full article.