Micronization and Spray Drying

At Siegfried we understand that physical properties of an Active Pharmaceutical Ingredient (API), such as particle size distribution or surface ratios, are crucial for the success of a drug formulation and its bioavailability. Therefore, we continually invest in the necessary physical operations (from crystallization to micronization) which best tailor an API’s properties to the needs of a formulation. By bridging the gap between bulk API manufacture and drug product formulation, Siegfried provides you with the physical processing capabilities you need & can expect.

We offer you more through a range of equipment and technical expertise for crystallization, drying and milling, and we further manipulate an API’s physical properties through micronisation & spray drying as follows:

Certain prevailing trends in pharmaceutical development are driving the increasing need for micronized API with particle sizes of 1–10 µm. One factor is that APIs are becoming more potent, such that a fine and narrow particle size distribution is needed to guarantee uniformity of the formulation. Secondly, increasingly APIs have lower solubility, and micronization is needed to increase the surface to volume ratio to improve bioavailability.

To meet this growing market need for micronized API Siegfried is expanding its Jet Mill capabilities. By using Design of Experiment and Quality of Design approaches we evaluate the most robust parameters for micronization to ensure reliable particle size distribution, working with our customers to achieve the desired specification.

Large scale cGMP spray drying requires both the infrastructure and operational excellence of a chemical plant and the mindset and environment of pharmaceutical manufacturing. With Siegfried’s longstanding background in drug substance and drug product manufacturing brings together the capability, experience and services your project needs. Please contact us to discuss openly how we can assist you.

• Capacity: Pilot Spray Dryer 125 m³ N₂/h; Plant Spray dryer 400 kg N₂/h
• Operating under full GMP in clean rooms (>100’000 and 10’000 particles/ft³)
• Closed loop with Nitrogen; suitable for flammable solvents; infrastructure and license to operate with HAP (hazardous air pollutant) solvents like Dichloromethane