Active Pharmaceutical Ingredients

Pharmaceutical drugs are made up of two main ingredients: APIs and excipients. An Active Pharmaceutical Ingredient (API) is the primary, active components of a tablet or capsule that produces the effects of the drug. Excipients are the inactive components of the drug. 

Particle size and the particle size distribution are crucial characteristics of APIs. The particle size of an API is usually less than 10 microns.  Most APIs are very cohesive and have bad flowing properties, which have an impact on the manufacturing process.

When processing APIs, Hosokawa offers several types of size reduction mills to choose from. For finer products, the Alpine AFG Fluidized Bed Jet Mill and the Alpine AS Spiral Jet Mill have the ability to grind particles down to a particle top size of less than 5 microns.  

The Alpine AFG Fluidized Bed Jet Mill  uses compressed gas that travels through a set of nozzles at extremely high velocities. Particles are drawn into the gas streams and are ground via inter-particle collisions in the jet stream.

The Alpine AS Spiral Jet Mill  is designed for the micronization of pharmaceuticals and certain chemical powders. Material is injected into the grinding zone by gas nozzles. Material flows around the perimeter of the mill wall in a spiral manner resulting in particle-to particle attrition and impact against the mill walls. As the material gets finer and lighter the ground particles are drawn towards the outlet at the center of the milling chamber.

For coarser products, Hosokawa produces the Mikro® UMP Pin Mill or the Mikro ACM® Air Classifying Mill.  The Mikro® UMP Pin Mill  was designed to meet the requirements of the Pharmaceutical Industry for both product performance and cleanability.

The Mikro ACM® Air Classifying Mill  is significant in that it was the first milling system to incorporate an internal classifier, which is what allows it to have a particle size distribution of D98 < 20 microns.

When it comes to mixing APIs, both low-shear and high-shear mixers can be used. For high-shear mixing, the Cyclomix  is recommended for its high speed, intensive paddle mixer, specially designed for cohesive powders with a high level of homogeneity in the end product.

For low-shear mixing, the Nauta® Conical Screw Mixer  is recommended for its low-intensity mixing suited to delicate products and processes where very gentle mixing of large volumes of up to 100,000 liters.

Hosokawa Micron Powder systems prides itself in understanding and meeting the needs and requirements of the pharmaceutical industry. Should you have any questions or would like to speak with a sales engineer, please do not hesitate to contact us.