Excipients are crucial to drug delivery within the body. Generally speaking, an excipient is the inactive part of a tablet or capsule that works alongside the Active Pharmaceutical Ingredient (API) to help maintain the integrity and assist in the delivery/absorption of the drug.
The particle size of an excipient can affect product performance, process-ability, stability and appearance of the end product. The link between particle size and product performance is well documented with regards to dissolution, absorption rates and content uniformity.
For processing excipients, Hosokawa offers several types of size reduction mills, classifiers, mixers and dryers to choose from. Depending upon the type of excipient being used, Hosokawa can offer multiple different solutions.
When it comes to size reduction for an excipient, Hosokawa offers the Mikro® UMP Universal Mill, Mikro® Pulverizer Hammer & Screen Mill, the Alpine AFG® Fluidized Bed Opposed Jet Mill, and the Alpine AS Spiral Jet Mill.
The Mikro® UMP Mill is a universal mill capable of using many different motor assemblies for coarse to medium sized particle size distribution (PSD). The design of this mill meets the requirements of the Pharmaceutical Industry for both product performance and cleanability. With a variety of feeding options and system configurations, this high speed impact mill is capable of fine size reduction to a D97 < 35 µm.
The Mikro Pulverizer® Hammer & Screen Mill is a high speed mechanical impact mill designed for continuous size reduction of a wide range of materials down to D90 < 45 µm. The Mikro Pulverizer® comes in many model sizes from small pilot scale to massive production models.
The Alpine AFG Fluidized Bed Opposed Jet Mill is used for ultra-fine particle size reduction of many materials to a D97 <3 µm. Compressed gas is accelerated through a radial nozzle arrangement at high velocities. Particles are drawn into the gas streams and are ground via inter-particle collisions. In order to alter product fineness, the AFG is equipped with a dynamic deflector-wheel classifier that can be operated at varying speeds. Due to the classifier wheel design, particle size distributions are narrow and steep.
The Alpine AS Spiral Jet Mill is capable of ultra-fine milling to D97 < 3 µm. A series of angled nozzles located around the perimeter of the grinding chamber allows for the introduction of grinding gas into the chamber. The grinding gas causes particles to flow around the chamber in a spiral manner. Size reduction occurs by particle to particle collisions and also impact against the walls of the chamber.
The Alpine ATP Turboplex Air Classifier is ideal for ultra-fine classification of superfine powders and can produce fines in the range of D97=4 µm or finer. The classification of the product is a function of the peripheral speed or the speed of the classifying wheel and the radial speed of the air flowing through the classifying wheel. The material’s fineness/cut point can be controlled by altering the speed of the classifier wheel.
When it comes to mixing excipients, 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.
The Nauta® Vacuum Dryer is a batch dryer suitable for drying heat sensitive materials such as powders, granules, pastes and viscous slurries. The thermal energy needed for drying is introduced into the product via a heated jacket that can be heated by various media including steam, hot oil and water. The jacket provides rapid distribution of heat into the product in combination with efficient mixing.
The vacuum inside the dryer allows vapor to be removed at low temperatures, which makes the Nauta® Vacuum Dryer ideal for drying heat-sensitive products. The vapors are removed through a dust filter fitted on top of the vessel.
Hosokawa Micron Powder Systems prides itself in understanding and meeting the requirements of the pharmaceutical industry. If you have any questions or would like to speak with an application engineer, please contact us!