Systems from a single supplier for perfect pellet manufacturing in the pharma industry

One challenge facing today's pharmaceutical industry is the production of preparations in easy-to-administer forms. End users want simple yet smart handling that can easily be integrated into their daily lives. Products in the form of (micro)pellets, or granules, meet precisely those demands. Pellet manufacturing can take place in various processes — but use of spheronizer technology has proven to be especially effective. Using spheronizers, a large quantity of granules in the required high level of quality and size can be manufactured.

In almost no other industry is precision as important as in the pharmaceutical industry. High-value systems for precise handling of active ingredients, as well as gentle manufacturing and processing into the final form for administering medication are significant requirements for customers in this industry. 

As part of the Coperion Food, Health & Nutrition Division, DIOSNA Dierks & Söhne GmbH (in Osnabruck, Germany) Gabler Engineering (in Malsch, Germany) and Coperion K-Tron (in Niederlenz, Switzerland) jointly offer a line for manufacturing pellets using spheronizer technology. Together, these companies make available a complete system — from the mixer to the feeder to extrusion up to the spheronizing, drying and coating solutions. 

Complete granule line for manufacturing high-value pharmaceutical products

Granule manufacturing takes place in a multi-step process. DIOSNA, Gabler Engineering and Coperion K-Tron offer complete granulating and pellet lines from a single source that perfectly adjust products and manufacturing steps to each other. 

First, all active and inactive ingredients are loaded into a DIOSNA high-shear mixer together with water or an alcohol-based granulating liquid to create a wet granulate mixture. DIOSNA’s high-shear mixer is particularly well suited for this step as it offers optimal active ingredient distribution as well as mass homogeneity with short mixing times and reproducible quality, even with poorly flowing ingredients possessing low pourability. 

The homogeneous wet granule mixture is then conveyed on a Coperion K-Tron K3-PH model high accuracy gravimetric loss-in-weight feeder, continuously feeding the mass into a Gabler extruder. The K3 product line encompasses pharmaceutical feeders featuring modular design and markedly reduced floor space. Thanks to its integrated quick-change design, the feeder is easy to quickly modify for new processes and recipes. With just a few hand movements, various feeder types and sizes as well as hoppers and agitators can be swapped in and out while the scale and drive remain as they are. Effortless cleaning and servicing can both be accomplished at the same time. 

Within the Gabler extruder, gentle processing and continuous conveying of the homogeneous mixture continues. The extruder’s co-rotating screws can be configured to satisfy every process requirement. The final mixture is continuously pressed through a die plate into small extrudates measuring 10-30 mm in length.

In a final step, the pellets are dried in a DIOSNA fluidized bed dryer and, depending upon the requirement, may be covered with a special coating. Use of a fluidized bed dryer offers great flexibility within the process, allowing drying and coating to be performed as separate steps within the same machine.  In the fluidized bed processor, the particles move freely, leading to a large contact surface with the process air. An optimal heat transfer results which then leads to efficient drying and outstanding mixing behavior. As a result, the pellets are accessible on all sides for the spraying process, achieving outstanding results. This coating step is essential for targeted active ingredient release. Thus, the active ingredient can be released at a constant rate or over a longer period of time using a time-release coating. 

With this pellet manufacturing system solution, DIOSNA, Gabler Engineering and Coperion K-Tron offer the ideal solution for your process. 

Your advantages at a glance:

• Process solution for optimal (micro)pellets with targeted active ingredient release
• Complete line from a single source, with reduced interfaces and products and process steps optimally adjusted to each other
• Overall control of the partially automated line
• Extremely precise and qualitatively high-value end products thanks to the machines’ state-of the-art quality
• Adherence to demanding industry requirements such as GMP guidelines and standards, as well as FDA regulations
• Years of experience and comprehensive expertise in granule manufacturing
• Option to test your product and process development in the DIOSNA DIOlab laboratory
• Secure scale up of the entire line