Granulation of Spherical Granule

In pharmaceutical manufacturing, shaping granules into spheres offers several advantages:
Highly spherical particles have smoother surfaces, allowing coating agents to adhere more evenly.Spherical granules are increasingly used as core particles for fine-particle coating and masking applications, highlighting the growing importance of granulation technology.

Compared to irregular shapes, spherical granules roll more easily and exhibit superior flowability.This contributes to smoother feeding into tablet presses and capsule filling machines, enhancing overall production efficiency.

Challenges

• Broad particle size distribution
• Insufficient strength leading to particle breakage
• Long processing time required for spheroidization
• Difficulty in achieving a truly spherical shape

Requirements

• High sphericity and uniform particle size
• Adequate strength to withstand subsequent processing
• Shorter processing time

Source: Asada, T., & Yoshida, M. (2023). Development of formulations and technologies using OPUSGRAN®: A novel technique for producing spherical granules with high drug content. The 20th Nakai Award-winning paper, Japan Pharmaceutical Manufacturers Association. (In Japanese)

We present a processing example of granulation of spherical granule using EIRICH CleanLine.
You can visually confirm the effects of granulation by comparing SEM images taken before and after processing.

“The granulated particles are well-suited for tableting, allowing us to consistently produce tablets with higher hardness than before.”

“Thanks to the system’s anti-adhesion measures, manual scraping during processing is no longer necessary.”

“Compared to our previous equipment, we appreciate how uniformly the materials mix and how effectively it prevents clumping.”

EIRICH CleanLine was developed for processing raw materials that require high levels of hygiene control—such as pharmaceuticals, food products, and advanced materials—while retaining the unique mixing principle of EIRICH Intensive Mixer.Designed with hygienic specifications that prioritize cleanability and corrosion resistance, the system enables easy maintenance of sanitary conditions.There are two main series: one manufactured in Japan and the other in Germany. The Japan-made series is designed to meet the needs of customers in the pharmaceutical and health food industries, and complies with GMP guidelines covering equipment design, manufacturing, inspection, installation, and commissioning.

Advantages of the Eirich mixing principles

1. Eccentrically positioned rotor tool (mixing tool)
　The rotor tool shape, rotation direction, and speed range can be selected to suit the application.
2. Tool Set (scrapers)
　It scrapes off raw materials adhering to the inner wall and bottom of the mixing pan, while simultaneously promoting efficient material transfer to the rotor tool.
3. Mixing Pan (mixing vessel)）
　Through rotation, all raw materials in the mixing pan are continuously supplied to the rotor tool.

Advantages of CleanLine

• Selecting the appropriate rotor shape and adjusting its rotational speed ensures optimal material processing.
• By adjusting the shear force, particle size and density can be controlled. This makes it possible to achieve particle size distributions such as D50 values ranging from below 200 μm to approximately 1 mm.
• By controlling the temperature through a jacketed structure, it is possible to perform granulation under cooling or heating conditions, and to process materials that are sensitive to temperature changes.
• Excellent material circulation and dispersion are achieved during both kneading and subsequent slurry formation.