Extrusion spheronization refers to the process of uniformly mixing drug and excipient powders with a binder, extruding them into a cylindrical shape using an extruder, cutting the cylindrical material into a uniform and regular spherical shape using a spheronizer, and finally drying and coating it.
This method is a relatively new pill making method, and foreign literature often shows that the particles obtained by this method have uniform size, narrow particle size distribution, and uniform drug content. The required equipment mainly includes extruders and rolling machines. The extruder can extrude the wet material after kneading into a cylindrical shape, while the rolling machine can roll the extruded cylindrical material into a spherical shape.

It has the following advantages:

1. The granulation time is short (only 3 minutes for a batch of materials) and the yield is high (the yield can basically reach over 95%) without the need for screening.

2. Performing process operations in a moist state avoids dust flying and meets GMP requirements.

3. The prepared microspheres have good roundness, creating excellent conditions for the next coating operation and greatly saving coating costs. The microspheres have good flowability, providing conditions for accurate capsule packaging and measurement.

4. The prepared microspheres have a narrow particle size distribution, high strength, high density, high product yield, high one-time pass rate, good reproducibility between batches, and can be used to prepare drugs with high drug loading capacity.

5. Easy to achieve mixing between incompatible active ingredients.

6. The equipment has a high degree of automation, is easy to operate, and saves labor costs.

Features of the integrated extrusion and rolling machine:

1. The extruder and rolling machine are integrated together, and the equipment is compact with a small footprint, making it particularly suitable for use by research and development units.

2. The extruded strip material is collected in an automatic storage device by the extruder, and the opening time is automatically set by the PLC. It falls into the rolling machine for rolling, and the extrusion and rolling operations are all automatically completed by the equipment, with a high degree of automation.

3. All parts in contact with materials can be easily and quickly disassembled and cleaned, with no cleaning dead corners, in compliance with GMP requirements

4. All electrical and pneumatic components are imported brands, ensuring stable performance, long lifespan, and easy maintenance and operation.

5. The device has an upgrade function and can be upgraded to a multi-purpose device with both centrifugal granulation and coating functions.

Introduction to equipment for preparing microspheres

1. Low temperature extruder

   The wet material made by the wet mixing granulation mechanism is manually or fed into the feeding hopper of the extruder by a feeder. The multi head spiral double rod rotates relative to each other to uniformly push the wet material from the feeding end to the radial end of the extruder in the spiral direction. When it encounters resistance at the mesh plate, the pressure inside the mesh plate increases, forming an extrusion force towards the outside of the mesh plate. The material is uniformly and tightly extruded through the small holes, forming a micro cylindrical strip. Then, the next process produces spherical pellets.

   Characteristics of extruder

   1. The unique dual cooling system can cool the extrusion screw and extrusion orifice plate, ensuring that the material does not produce heat and remains unchanged during the extrusion process. It is suitable for fast and efficient extrusion of heat sensitive materials.

   2. Uniform extrusion, good density, and high yield of finished products.

   3. Continuous operation, high production efficiency.

   4. The disassembly, installation, and cleaning of the extrusion screw are extremely convenient;

   5. The spherical extrusion method is a structure with uniform force distribution in the screw extrusion method, and the gap uniformity between the extrusion orifice plate and the extrusion head is designed to be 1mm equidistant.

   6. Compared to other screw extrusion methods, this structure has a shorter feeding and extrusion stroke, a lower extrusion pressure on the arc-shaped extrusion head, and the smaller the orifice plate thickness, the more adjustable it can be. Therefore, the heat generation during the extrusion process is low;

   7. The orifice plate is formed by a mold in one go, and the extrusion holes are precisely drilled by laser, resulting in high uniformity of the particles produced.

   8. The standard configuration includes a 1.0mm orifice plate, and various specifications of spherical orifice plates (0.3mm, 0.4mm, 0.6mm, 0.8mm) are available for selection, which can be used to prepare particles of different sizes.

   
   

   Main Technical Parameters Table

   (Due to differences in products or technological updates, the parameters need to be confirmed by our company before they have any constraints on us.)

Rolling machine

The rolling machine can be conveniently installed with a uniquely designed rolling special gear plate, and the wet "cylindrical strip" produced by the previous extrusion process is put into the rolling machine. The "cylindrical strip" is cut into short cylindrical particles of equal length by the high-speed rotating centrifugal gear plate (the length of the cylinder is proportional to the diameter). Under the comprehensive action of the rotating gear plate, particles and gear plate, cylinder wall and particles, and gas thrust between the turntable and cylinder wall, all particles are in three-dimensional spiral rolling, forming a uniform rubbing effect, which quickly rolls the particles into round balls.

Characteristics of rolling machine

1. The production operation time is short, usually within 5 minutes for rolling a batch. The produced pellets have good roundness, smooth surface, and high yield.

2. The turntable undergoes dynamic balance verification to ensure safe and stable operation of the equipment during rolling.

3. The turntable speed is infinitely adjustable to meet the different requirements of rolling parameters for different products, and has a wide range of process adaptability.

4. The SUS304 stainless steel cooling/insulation jacket design ensures that the product does not experience temperature changes during the rolling process, making it particularly suitable for products that use heat sensitive materials and volatile organic solvents as wetting agents.

5. The entire equipment is designed strictly in accordance with CGMP requirements, and all key parts can be cleaned in place, meeting CGMP requirements.

There are various parameter operations such as manual parameter setting and automatic parameter running, which have a high degree of automation and save labor costs.

Schematic diagram of rolling process

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Main technical parameters of the rolling machine

(Due to differences in products or technological updates, the parameters need to be confirmed by our company before they have any constraints on us.)