Extruder and spheronizer manufactured by Umang Pharmatech:

Extrusion/Spheronization is one of the oldest techniques of manufacturing pellets.
The extrusion-spheronization process is comonnly used in the pharmaceutical industry to make uniformly sized spheroids. It is especially useful for making dense granules for controlled-release solid dosage oral forms with a minimum amount of excipients.

The process consists of the following steps:

• Dry mixing of the active and excipients to achieve a homogeneous powder
• Wetting the dry mass, with binder solution
• Extrusion into cylindrical extrudates
• Spheronization to form the extrudate in to spheres of uniform size
• Drying
• Sifting to acheive the desired size distribution(optional)
• Coating the formed pellets(optional)

The dry, powder active substances and excipients are mixed and kneaded into dough with the help of a liquid as a binder. This dough is then pressed through an extruder. The diameter of the openings in the extrusion plate will determine the strength of the extrusion threads that result.

The ratio of solid to liquid material together with the size of the extruder holes determines the quality of the extrudates. The final drying step will ensure the pellet hardness.

Even if the ball-shaped extrudate is imperfect, the evenness of the surface will still create good conditions for subsequent coating. For many pharmaceutical applications, extruded pellets are achieved in suitable quality if a sufficient portion of microcrystalline cellulose is added.

The UMANG Extrusion/ Spheronization System are a turnkey pellet production plant, which will meet all your pelletization needs. Continuously wet powders pass through a low-shear radial extruder / cone extruder / pressure extruder / basket extruder. The extrusions are fragmented and formed into pellets in the spheronizer.

We have single and twin spheronization options possible in the integrated system, for high throughput systems we recommend single extruder and twin spheronizers with twin bucket assembly for feeding the spheronizers.

Features:

• Continuous process one bucket is filling at one time and the other is discharging the product into the other spheronizer.
• Fast throughput process
• Easy to up-scale from a lab scale to production scale
• Stand alone units but also fully integrated systems available called the Integerated Pelletization series.
• Very high drug loads possible due to special extruder design we have typically achieved 95% drug loads using various extrusion systems we make.
• Integration with up-stream equipments like high shear mixers and downstream equipments like fluid bed dryers / processors / coaters is possible.
• We also assist with a Pellet line : where we install the complete line for customers from powder mixing to blending and packaging.

Benefits:

• Fast process.
• Robust process.
• Uniform pellet size.

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