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A great innovation step how to make smaller pellets with higher drug loadings.

Introduction

Conventional pellet manufacturing techniques are frequently based upon extrusion of prewetted masses or on fluid bed layering and coating processes. Obtained pellet sizes are typically in a range between 500 to 1500 µm. Our newly developed MicroPx ™ fluid bed technology allows numerous and different formulation approaches, extending the scope and applicability of traditional pelletizing techniques. This eminent improvement is due to the provision of micropellets with a particle size smaller than 500 µm.

Micro Px™ Pelletization Technology

The Micro Px™ Technology consists of a continuous fluid bed process. After liquid spraying and coating of APIs, generated micropellets are classified by applying a vertical online air sifting system. The entire process constitutes of a well balanced system of spray drying and consecutive drug layering. The Micro Px™ Technology process results in manufacturing of high drug loaded matrix-type micropellets. Drug loadings of produced pellets can be up to 95%.

Our Micro Px™ Technology process can be also applied for taste masking, which usually have an ideal particle size distribution between 200 to 400 µm. Any functional exipient can be integrated into the coated micropellet matrix.

Both, in the pilot and in the commercial scale, the Micro Px™ Technology process takes place in a rectangular shaped fluid bed processing chamber. A directed fluid bed air stream provides for the specific circulation of coated products. Micropellets matured to the desired particle size distribution are being discharged through a hooked-up multiple chamber classifier. In this device bigger and smaller particles are separated and unmature pellets are led back to the ongoing pelletization process by air pressure.

Taste Masking

As example to depict the performance of our Micro Px™ Technology process, taste masking of bitter tasting APIs is given. Applying Wurster fluid bed technology, micropellets with a particle size distribution between 200 to 400 µm were coated with two functional coatings. Manufactured Micro Px™ core pellets proved to be extremely mechanically stable, a prerequisite for application of subsequent functional coatings like taste masking, enteric coatings, modified release coating and similar processes. The Micro Px™ core pellets manufacturing process was developed at a laboratory standard and then upscaled to commercial scale and validated.

As requirement for stability, the taste masking layer must outlive two weeks in an aqueous suspension at room temperature. Further, in vivo dissolution of active ingredients from coated micropellets must be more than 80% after 30 min.

Advantages of the Micro Px™ Pelletization Technology

• small particle size
• spherical pellet shape
• manufactured Micro Px™ pellets reach very homogeneous and narrow particle size distribution
• drug loads achievable of up to 95% available in
• laboratory, pilot and industrial production scales