Pharma Focus Asia

The Effect Of Silicification On The Roller Compaction Performance Of Microcrystalline Cellulose: A JRS Pharma White Paper

Summary:

Roller compaction, or dry granulation, is a manufacturing method for pharmaceutical and nutraceutical tablets that continues to gain importance. In order to achieve the desired granule properties, it is vital to use efficient binder-filler systems, which enable easy compaction, reproducible grinding results, and high re-compactibility during the final tableting step.

In this study, microcrystalline cellulose, as well as two grades of silicified microcrystalline cellulose were tested in regards to their performance as roller compaction binders. All three binders were found to be highly efficient in roller compaction.

Differences in their powder characteristics translated into modification of the resulting granule properties. Proper selection of the initial microcrystalline cellulose (MCC) or silicified microcrystalline cellulose (SMCC) material can, therefore, be used to fine-tune the granules in terms of their flowability, particle size, and tabletability.

Overview:

Today, direct compression, or tableting of powder blends without prior granulation, is the health science industry's preferred manufacturing method. There are, however, formulations which do not lend themselves to direct compression and still require a granulation step in order to achieve the desired tablet flow in compression to yield satisfactory properties.

Wet processing, the traditional granulation technique, is a time and cost intensive procedure which stresses active pharmaceutical ingredients (APIs) by exposure to heat and moisture. Roller compaction is a powerful alternative to wet granulation. Granulation is achieved via compaction of a powder blend and subsequent grinding to the required particle size. This method continues to become more popular because it needs no water and, thus, requires no drying step.

Furthermore, it can easily be scaled up since the output of granulated material is only dependent on the roller speed settings. In order to achieve uniform granules, it is of utmost importance to use highly compactible binders of constant quality.

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