For decades, starch has been used as a binder in wet granulation for pharmaceutical applications. Initially available as native starch, pregelatinized starch was later introduced, significantly improving ease of use and eliminating the complex and difficult-to-control starch cooking and slurry preparation steps. The high shear forces provided by modern wet granulators allow for faster dispersion and wetting of the binder and granulating liquid, enabling efficient granulation; 15% pregelatinized starch can be used as a binder. Comprehensive improvements in formulation and process have also resulted in different properties of granules and tablets.

　　A mannitol/starch mixture was granulated using varying amounts of fully pregelatinized starch (LYCATAB® PGS) as a binder. The aim was to determine the optimal binder content for this formulation, considering granulation process conditions, granule properties, and tablet properties.

Pregelatinized starch is a modified starch obtained by chemically or mechanically breaking down starch granules partially or completely. Commonly used as a binder, diluent, and disintegrant in tablets, pregelatinized starch has self-lubricating properties; when used with other excipients, magnesium stearate should be added as a lubricant. This product is non-toxic and non-irritating, but large oral doses are harmful.

Pregelatinized starch is produced by chemically or mechanically breaking down starch granules partially or completely, giving the starch flowability and direct compressibility. Pregelatinized starch is a modified starch, a white or off-white powder of appropriately coarse to fine texture, odorless, with a slightly special taste, commonly used in the pharmaceutical field as a binder, diluent, and disintegrant in oral tablets and capsules.

Precautions for using pregelatinized starch:

1. Storage of pregelatinized starch should be in a cool, dry, and ventilated place;

2. When using dry binder to directly compress powder, the use of alkali metal salts of stearic acid (such as magnesium stearate) as lubricant should be minimized to avoid affecting the hardness of the tablets. If necessary, stearic acid can be used as a lubricant, which has a smaller adverse effect on tablet hardness.