Pregelatinized Starch

　　Pregelatinized starch is produced by chemically or mechanically disrupting 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 appropriate coarseness to fineness, odorless, with a slightly special taste, used in the pharmaceutical field

　　commonly used as a binder, diluent, and disintegrant in oral tablets and capsules.

　　Name

　　Generic Name: Pregelatinized Starch

　　Other Names: Pregelatinised Starch, compressible starch

　　CAS Number: 9005-25-8

　　Grade: Pharmaceutical Grade, Pharmaceutical Excipient

　　Packaging: 25kg woven bag

　　Composition

　　Generally, pregelatinized starch contains 5% free amylose, 15% free amylopectin, and 80% unmodified starch.

　　Molecular Formula (C6H10O5)n, n=300～1000.

　　Properties

　　Acidity: pH=4.5-7.0 [10%(w/v) aqueous solution]

　　Angle of Repose: 40.7°

　　Bulk Density: 0.586g/cm3

　　True Density: 1.516g/cm3

　　Flowability: 18%-23% (Carr Compressibility Index)

　　Stability: Stable but hygroscopic, should be stored in a sealed container in a cool, dry place.

　　Incompatibilities: None

　　Solubility: Insoluble in organic solvents, slightly soluble or soluble in cold water depending on the degree of gelatinization. A starch paste is obtained by sieving pregelatinized starch into stirred cold water.

　　Some pregelatinized starch is soluble in cold water by 10%-20%.

　　Safety: Widely used in oral solid preparations, non-toxic, non-irritating. However, large oral doses are harmful.

　　For decades, starch has been used as a binder in wet granulation in pharmaceutical applications. Initially supplied in its native form, pregelatinized starch was later introduced, greatly improving ease of use and eliminating the complex and difficult-to-control steps of starch cooking and slurry preparation. 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.

　　Different amounts of fully pregelatinized starch (LYCATAB® PGS) were used as a binder to granulate a mannitol/starch mixture. The aim was to determine the optimal binder amount for this formulation, taking into account granulation process conditions, granule properties, and tablet properties.

Pregelatinized starch is a modified starch obtained by chemically or mechanically disrupting starch granules partially or completely. It is commonly used as a binder, diluent, and disintegrant in tablets. Pregelatinized starch has self-lubricating properties, and 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 disrupting 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 appropriate coarseness to fineness, 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 press 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 less adverse effect on the hardness of the tablets.