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Starch, Pregelatinized

    Synonyms: Amylum pregelificatum; compressible starch; C*PharmGel; Instastarch; Lycatab C; Lycatab PGS; Merigel; National 78-1551; Pharma-Gel; Prejel; Sepistab ST200; Spress B820; Starch 1500 G; Tablitz; Unipure LD; Unipure WG220.

    Description: Pregelatinized starch occurs as a moderately coarse to fine, white to off-white colored powder. It is odorless and has a slight characteristic taste.

    Chemical Name: Pregelatinized starch

    Tablet and capsule diluent; tablet and capsule disintegrant; tablet binder.

    • Partially pregelatinized starch is a modified starch used in oral capsule and tablet formulations as a binder, diluent and disintegrant

    • In comparison to starch, partially pregelatinized starch may be produced with enhanced flow and compression characteristics such that the pregelatinized material may be used as a tablet binder in dry-compression or direct compression processes.

    • In such processes, pregelatinized starch is self-lubricating. However, when it is used with other excipients it may be necessary to add a lubricant to a formulation.

    • Although magnesium stearate 0.25% w/w is commonly used for this purpose, concentrations greater than this may have adverse effects on tablet strength and dissolution.

    • Therefore, stearic acid is generally the preferred lubricant with pregelatinized starch.

    • Partially pregelatinized starch is used in oral dry powder hard capsule formulations. Both partially and fully pregelatinized starch may also be used in wet granulation processes.

    • Fully pregelatinized starches can be used to make soft capsules, shells, and coatings as well as binders in tablets.

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    Pregelatinized starch and starch are widely used in oral solid-dosage formulations. Pregelatinized starch is generally regarded as a nontoxic and nonirritant excipient. However, oral consumption of large amounts of pregelatinized starch may be harmful. See Starch for further information

    Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and a dust mask are recommended. Excessive dust generation should be avoided to minimize the risks of explosions.

    Corn starch and pregelatinized starch; starch; starch, sterilizable maize.