Sodium Starch Glycolate

Synonyms: Carboxymethyl starch, sodium salt; carboxymethylamylum natricum; Explosol; Explotab; Glycolys; Primojel; starch carboxymethyl ether, sodium salt; Tablo; Vivastar P.

Description:

Sodium starch glycolate is a white or almost white free-flowing very hygroscopic powder. The PhEur 6.0 states that when examined under a microscope it is seen to consist of: granules, irregularly shaped, ovoid or pear-shaped, 30–100 mm in size, or rounded, 10–35 mm in size; compound granules consisting of 2–4 components occur occasionally; the granules have an eccentric hilum and clearly visible concentric striations. Between crossed nicol prisms, the granules show a distinct black cross intersecting at the hilum; small crystals are visible at the surface of the granules. The granules show considerable swelling in contact with water.

Chemical Name: Sodium carboxymethyl starch

Tablet and capsule disintegrant. 

• Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in capsule and tablet formulations.

• It is commonly used in tablets prepared by either direct-compression or wet-granulation processes.

• The usual concentration employed in a formulation is between 2% and 8%, with the optimum concentration about 4%, although in many cases 2% is sufficient.

• Disintegration occurs by rapid uptake of water followed by rapid and enormous swelling.

• Although the effectiveness of many disintegrants is affected by the presence of hydrophobic excipients such as lubricants, the disintegrant efficiency of sodium starch glycolate is unimpaired.

• Increasing the tablet compression pressure also appears to have no effect on disintegration time.

• Sodium starch glycolate has also been investigated for use as a suspending vehicle.

Sodium starch glycolate is incompatible with ascorbic acid.

Sodium starch glycolate is widely used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material. However, oral ingestion of large quantities may be harmful.

Observe normal precautions appropriate to the circumstances and quantity of material handled. Sodium starch glycolate may be irritant to the eyes; eye protection and gloves are recommended. A dust mask or respirator is recommended for processes that generate a large quantity of dust.

Pregelatinized starch; starch.