Docusate Sodium

Synonyms: Bis(2-ethylhexyl) sodium sulfosuccinate; dioctyl sodium sulfosuccinate; DSS; natrii docusas; sodium 1,4-bis(2-ethylhexyl) sulfosuccinate; sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2- sulfonate; sodium dioctyl sulfosuccinate; sulfo-butanedioic acid 1,4-bis(2-ethylhexyl) ester, sodium salt; sulfosuccinic acid 1,4-bis(2- ethylhexyl) ester S-sodium salt.

Description:Docusate sodium is a white or almost white, waxlike, bitter tasting, plastic solid with a characteristic octanol-like odor. It is hygroscopic and usually available in the form of pellets, flakes, or rolls of tissuethin material.

Chemical Name: Sodium 1,4-bis(2-ethylhexyl) sulfosuccinate

Anionic surfactant; fecal softener; wetting agent.

• Docusate sodium and docusate salts are widely used as anionic surfactants in pharmaceutical formulations.

• Docusate sodium is mainly used in capsule and direct-compression tablet formulations to assist in wetting and dissolution.

• Docusate salts are also used in oral formulations as laxatives and fecal softeners

Electrolytes, e.g. 3% sodium chloride, added to aqueous solutions of docusate sodium can cause turbidity.(2,3) However, docusate sodium possesses greater tolerance to calcium, magnesium, and other polyvalent ions than do some other surfactants. Docusate sodium is incompatible with acids at pH < 1 and with alkalis at pH > 10.

Docusate salts are used in oral formulations as therapeutic agents for their fecal softening and laxative properties. As a laxative in adults, up to 500 mg of docusate sodium is administered daily in divided doses; in children over 6 months old, up to 75 mg in divided doses is used. The quantity of docusate sodium used as an excipient in oral formulations should therefore be controlled to avoid unintended laxative effects. Adverse effects associated with docusate sodium include diarrhea, nausea, vomiting, abdominal cramps, and skin rashes. As with the chronic use of laxatives, the excessive use of docusate sodium may produce hypomagnesemia.

Observe normal precautions appropriate to the circumstances and quantity of material handled. Docusate sodium may be irritant to the eyes and skin, and when inhaled. Eye protection, gloves, and a dust mask or respirator are recommended. When heated to decomposition, docusate sodium emits toxic fumes.

Docusate calcium; docusate potassium.