Docusate sodium

• BPDocusate Sodium
• Ph. Eur.Docusate Sodium
• USP–NFDocusate Sodium

Aerosol OT; dioctyl sodium sulfosuccinate; DSS; sodium bis(2-ethylhexyl) sulfosuccinate; sodium dioctyl sulfosuccinate

Sodium 1,4-bis(2-ethylhexyl) sulfosuccinate · [577-11-7]

UNII F05Q2T2JA0 · PubChem CID 23673837

C20H37NaO7S · 444.56

Surfactant, emulsifier

Typical concentrations: — · Dosage forms: Solid, Liquid

An anionic surfactant used as a wetting, dispersing and solubilising agent in tablets, capsules, suspensions and topical products, typically at 0.01–1.0%; it improves wetting and dissolution of hydrophobic drugs and has been used at about 0.5% as a disintegration aid. It is also used therapeutically as a faecal softener.

A white or almost white, waxy, bitter-tasting, hygroscopic solid with a characteristic odour, supplied as pellets, flakes or rolls; powder grades often contain sodium benzoate as a processing aid.

Melting point

about 153–157 °C

Critical micelle concentration

about 0.11% w/v in water at 25 °C

Surfactant type

anionic

Solubility

sparingly soluble in water (solubility increases with temperature); freely soluble in ethanol, glycerol, chloroform and ether

The solid is stable but hygroscopic. Aqueous solutions are stable between about pH 1 and 10 at room temperature, but are hydrolysed outside this range. Store in an airtight container in a cool, dry place.

Electrolytes, for example sodium chloride at a few per cent, reduce its solubility and cause turbidity. As an anionic surfactant it is incompatible with cationic surfactants and some cationic drugs, and it is hydrolysed by strong acids and alkalis.

Made by esterifying maleic anhydride with 2-ethylhexanol and then adding sodium bisulfite across the double bond of the resulting diester.

At excipient levels it is generally well tolerated. Therapeutic oral doses can cause abdominal cramps and diarrhoea, and oral liquids have a bitter taste and can irritate the throat. Concentrated solutions irritate the eyes and skin.

Observe normal precautions for the quantity handled. It is an eye irritant; wear eye protection and gloves.

Included in the FDA Inactive Ingredient Database (intramuscular injections; oral capsules, suspensions and tablets; topical preparations) and in non-parenteral medicines licensed in Europe. Permitted as a food additive in the USA.

Docusate calcium; docusate potassium; sodium lauryl sulfate.

Its waxy form makes it difficult to disperse in dry blends; it is often added as a solution in the granulating liquid or used as a pre-blend with a carrier such as sodium benzoate. Because it is effective at low concentrations, check that it does not over-soften tablets or cause foaming during processing.