Docusate Sodium

Cytec Specialty Additives is the premier manufacturer of Docusate Sodium a pharmaceutical grade surfactants used as both an excipient and active pharmaceutical ingredient.

Cytec is the world’s leading manufacturer of Docusate sodium (DSS), a versatile and highly effective and efficient pharmaceutical grade surfactant. Cytec’s Docusate is often used as an exicipient in pharmaceutical production processes where it acts as a solubilizing agent for poorly soluble API’s as well as a dispersing and emulsifying agent. It is also used as active pharmaceutical ingredients (API) in the production of stool softeners and prenatal and geriatric iron preparations.

Cytec produces docusate sodium at our FDA approved, cGMP manufacturing facility in Willow Island, West Virginia. Cytec is the holder of USA Drug Master File (DMF), No. 3235. Cytec’s docusate sodium conforms to USP and EP monographs and we will submit an application for a certificate of suitability (CEP) to the European Directorate for the Quality of Medicines (EDQM) early in 2015.

Docusate sodium – Effective active pharmaceutical ingredient (API)

Docusate sodium is a versatile surfactant that is used as an active pharmaceutical ingredient (API) for a variety of laxative and stool softener formulations, where it is appropriate for capsules, tablets or liquid preparations. Docusate sodium can be used alone or in combination with peristaltic stimulants and bulking agents and in prenatal and geriatric iron preparations to counteract potential constipation induced by the consumption of iron salts.

Docusate sodium – A pharmaceutical grade excipient

Historically, docusate sodium has been used as a pharmaceutical grade excipient in a variety of drug formulations where it has proven to be effective as a dispersing agent for tablet manufacture, liquid or gel suspensions and as a dispersant and disintegrant for effervescing tablets. It has been used as an emulsifier for creams and gels, and as an emulsifier and softener for ear wax removal compounds. In addition due to its excellent wetting properties it is also used in pre-operative colon cleaning preparations.

Docusate sodium is also a powerful solubilizing agent, meeting the pharmaceutical need to aid the formulation of poorly soluble active ingredients. Many new APIs (reported to be 40-70%) have a poor aqueous solubility leading to reduced bioavailability (Hauss, D.J. Oral lipid based formulations, Advanced Drug Delivery Reviews, 59:667-676(2007)).

Docusate sodium can be used to overcome this bioavailability issue using a variety of manufacturing techniques such as wet granulating, nano milling and hot melt extrusion (HME). Cytec can provide formulation examples of these various techniques with several class 2 and 4 APIs.

In addition to excellent solubilizing, wetting, dispersing and emulsifying properties, docusate sodium gives a low order of toxicity and is stable and compatible with a wide range of pharmacologically active drugs. When used as an excipient docusate sodium is used at concentrations well below its no effect level (as a stool softener.)