Docusate Sodium U.S.P.
A Versatile Formulating Aid for Oral Dosage Forms
A p p l i c a t i o n B u l l e t i n |
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Docusate sodium U.S.P. (DSS) is one of the most versatile and
effective anionic surfactants (surface active agents) currently available.
It is an excellent solubilizing, wetting, dispersing, and emulsifying
agent, beneficial for use as a formulating aid for oral dosage forms.
Cytec’s pharmaceutical-grade DSS products are manufactured to the
highest quality standards under cGMP, and offer exceptional quality
and performance as both active ingredients and excipients.
In addition to acting as a formulating aid for oral dosage forms, DSS
also has application as an active ingredient in laxative and stool
softener formulations, as well as in vitamin preparations and ear wax
removal compounds. |
Applications
DSS is particularly suitable as an excipient in:
- Aiding the granulation process – Good quality granulation may
be achieved rapidly by facilitating the wetting of a relatively
hydrophobic powder
- Improving tablet disintegration and dissolution – May eliminate
the need to incorporate a separate disintegrating agent
- Facilitating tablet coating – Provides physical stability and
enhances patient acceptance
- Emulsifying gel and liquid suspensions – Ensures homogeneity of
ingredients and dosages
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Features
- Pharmaceutical grade, manufactured under cGMP;
EP and USP compliant
- Compatible with broad range of pharmacologically
active drugs
- Effective as a wetting agent at relatively low concentrations
- Promotes accelerated tablet dissolution
- Aids in uniform diffusibility of components
- Three product forms: 100%, 85% granular, 50% in PEG
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Benefits
- Meets standards of quality, strength, purity, and
potency recognized worldwide
- Wide range of excipient applications and pharmaceutical products
- Improves manufacturing efficiency and helps lower
overall production costs
- Facilitates rapid absorption of active constituents
- Enhances efficacy of time-release formulations
- Multiple product types provide flexibility in handling
and ease of use
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| Example: Acetaminophen tablets |
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P r o d u c t I n f o r m a t i o n |
Docusate Sodium U.S.P. (DSS) |
Composition
DSS is the dioctyl ester of sodium sulfosuccinate (bis-2-ethylhexyl sodium sulfosuccinate). |
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| Typical Properties |
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| Products |
100% DSS |
85% DSS granular
with sodium benzoate |
50% DSS in
polyethylene glycol |
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STORAGE
DSS should be stored in tightly closed containers at temperatures below 75°F (24°C) with relative humidity of less than 60%. Higher temperatures may
cause the 100% material to fuse and discolor.
HEALTH AND SAFETY INFORMATION
Direct contact may cause eye or skin irritation. Sodium dioctyl sulfosuccinate has acute oral LD50 values for the rat and mouse of 1,900-4,000 mg/kg and
2,640 mg/kg, respectively. Acute dermal (rabbit) LD50 value is greater than 10,000 mg/kg. Read the Cytec Industries Inc. Material Safety Data Sheet on this
product, before using, for detailed safety and handling information. The Material Safety Data Sheet is available and is routinely provided at the time of first
shipment of this product. |
IMPORTANT NOTICE
The information and statements herein are believed to be reliable, but are not to be construed as a warranty or representation for which we assume legal
responsibility or as an assumption of a duty on our part. Users should undertake sufficient verification and testing to determine the suitability for their own
particular purpose of any information, products, or vendors referred to herein. NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE IS MADE.
Nothing herein is to be taken as permission, inducement or recommendation to practice any patented invention without a license. |
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