CAS 577-11-7 Docusate Sodium/ Dioctyl Sulfosuccinate Sodium Salt DDS Waxy Solid

CAS 577-11-7 Docusate Sodium/ Dioctyl Sulfosuccinate Sodium Salt DDS Waxy Solid

1. Description

Docusate Sodium is an anionic surfactant widely used in the pharmaceutical industry as a stool softener (emollient laxative). It works by reducing the surface tension of the oil-water interface in the intestinal contents, allowing water and lipids to penetrate and soften hardened stools. This makes defecation easier without directly stimulating peristalsis.

It is typically available as a white, amorphous, or wax-like solid with a characteristic faint odor and a slightly bitter taste. It is hygroscopic (absorbs moisture from the air) and is soluble in water, glycerol, and alcohol.

2. Specification 

3. Key Features

• Effective Stool Softener: Its primary mechanism is emollient, not stimulant, making it gentler on the bowels.
• Surfactant Properties: Acts as a wetting agent and emulsifier, allowing water and fat to mix into the stool.
• Low Systemic Absorption: Minimally absorbed from the gastrointestinal tract, leading to a high safety profile and few systemic side effects.
• Non-Habit Forming: Does not cause dependence or "lazy bowel syndrome" associated with stimulant laxatives.
• Versatile Formulation: Compatible with various dosage forms like oral liquids, soft gelatin capsules, solid oral dosage forms, and enemas.

4. Applications

Docusate Sodium is primarily used in the pharmaceutical and medical fields.

• Pharmaceuticals:

  • Treatment of Constipation: Used for temporary relief of constipation, particularly in cases where straining should be avoided (e.g., post-operative patients, patients with hemorrhoids or anal fissures).
  • Prophylactic Use: Preventative measure for constipation in patients on opioid pain medications (which cause constipation) or those with reduced mobility.
  • Formulation Excipient: Used in low concentrations as a wetting agent, emulsifier, or stabilizer in various drug formulations to improve dissolution or bioavailability of poorly soluble active ingredients.

• Medical & Healthcare:

  • Pre- and Post-Operative Care: Standard medication to prevent constipation and straining after surgery.
  • Cardiology: Recommended for patients after a heart attack or with severe hypertension to avoid dangerous increases in blood pressure from straining (Valsalva maneuver).
  • Geriatric Care: Commonly used in elderly populations who are prone to constipation.
  • Obstetrics: Used to manage constipation during pregnancy and postpartum.

5. Packing

Docusate Sodium is a hygroscopic material and must be packed to protect it from moisture.

• Primary Packaging: Double-lined polyethylene bags inside a fiber drum are most common. For smaller quantities, high-density polyethylene (HDPE) bottles or containers with tight-sealing lids are used.
• Secondary Packaging: Packed in sealed, moisture-proof containers (e.g., corrugated cardboard boxes) to ensure integrity during transport and storage.
• Standard Quantities: Available in various commercial quantities such as 1 kg, 5 kg, 10 kg, 20 kg, and 25 kg drums, depending on the supplier.

6. Storage

Proper storage is critical to maintain the stability and efficacy of Docusate Sodium.

• Conditions: Store in a well-closed, airtight container.
• Environment: Keep in a cool, dry, and well-ventilated place. Protect from moisture and direct sunlight.
• Temperature: Store at room temperature (typically 15°C - 30°C / 59°F - 86°F). Avoid excessive heat.
• Shelf Life: Typically 36 months (3 years) from the date of manufacture when stored under the recommended conditions.