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Sodium Stearyl Fumarate – A Hydrophilic Lubricant

Sodium Stearyl Fumarate (SSF) is a hydrophilic lubricant widely used in the manufacture of tablets and hard capsules. It is particularly suitable for formulations requiring rapid drug dissolution or containing APIs that are sensitive to the hydrophobic effects of magnesium stearate.

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    1. General Introduction to Sodium Stearyl Fumarate 

    Sodium Stearyl Fumarate (SSF) is a hydrophilic lubricant excipient widely used in the formulation of tablets and hard capsules. Unlike conventional hydrophobic lubricants, SSF does not adversely affect tablet hardness after prolonged blending and does not prolong tablet disintegration or drug dissolution. As a result, SSF has become an increasingly popular choice for formulations requiring rapid dissolution or containing APIs that are sensitive to hydrophobic lubricants.

    2. Physicochemical Properties of Sodium Stearyl Fumarate

    • Material Name: Sodium Stearyl Fumarate
    • Origin: India
    • Material Category: Pharmaceutical Excipients.
    • Function: Lubricant for tablets and capsules.
    • Chemical Formula: C22H39NaO4.
    • Material Form: Fine white powder, hydrophilic.
    • Solubility: Practically insoluble in water, slightly soluble in methanol and ethanol.
    • Quality Standards: Meets USP, EP, BP standards.

    3. Advantages of Sodium Stearyl Fumarate from Gangwal

    • Hydrophilic nature: Does not form a hydrophobic film that impedes tablet disintegration or drug dissolution, enabling rapid drug release.
    • No adverse effect on tablet hardness:Resistant to over-lubrication, thereby maintaining tablet hardness even after prolonged blending.
    • No metallic aftertaste: Ideal for orally disintegrating tablets (ODTs), lozenges, and chewable tablets where taste is an important quality attribute.
    • No hydrophobic surface film: Does not produce a hydrophobic scum or surface film in effervescent formulations, ensuring rapid wetting and complete dispersion.
    • Excellent compatibility: Chemically stable and compatible with most APIs. It is particularly effective as an alternative to magnesium stearate in formulations containing proton pump inhibitors (PPIs).
    • High lubrication efficiency at low use levels:Provides excellent lubrication at concentrations of only 0.5–1.0% w/w in tablet formulations.
    • Reduced risk of nitrosamine formation:SSF contains no amine functional groups and typically has very low nitrite impurity levels. It is therefore considered a suitable lubricant for formulations designed to minimize the risk of nitrosamine formation, particularly those containing APIs susceptible to nitrosation.
    • Cost-effective with a reliable supply:Manufactured in India, offering a high-quality, cost-competitive solution with a stable supply chain for pharmaceutical manufacturers.

    4. Applications of Sodium Stearyl Fumarate

    • In Pharmaceuticals: An ideal lubricant excipient for tablet formulations (conventional tablets, lozenges, effervescent tablets, and formulations containing APIs incompatible with magnesium stearate) as well as hard capsules.
    • In Health Supplements: Applied in nutritional supplement formulations that require rapid dissolution and high mechanical strength.

    5. Commercial Products Using Sodium Stearyl Fumarate

    6. Product Contact Information 

    For more information on the supply chain, technical specifications of Sodium Stearyl Fumarate, or to place an order, please contact us:

    • Consultation Hotline: +84 (0) 834 560 500
    • Email: director@biorichgroup.com
    • Website:www.biorichgroup.com
    • Request for Sample/COA: Please contact us via email to request a sample and the latest Certificate of Analysis (COA) for the material from the manufacturer.
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