Sodium stearyl fumarate

TECHNICAL PROFILE

Technical name: Sodium stearyl fumarate

CAS No: 4070-80-8

Empirical formula: C₂₂H₃₉NαO₄

Molecular weight: 390.53

ADVANTAGES

Sodium stearyl fumarate is a lubricant used in the manufacturing of tablets, capsules and other dosage forms. Due to its high hydrophilicity, it is especially designed for robust and high performance formulations, where the commonly used lubricating agents fail to provide tablets of adequate hardness, stability, content uniformity, disintegration and dissolution rate. Particle size distribution of the used Sodium stearyl fumarate is a key factor for optimal tableting results. Especially the influence of the particle size on disintegration time is very well documented. Reduced particle sizes are directly linked with higher disintegration times combined with small effects on tablet hardness only. VIO Chemicals can offer micronized Sodium stearyl fumarate with controlled D₅₀ particle sizes of 10 μm and below.

FEATURES

• Hydrophilic
• Highly soluble
• Highly stabilizing
• Flexible but controlled particle size
• High degree of API compatibility

BENEFITS

• Improved drug stability
• Faster dissolution rates
• Harder tablets
• Shorter disintegration times
• Fast formulation development

APPLICATIONS

Sodium stearyl fumarate has already been used in the formulation of a great number of APIs, including: Omeprazole, Esomeprazole, Ramipril, Diclofenac, Ibuprofen, Irbesartan, Lamotrigin, Levetiracetam, Levofloxacin, Metoprolol, Ritonavir, Pravastatin, Sildenafil, Oseltamivir, Telmisartan, Valsartan and Sitagliptin.

COMPLIANCE

EP, USP/NF, JPE