Sodium stearyl fumarate
Technical name: Sodium stearyl fumarate
CAS No: 4070-80-8
Empirical formula: C22H39NαO4
Molecular weight: 390.53
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.
- Highly soluble
- Highly stabilizing
- Flexible but controlled particle size
- High degree of API compatibility
- Improved drug stability
- Faster dissolution rates
- Harder tablets
- Shorter disintegration times
- Fast formulation development
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.
EP, USP/NF, JPE
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