Sodium stearyl fumarate

Sodium stearyl fumarate is a pharmaceutical lubricant used in the manufacture of tablets and other solid oral dosage forms. It reduces friction between the compact and tooling during tablet ejection and helps limit adhesion of formulation material to metal surfaces. These actions support reliable compression and release of the finished compact from the die.

The selected use is as an external-phase lubricant blended with powders or granules before compression. It is a recognized alternative lubricant for formulations in which compaction behavior and drug release must be balanced. Its contribution is interfacial lubrication, with the effect on hardness, disintegration and dissolution depending on the complete formulation and blending process. Commercial applications include directly compressed tablets, granulated tablet blends and effervescent dosage forms.

Typical Applications

• Direct-compression tablets: Used in powder blends to lower die-wall friction and facilitate tablet ejection during compression.
• Tablets made from granules: Used in the final blending stage after granulation and drying to lubricate the granules before tableting and help reduce sticking to tooling.
• Effervescent tablets: Used as a lubricant in effervescent-tablet formulations where ejection behavior must be compatible with rapid breakup of the dosage form in water.

Specifications

Specifications describe the standard grade. Tolerance, test method and documentation package are confirmed per order.