Sodium Stearyl Fumarate
What Is Sodium Stearyl Fumarate?
SODIUM STEARYL FUMARATE serves as a hydrophilic lubricant, making it an excellent choice for APIs with low water solubility and those that are incompatible with magnesium stearate. It is the preferred lubricant for the production of orally disintegrating tablet (ODT) and effervescent powder formulations.
Name: SODIUM STEARYL FUMARATE
Pharmacopoeia / DMF: USP/NF/BP/EP
Grade: Granular & Powder
- It is employed for medications that are compatible with traditional metallic stearates commonly used for lubrication.
- Its superior mouthfeel compared to conventional metallic stearates makes it well-suited for the production of Melt-in-Mouth and effervescent tablets.
- It exerts a minimal impact on the dissolution characteristics of tablets, making it highly beneficial for tablets containing poorly soluble drugs.
- Its lubricating properties are effective even when used in lower concentrations, enabling its application in formulations where high concentrations of lubricants are not feasible.
Advantages of Sodium Stearyl Fumarate
- It exhibits superior effects on tablet hardness and the necessary ejection force during the tabletting process.
- It enhances tablet disintegration and reduces friability, improving overall tablet quality.
- Its lower hydrophobicity has a minimal impact on the drug dissolution profile from the tablets.
- It streamlines production by reducing the blending times required, resulting in faster output.
- It demands lower concentrations of lubricant for effective application.
Parameters to be considered while using Sodium Stearyl Fumarate
- When formulating, it is advisable to use lower concentrations of Sodium Stearyl Fumarate compared to conventional lubricants.
- Thorough research and analysis should be conducted before substituting the conventional lubricant.
- Sodium Stearyl Fumarate is suggested for high-value, low-volume tablet production because of its higher cost.