Abstract

EFFECTS OF VARIOUS CONCENTRATIONS OF SODIUM STEARYL FUMARATE ON TABLET STRENGTH AND DISINTEGRATION

Ellen Hackl*

ABSTRACT

This study investigates the effects of varying concentrations (from 1 to 10 wt.%) of the lubricant Sodium Stearyl Fumarate (SSF) on the mechanical properties, wettability, and disintegration of placebo tablets manufactured by direct compression. The results show that over-lubrication with SSF reduces tablet tensile strength and increases friability, but not to a degree that fails British Pharmacopoeia standards. Additionally, SSF maintains good wettability and disintegration times, contributing to improved drug bioavailability and therapeutic consistency. The findings indicate that while over-lubrication with SSF reduces tablet tensile strength and increases friability, it does not compromise compliance with British Pharmacopoeia standards. The study also reveals that under certain manufacturing conditions (SSF concentration and compression forces), SSF concentration has a relatively minor effect on tablet mechanical properties and water uptake, making it a less crucial parameter when optimizing the formulation. Overall, these findings demonstrate that SSF is a viable lubricant for direct compression tablet manufacturing, particularly for formulations requiring robust mechanical properties and rapid drug release, and it can be used in varying concentrations while maintaining the quality and robustness of the final product.

Keywords: lubricants, Sodium stearyl fumarate, Tensile strength, Disintegration, Wettability.