PRUV® -The original Sodium Stearyl Fumarate

JRS Pharma's PRUV® is the original sodium stearyl fumarate (SSF) introduced in the market over 20 years ago

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Pharma lubricants are the inactive agents i.e. excipients added into tablet and capsule formulations in a very small quantity (usually 0.25-5.0 % w/w) to improve the processing properties of formulations. They decrease the friction at the interface between tablet’s surface and the die wall during the compression and ejection phase of the tableting so that the wear on punches and dies are reduced. They prevent sticking of tablets to punch faces as well as sticking of capsules to dosators and tamping pins. In terms of powder flow, lubricants can improve the flowability of blends and aid unit operations[1].

A good balance between hydrophobic and hydrophilic moieties in PRUV® (Sodium Stearyl Fumarate) makes it an ideal lubricant [2].

Common lubricants used in drug development

Most of the lubricants used in the pharma processes are boundary lubricants. Certainly, metallic salts of fatty acids such as magnesium stearate; stearic acid and sodium salt of fatty acid such as sodium stearyl fumarate are the most common ones.

A. Fatty acid esters: Fatty acid esters, including glyceride esters (glyceryl monostearate, glyceryl tribehenate, and glyceryl dibehenate), sugar esters (sorbitan monostearate and sucrose monopalmitate) and alcohol ester of stearic alcohol with fumaric acid, including sodium stearyl fumarate are often used as lubricants.

In particular, sodium stearyl fumarate and glyceryl dibehenate are effective lubricants to replace magnesium stearate when the latter hampers dissolution and has chemical incompatibility issues. Relative to magnesium stearate, sodium stearyl fumarate has similar lubrication efficiency with a higher optimal concentration (around 2%, w/w). In addition, the use of sodium stearyl fumarate does not affect compressibility[1].