Superior Lubrication Performance of Sodium Stearyl Fumarate (Alubra®) in Direct Compression and Continuous Manufacturing
Lubricants are agents added in small quantities to tablet and capsule formulations to improve certain processing characteristics such as decreasing friction, preventing adherence and improving flowability. For the last many decades, the process of lubrication is considered sensitive to overmixing leading to segregation, low hardness, increase in disintegration time and ultimately impacting tablet quality. Therefore, the most commonly used lubricant i.e. magnesium stearate (MgSt) is mixed with other ingredients just before tableting for minimum mixing time possible. This means there are at least a minimum of two steps required for tablet powder mixing. An alternative to MgSt is sodium stearyl fumarate (SSF, e.g. Alubra® from DuPont). It can provide enhanced dissolution, compatibility with range of APIs, flexibility in blending, improved compactibility with similar lubrication performance, and better tablet quality. Continuous manufacturing (CM) is currently a hot topic in the pharmaceutical industry.
In CM, the direct compression blending processes is conducted by two consecutive continuous dry powder blenders which separate the blending process into two distinct stages: the first blender is used for intensive mixing, whilst shear-sensitive materials such as the lubricant are introduced in the second blender. In order to provide more flexibility and reduce blending sensitivity associated with lubricants, this work investigates the effects of addition of SSF compared to MgSt in the first and second blending stages. In combination with colloidal silica, a lubricant effect on tablet hardness could be nearly suppressed or significantly reduced using SSF.
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