Comparative evaluation of a co-processed self-lubricating excipient LubriTose SD as a direct compression vehicle

LubriTose SD is a new co-processed excipient consisting of spray-dried monohydrate lactose and distilled glyceryl monostearate. In this study, the new self-lubricating excipient LubriTose SD was characterized from the aspects of powder technological properties and tableting properties. Micromeritic properties, including particle shape, size distribution, flowability, compressibility, and also the dilution potential were determined. Its applications in powder direct compression have been evaluated, including the effects on flowability, compressibility, the lubricating ability, hygroscopic drugs stability, content uniformity of the low-dose drugs and dissolution of poorly soluble drugs. LubriTose SD is 100 μm with very uniform size distribution and with spherical shape, shows the best flowability, has the same deformation mechanism with the spray-dried monohydrate lactose, has high dilution potential to the hydrophobic drug and has improved function of drug tableting. Its lubricating effect is satisfactory. The results of the investigation imply that the LubriTose SD is a good co-processed excipient with self-lubricating properties, which is promisingly suitable for powder direct compression.