The influence of product brand and batch-to-batch variability on super-disintegrant performance

The aim of this work was to compare different brands of super-disintegrants (three brands of sodium starch glycolate and five brands of sodium croscar mellose) for their capability to interact with water either as lease powder s or in tablets and to produce swelling force in tablets, Various batches o f each brand were examined to check if the batch-to-batch variability could allow differentiation between various brands of the same product. The pred ictive power of measurements effected on powders with respect to disintegra nt performance in model tablets, based on a sparingly soluble drug, was als o investigated. As for the batch-to-batch variability of disintegrant powde rs, the Sive sodium croscarmellose brands showed a batch-to-batch variabili ty higher than that observed for sodium star ch glycolate samples: such a v ariability in some cases lead to the annihilation of the differences pointe d out between the various brands. Similar considerations as for powders can be made with respect to the batch-to-batch variability of tablets. Only fo r sodium croscarmellose brands were the results of water penetration measur ements effected on powders predictive of disintegrant efficiency in tablets , expressed by disintegration time.