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 croscarmellose) for their capability to interact with water either as loose powders or in tablets and to produce swelling force in tablets. Various batches of each brand were examined to check if the batch-to-batch variability could allow differentiation between various brands of the same product. The predictive power of measurements effected on powders with respect to disintegrant performance in model tablets, based on a sparingly soluble drug, was also investigated. As for the batch-to-batch variability of disintegrant powders, the five sodium croscarmellose brands showed a batch-to-batch variability higher than that observed for sodium starch glycolate samples: such a variability in some cases lead to the annihilation of the differences pointed out between the various brands. Similar considerations as for powders can be made with respect to the batch-to-batch variability of tablets. Only for sodium croscarmellose brands were the results of water penetration measurements effected on powders predictive of disintegrant efficiency in tablets, expressed by disintegration time.