The relationship between molecular-structural properties and functional-related characteristics of croscarmellose sodium produced by different manufacturers

Croscarmellose sodium (CCS) is a superdisintegrant used in the formulation of pharmaceutical tablets. As with most other pharmaceutical ingredients, CCS is produced by various manufacturers. Our previous work has shown that products of different manufacturers can have varying properties and performance. The aim of this study was to find the underlying cause of this variation. CCS was obtained from four manufacturers. Different physical and molecular properties of the four samples of CCS were studied using tests such as SEM, BET, particle size analysis, XRD, DSC, TGA, settling volume, and wetting time. While swelling is the primary mechanism of action of CCS, the CCS samples studied could be divided into two groups of low and highly-swelling products based on the results obtained. The XRD results indicated that the high-swelling CCSs were primarily amorphous, while the low-swelling products were semi-crystalline. The other test results corroborated these conclusions. This ‘polymorphism’, which has not been reported before, was explained by possible variations in the manufacturing process of this superdisintegrant.