Chemical and biological differences between original and mimetic pentosan polysulfates

Lenhart D, Tischhöfer MT, Gruber R, Maag K, Reiter C, Alban S · Carbohydrate Polymers

PPS is a mixture of sulfated glucuronoxylans that physicochemical analysis cannot fully specify, and the ten products differed measurably in both structure and biological activity — enough that the authors conclude follow-on products are at best similar to the original, not identical, and that their efficacy and safety would have to be shown separately.

Population

Ten commercially available PPS preparations from different manufacturers

Intervention

Orthogonal physicochemical characterization plus plasma kallikrein generation and factor XII activation assays

Comparator

The original beech-wood PPS

Limitations

Three authors work for bene pharmaChem, which makes the original PPS, and one for Paradigm, which is developing the injectable — an interested party arguing that competitors' material differs; the underlying analytical finding of structural heterogeneity is independently corroborated by earlier capillary-electrophoresis work.