Impact of functional-related characteristics (FRCs) of crospovidone on tablet disintegration performance.

Abstract

Crospovidone, a widely used superdisintegrant, exists in two pharmacopeial grades - Type A (coarser particle size) and type B (finer particle size). The differences in particle size among different crospovidone grades lead to variations in functional related characteristics (FRCs), such as hydration capacity and powder flowability. The present study investigates the relative impact of crospovidone FRCs on tablet disintegration time. Multiple lots of different crospovidone grades were evaluated for their particle size distribution, hydration capacity and powder flowability. Subsequently, tablets were prepared from the different lots of crospovidone and evaluated for their disintegration time. Correlation analyses were performed to evaluate the independent effects of FRCs on disintegration time. While initial correlations showed strong interdependence among particle size, hydration capacity, and powder flowability, the decoupling of particle size as the most impacting factor revealed that hydration capacity and powder flowability had no or only limited impact on the tablet disintegration time.