Brand to Brand Variation in Disintegrant Functionality of Polacrilin Potassium NF

Abstract

The current monograph for Polacrilin Potassium NF does not specify tests that could help in distinguishing between different brands of this disintegrant. The objective of this work was to study the physical characteristics of four brands of Polacrilin Potassium NF and relate the observed differences to the differences in their functionality. Significant differences were observed in particle size, true density, porosity, surface area, viscosity and morphology of the samples of the four brands of Polacrilin Potassium NF. Functionality tests such as settling volume, intrinsic swelling, rate and extent of water uptake were performed. The differences in settling volumes were not significant. However, significant differences were observed in intrinsic swelling and initial rate of water uptake rate. The disintegration times of the tablets were found to be a function of the rate of water uptake in the initial few seconds of disintegration. Since the disintegration times were observed to be significantly different in spite of negligible differences in settling volumes, wicking and water uptake appear to be the major mechanism of disintegration performance for Polacrilin Potassium NF. The measurement of water uptake rate may be a useful functionality test for ion exchange resin disintegrants. The settling volume test, however, was unable to distinguish between the samples of different sources of Polacrilin Potassium NF.