Brand to brand variation in the disintegrant functionality of Polacrilin Potassium, NF.

The current monograph for Polacrilin Potassium, NF does not specify tests that could assist in distinguishing between different brands of this disintegrant. The objective of this work was to examine the physical characteristics of four brands of Polacrilin Potassium, NF and relate the observed differences to differences in their functionality. Significant differences were observed in the particle size, true density, porosity, surface area and morphology of the samples. Functionality tests, such as settling volume, intrinsic swelling, rate and extent of water uptake were carried out. Significant differences were observed in intrinsic swelling and the initial rate of water uptake. The disintegration times of the tablets were found to be a function of the initial rate of water uptake. Since the disintegration times were shown to be significantly different despite negligible differences in settling volumes, wicking and water uptake, as opposed to the magnitude of swelling, appear to be the major mechanisms that distinguish disintegration performance between different brands of Polacrilin Potassium, NF when incorporated into insoluble tablet matrices. Thus, the measurement of the rate of water uptake may be a useful functionality test for Polacrilin Potassium in particular, and for ion exchange resin type disintegrants in general.