Use of PLIF to assess the mixing performance of small volume USP 2 apparatus in shear thinning media

AbstractPlanar Laser Induced Fluorescence (PLIF) was used to assess mixing in small volume USP 2 dissolution apparatus for a range of viscous fluids which mimic gastrointestinal media, especially in the fed state. The release into the media from a specially prepared tablet containing Rhodamine 6G dye was tracked in time and the areal distribution method developed by Alberini et al. (2014a) was implemented to characterise the mixing performance. The distributions of the individual striations for selected mixing levels were also presented. These findings illustrate the poor mixing performance of the apparatus resulting in high variance of the dissolution data when working with viscous media. Analysis of data using CoV gives misleading results for the mixing performance of the small volume USP 2 dissolution apparatus. The results showed that the best mixing was mainly located above the blade and close to the wall, i.e. in the region where intensive motion takes place. This work presents important guidelines and precautions for choosing the proper sampling point for a wide range of liquid viscosities to minimize the variability of the dissolution data