(205a) Tartrazine and Dextran Blue as Surrogates to Characterize Biopharmaceutical Properties of Compacted Microcrystalline Cellulose Tablets

Peng Peng, Gabriella Reis Barham, and Aaron Moment*, Columbia University

Biopharmaceutical formulation properties are conveniently assessed indirectly by dissolution and disintegration under controlled conditions. In this work we report using the dyes tartrazine (CAS 1934-21-0) and dextran blue (CAS 87915-38-6, MW 2x106) to assess the dissolution and disintegration rates of microcrystalline cellulose 10 mm tablets made on an MTS Universal Testing Instrument, as a function of compaction pressure, loading of the dye, and test configuration. In batch, the formulations are distinguished using a lumped Noyes-Whitney equation model. On the other hand, with a custom designed flow cell we report more detailed measurements including diffusion coefficients and overall mass transfer coefficients under low Reynolds number conditions mimicking saliva flow for an intra oral delivery project. We also offer a preliminary assessment of image analysis algorithms to assess spatial content uniformity of the formulations based on micrographs and photographs.

Key words: compaction, tensile strength, dissolution, disintegration, dextran blue, tartrazine, FD&C Yellow 5, MTS Universal Testing Instrument, microcrystalline cellulose, image analysis, flow cell, UV-VIS spectroscopy, diffusion coefficient, mass transfer coefficient