Correlation Between Drug Dissolution and Polymer Hydration: a Study Using Texture Analysis

Texture analysis is a new approach in pharmaceutical research and development; this study evaluated the correlation between drug dissolution and polymer hydration from a modified release matrix tablet of pseudoephedrine hydrochloride using a texture analyzer. A series of matrix tablets of pseudoephedrine was designed and prepared. Modified drug release was achieved by combined use of matrix excipients Polyox WSR301 (PEO) and Compritol 888ATO (GB). Dissolution profiles of the tablets were assessed using USP Method II. Polymer swelling behaviors during dissolution were measured using a texture analyzer. Increase in proportion of PEO and GB in the formulation reduced drug dissolution within the first 90 min. However, drug release was complete in 6h due to high aqueous solubility of pseudoephedrine. Linear correlations were observed among drug dissolution, polymer content and parameters of texture analysis including hydrogel thickness and AUC(TA) for formulations that contained hydrophilic PEO. The study demonstrated a unique application of a texture analyzer in characterization of modified release matrix tablets.