Comparison of drug release and mechanical properties of tramadol-hydrochloride matrix tablets prepared with selected hydrophilic polymers

Abstract

This study investigates using of high molecular weight hydrophilic polymers, hypromellose and hydroxypropylcellulose, for the preparation of sustained release matrix tablets containing high dose, highly soluble drug, tramadol HCl. Proportion of polymer, type of insoluble filler, proportion of tramadol HCl, amount of drug in the tablet and compression pressure were recognized as critical formulation and process parameters and their influence on drug release and tablet mechanical properties was evaluated. Tensile strength was used as indicator of mechanical properties of the tablets. Experiments were performed with utilization of compaction simulator as a device which simulates compaction profiles of large scale rotary tablet presses. In formulations with both polymers proportion of tramadol HCl was the most critical formulation parameter wherein increasing of the tramadol HCl proportion increased its release rate in early stages of drug release. Regarding the tablet mechanical characteristics, the influence of the filler type has the most pronounced effect in formulations with both polymers. Higher tensile strengths were obtained with Avicel PH 102 as filler in formulations with both HPMC and HPC.