Fully-automated system for dissolution rate of solid oral dosage forms according to the paddle method

This paper describes a fully-automated system (AUTO DISS(®)) for the determination of active ingredient release of solid oral dosage forms according to the paddle method of the US Pharmacopoeia (USP) and European Pharmacopoeia. Twenty batches can be tested continuously, with the six individuals (tablets, capsules etc.) of one batch being examined synchronous. The components of the AUTO DISS(®) system are presented and the operating steps of automatic filling with dissolution medium, dropping in of tablets, sampling and cleaning of vessels are described. Suitability for testing controlled-release drugs by means of automated buffer change from simulated gastric fluid to simulated intestinal fluid according to USP is also demonstrated. On-line determination of active ingredient concentration, as well as evaluation and documentation of measured values, is possible using an integrated automatic sampler in combination with various measuring instruments. The AUTO DISS(®) system is shown to be both rugged and accurate.