Practical Aspects of Dissolution Testing

Abstract

The introduction of in vitro dissolution tests into the British Pharmacopoeia necessitated a considerable programs of laboratory investigation and collaborative testing. The importance of minimising variation and identifying and controlling some of the factors causing variation was an important aspect of this programme. Factors which were identified were sampling position, temperature of the dissolution medium, dissolved air, filter adsorption and filter release of interfering substances, drive motor speed variation, stirrer shaft eccentricity, basket dimensions, displacement vibration, and flask shape. Reference is made to automated sampling systems and to the use of Dissolution Calibrators.