System for automated determination of dissolution rate

✍ Scribed by J. B. Johnson; P. G. Kennedy; S. H. Rubin

• Publisher: John Wiley and Sons
• Year: 1974
• Tongue: English
• Weight: 497 KB
• Volume: 63
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.2600631221

✦ Synopsis

An automated dissolution rate apparatus meeting requirements of the USP-NF dissolution test and applicable to various other agitation systems in common usage is described. The equipment allows simultaneous determination of the dissolution rate of six unit doses, enabling evaluation of a statistically significant number of samples. The system, composed of readily available standardized components, has a disposable filter unit and can measure the concentration of dissolution solutions in the 0.020-3.000 absorbance range. Dose-to-dose uniformity and stability of dissolution characteristics are shown for several products. Data relating the USP-NF agitation system to the beaker-stirrer (Levy) method are presented. Dissolution rates of sulfisoxazole formulations are correlated with in vioo availability, and the adverse effects of inadequate packaging and severe environmental storage conditions on dissolution rate are demonstrated.