Monitoring Dissolution Rate of Amiodarone Tablets by a Multiple Fiber-Optic Sensor System

Abstract

Afiber-optic dissolution testing (FODT) system for solid pharmaceutical formulations has been constructed. The system is based on a charge-coupled device (CCD) detector and includes six fiber-optic probes. Light is produced by a small deuterium arc lamp illuminating an optical fiber bundle. Six fiber-optic dipping probes were constructed with reflection geometry. The light passes back and forth through the flow-through cuvette backed by a coated aluminum mirror. The sampling interval was typically 30 sec for all probes. The system was tested for different tablet and capsule formulations. Amiodarone is a Class III anti-arrhythmic agent. It is used for treatment of many ventricular and supraventricular arrhythmias, including arterial fibrillation. It is a highly hydrophobic drug, and factors of its formulation, including constitutional heterogeneity, surface membrane, and production technology, influence its absorption. The dissolution of marketed amiodarone tablets was tested by the system, and dissolution parameters were directly obtained from the dissolution curves. It was found that there were significant differences in the dissolution of these products.