Multiple fiber-optic dual-beam UV/Vis system with application to dissolution testing.

ABSTRACT

A system for fiber-optic probing in dissolution testing of solid pharmaceutical formulations has been constructed. The system is based on an imaging spectrometer and a charged coupled device (CCD) detector and includes 12 fiber-optic probes with a novel dual-path design. UV light was produced by a small arc deuterium lamp illuminating an optical fiber bundle. Twelve fiber-optic dipping probes were constructed with a reflection geometry. A 5 mm diameter lens was used to achieve a parallel light beam. The light passed back and forth through the flow-through cuvette defined by a sapphire window and a coated aluminium mirror. The mirror was cut in half and each segment was tilted and set at different distances from the window to obtain two separate paths with different lengths. Two receiver fibers were used for each probe to collect the transmitted light. The 24 receiver fibers from the 12 probes were bunched to a linear bundle and fed to an imaging spectrometer and the corresponding spectra were detected with a 512 x 512 pixel cooled CCD detector. The sampling interval was typically a few seconds for all probes. A software package was developed for data recording and on-line analysis. The program includes tools for multi-component analysis. The system was tested for different tablet formulations. Prednisone 50 mg tablets, normally used for control tests of dissolution baths, were followed for 3 h. Secondly, an extended release low dosage tablet was followed for 7 h resulting in a linear dissolution profile. Finally, a combination tablet containing two active drugs was tested for 60 min profiles. In the latter case, separate dissolution curves for the two active components were obtained. Future work will mainly focus on further development of the multi-component capability of the system.