Y. T. Cain, J. L. Edgar, Wyeth Research, Wyeth
Background: The future of dissolution is moving toward increasing productivity in laboratories. This can be accomplished is by utilizing dissolution with online fiber optic UV analysis.
Methods: Fiber optics changes the traditional way of sampling for dissolution by bringing the UV spectrometer to the sample solution in-situ.
Results: The use for fiber optics allows real-time determination of drug release levels in-situ and effectively eliminates many common issues with traditional dissolution testing and analysis including carryover, sipper, line or filter malfunction and cost of consumables such as filters, test tubes and HPLC solvents. Since no sample is removed from the dissolution vessels, readings can be taken as often as every few seconds if necessary; thereby setting a new precedent for dissolution profiles. Direct comparison of fiber optic analysis with conventional quartz cell UV analysis shows agreement well within 2%.
Conclusion: The use of fiber optic analysis for dissolution testing saves analyst time, which reduces laboratory operating costs. Product development data is more meaningful since the number of sampling time points is not limited by volume removal. This technology has been successfully implemented at Wyeth research and commercial manufacturing sites.