Abstract
An experimental study was made to assess a potential new method for quantifying the homogeneity of pharmaceutical ordered mixes. A UV fluorescence microscope fitted with a photomultiplier system was used to determine the distribution of fluorescing fine drug particles on the surface of non-fluorescing coarser excipient particles after mixing. The concentration of drug in a given field of view was related to the fluorescence level determined by measuring the current output from the photomultiplier. The change in current levels measured in different sample fields was used to quantify homogeneity. Mechanistic interpretation of data was also possible by comparison of quantitative and qualitative microscopical analyses. Homogeneity data obtained using UV fluorescence microscopic analysis was compared with data obtained from similar experiments using UV spectrophotometric analysis. It was found that the two methods produced quantitatively similar results. It was considered that the fluorescence microscope method offered several potential advantages over other conventionally used analytical methods for assessing powder homogeneity.
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