tests. This process is not only time consuming, but the solid dosage forms are destroyed. Tablets from the batch of formulation will normally be completed before the results of quantitative analysis for content uniformity of the tablets are known. If the analysis on unit dosage or content uniformity fails to satisfy the acceptance criteria, then no remedial action can be taken except to regrind, remix, and repress the tablets.
ABSTRACTtests. This process is not only time consuming, but the solid dosage forms are destroyed. Tablets from the batch of formulation will normally be completed before the results of quantitative analysis for content uniformity of the tablets are known. If the analysis on unit dosage or content uniformity fails to satisfy the acceptance criteria, then no remedial action can be taken except to regrind, remix, and repress the tablets.A system using light-induced fluorescence (LIF) technology was developed for rapid and nondestructive analysis of active pharmaceutical ingredients on tablet surfaces. Nonhomogeneous tablets with defined layer of active ingredients were made by 3-Dimensional Printing technology to determine penetration depths of the light source and the resultant fluorescence responses. The LIF method of analysis showed penetration to depths of up to 3 mm into tablets. A correlation between LIF signals from analysis of tablet surfaces and the total drug content of the respective tablets was established. This method of surface analysis was verified with UV spectrometric methods for the total drug content of each respective tablet. The results from a small sample population of tablets made from both homogeneous and nonhomogeneous powder mixtures established good correlation between LIF surface monitoring and total tablet content. The use of on-line monitoring of the individual tablet for surface content demonstrated consistent LIF profiles from simulated production rates up to 3000 tablets a minute. The instrument was also field tested successfully on a tablet analyzer.Hence, it would be useful if a nondestructive analysis method were available as it would provide an additional dimension for tracking and characterizing historical and shelf-life properties of the solid dosage forms. With the improved production rates of tablets (>3000 tablets per minute) and the development of higher potency drugs (eg, less than 1% active pharmaceutical ingredient (API) wt/wt), there is a need for both faster and more sensitive monitoring technology for on-line analysis. A portable light-induced fluorescence (LIF) sensor that can perform quantitative analysis of solid samples and surfaces rapidly and nondestructively has recently been described by Lai et al.1,2 By examination of the vast sources of drug-like chemical structures, a large proportion of pharmaceutical active ingredients are predicted to fluoresce when excited at the appropriate wavelength, 3 while most excipients such as calcium phosphate, lactose, microcrystalline cellulose, starch, and many others remain nonfluorescent. A review of the chemical structures of the top 200 pharmaceuticals from the Rx Web site 4 also showed that greater than 60% of the compounds are potential candidates with fluorescence property. By a careful selection of excitation and emission bandwidth filters, specific concentration-dependent fluorescence signals can be quantitatively measured in a rapid fashion. From the fluorescence emission of the excited sample, information about t...
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