Acoustic-resonance spectrometry as a process analytical technology for rapid and accurate tablet identification |
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Authors: | Joseph Medendorp Robert A Lodder |
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Institution: | (1) Department of Pharmaceutical Sciences, College of Pharmacy, A123 ASTeCC Building 0286, 40536 Lexington, KY |
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Abstract: | This research was performed to test the hypothesis that acoustic-resonance spectrometry (ARS) is able to rapidly and accurately
differentiate tablets of similar size and shape. The US Food and Drug Administration frequently orders recalls of tablets
because of labeling problems (eg, the wrong tablet appears in a bottle). A high-throughput, nondestructive method of online
analysis and label comparison before shipping could obviate the need for recall or disposal of a batch of mislabeled drugs,
thus saving a company considerable expense and preventing a major safety risk. ARS is accurate and precise as well as inexpensive
and nondestructive, and the sensor, is constructed from readily available parts, suggesting utility as a process analytical
technology (PAT). To test the classification ability of ARS, 5 common household tablets of similar size and shape were chosen
for analysis (aspirin, ibuprofen, acetaminophen, vitamin C, and vitamin B12). The measures of successful tablet identification
were intertablet distances in nonparametric multidimensional standard deviations (MSDs) greater than, 3 and intratablet MSDs
less than 3, as calculated from an extended bootstrap erroradjusted single sample technique. The average intertablet MSD was
65.64, while the average intratablet MSD from cross-validation was 1.91. Tablet mass (r2=0.977), thickness (r2=0.977), and density (r2=0.900) were measured very accurately from the AR spectra, each with less than 10% error. Tablets were identified correctly
with only 250 ms data collection time. These results demonstrate that ARS effectively identified and characterized the 5 types
of tablets and could potentially serve as a rapid high-throughput online pharmaceutical sensor.
Published: March 17, 2006 |
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Keywords: | Sound chemometrics pharmaceuticals process analytical technology (PAT) integrated sensing and processing (ISP) |
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