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A modified enteric disintegration test was used to investigate the possibility of damage to the functional coating. The percentage weight gain of the enteric- coated aspirin tablets after disintegration testing in pH 1.2 for 2 hours is shown in Figure 6. Manually de-inked tablets exhibited the greatest weight gain, followed by the automatically de-inked tablets, although these results were not statistically significant. It should be noted, how- ever, that all tablets exhibited high variability, including the unaltered controls. Data from disintegration testing in pH 6.8 are shown in Figure 7. Again, no statistically significant differences in the time required for initial disintegration were found (Figure 7a). However, both de-inking methods signifi- cantly reduced the time to complete disintegration com- pared to the control (Figure 7b.) Manipulation of a commercially available drug product has the potential to alter its release or stability and could be considered a flaw in extrapolation of the resulting clin- ical data [3, 8]. Ideally, no manipulation of a commer- cially available drug product would be done, and if the study design called for only objective data, an unblinded study might be acceptable. Using placebos that look sim- ilar to a comparator is another option to eliminate the need to manipulate the comparator [6]. However, the "gold standard" for conducting clinical trials is the dou- ble-blind design [1], and blinding drug products remains an issue. De-inking, where the identifying print on the surface of a solid dosage form is removed, could be used to mini- mize the manipulation of the product. In the current study, the results of the automated ink removal system and manual ink removal were comparable. Moreover, the automated system significantly reduced manual labor and would likely produce more consistent results, especially when large quantities of product must be blinded. Parameters such as solvent selection, amount and rate of solvent dispensed on the fabric tape, and the speed of the fabric tape in the automated system must be optimized to ensure that the printed markings are removed with little effect on the tablet or capsule surface, especially when they have functional coatings. Conclusions The current study investigated the ability of an auto- mated system to remove ink from the surface of solid dosage forms. This newly developed apparatus was shown to be capable of removing the majority of ink from both tablet and capsule surfaces, and the results were comparable to those of a manual process. Processing parameters such as solvent selection, amount and rate of solvent dispensed, and the speed of the fabric tape must be optimized to ensure that the printed markings are suf- ficiently removed to prevent identification while mini- mizing the effect on the tablet or capsule surface. T&C 12 October 2014 Tablets & Capsules Figure 6 Weight change after 2 hours of disintegration testing at pH 1.2 180 160 140 120 100 80 60 40 20 0 Control Automatic Manual Weight gain (%) Figure 7 Disintegration at pH 6.8 10 8 6 4 2 0 Control Automatic Manual Time (min) a. Time of initial disintegration 10 8 6 4 2 0 Control Automatic Manual Time (min) b. Time of complete disintegration