Uneven Distribution of Microgranules in Divided Lansoprazole Tablets
Abstract
OBJECTIVES: Lansoprazole is a proton pump inhibitor commonly used in children <12 months of age despite a lack of efficacy and safety data in this age group. To achieve lower doses in this population, many divide standard oral disintegrating tablets. This study seeks to determine if the medication is equally distributed within the tablet to allow for accurate dosing.
METHODS: Ten 15-mg Prevacid SoluTabs were divided. Each portion was dissolved separately (half A, B, and the residual "dust" C) and photographed. A magnified view of the image allowed for counting each microgranule.
RESULTS: The mean number and standard deviation of microgranules in half A, B, and part C were 2514.7 ± 130.5, 2342.9 ± 130.1, and 49.4 ± 38.8, respectively. The total number of microgranules per tablet was 4907 ± 140.5. There was a statistically significant difference in the mean number of microgranules in half A versus B (P = 0.0086).
CONCLUSIONS: There are statistically significant differences in the amount of lansoprazole-containing microgranules within each half of a divided tablet. Clinicians must determine whether this difference is clinically relevant when prescribing "divided" medication to children.
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