The Food and Drug Administration (FDA) have reported that split tablets from amlodipine drug products did not meet the United States Pharmacopeia (USP) Uniformity of Dosage Units <905> accepted criteria for content uniformity.
Researchers from the FDA tested the presence of a tablet score on the dose uniformity of amlodipine and gabapentin. They purchased tablets from 5 amlodipline and 6 gabapentin manufacturers. Two splitters were used on each product while the gabapentin tablets were also split by hand.
When the unscored amlodipine was split, researchers found a significant increase in the dose variability, with the standard deviation (SD) ranging from 6.5–25.4 when compared to whole tablets which ranged from 0.5–2.1 SD of the label’s percentage claim. None of the split amlodipine tablets met the USP acceptance criteria for content uniformity.
For gabapentin, the weight variation method was used for split tablets based on the recommendation of guidance. Results showed that all fully scored tablets met the USP acceptance criteria for weight, with the variation ranging from 1.3–9.3 SD.
The researchers noted how splitting tablets produced a greater level of dose variability in both drugs, with the changes in amlodipine being particularly significant.
These findings are in line with the FDAs consumer advice, which cautions against splitting tablets as a practice in saving money. As stated in the FDA guidance, tablet splitting “can affect how much drug is present in the split tablet and available for absorption.”
For more information visit FDA.org.