Background: In pharmacies, the dispensation of halved tablets is important for the administration of the appropriate doses. However, a standard method for tablet splitting has not been established in Japan. Furthermore, the practices in this field have not been evaluated. In Japan, the splitting of tablets with score lines is commonly practiced, whereas tablets without score lines are split in some cases. Aim: To examine the accuracy of splitting tablets with a score line and tablets without a score line, as an evaluation of the accuracy of half-tablet dispensing, we applied the weight variation test, which has been approved by the Japanese pharmacopeia. Method: Five products that contained tablets with score lines and five products that contained tablets without score lines were used as the target products. For each of the 10 target products, 20 tablets were prepared, respectively, and split using a splitting device. The tablets were evaluated using a weight variation test of the whole tablet according to the practices recommended in the Japanese pharmacopeia. The collection rate and coefficient of variation (CV) were also calculated. Results: Two out of the five products without a score line yielded appropriate results in the weight variation test, whereas three out of the five products with a score line did not. The median collection rate was >99% for all target drugs, and the CV for the drugs that passed the weight variation test was 4%–6%; in contrast, the CV for the drugs that did not pass the weight variation test was 7%–12%. Conclusion: We concluded that, if half-dose tablets of pharmaceutical products are available, it is undesirable to split tablets. If tablet splitting cannot be avoided, it is also necessary to consider the accuracy of the procedure, regardless of the presence or absence of a score line.
郁 et al. (Sun,) studied this question.