STATISTIC ESTIMATION OF BREAKING TABLETS OF ENALAPRIL 20 MG
Keywords:enalapril, breaking tablets, pediatric formulations, score line
Objective: The aim of this study was to evaluate the accuracy of breaking into half and quarter-tablets Enalapril 20 mg sold in the Albanian market, in dosages suitable for use in children.
Methods: 100 whole tablets of Enalapril 20 mg were chosen at random from each of three different manufacturers based on scoring characteristic: scored on one side, scored on both sides and not scored. Whole tablets from each of the three product types were weighed and the mean weight calculated. The pills were then split in half and quarter by using a pill-splitter. The resulting half-tablets and quarter-tablets were weighed and the mean weights were calculated.
Results: All the whole tablets were found to conform to the set criteria. Only halves from those tablets scored on both sides passed the weight uniformity test, with no individual half outside the 85-115 % range. Quarter-tablets failed the weight uniformity test. A higher relative standard deviation was observed for half and quarter-tablets of the not-scored tablet.
Conclusion: The study shows that deviations in weight were observed in half tablets and quarter tablets of Enalapril 20 mg. These deviations were related to the presence or not of the score line. Such inadequate breaking of the tablets may result in dose variability and complicate therapeutic outcome.
Keywords: Enalapril, Breaking tablets, Pediatric formulations, Score line
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