The aim of this study was to evaluate the weight uniformity of commonly divided tablets produced by Palestinian Pharmaceutical Companies and to evaluate the importance of both patient- and formulation-related variables on the splitting results. Eighty-four volunteers were enrolled in this study; their age, gender and occupation were documented in order, and the effect of these variables on the tablet splitting results was evaluated. Each volunteer was asked to divide six scored tablets of each product tested and was given clear instructions on how to conduct the splitting process. The split units were individually weighed and the RSD for each product was calculated as instructed in the European Pharmacopoeia (Ph. Eur. 5.5). Only one scored tablet product passed the Ph. Eur. test of mass uniformity, while the remaining 13 products failed; this indicates that the splitting of these tablet products is not a reliable means for the provision of accurate doses to patients. Age, gender and occupation of volunteers were not found to be predictive of any variability noted in the splitting results. The only factors that were suspected to be linked to passing the splitting test, as per the European Pharmacopoeia, were the shape, friability and hardness of the tablets. As a result of this study, we believe that the practice of dividing tablets, which should provide therapeutic and economic benefits for the patient, may potentially cause significant problems, especially in drugs with low therapeutic indices. Tablets produced by Palestinian Pharmaceutical Companies should comply with the new Ph. Eur. splitting regulations to reduce this potential for complications.
Objectives: To decide on whether tablet splitting scenarios represent prescribing error situations or not by a panel of expert judges composed of thirty members and to analyze splitting of tablets orders in two teaching hospitals.
Methods: A questionnaire containing scenarios was submitted to each member of the panel of expert judges, and a two round Delphi technique was followed to obtain consensus. Based on the Delphi rounds results, 902 and 316 medication orders were screened from Services hospital and Punjab Institute of Cardiology, respectively.
Results: Two scenarios were considered prescribing error situations, one was excluded and one was partially agreed upon. In Services Hospital 42 errors were detected, out of which 20 errors involved splitting of modified release tablets while 22 errors involved splitting of coated tablets. In Punjab Institute of Cardiology 41 errors were detected, out of which 23 errors involved splitting of modified release tablets while 18 errors involved splitting of coated tablets.
Conclusion: It was concluded that programs are needed to increase the current awareness regarding unsuitability of splitting all tablet types.
The aim of this study was to investigate the degree of correlation between the weight and the content of spilt-halves of lorazepam 2.5 mg tablets. Weight variation and drug content of lorazepam half-tablets were evaluated according to the European Pharmacopoeia tests. Only one individual mass of the 30 half tablets was outside the limits of 85–115% of the average mass, but since it was within 75–125% of the average mass, the product passed the test. Each individual content was between 85% and 115% of the average content (99.8% expressed as a percent to label claim) and within the limits of 75–125%, so the product passed the uniformity of content test. The correlation coefficient (r) between the weight and the content of split halves was found to be 0.994. The weights of split tablet halves appear to be directly correlated with their drug content even for a medication with a low drug content, thus it is recommended that pharmacists who split tablets into two halves, assure the weight uniformity of the resultant halves. Manufacturers should develop formulation and manufacturing procedures that ensure high degree of correlation between weight and content not only among the whole tablet but also among the obtained tablet halves.