Weight
Compliance of Scored Tablet Halves Produced by Palestinian Pharmaceutical Companies with the New European Pharmacopoeia Requirements
Sun, 2014-06-29 12:00 — Abdel Naser ZaidThe 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.
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TwitterInfluence of Physical Factors on Tablet Splitting, Weight and Content Uniformity of Atenolol Tablets
Sun, 2014-06-29 09:32 — Abdel Naser ZaidWeight and Content Uniformity of Lorazepam Half-Tablets: a Study of Correlation of a Low Drug Content Product
Fri, 2013-02-15 20:52 — Abdel Naser ZaidThe 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.
Influence of Physical Factors on Tablet Splitting, Weight and Content Uniformity of Atenolol Tablets
Fri, 2013-02-15 17:10 — Rowa' Jamal Al-Ramahi
