Abstract
Tablet splitting is an accepted practice for the administration of drugs for a variety of reasons, including dose adjustment, ease of swallowing and cost savings. The purpose of this study was to evaluate the physical properties of lisinopril tablets as a result of splitting the tablets either by hand or with a splitting device. The impact of the splitting technique of lisinopril (Zestril® tablets, 20 mg) on certain physical parameters such as weight variation, friability, disintegration, dissolution and drug content were studied. Splitting the tablets either by hand or with a splitter resulted in a minute but statistically significant average weight loss of <0.25% of the tablet to the surrounding environment. The variability in the weight of the hand-split tablet halves was more pronounced (37 out of 40 tablet halves varied by more than 10% from the mean weight) than when using the tablet splitter (3 out of 40 tablet halves). The dissolution and drug content of the hand-split tablets were therefore affected because of weight differences. However, the pharmacopoeia requirements for friability and disintegration time were met. Hand splitting of tablets can result in an inaccurate dose and may present clinical safety issues, especially for drugs with a narrow therapeutic window in which large fluctuations in drug concentrations are undesirable. It is recommended to use tablets with the exact desired dose, but if this is not an option, then a tablet splitter could be used.
Highlights
Tablet splitting is a known practice in inpatient and outpatient settings
Some studies revealed that splitting may result in the administration of an inaccurate dose, which can be of significant risk, especially if the split tablet formulation has a narrow therapeutic index [4,5]
When comparing hand splitting and tablet cutter procedures, a higher accuracy of tablet splitting was reported for tablet cutting devices versus hand splitting [15]
Summary
Several studies studied the advantages of tablet splitting with regard to the health outcomes of patients, within the geriatric and psychiatric communities These advantages include dose adjustment [1], ease of swallowing and cost savings [2,3]. Studies have suggested that splitting lisinopril tablets does not result in a significant change in blood pressure in patients with hypertension when comparing patients taking split lisinopril tablets versus whole lisinopril tablets [16]. This crossover study design on lisinopril did not indicate how the patients were instructed to split their tablets, nor did it address the individual outcome variations (i.e., only reported variations in the group outcomes). The purpose of our current study is to investigate the difference in the weight variation of the lisinopril split tablets (model drug) using two different tablet splitting methods and to analyse the impact of splitting lisinopril tablets on certain physical parameters such as the friability, dissolution and disintegration
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