Original Article
Accuracy of tablet splitting: Comparison study between hand splitting and tablet cutter

https://doi.org/10.1016/j.jsps.2013.12.014Get rights and content
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Abstract

Background

Tablet splitting is often used in pharmacy practice to adjust the administered doses. It is also used as a method of reducing medication costs.

Objective

To investigate the accuracy of tablet splitting by comparing hand splitting vs. a tablet cutter for a low dose drug tablet.

Methods

Salbutamol tablets (4 mg) were chosen as low dose tablets. A randomly selected equal number of tablets were split by hand and a tablet cutter, and the remaining tablets were kept whole. Weight variation and drug content were analysed for salbutamol in 0.1 N HCl using a validated spectrophotometric method. The percentages by which each whole tablet’s or half-tablet’s drug content and weight difference from sample mean values were compared with USP specification ranges for drug content. The %RSD was also calculated in order to determine whether the drugs met USP specification for %RSD. The tablets and half tablets were scanned using electron microscopy to show any visual differences arising from splitting.

Results

27.5% of samples differed from sample mean values by a percentage that fell outside of USP specification for weight, of which 15% from the tablet cutter and 25% from those split by hand fell outside the specifications. All whole tablets and half tablets met the USP specifications for drug content but the variation of content between the two halves reached 21.3% of total content in case of hand splitting, and 7.13% only for the tablet cutter. The %RSDs for drug content and weight met the USP specification for whole salbutamol tablets and the half tablets which were split by tablet cutter. The halves which were split by hand fell outside the specification for %RSD (drug content = 6.43%, weight = 8.33%). The differences were visually clear in the electron microscope scans.

Conclusion

Drug content variation in half-tablets appeared to be attributable to weight variation occurring during the splitting process. This could have serious clinical consequences for medications with a narrow therapeutic-toxic range. On the basis of our results, we recommend to avoid tablet splitting whenever possible or the use of an accurate tablet splitting device when splitting cannot be avoided.

Keywords

Salbutamol
Tablets
Low dose
Weight variation
Drug content
Electron microscopic scan
Hand splitting
Tablet cutter
Tablet splitter
Half tablets

Cited by (0)

Peer review under responsibility of King Saud University.

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