Accuracy of tablet splitting: Comparison study between hand splitting and tablet cutter.

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Pharmacokinetics

Background:

• Tablet splitting is a common practice in pharmacy for dose adjustment and cost reduction.
• Inaccurate tablet splitting can lead to significant variations in drug content and weight.

Purpose of the Study:

• To compare the accuracy of hand splitting versus using a tablet cutter for low-dose tablets.
• To evaluate drug content and weight variations in split tablets against United States Pharmacopeia (USP) specifications.

Main Methods:

• Salbutamol (4 mg) tablets were split manually and with a tablet cutter.
• Weight variation and drug content analysis were performed using spectrophotometry.
• Electron microscopy was used to visualize differences in split tablet surfaces.

Main Results:

• 27.5% of split tablets fell outside USP weight specifications; hand-split tablets showed higher deviation (25%) than cutter-split (15%).
• Hand-split halves exhibited up to 21.3% drug content variation, while cutter-split halves showed only 7.13% variation.
• Hand-split tablets failed USP %RSD specifications for drug content and weight, unlike cutter-split tablets.

Conclusions:

• Weight variation during splitting directly impacts drug content uniformity in half-tablets.
• Inaccurate splitting, especially by hand, poses clinical risks due to potential dose inaccuracies.
• Avoid tablet splitting when possible; if necessary, use a validated tablet splitting device for accuracy.