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Lack of medication dose uniformity in commonly split tablets
Jaja Teng1, Clara K Song, Roger L Williams
1School of Pharmacy, University of Maryland-Baltimore, 21201, USA.
Journal of the American Pharmaceutical Association (Washington, D.C. : 1996)
|April 3, 2002
Summary
Splitting tablets often results in uneven doses, failing uniformity tests. This practice is not recommended for medications with significant toxicity or steep dose-response curves.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation and Delivery
Background:
- Tablet splitting is a common practice for dose adjustment or cost savings.
- Concerns exist regarding the accuracy and uniformity of doses after tablet division.
Purpose of the Study:
- To evaluate the content uniformity of half-tablets created from 11 commonly split pharmaceutical products.
- To assess the reliability of tablet splitting for achieving accurate dosing.
Main Methods:
- A pre-post comparison design was employed in a laboratory setting.
- Tablets were split using a razor blade (11 products) or by hand (3 products).
- The United States Pharmacopeia (USP) Uniformity of Dosage Units test was adapted to assess split tablets.
Main Results:
- Eight out of 11 razor-split products failed the adapted uniformity test.
- All three hand-split products failed the uniformity test, showing poorer results than razor-split tablets.
- No visible tablet characteristics predicted successful splitting for uniformity.
Conclusions:
- The majority of tested drug products, when split, did not meet content uniformity standards.
- Tablet splitting is not advisable for drugs with high toxicity or steep dose-response curves.
- While potentially acceptable for low-toxicity drugs, splitting poses risks for dose accuracy.