Weight uniformity of split tablets required by a Veterans Affairs policy

J Manag Care Pharm. 2003 Sep-Oct;9(5):401-7. doi: 10.18553/jmcp.2003.9.5.401.

Abstract

Objective: To split several tablet products relevant to the Veterans Affairs (VA) Maryland Healthcare System and assess whether the resulting half tablets provide equal doses.

Methods: From a VA list of products that are required to be split, 7 products were evaluated, along with 5 other commonly split tablet products. A trained pharmacy student split tablets using a tablet splitter provided by the VA. Half tablets were assessed for weight uniformity.

Results: Of the 12 products subjected to splitting, 8 products (atorvastatin, citalopram, furosemide, glipizide, metoprolol, paroxetine, sertraline, and warfarin) yielded half tablets that passed the weight-uniformity test. The 4 failing products were lisinopril, lovastatin, rofecoxib, and simvastatin. Unusual tablet shape and high tablet hardness predisposed products to failing the weight-uniformity test. The 4 failing products resulted in half tablets that were generally within 20% of their target weight range, suggesting that splitting these specific products would not result in adverse therapeutic effects due to dose variation created by tablet-splitting.

Conclusion: Split-tablet results were relatively favorable and generally support a VA practice to split specific tablets. Public quality standards for half tablets, including their content uniformity, are needed to better delineate the policies for acceptable tablet splitting.

MeSH terms

  • Dose-Response Relationship, Drug
  • Maryland
  • Pharmaceutical Preparations / standards*
  • Tablets / standards
  • United States
  • United States Department of Veterans Affairs

Substances

  • Pharmaceutical Preparations
  • Tablets