James E Polli1, Sharon Kim, Brian R Martin. 1. University of Maryland School of Pharmacy, 20 North Pine St., Baltimore, MD 21201, USA. jpolli@rx.umaryland.edu
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.
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.
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