Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

Polli, James E.; Kim, Sharon; Martin, B.R.

doi:10.18553/jmcp.2003.9.5.401

Cited by 41 publications

(39 citation statements)

References 19 publications

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“…A similar study performed by Polli et al assessed content uniformity through the analysis of half-tablet weights using the same adapted USP methods as used by Teng et al 7 In contrast to the results found by Teng et al, this study, performed at a Department of Veterans Affairs (VA) center, found that 8 out of 12 medications split with a tablet-splitting device passed the adapted uniformity test. 7 Another study analyzed the drug weight uniformity of cyclobenzaprine tablets split in half using either a tablet splitter or a kitchen knife.…”

Section: What This Study Addsmentioning

confidence: 71%

“…7 Another study analyzed the drug weight uniformity of cyclobenzaprine tablets split in half using either a tablet splitter or a kitchen knife. 8 The results showed that both methods resulted in a wide variation in fragment weight between 49.9% to 149.5% of the theoretical weight (defined as one-half of the mean weight of the intact tablet) using a kitchen knife and 69.4% to 130.2% using the tablet splitter.…”

Section: What This Study Addsmentioning

confidence: 99%

See 1 more Smart Citation

Analysis of Drug Content and Weight Uniformity for Half-Tablets of 6 Commonly Split Medications

Hill¹,

Varker²,

Karlage³

et al. 2009

JMCP

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BACKGROUND: Cost savings can be achieved with the practice of tablet splitting. Previous research has shown weight nonuniformity within tablet halves. However, limited research to date has found that the potential dose inaccuracy resulting from splitting tablets does not significantly affect clinical outcomes. OBJECTIVE: To determine the drug content and weight in split half-tablets of 6 commonly split medications using drug assay analysis. METHODS: This study was performed by 2 fourth-year pharmacy students using 30 randomly selected tablets of each of the following 6 medications: warfarin sodium 5 milligrams (mg), simvastatin 80 mg, metoprolol succinate 200 mg, metoprolol tartrate 25 mg, citalopram 40 mg, and lisinopril 40 mg. A randomly selected half of the tablets were split by a single pharmacy student using a tablet cutter, and the remaining tablets were kept whole. Drug content was analyzed for 15 whole tablets and 30 half-tablets for each of the 6 drugs using high performance liquid chromatography, an analytical tool used to identify and quantify substances in solution. Drug content uniformity was assessed by comparing drug content within halftablets with one-half of the drug content mean found for all whole tablets in the sample. Weight uniformity was assessed by comparing half-tablet weights, as determined by a Mettler analytical balance, with one-half of the mean weight for whole tablets in the sample. The percentages by which each whole tablet's or half-tablet's drug content and weight differed from sample mean values were compared with proxy United States Pharmacopeia (USP) specification ranges for drug content (95%-105% for warfarin sodium and 90%-110% for the other 5 drugs). Additionally, these outcomes were compared for nonscored versus scored tablets. The percent relative standard deviation (%RSD, ratio of the standard deviation to the mean), a commonly used measure of the repeatability and precision of assays used to analyze drug content, was also calculated in order to determine whether the drugs met proxy USP specification for %RSD (less than 6% for all drugs studied). RESULTS: A total of 43 of 180 half-tablets (23.9%) differed from sample mean values by a percentage that fell outside of proxy USP specification for drug content; warfarin sodium (11 of 30 half-tablets, 36.7%), simvastatin (3 of 30 half-tablets, 10.0%) metoprolol succinate (10 of 30 half-tablets, 33.3%), metoprolol tartrate (4 of 30 half-tablets, 13.3%), citalopram (5 of 30 half-tablets, 16.7%), and lisinopril (10 of 30 half-tablets, 33.3%). Half-tablets outside of proxy USP specification for weight included warfarin sodium (10 of 30 half-tablets, 33.3%), metoprolol succinate (6 of 30 half-tablets, 20%), and lisinopril (7 of 30 half-tablets, 23.3%). The %RSDs for drug content and weight fell outside of the proxy USP specification for %RSD for metoprolol succinate (drug content = 8.98%, weight = 7.70%) and lisinopril (drug content = 10.41%, weight = 8.13%). Mean percent weight loss after splitting was less than 1% for al...

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Section: What This Study Addsmentioning

confidence: 71%

Section: What This Study Addsmentioning

confidence: 99%

Analysis of Drug Content and Weight Uniformity for Half-Tablets of 6 Commonly Split Medications

Hill¹,

Varker²,

Karlage³

et al. 2009

JMCP

View full text Add to dashboard Cite

show abstract

“…Another study performed by Polli et al (2003) found that 4 of 12 medications failed the weight uniformity test with a variation up to 20% of the theoretical half weight, according to an adapted USP Uniformity of Dosage Units criterion for whole tablets. They also pointed that split-tablets of lovastatin, lisinopril, rofecoxib, and simvastatin were out of %RSD specification, with %RSD values ranging from 10.4 to 21.1% (30).…”

Section: Resultsmentioning

confidence: 99%

Evaluation of Quality Attributes of Propranolol Split Tablets: Focus on Dose Variability

Eserian

Lombardo

2017

Infarma

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Tablet splitting is a widespread practice among patients and health professionals aiming the administration of lower doses and the reduction of the cost of prescriptions. Nevertheless, potential concerns such as weight variation, stability and uneven drug content of the halves are related to this practice. The objective of this study was to evaluate the uniformity of half-tablets regarding weight and drug content in three different commercial products containing propranolol. Also, it was assessed drug content for whole tablets. Weight variation and drug content uniformity tests were evaluated for whole and split tablets, as well as the weight loss due to the splitting process. Drug content evaluation for whole tablets showed that all products were satisfactory. All the products were approved in the weight variation and drug content uniformity tests before splitting, with results close to 100%, but the halves of all products failed the tests, presenting a high variability between the portions. In one of the products, halves ranged from 75.5 to 120.4% of the target drug content, indicating that when administered to patients, daily doses may vary around 45%. Splitting propranolol tablets might compromise clinical treatment, affecting blood pressure and consequently producing side effects. Clinical implications due to tablet splitting might not be critical in some cases. Nevertheless, the high variability between doses should be considered by healthcare professionals when prescribing a therapy involving this practice.Keywords: tablet splitting; uniformity of dosage; propranolol RESUMO A divisão de comprimidos é uma prática comum entre pacientes e profissionais da área de saúde visando à administração de doses mais baixas e redução do custo do tratamento. No entanto, problemas potenciais como variação no peso, estabilidade e distribuição desigual de substância ativa nas metades estão relacionados a esta prática. O objetivo deste estudo foi avaliar a uniformidade de comprimidos divididos em relação ao peso e conteúdo de substância ativa em três medicamentos comerciais diferentes contendo propranolol. Também avaliou-se o teor dos comprimidos inteiros. A determinação de peso e uniformidade de conteúdo foram avaliadas tanto nos comprimidos inteiros quanto nas metades, assim como a perda de massa devido ao processo de divisão. O ensaio de teor dos comprimidos inteiros foi satisfatório para todos os medicamentos. Os ensaios de determinação de peso e uniformidade de conteúdo apresentaram resultados satisfatórios para todos os medicamentos antes do processo de divisão, com resultados próximos a 100%, mas suas metades apresentaram resultados insatisfatórios, evidenciados pela alta variabilidade entre as mesmas. Em um dos medicamentos, as metades variaram de 75,5 a 120,4% do conteúdo de substância ativa, indicando que, quando administradas aos pacientes, as doses podem variar cerca de 45%. Dividir comprimidos de propranolol pode comprometer o tratamento clínico, afetando a pressão sanguínea e consequentemente produzind...

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“…10 One source identified annual savings of approximately $342,000 through tablet-splitting in a plan with $10 million in annual pharmacy benefit expenditures. 11 In 2004, the VA announced that splitting simvastatin tablets saved $46.5 million systemwide in fiscal year 2003.…”

Section: Tablet Splitting As a Managed Care Issuementioning

confidence: 99%

Tablet Splitting: Much Ado About Nothing?

Navarro

2009

JMCP

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Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

Cited by 41 publications

References 19 publications

Analysis of Drug Content and Weight Uniformity for Half-Tablets of 6 Commonly Split Medications

Analysis of Drug Content and Weight Uniformity for Half-Tablets of 6 Commonly Split Medications

Evaluation of Quality Attributes of Propranolol Split Tablets: Focus on Dose Variability

Tablet Splitting: Much Ado About Nothing?

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