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Cited by 20Pharmaceutical studies and practicesEpilepsy research and treatmentPharmacy and Medical Practices

Tablet Splitting of Antiepileptic Drugs in Pediatric Epilepsy: Potential Effect on Plasma Drug Concentrations

Nidanapu, Ravi Prasad, Rajan, Sundaram, Mahadevan, Subramanian, Gitanjali, Batmanabane·2016·Pediatric Drugs
DOI 10.1007/s40272-016-0193-1
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Abstract

Introduction Tablet splitting is the process of dividing a tablet into portions to obtain a prescribed dose of medication. Very few studies have investigated whether split parts of a tablet deliver the expected amount of drug to patients. Objective Our objectives were to evaluate the split parts of adult-dose tablet formulations for percentage of weight deviation, weight uniformity, weight loss, drug content, and the content uniformity of four antiepileptic drugs (AEDs) prescribed to pediatric patients. We also measured AED plasma concentrations in the children. Methods We chose to study first-line AEDs (phenytoin sodium [PHE], sodium valproate [SVA], carbamazepine, and phenobarbitone) as they are routinely prescribed in India. We asked caregivers to perform the same splitting process they follow in their homes on three whole tablets during their routine visit to the outpatient department. After caregivers split the tablets, we studied the weight and content of the split parts. We also used high-performance liquid chromatography to study plasma drug concentrations in children who had received split AEDs for at least 4 months. Results A total of 168 caregivers participated in the study, and we analyzed 1098 split tablet parts. In total, 539 (49.0 %) split parts were above the specified limit of the 2010 Indian Pharmacopeia (IP) acceptable percentage weight deviation (PHE 169 [48.8 %], SVA 187 [51.9 %], carbamazepine 56 [41.1 %], phenobarbitone 127 [49.6 %]); 456 (41.5 %) split…

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  • In one included study, over three-quarters of participants stated they would pay more for a lower dosage strength, with the median amount being 20% over the original prescription price.

    “over three-quarters of participants interviewed within this study stated that they would pay more for a lower dosage strength, with the median amount being 20% over the original price of the prescription.26”

    From Does splitting a tablet obtain an accurate dose? A systematic review and meta‐ analysis (2022) · cites this paper as [26]

  • In one included study, given the choice, 96.8% of volunteers would prefer a lower-dose formulation rather than splitting a tablet.

    “given the choice, 96.8% of volunteers would prefer a lower-dose formulation rather than splitting a tablet.”

    From Does splitting a tablet obtain an accurate dose? A systematic review and meta‐ analysis (2022) · cites this paper as [26]

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Authors
Nidanapu, R. P., Rajan, S., Mahadevan, S., & Gitanjali, B.
Affiliations
Jawaharlal Institute of Post Graduate Medical Education and Research (IN)
ORCID
Mahadevan, Subramanian
Venue
Pediatric Drugs
Publisher
Springer Science and Business Media LLC
Published
2016-10-05
Volume
18
Issue
6
Pages
451-463
ISSN
  • 1174-5878 (ISSN-L)
  • 1179-2019
DOI
10.1007/s40272-016-0193-1
OpenAlex
W2528302134
Cited by
20
References
0
Citations by year
2026: 1 · 2024: 1 · 2022: 3 · 2021: 4 · 2020: 4 · 2019: 2 · 2018: 2 · 2017: 1 · 2016: 1
FWCI
2.33
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (unspecified)
Locations
  • Pediatric Drugs (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Psychiatry and Mental health › Epilepsy research and treatment
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacy and Medical Practices
Keywords
tablet splitting, antiepileptic drugs, pediatric epilepsy, dose accuracy, weight variation, content uniformity, phenytoin sodium, valproic acid, carbamazepine, phenobarbital, plasma drug concentration, caregivers, drug dosing, India
MeSH terms
Anticonvulsants, Chemistry, Pharmaceutical, Child, Child, Preschool, Epilepsy, Female, Humans, Infant, Male, Pediatrics, Tablets

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