Splitting adult-strength formulations of antiepileptic drugs (AEDs) led to pediatric patients not receiving the optimal dose, a study published in Pediatric Drugs has found.
Not many studies have evaluated whether split parts of a tablet provide the expected amount of drug to patients. Researchers from the Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India, aimed to evaluate the split parts of adult-dose tablets for their percentage of weight deviation, weight uniformity, weight loss, drug content, and content uniformity of 4 AEDs prescribed to pediatric patients. Study authors also measured AED plasma concentrations in the pediatric patients using high-performance liquid chromatography for at least 4 months.
Phenytoin sodium, sodium valproate, carbamazepine, and phenobarbitone were chosen for analysis. At their routine outpatient visits, a total of 168 caregivers were asked to perform the same tablet splitting process for 3 whole tablets as they usually did in their homes. After the tablets were split, researchers analyzed their weight and content.
Of the total 1,098 split tablet parts examined, 539 (49%) split parts were above the specified limit of the acceptable percentage weight deviation: phenytoin (48.8%), sodium valproate (51.9%), carbamazepine (41.1%), phenobarbitone (49.6%). The authors also noted that 456 (41.5%) split parts were not within the proxy specification for drug content: phenytoin (39.0%), sodium valproate (38.8%), carbamazepine (37.5%), phenobarbitone (50.7%), and 253 split parts were outside the acceptable content uniformity range of <85% and >115%.
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Overall findings indicated that 72.2% of patients exhibited plasma drug concentrations outside the therapeutic range: phenytoin (72.0%), sodium valproate (78.0%), carbamazepine (68.0%), phenobarbitone (70.0%).
Adult dosage AED tablets that were split led to suboptimal plasma drug concentrations and dose in the recipients, the authors concluded. Pediatric dosage formulations should be preferred over splitting adult-dosage formulations for pediatric epilepsy.
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