An orange-peppermint flavored, dispersible levofloxacin tablet was reported to be more palatable and easier to prepare by caregivers of children with multidrug-resistant tuberculosis, according to research published in The Pediatric Infectious Disease Journal. The researchers said the new formulation may be more acceptable for young children and improve adherence.
Susan E. Purchase, MD, from the department of pediatrics and child health at Stellenbosch University and the Desmond Tutu TB Centre in South Africa, and colleagues said that both patient and medicinal characteristics determine whether a product is acceptable to use. These factors may include the taste of the drug, whether a patient is able to swallow it, and its appearance, dosing and mode of administration.
“Adult formulations of moxifloxacin and levofloxacin are not dispersible and are bitter when crushed,” Purchase and colleagues wrote. “Thus, there is an urgent need for child-friendly formulations of fluoroquinolones and for any new formulations to be appropriately assessed for acceptability in children prior to their use in clinical trials and routine care.”
Children aged younger than 5 years in Cape Town, South Africa, who were exposed to a household contact with MDR-TB were given standard care, which included an adult dose of levofloxacin (250 mg), ethambutol and high-dose isoniazid. When children enrolled in the study, the standard of care was interrupted, and the patients received a weight-balanced dose (15 mg/kg to 20 mg/kg) of the dispersible levofloxacin formulation.
The researchers evaluated the dispersible drug’s acceptability among children at follow-up visits 7 to 14 days after enrollment.
All 27 patients (median age, 1.9 years) were uninfected by HIV and clinically well at enrollment. Most children (85%) were able to take the full dose of the medication or swallowed it with only “minimal spillage,” the researchers said. The dose was refused by 12% of children, and 4% spat out the dose.
Most caregivers (93%) administered the medication dissolved in water at home, but one child swallowed the tablet whole and one child was administered the medication crushed into food.
Nearly all caregivers reported that the tablet size (82%) and volume of dispersion (93%) were acceptable. Additionally, caregivers reported that the flavor-masked medication was more palatable (69%) and easier to prepare (81%) than adult levofloxacin formulations.
“The much-improved acceptability of this dispersible formulation over existing adult tablets provides strong evidence for TB programs to take up this formulation for pediatric MDR-TB therapy, as it is now WHO prequalified and available from the Global Drug Facility,” the researchers wrote. – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.