Bioavailability testing of a newly developed clindamycin oral suspension in a pediatric porcine model.

Background: Clindamycin's bitter taste and odor is known to affect treatment adherence in children. Recently, a formulation of clindamycin HCl complexed with ion exchange resin IRP 69 was shown to mask the bitter taste. Because of the potential benefit of this formulation for children, a pilot study using a porcine model was conducted to evaluate its relative bioavailability. Methods: A randomized two-way crossover study design using six (n = 6) healthy male piglets 10-12 kg was used to evaluate the absorption profiles and pharmacokinetic parameters of clindamycin from the resinate complex formulation (Test) compared to a commercialized reference suspension. A dose of 15 mg/kg was administered orally by gastric gavage to each piglet followed by repeated blood sampling over 12 h. A wash-out period of 48 h occurred between treatments. Plasma concentration vs. time data was analyzed by non-compartmental analysis. Results: The mean relative bioavailability of clindamycin from the resinate formulation was 78.8%. A two-tailed, paired Student t test yielded a p < 0.05 for AUC∞ and Tmax parameters. A two one-sided test (TOST) suggested a difference in AUC∞ and Cmax for the Test formulation compared to the reference formulation according to the FDA's criteria for bioequivalence. Conclusion: The bioavailability of clindamycin from this novel oral formulation supports continued evaluation of the drug in humans for potential pediatric applications.

A Pilot Comparison of High- Versus Low-Tech Palatability Assessment Tools in Young Children.

BACKGROUND: Medication refusal in children is largely driven by aversive taste profiles, which in turn influence adherence and therapeutic outcomes. However, there are no standardized methods for evaluating taste in young children. This study compares facial recognition technology with three hedonic visual scales in this population. METHODS: Children, 3-7 years of age, were enrolled with informed parental permission into an institutional review board-approved, double-blind, randomized investigation. Each child received three test articles: prednisone (bitter), simple syrup (sweet), and filtered water (neutral), with an appropriate washout. Facial recognition software (Noldus FaceReader 7) recorded facial expression and intensity for 30-60 s after administration. Participants subsequently rated taste using three hedonic scales (5-point Sjövall and 5- and 3-point TASTY) and responded to simple questions on their perception of the test article. Repeated measures analysis of variance and multiple regression analysis were used to explore associations between palatability measures. RESULTS: Twelve children (seven males: ten white and two black) completed the study without adverse effects. There were no significant differences in participant characteristics by randomization sequence. The three hedonic scales tracked similarly for each test substance, with correlations between the 5-point scales (r = 0.899) comparable to those between the 3- and 5-point scales (r = 0.860-0.903). Hedonic scales appeared more reliable in assessing taste response than facial recognition, which did not effectively discriminate positive and negative responses. CONCLUSIONS: Our experience suggests that the TASTY scales appear to offer the greatest promise for assessing palatability in future clinical use.