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

Abstract

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 T_max parameters. A two one-sided test (TOST) suggested a difference in AUC_∞ and C_max 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.

Keywords:

• Amberlite IRP 69
• bioequivalent
• clindamycin
• ion exchange resin
• pediatric formulations
• pharmacokinetics
• piglet
• taste masking

Acknowledgements

The authors gratefully acknowledge the financial support provided by the Arkansas Children’s Research Institute (ACRI) and the efforts of Mr. Blake Harrison and the staff of the ACRI large animal research facility. Support from the University of Tennessee–Memphis is also acknowledged.

Disclosure statement

None of the coauthors have an apparent conflict of interest pertaining to the products used in this investigation or the development of the manuscript.