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 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.
journal_name
Pharm Dev Technoljournal_title
Pharmaceutical development and technologyauthors
Goode GA,Wagh SJ,Irby DJ,Ma D,Jacobs RF,Kearns GL,Almoazen Hdoi
10.1080/10837450.2019.1624771subject
Has Abstractpub_date
2019-10-01 00:00:00pages
1038-1043issue
8eissn
1083-7450issn
1097-9867journal_volume
24pub_type
杂志文章,随机对照试验abstract::Starches obtained from four different Dioscorea species namely White (D. rotundata), Bitter (D. dumetorum), Chinese (D. oppositifolia) and Water yam (D. alata), were modified by acid hydrolysis and the physicochemical, material and tablet formation properties of the starches were investigated with the aim of determini...
journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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