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metadata.dc.type: | Artigo de Periódico |
Title: | A PK/PD approach on the effects of clarithromycin against oral and nasal microbiota of healthy volunteers |
Authors: | Ruenis, Ana Paula Del Bortolo Franco, Gilson César Nobre Baglie, Sinvaldo Motta, Rogério Heládio Lopes Simões, Roberta Pessoa Simões Rosalen, Pedro Luiz Franco, Luís Fernando Mercier Moreno, Ricardo Alberto Abib Junior, Eduardo Groppo, Francisco Carlos |
Abstract: | Objective: To assess the pharmacokinetics of clarithromycin (CLR) and its effects oil oral and nasal microbiota in healthy volunteers in an open, randomized, two-period crossover design. Methods: A single 500 mg oral dose of CLR (Group 1: Merck Group 2: Klaricid) was administered observing a 1-week interval between doses. Blood samples were collected from pre-dose to 24 h. plasmatic concentrations of CLR were quantified by the LC-MS-MS method. Saliva and nasal mucosa swabs were obtained previously and after 1.33, 2, 6 and 12 11 of drug administration. Pharmacokinetics and PK/PD (t>MIC, %t>MIC and AUC(0-24)/MIC ratio) parameters were estimated. The microogranism counts were obtained on different Culture media. Results: No statistically significant differences were observed between the two formulations (p>0.05) regarding the pharmacokinetic parameters. Total microorganisms, staphylococci and streptococci counts did not show statistical differences (p>0.05) between the two groups during each sampling time. Considering the microorganisms of each group, no statistically significant differences were found after drug administration, but all differed from pre-dose Counts (p<0.05). The observed t>MIC ranged from 14.45 h (+/- 1.69) to 1.19 h (+/- 2.17) considering MICs of 0.25 mu g/ml and 2.0 mu g/ml, respectively. There was no correlation between any t>MIC %t>MIC or AUC(0-24) and bacterial reduction (between 0- and 12-h periods), However, the profile or reduction Of Microorganisms in both saliva and nasal samples were compatible with high values of %t>MIC verified for both clarithromycin formulations. Conclusion: Both formulations of clarithromycin had similar pharmacokinetics and efficacy. |
metadata.dc.language: | Inglês |
metadata.dc.publisher.country: | Alemanha |
Publisher: | Dustri-Verlag Dr Karl Feistle |
metadata.dc.rights: | Em verificação |
URI: | http://repositorio.unitau.br/jspui/handle/20.500.11874/3178 |
Issue Date: | 2009 |
Appears in Collections: | Artigos de Periódicos |
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