Comparative bioavailability of two zolpidem hemitartrate formulations in healthy human Brazilian volunteers using high-performance liquid chromatography coupled to tandem mass spectrometry
Gustavo D. Mendes, Thais da Silva Pereira, Julio Cesar Rodrigues, Elaine Marcilio Santos, Mariani Rafaela Souza, Rodrigo Alvaro Brandao Lopes-Martins, Natalicia de Jesus Antunes, Ronilson Agnaldo Moreno, Gilberto De Nucci
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Inglês
To assess the bioequivalence of two zolpidem hemitartrate formulations in 30 healthy volunteers. Plasma samples were obtained over a 24 h period. Plasma concentrations of zolpidem were analyzed by liquid chromatography coupled to tandem mass spectrometry with positive ion electrospray ionization...
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To assess the bioequivalence of two zolpidem hemitartrate formulations in 30 healthy volunteers. Plasma samples were obtained over a 24 h period. Plasma concentrations of zolpidem were analyzed by liquid chromatography coupled to tandem mass spectrometry with positive ion electrospray ionization using multiple reaction monitoring. Values of peak concentration (C-max), area under curve (AUC), half-life, elimination constant, volume of distribution and clearance showed statistically significant differences when comparing women (604.34 ng h/ml, 127.36 ng/ml, 4.4 h, 0.18 1/h, 50.56 L and 8.55 L/h, respectively) and men (276.1 ng h/ml, 70.9 ng/ml, 3.3 h, 0.26 1/h, 91.42 L and 24.34 L/h, respectively), receiving the same dose (5 mg), respectively. The geometric means with corresponding 90% confidence interval for Test/Reference percentage ratios were 99.73% (CI 93.69-106.16) for C-max,C- 97.44% (90% CI = 91.85-103.37%) for area under curve of plasma concentration until the last concentration observed (AUC(last)) and 98.30% (90% CI = 92.48-104.49) for the area under curve between the first sample (pre-dosage) and infinity (AUC(0-inf)). Since the 90% CI for AUC(last), AUC(0-inf) and C-max ratios were within the 80-125% interval proposed by the US Food and Drug Administration, it was concluded that zolpidem hemitartrate formulation (5 mg orodispersible tablet) is bioequivalent to the zolpidem hemitartrate formulation (Patz SL 5 mg sublingual tablet) with regard to both the rate and the extent of absorption. A new formulation of zolpidem 2.5 mg may be useful in women for the same clinical benefits as the 5 mg formulation in men.
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Comparative bioavailability of two zolpidem hemitartrate formulations in healthy human Brazilian volunteers using high-performance liquid chromatography coupled to tandem mass spectrometry
Gustavo D. Mendes, Thais da Silva Pereira, Julio Cesar Rodrigues, Elaine Marcilio Santos, Mariani Rafaela Souza, Rodrigo Alvaro Brandao Lopes-Martins, Natalicia de Jesus Antunes, Ronilson Agnaldo Moreno, Gilberto De Nucci
Comparative bioavailability of two zolpidem hemitartrate formulations in healthy human Brazilian volunteers using high-performance liquid chromatography coupled to tandem mass spectrometry
Gustavo D. Mendes, Thais da Silva Pereira, Julio Cesar Rodrigues, Elaine Marcilio Santos, Mariani Rafaela Souza, Rodrigo Alvaro Brandao Lopes-Martins, Natalicia de Jesus Antunes, Ronilson Agnaldo Moreno, Gilberto De Nucci
Fontes
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Biomedical chromatography (Oct., 2019), n. art. e4731 |