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Study on Pharmacokinetics of Melatonin Orally Disintegrating Tablets and Common Tablets in Beagle Dogs

Shenghua Gu, Jianchang He, Liu Di, Guili Xu

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Abstract

OBJECTIVE To compare pharmacokinetic parameters of melatonin orally disintegrating tablets and common tablets in Beagle dogs. METHODS The plasma concentrations of melatonin in 6 Beagle dogs were determined by HPLC and the pharmacokinetic parameters were calculated with DAS software after a single dose of 6 mg melatonin common tablets or orally disintegrating tablets.RESULTS The pharmacokjinetic parameters of the orally disintegrating tablets and common tablets of melatonin were as follows:ρmax(52.2±23.0) and(37.8±22.7) μg·L-1,tmax(0.37±0.10)and(0.56±0.17)h,AUC0-6(45.52±32.39) and(43.46±29.42) μg·h·L-1,t1/2(1.05±0.76) and(1.13±0.52)h.The relative bioavailability F0-6 was(106.91±17.30)% and F0-∞was(107.62±16.71)%.CONCLUSION Compared with the common tablets,the orally disintegrating tablets showed faster absorption and higher peak concentration.The two preparations are not bioequivalent.

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OBJECTIVE To compare pharmacokinetic parameters of melatonin orally disintegrating tablets and common tablets in Beagle dogs. METHODS The plasma concentrations of melatonin in 6 Beagle dogs were determined by HPLC and the pharmacokinetic parameters were calculated with DAS software after a single dose of 6 mg melatonin common tablets or orally disintegrating tablets.RESULTS The pharmacokjinetic parameters of the orally disintegrating tablets and common tablets of melatonin were as follows:ρmax(52.2±23.0) and(37.8±22.7) μg·L-1,tmax(0.37±0.10)and(0.56±0.17)h,AUC0-6(45.52±32.39) and(43.46±29.42) μg·h·L-1,t1/2(1.05±0.76) and(1.13±0.52)h.The relative bioavailability F0-6 was(106.91±17.30)% and F0-∞was(107.62±16.71)%.CONCLUSION Compared with the common tablets,the orally disintegrating tablets showed faster absorption and higher peak concentration.The two preparations are not bioequivalent.

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Available abstract

OBJECTIVE To compare pharmacokinetic parameters of melatonin orally disintegrating tablets and common tablets in Beagle dogs. METHODS The plasma concentrations of melatonin in 6 Beagle dogs were determined by HPLC and the pharmacokinetic parameters were calculated with DAS software after a single dose of 6 mg melatonin common tablets or orally disintegrating tablets.RESULTS The pharmacokjinetic parameters of the orally disintegrating tablets and common tablets of melatonin were as follows:ρmax(52.2±23.0) and(37.8±22.7) μg·L-1,tmax(0.37±0.10)and(0.56±0.17)h,AUC0-6(45.52±32.39) and(43.46±29.42) μg·h·L-1,t1/2(1.05±0.76) and(1.13±0.52)h.The relative bioavailability F0-6 was(106.91±17.30)% and F0-∞was(107.62±16.71)%.CONCLUSION Compared with the common tablets,the orally disintegrating tablets showed faster absorption and higher peak concentration.The two preparations are not bioequivalent.

Key concepts: Beagle, Bioequivalence, Pharmacokinetics, Bioavailability, Melatonin, Pharmacology, Medicine, Oral administration

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