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Pharmacokinetics of Propafenone Hydrochloride Sustained-Release Capsules in Male Beagle Dogs

Pharmacokinetics of Propafenone Hydrochloride Sustained-Release Capsules in Male Beagle Dogs

Liping Pan, Yafang Qian, Minlu Cheng, Pan Gu, Yanna He, Xiaowen Xu, Li Ding

Acta Pharm Sin B. 2015 Jan;5(1):74-8.

PMID: 26579428

Abstract:

This paper describes the development and validation of a liquid chromatography-mass spectrometric assay for propafenone and its application to a pharmacokinetic study of propafenone administered as a new propafenone hydrochloride sustained-release capsule (SR-test), as an instant-release tablet (IR-reference) and as the market leader sustained-release capsule (Rythmol, SR-reference) in male beagle dogs (n=8). In Study A comparing SR-test with IR-reference in a crossover design T max and t 1/2 of propafenone for SR-test were significantly higher than those for IR-reference while C max and AUC were lower demonstrating the sustained release properties of the new formulation. In Study B comparing SR-test with SR-reference the observed C max and AUC of propafenone for SR-test (124.5±140.0 ng/mL and 612.0±699.2 ng·h/mL, respectively) were higher than for SR-reference (78.52±72.92 ng/mL and 423.6±431.6 ng·h/mL, respectively) although the differences were not significant. Overall, the new formulation has as good if not better sustained release characteristics to the market leader formulation.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP34183227-A	Propafenone hydrochloride		34183-22-7	Price

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