Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs.
10.1016/j.apsb.2014.11.003
- Author:
Liping PAN
1
;
Yafang QIAN
1
;
Minlu CHENG
1
;
Pan GU
1
;
Yanna HE
1
;
Xiaowen XU
1
;
Li DING
1
Author Information
1. Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
- Publication Type:Journal Article
- Keywords:
Beagle dog;
Pharmacokinetics;
Plasma;
Propafenone;
Sustained-release
- From:
Acta Pharmaceutica Sinica B
2015;5(1):74-78
- CountryChina
- Language:English
-
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.
