کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2474752 1113161 2015 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs
ترجمه فارسی عنوان
فارماکوکینتیک کپسولهای پروپیفنون هیدروکلراید پایدار در سگهای سگ نر
کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی

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 Tmax and t1/2 of propafenone for SR-test were significantly higher than those for IR-reference while Cmax and AUC were lower demonstrating the sustained release properties of the new formulation. In Study B comparing SR-test with SR-reference the observed Cmax 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.

This paper compares the pharmacokinetics of propafenone administered as a new formulation of sustained-release capsules with those for instant-release tablets and the market leader sustained-release capsules in male beagle dogs. The results show the new sustained-release capsule provides significantly slower release than from the instant-release tablet and similar pharmacokinetics to the market leader sustained-release capsules.Figure optionsDownload as PowerPoint slide

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Acta Pharmaceutica Sinica B - Volume 5, Issue 1, January 2015, Pages 74–78
نویسندگان
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