Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2005-12-09
2011-12-06
Wax, Robert A (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
active
08071125
ABSTRACT:
This invention relates to a transdermal patch in the form of a layer complex, comprising a backing layer, a drug-reservoir layer comprising pharmacologically active ingredients and pharmaceutically acceptable adjuvants, and a release liner covering the drug-reservoir layer, characterized in that the drug-reservoir layer comprises isosorbide dinitrate and Bisoprolol at a ratio of 1:3 to 3:1 by weight, as the pharmacologically active ingredients. Animal tests show that said patch can reduce the elevation of T wave of cardiogram, the increase of the level of myocardial enzyme in blood serum, and the extension of the range of myocardial infarction caused by ligating the coronary artery in animals. Results show that said patch exhibits a considerable synergistic effect in the treatment of cardiovascular diseases and has good preventive and therapeutic effects on several adverse events on heart. In addition, the animal tests show that the patch according to the invention has a better pressure-reducing effect than the application of the patch containing only one of isosorbide dinitrate and Bisoprolol, and does not worsen the arrhythmia that is easily caused by the application of the patch containing only isosorbide dinitrate or Bisoprolol.
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Lui, W., “Analysis of Therapeutic Effect of the Compatibility of Metoprolol with ISOSORBIDE Dinitrate for the Treatment of Angina Pectoris” (1999) pp. 54, vol. 18(1), together with English Translation.
De Divitiis O. et al., “Bisoprolol in the Treatment of Angina Pectoris: A Double Blind Comparison with Verapamil”,European Heart Journal 8(supplement M):43-54 (1987).
Portegies M.C.M. et al., “Effects of Bisoprolol and Isosorbide Dinitrate on the Circadian Distribution of Myocardial Ischema”,Current Therapeutic Research 56(12):1225-1236 (1995).
Fan Xiaoling
Li Chun
Lu Yucheng
Song Li
Wang Li
Barham Bethany
Beijing Kangbeide Pharmaceutical Technology Development Co., Ltd
Scully , Scott, Murphy & Presser, P.C.
Wax Robert A
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