INVITRO RELEASE OF NITROGLYCERIN FROM TOPICAL PRODUCTS BY USE OF ARTIFICIAL MEMBRANES

被引:16
作者
WU, ST
SHIU, GK
SIMMONS, JE
BRONAUGH, RL
SKELLY, JP
机构
[1] US FDA,CDER,BIOPHARMACEUT RES BRANCH,200 C ST SW,WASHINGTON,DC 20204
[2] US FDA,CDER,OFF GENER DRUGS,WASHINGTON,DC 20204
[3] US FDA,CFSAN,DIV TOXICOL STUDIES,WASHINGTON,DC 20204
[4] US FDA,CDER,OFF RES RESOURCES,WASHINGTON,DC 20204
关键词
D O I
10.1002/jps.2600811204
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
An in vitro testing method for measuring the release of nitroglycerin from topical drug products was evaluated. The method involved measuring the amount of nitroglycerin that diffused from ointments and patches through various synthetic membranes into receptor fluid contained in a modified Franz diffusion cell. Plots of the amount of nitroglycerin released against the square root of time for all 10 synthetic membranes were linear. Five membranes (group I) were found to release nitroglycerin at similar rates (difference not significant; p > 0.05). Use of the other five membranes (group II) in diffusion cells resulted in release rates significantly slower than those of group I membranes (p < 0.05). Rapid permeation of nitroglycerin from a solution through a polysulfone membrane demonstrated a lack of significant diffusion barrier properties of this membrane. Rates of release of nitroglycerin from commercially available ointments were found to be similar. A comparison of three commercial nitroglycerin patches revealed that these products released nitroglycerin at different rates in vitro.
引用
收藏
页码:1153 / 1156
页数:4
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