| 摘要 |
The invention concerns a novel galenical form for oral administration with prolonged release of molsidomine for treating angina attack in its various forms (exertion angina, spastic angina, mixed angina). The invention is characterised in that said novel galenical form contains a therapeutically efficient amount of molsidomine or one of its active metabolites and it has the following dissolution rate in vitro [measured by spectrophotometry at 286 or 311 nm according to the European Pharmacopeia, 3rd edition (or U.S.P XXIV) at 50 r.p.m in 500 ml of a HCl 0,1N medium, at 37 o??]: 15 to 25 % of molsidomine released after 1 hour, 20 to 35 % of molsidomine released after 2 hours, 50 to 65 % of molsidomine released after 6 hours, 75 to 95 % of molsidomine released after 12 hours, > 85 % of molsidomine released after 18 hours, > 90 % of molsidomine released after 24 hours, the plasma peak of molsidomine obtained in vivo occurring between 2.5 to 5 hours, preferably between 3 to 4 hours, depending on the administration of said form and exhibiting a value between 25 and 40 ng/ml of plasma. The invention has therapeutic uses.
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