Invention Grant
US07767227B2 Galenical form for oral administration with prolonged release of molsidomine 有权
用于长时间释放莫西多胺的口服给药的格列尼霉素

Galenical form for oral administration with prolonged release of molsidomine
Abstract:
The present invention relates to a novel sustained-release oral galenical form of molsidomine for the treatment of all forms of angina attack (angina of effort, spastic angina, mixed angina). According to the invention, this novel galenical form contains a therapeutically effective amount of molsidomine or one of its active metabolites and has an in vitro dissolution rate [measured spectrophotometrically at 286 or 311 nm by the method described in the European Pharmacopoeia, 3rd edition (or USP XXIV), at 50 rpm, in 500 ml of a 0.1 N HCl medium, at 37° C.] of: 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 and >90% of molsidomine released after 24 hours, the plasma peak of molsidomine obtained in vivo occurring 2.5 to 5 hours, preferably 3 to 4 hours, following the administration of said form, and having a value of between 25 and 40 ng/ml of plasma. Application: therapeutics industry.
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