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CRYSTALLINE BASE OF ESCITALOPRAM AND ORODISPERSIBLE TABLETS COMPRISING ESCITALOPRAM BASE

机译:秘方的水晶基和包含秘方的可食药片剂

摘要

The present invention relates to the crystalline base of the well known antidepressant drug escitalopram, S -1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzo-furancarbonitrile, formulations of said base, a process for the preparation of purified salts of escitalopram, such as the oxalate, using the base, the salts obtained by said process and formulations containing such salts, and a process for the preparation of purified escitalopram free base or salts of escitalopram, such as the oxalate, using the hydrobromide, the salts obtained by said process and formulations containing such salts. Finally the present invention relates to an orodispersible tablet having a hardness of at least 22 N and an oral-disintegration time of less than 120 s and comprising an active pharmaceutical ingredient adsorbed onto a water soluble filler wherein the active pharmaceutical ingredient has a melting point in the range of 40-100 °C, as well as a method for making such an orodispersible tablet.
机译:本发明涉及众所周知的抗抑郁药艾司西酞普兰S -1- [3-(二甲基氨基)丙基] -1-(4-氟苯基)-1,3-二氢-5-异苯并呋喃甲腈的结晶基质,制剂所述碱,使用所述碱制备艾司西酞普兰纯化的盐例如草酸盐的方法,通过所述方法获得的盐和含有此类盐的制剂以及制备纯化的艾司西酞普兰游离碱或其盐的方法使用氢溴酸盐的艾司西酞普兰,例如草酸盐,通过所述方法获得的盐和含有这种盐的制剂。最后,本发明涉及一种口腔分散片剂,其具有至少22N的硬度和小于120s的口腔崩解时间,并且包含吸附在水溶性填充剂上的活性药物成分,其中所述活性药物成分的熔点为1℃。 40-100℃的温度范围,以及制备这种口腔分散片剂的方法。

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