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DOSAGE FORM WITH ACE INHIBITOR
专利权人:
HEXAL AKTIENGESELLSCHAFT
发明人:
WOLF, Claudia
申请号:
EPEP2017/068335
公开号:
WO2018/019694A1
申请日:
2017.07.20
申请国别(地区):
WO
年份:
2018
代理人:
摘要:
The present invention is directed to a pharmaceutical dosage form exhibiting improved stabilization of an angiotensin-converting-enzyme inhibitor (ACE inhibitor) present therein. The dosage form comprises the angiotensin-converting-enzyme inhibitor and a stabilizer and has at least two separate portions, wherein the angiotensin-converting-enzyme inhibitor is contained in one of the portions and the stabilizer compound is contained in another portion. The dosage form can make use of an intra- granular/extra-granular structure, wherein preferably the ACE inhibitor compound is placed within the intra-granular portion and the stabilizer is placed in the extra-granular portion, or vice versa the stabilizer is placed within the intra-granular portion and the ACE inhibitor compound is placed in the extra-granular portion, and further alternatively when adopting a core/shell structure, such that the ACE inhibitor is contained in the core and the stabilizer compound is contained in a surrounding layer, or the ACE inhibitor is contained in a surrounding layer and the stabilizer compound is contained in the core, wherein optionally an intermediate layer, such as a layer basically formed from a film-forming polymer, can be provided between the core and the surrounding layer.La présente invention concerne une forme de dosage pharmaceutique présentant une stabilisation améliorée dun inhibiteur de lenzyme de conversion de langiotensine (inhibiteur ACE). La forme de dosage comprend linhibiteur de lenzyme de conversion de langiotensine et un stabilisateur et possède au moins deux parties séparées, linhibiteur de lenzyme de conversion de langiotensine étant contenu dans lune des parties et le composé stabilisateur étant contenu dans une autre partie. La forme de dosage peut utiliser une structure intra-granulaire/extra-granulaire, de préférence le composé inhibiteur de lenzyme de conversion de langiotensine (ACE) est placé à lintérieur de la partie intra-granulaire et le stabilisateu
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