A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/4422 (2006.01) A61K 9/20 (2006.01) A61P 9/00 (2006.01)
Patent
CA 2559670
The present invention provides improved, more stable formulations of amlodipine maleate where the formulations comprise from none to a minimal amount of magnesium. Such stable formulations show decreased production of the impurity amlodipine aspartate. Accordingly, the present invention provides formulations of amlodipine maleate comprising lubricants such as sodium stearyl furmarate, dimeticone, macrogol 6000, hydrogenated castor oil, and stearic acid. Methods of making and using the improved formulations are also provided.
La présente invention concerne des formulations améliorées de stabilité supérieure de maléate d'amlodipine qui comprennent une quantité de nulle à minimale de magnésium. Ces formulations stables se caractérisent par une production réduite d'impuretés d'aspartate d'amlodipine. La présente invention a pour objet des formulations de maléate d'amlodipine comprenant des lubrifiants tels que le stéaryl furmarate de sodium, le diméticone, macrogol 6000, l'huile de castor déshydrogénée, et l'acide stéarique. L'invention a également pour objet des procédés pour préparer et utiliser les formulations améliorées.
Ban Lidia
Nagy Edit
Orosz Eva
Pragai Gabor
Szilagyi Judit
Heenan Blaikie Llp
Teva Pharmaceutical Industries Ltd.
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