A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A01N 25/00 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/26 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 9/52 (2006.01) A61K 9/54 (2006.01) A61K 9/56 (2006.01) A61K 9/58 (2006.01) A61K 9/64 (2006.01) A61K 31/352 (2006.01)
Patent
CA 2382218
There is provided an orally-administrable formulation for the controlled release or stable storage of a granulated isoflavone-enriched fraction or mixture of such fractions, comprising at least one granulated isoflavone- enriched fraction and at least one carrier, diluent or excipient therefor. Preferably, the formulation is characterized in that the total in vitro dissolution time of said formulation required for release of 75 % of the active ingredients available from the formulation is between about 4 and about 18 hours, as determined by the U.S.P. XXIII paddle method at a paddle speed of 75 rpm, using simulated intestinal fluid without the digestive enzymes normally found in intestinal fluid, at pH 6.8, and a temperature of 37 ~C. A process for the preparation of such a formulation is also provided.
L'invention concerne une formulation pouvant être administrée oralement et destinée à la libération régulée ou au stockage stable d'une fraction granulée enrichie en isoflavone ou un mélange de telles fractions constitué d'au moins une fraction granulée enrichie en isoflavone et d'au moins un support, un diluant ou un excipient. La formulation se caractérise, de préférence, par le fait que le temps de dissolution total in vitro de ladite formulation requis pour la libération de 75 % de ses principes actifs est compris entre 4 et 18 heures environ, comme l'a déterminé la méthode utilisant un appareil à palette U.S.P. XXIII à une vitesse de 75 tours/min., au moyen d'un fluide intestinal simulé sans les enzymes de digestion normalement présentes dans le fluide intestinal, à un pH de 6,8 et une température de 37 ·C. L'invention concerne également un procédé de préparation d'une telle formulation.
Arad Oded
Blatt Yoav
Cohen David
Kimelman Eugene
Pinto Rivka
Bio Dar Ltd.
Kirby Eades Gale Baker
LandOfFree
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