Sustained release ranolazine formulations

Details Sustained release ranolazine formulations Sustained release ranolazine formulations

A - Human Necessities

61

K

A61K 31/495 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61P 9/06 (2006.01) A61P 9/10 (2006.01)

Patent

CA 2402222

A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 850 and 4000 ng base/mL.

L'invention concerne des formulations de ranolazine à libération prolongée contenant un mélange intime de ranolazine et d'un liant dépendant d'un pH partiellement neutralisé, afin de former un film essentiellement insoluble dans un milieu aqueux contenant un pH inférieur à 4,5 et soluble dans milieu aqueux contenant un pH supérieur à 4,5. Ces formulations sont appropriées pour une administration biquotidienne de ranolazine, sont utilisées pour réguler le taux de dissolution de ranolazine, et pour maintenir les niveaux de ranolazine du plasma humain entre 850 et 4000 ng base/mL.

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