A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/495 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/28 (2006.01)
Patent
CA 2342390
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 550 and 7500 ng base/mL.
La présente invention concerne une formulation de ranolazine à libération lente qui contient un mélange intime de ranolazine et un liant à dépendance du pH et partiellement neutralisé, et ce, de façon à former un film qui est sensiblement insoluble dans un milieu aqueux de pH inférieur à 4,5, et soluble dans un milieu aqueux de pH supérieur à 4,5. Cette formulation, qui convient à une administration biquotidienne de ranolazine, permet de réguler la cadence de dissolution de la ranolazine et de maintenir la teneur de ranolazine dans le plasma humain entre 550 et 7500 ng de base/mL.
Baker Fiona
Langridge John
Wolff Andrew A.
Cv Therapeutics Inc.
Mbm Intellectual Property Law Llp
Roche Palo Alto Llc
Syntex (u.s.a.) Inc.
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