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PHARMACEUTICAL COMPOSITIONS AND ORAL ORAL DOSED FORMS OF LEVERODOPE'S MEDICINAL PRODUCTS AND METHODS OF APPLICATION

机译:乐百氏药用产品的药物成分和口服剂量形式及使用方法

摘要

1. A pharmaceutical composition comprising: crystalline (2) -2-phenylcarbonyloxypropyl (2) -2-amino-3- (3,4-dihydroxyphenyl) propanoate mesylate; and alkyl sulfate or a pharmaceutically acceptable salt thereof. 2. The pharmaceutical composition according to claim 1, containing granules, where the granules contain: from about 90 wt.% To about 99 wt.% Crystalline (2) -2-phenylcarbonyloxypropyl (2) -2-amino-3- (3,4-dihydroxyphenyl ) mesylate propanoate; iota from about 0.5 wt.% to about 2 wt.% Calkyl sulfate or its pharmaceutically acceptable sa where wt.% is calculated from the total dry matter of the granules. 3. The pharmaceutical composition of claim 2, wherein the C1-6 alkyl sulfate or a pharmaceutically acceptable salt thereof is sodium lauryl sulfate. The pharmaceutical composition according to claim 1, containing one or more pharmaceutically acceptable excipients. The pharmaceutical composition according to claim 1, comprising: from about 50 wt.% To about 90 wt.% Crystalline (2) -2-phenylcarbonyloxypropyl (2) -2-amino-3- (3,4-dihydroxyphenyl) propanoate mesylate; from about 0.5% to about 2.0% by weight of a C 1-6 alkyl sulfate or a pharmaceutically acceptable salt thereof; from about 6% to about 20% by weight hydroxypropyl methylcellulose; and from about 0.5 wt.% to about 2.0 wt.% magnesium stearate, where wt.% is calculated from the total dry weight of the composition. The pharmaceutical composition according to claim 1, comprising an L-aromatic amino acid decarboxylase inhibitor, a catechol methyltransferase inhibitor, or a combination of an L-aromatic amino acid decarboxylase inhibitor and a catechol inhibitor methyltransferase. Oral dose
机译:1.一种药物组合物,其包含:结晶的(2)-2-苯基羰基氧丙基(2)-2-氨基-3-(3,4-二羟基苯基)丙酸酯甲磺酸盐;和烷基硫酸盐或其药学上可接受的盐。 2.根据权利要求1的药物组合物,其包含颗粒,其中所述颗粒包含:约90重量%至约99重量%的结晶(2)-2-苯基羰基氧丙基(2)-2-氨基-3-(3 ,4-二羟苯基)甲磺酸丙酸酯;约0.5重量%至约2重量%的烷基硫酸烷基酯或其药学上可接受的盐;其中wt。%是根据颗粒的总干物质计算的。 3.权利要求2的药物组合物,其中所述C 1-6烷基硫酸盐或其药学上可接受的盐是月桂基硫酸钠。 2.根据权利要求1的药物组合物,包含一种或多种药学上可接受的赋形剂。 2.根据权利要求1的药物组合物,其包含:约50重量%至约90重量%的结晶(2)-2-苯基羰氧基丙基(2)-2-氨基-3-(3,4-二羟基苯基)丙酸酯甲磺酸盐;和按重量计约0.5%至约2.0%的C 1-6烷基硫酸盐或其药学上可接受的盐;按重量计约6%至约20%的羟丙基甲基纤维素;约0.5重量%至约2.0重量%的硬脂酸镁,其中重量%由组合物的总干重计算。 2.根据权利要求1所述的药物组合物,其包含L-芳族氨基酸脱羧酶抑制剂,邻苯二酚甲基转移酶抑制剂或L-芳族氨基酸脱羧酶抑制剂与邻苯二酚抑制剂甲基转移酶的组合。口服剂量

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