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    • 1. 发明授权
    • Pramipexole once-daily dosage form
    • 普拉克索每日一次剂型
    • US08679533B2
    • 2014-03-25
    • US10626275
    • 2003-07-24
    • Ernest J. LeeGerard M. BredaelJohn R. BaldwinSteven R. CoxMark J. Heintz
    • Ernest J. LeeGerard M. BredaelJohn R. BaldwinSteven R. CoxMark J. Heintz
    • A61K9/22A61K9/32A61K31/428
    • A61K31/428A61K9/2054A61K9/2059A61K9/28A61K9/2866A61K31/4745
    • An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.
    • 可口服递送的药物组合物包含治疗有效量的普拉克索或其药学上可接受的盐和至少一种药学上可接受的赋形剂,所述组合物显示以下至少一种:(a)体外释放曲线,其平均不超过约20% 的普拉克索在将组合物放入标准溶出试验后2小时内溶解; 并且(b)对健康成年人单剂量给药后的体内普拉克索吸收曲线,其中达到平均20%吸收的时间大于约2小时和/或达到平均40%吸收的时间更大 超过约4小时。 该组合物可用于每天不超过一次给予具有指示多巴胺受体激动剂的病症或病症的受试者。