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    • 2. 发明授权
    • Pharmaceutical composition for combination of
piperidinoalkanol-decongestant
    • 用于组合哌啶基链烷醇 - 减充血剂的药物组合物
    • US6039974A
    • 2000-03-21
    • US127478
    • 1998-07-31
    • David D. MacLarenJohn R. LeflerSharon K. Minish
    • David D. MacLarenJohn R. LeflerSharon K. Minish
    • A61K9/20A61K9/22A61K9/24A61K31/445A61K45/00A61K45/06A61K47/04A61K47/12A61K47/38A61K47/44A61P11/02A61P11/08A61P37/08A61P43/00A61K9/28
    • A61K9/209A61K31/445A61K9/2013A61K9/2054Y10S514/853
    • The present invention provides a pharmaceutical composition in the form of a bilayer tablet comprising,(a) a first discrete zone made with Formulation (A) which comprises, a therapeutically effective decongestant amount of a sympathomimetic drug, or a pharmaceutically acceptable salt thereof, in an amount of about 18% to about 39% by weight of Formulation (A), and a first carrier base material, the first carrier base material comprising a mixture of;(I) carnauba wax in an amount of about 59% to about 81% by weight of Formulation (A); and(ii) a suitable antiadherent in an amount of about 0.25% to about 2.00% by weight of Formulation (A);wherein said first carrier base material provides a sustained release of the sympathomimetic drug; and(b) a second discrete zone made with Formulation (B) which comprises a therapeutically effective antihistaminic amount of a piperidinoalkanol, or a pharmaceutically acceptable salt thereof, in an amount of about 15% to about 30% by weight of Formulation (B) and a second carrier base material, the second carrier base comprising a mixture of;(I) a cellulose diluent in an amount of about 27% to about 73% by weight of Formulation (B);(ii) pregelatinized starch in an amount of about 15% to about 30% by weight of Formulation (B);(iii) a suitable disintegrant in an amount of about 0.25% to about 6.00% by weight of Formulation (B); and(iv) a suitable lubricant in an amount of about 0.25% to about 2.00% by weight of Formulation (B);wherein said second carrier base material provides an immediate release of the piperidinoalkanol or the pharmaceutically acceptable salt thereof.
    • 本发明提供了一种双层片剂形式的药物组合物,其包含:(a)由制剂(A)制成的第一离散区,其包含治疗有效的减充血剂量的拟交感神经药物或其药学上可接受的盐, 约占制剂(A)的约18重量%至约39重量%的第一载体基材,第一载体基材包含混合物; (I)巴西棕榈蜡的量为制剂(A)的约59%至约81%重量; 和(ii)配方(A)的约0.25重量%至约2.00重量%的合适的抗粘附剂; 其中所述第一载体基材提供所述拟交感神经药物的持续释放; (B)由制剂(B)制成的第二离散区,其包含治疗有效的抗组胺量的哌啶子基链烷醇或其药学上可接受的盐,其量为制剂(B)的约15重量%至约30重量% 和第二载体基材,所述第二载体基底包括: (I)配方(B)的约27%至约73%重量的纤维素稀释剂; (ii)预胶化淀粉,其量为制剂(B)的约15重量%至约30重量%; (iii)配方(B)的约0.25%至约6.00%重量的合适的崩解剂; 和(iv)配方(B)的约0.25%至约2.00%重量的合适润滑剂; 其中所述第二载体基料提供哌啶子基链烷醇或其药学上可接受的盐的即时释放。