Pharmaceutical composition of combination of piperidinoalkanol-decongestant

本发明提供一种双层片剂形式的药物组合物，其包括：(a)用组合物(A)制成的第一独立区域，该组合物(A)包括治疗性有效减充血剂量的拟交感神经药物或其药物学上可接受的盐，其量为组合物(A)重量的18-39％，还包括第一载体基质，该第一载体基质包括以下物质的混合物：(i)巴西棕榈蜡，其量为组合物(A)重量的59-81％；和(ii)合适的抗粘附剂，其量为组合物(A)重量的0.25-2.00％；其中所述第一载体基质使所述拟交感神经药物持续释放；以及(b)用组合物(B)制成的第二独立区域，该组合物(B)包括治疗性有效抗组胺量的哌啶子基烷醇或其药物学上可接受的盐，其量为组合物(B)重量的15-30％，还包括第二载体基质，该第二载体基质包括以下物质的混合物：(i)纤维素稀释剂，其量为组合物(B)重量的27-73％，(ii)预明胶化的淀粉，其量为组合物(B)重量的15-30％，(iii)合适的崩解剂，其量为组合物(B)重量的0.25-6.00％，和(iv)合适的润滑剂，其量为组合物(B)重量的0.25-2.00％；其中所述第二载体基质使所述哌啶子基烷醇或其药物学上可接受的盐快速释放。 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.