申请人:Biodynamic Research Foundation
公开号:EP3453390A1
公开(公告)日:2019-03-13
The present invention provides a formulation having excellent solubility and/or stability of a macromolecular drug, and more specifically, a pharmaceutical composition containing a macromolecular drug, a dissolution-enhancing and/or stabilizing agent, and an aqueous solvent, wherein the dissolution-enhancing and/or stabilizing agent is at least one selected from the group consisting of (1) proteins, (2) synthetic polymers, (3) sugars or sugar alcohols, (4) inorganic salts, (5) amino acids, (6) phospholipids, (7) aliphatic alcohols, (8) medium-chain fatty acids, and (9) mucopolysaccharides.
本发明提供了一种具有优异溶解性和/或高分子药物稳定性的制剂,更具体地说,是一种含有高分子药物、溶解促进剂和/或稳定剂以及水性溶剂的药物组合物、其中,溶出促进剂和/或稳定剂至少是选自以下组别的一种:(1) 蛋白质;(2) 合成聚合物;(3) 糖或糖醇;(4) 无机盐;(5) 氨基酸;(6) 磷脂;(7) 脂肪醇;(8) 中链脂肪酸;(9) 粘多糖。