Optimum ratio of amino acids and sugars as amorphous stabilized compounds in pharmaceutical compositions containing high concentration of protein based therapeutic agents

摘要

Problem to be solved: to provide an improved pharmaceutical composition containing one or more protein biomolecules at a high concentration.Protein biomolecules and proteinsOne or more amorphous stabilized compoundsEspecially sucroseTrehaloseGlucoseSugar or lactose or sorbitolArginine orAlanineGlycineOne or more amino acid molecules such as lysine or prolineOr these derivatives and saltsOr a pharmaceutical composition comprising an optimum ratio of these mixtures.Including such an amorphous stabilizing compound in an optimal ratio results in an acceptable long-term stability of protein biomolecules, shortening the freeze drying time, more specifically reducing the drying time, and more specifically reducing the primary drying time.Diagram