Optimal ratio of amino acids and sugars as amorphous stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutics

摘要

The present invention relates to improved pharmaceutical compositions containing high concentrations of one or more protein biomolecules. In particular, the invention relates to protein biomolecules and one or more amorphous stabilizing compounds, in particular sugars such as sucrose, trehalose, glucose, lactose or sorbitol or mixtures thereof, or arginine, alanine, glycine, It relates to a pharmaceutical composition comprising an optimal ratio with one or more amino acid molecules such as lysine or proline, or derivatives and salts thereof, or mixtures thereof. Inclusion of such amorphous stabilizing compounds at such optimal ratios provides acceptable long-term stability of protein biomolecules and shortens lyophilization time, more specifically, drying time, and even more Specifically, shortening of the primary drying time is promoted.