PURIFICATION AND STABILIZATION OF PEPTIDE AND PROTEIN PHARMACEUTICAL AGENTS

摘要

PROBLEM TO BE SOLVED: To provide methods for purifying peptides or proteins by facilitating removal of one or more impurities from a peptide or a protein such as insulin.SOLUTION: The invention relates to a use of peptide compositions in manufacturing pharmaceutical preparations used for delivering the peptide to patients in need of the peptide, such as insulin for type II diabetes. The peptide compositions are complexed with specific diketopiperazine, and prepared by complexing which comprises the steps of: (a) preparing diketopiperazine microparticles previously formed in a suspension comprising a solvent; (b) adding the peptide into the suspension; and (c) removing the solvent from the suspension. The microparticles are dissociated to release the peptide.