Peptide Formulation Science¶
Peptide drugs present unique formulation challenges due to their structural complexity, chemical lability, and propensity for aggregation. This section provides the scientific foundations for designing stable, effective peptide formulations.
Peptide Formulation Stability
Chemical and physical degradation pathways — deamidation, oxidation, hydrolysis, aggregation — and strategies to maintain peptide stability in formulation.
Lyophilization Formulation Design
Freeze-drying cycle development, cryoprotectant and lyoprotectant selection, glass transition temperature, and cake appearance optimization.
pH and Buffer Selection for Peptide Formulations
pH-solubility profiles, buffer catalysis of degradation, ionic strength effects, and rational buffer selection for peptide stability.
Peptide Aggregation Prevention
Mechanisms of peptide aggregation — nucleation, fibril formation, amorphous aggregation — and formulation strategies including surfactants and amino acid excipients.
Excipients for Peptide Formulations
Functional classification of pharmaceutical excipients — bulking agents, tonicifiers, preservatives, antioxidants — and their compatibility with peptide drugs.