USFDA-approved parenteral peptide formulations and excipients: Industrial perspective

Parenteral preparations are sterile and non-pyrogenic formulations designed for delivery into the human or animal body by injection, infusion, or implantation. Peptides are widely employed as therapeutic aids in the healthcare business, accounting for more than half of the pharmaceutical market, with over 100 peptides prescribed worldwide. Although FDA-approved parenteral peptide formulations have transformed significantly, they also pose significant hurdles. The most difficult task for formulation experts is to formulate the peptides into parentally deliverable dose forms while maintaining their stability, safety and efficacy. The stability of the peptide formulation is mostly influenced by the excipient used since it constitutes the majority of the formulation. The selection of acceptable excipients is critical, necessitating a thorough examination of compatibility, safety, and their impact on product stability. Furthermore, knowing peptide interactions with certain excipients and container-closure systems is critical for its safety and efficacy. This review focuses on the excipients utilized in clinically approved peptide formulations, critical challenges associated with the development of parenteral peptide formulations, safety issues, evidence on the possible interaction between peptide-excipient and packaging material, and future perspectives. Readers will be able to comprehend excipients utilized in parenteral peptide formulations and FDA-approved peptide products in great detail.