Vol 4, No 3 (2022)

Formulation Challenges of Biopharmaceuticals and Peptide Drugs: Strategies for Stability and Efficacy

Authors: Dr. Meera Kapoor, Dr. Arnav Patel

Abstract: Biopharmaceuticals and peptide drugs represent a rapidly growing sector in modern therapeutics due to their specificity, potency, and ability to modulate complex biological pathways. However, their formulation poses significant challenges, including instability, susceptibility to enzymatic degradation, poor solubility, and immunogenicity. This paper reviews the critical formulation challenges of biopharmaceuticals and peptide drugs and explores strategies to enhance stability, bioavailability, and therapeutic efficacy. Emphasis is placed on novel drug delivery systems, excipient selection, protein engineering, and analytical characterization. Comparative studies of conventional and advanced formulation approaches highlight improvements in drug stability and patient outcomes. Regulatory considerations and future directions in optimizing formulation strategies are also discussed.

Keywords: Biopharmaceuticals, Peptide drugs, Drug stability, Delivery systems, Protein therapeutics, Formulation strategies, Bioavailability enhancement.

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Table of Contents