
Appropriate selection of excipients during the new product development is one of the critical in the pharmaceutical formulations. Criteria for selection of suitable excipient depend on the physical, chemical and biological properties of the excipient. Primarily, it should help stabilize and protect the drug/active pharmaceutical ingredient (API) in the formulation against degradation, oxidation or aggregation, during manufacturing, transport and storage. Preformulation studies comprise investigation of drug-excipient interactions that help in selection of appropriate excipients to achieve the desired properties for the final drug product. Albumin is a well characterized protein and functions as a therapeutic, diagnostic agent, as well as an excipient. As an excipient, albumin has wide applications in drug formulation, drug delivery, vaccine manufacturing and as a component of media in vaccine production. Stable nature of albumin makes its handling and storage easier than other proteins, making it suitable for use as an excipient. Albumin due to its intrinsic stability can be heated at 60°C for 10 hours facilitating virus inactivation during manufacturing.