It is well established that proteins have great physiological importance, thus possessing great potential for therapeutic use. There is increased interest in protein/peptide pharmaceuticals delivery due to recent improvements in analytical methods, advancements in molecular biology and genetic engineering, and a better understanding of regulatory roles of proteins and peptides. There are however major challenges that need to be overcome for systemic delivery of these biological molecules. The major hurdles that contribute to low biological activity are low stability, immunogenicity, and toxicity. A combination of strategies can be used to overcome these challenges and improve the bioavailability of protein drugs. Alternative delivery routes (e.g., nasal and pulmonary) and the development of new methods for overcoming delivery challenges (e.g., nanomedicine, and PEGylation), along with the development of innovative formulation strategies (e.g., spray-freeze drying, supercritical fluid methods, fluidized-bed spray coating, lyophilization, jet milling and spray drying), have resulted in improved pharmacokinetics of protein drugs and in some cases increased patient compliance.
Part of the book: Smart Drug Delivery System