Abstract
Protein and peptide therapeutiProtein and peptide therapeutics have been marketed since the approval of Insulin. However, most peptides and proteins are delivered through parenteral route of administrations because of some well known issues with oral peptide and protein delivery. More recently, oral delivery has been attempted for peptides and proteins but they present unique drug delivery challenges to pharmaceutical scientists including large molecular size, susceptibility to enzymatic degradation, short plasma half-life, ion permeability, immunogenicity, and the tendency to undergo aggregation, adsorption, and denaturation. Along with technical formulation, chemistry, manufacturing, and controls (CMC) considerations for oral peptide and protein formulations present a whole new set of challenges for the pharmaceutical scientists. This chapter describes the different challenges for scale up and validation of manufacturing and analytical processes for development of conventional oral peptide formulations.
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