Clinical Trials

Biography

Biography: Panayiotis P Constantinides

Abstract

The oral route is the most preferred non-invasive route of drug administration due to increased patient compliance. However, advancing oral peptide and protein therapeutics from bench to clinic and commercialization has been a formidable task. Despite major investments and scientific advances in this area over the last three decades, there is no oral water-soluble and poorly permeable (BCS III) peptide/protein drug product on the market. Oral drug delivery approaches used alone and in combination in preclinical and clinical studies include, chemical modifications, intestinal permeability/ absorption enhancers, such as lipids, surfactants, and proprietary molecules, and lipidic and polymeric micro-/nanoparticles with and without targetable ligands directed towards M-cells/Peyer’s patches in the intestinal mucosa. Upon introductory remarks on the Biopharmaceutics Classification Scheme (BCS) as applied to peptide therapeutics and characteristics of an ideal oral formulation, advantages and limitations with peptide therapeutics and drug development needs will be presented during the first part of the talk. Then preformulation and formulation development aspects of oral peptides, assessment criteria and development considerations with various delivery technologies will be discussed, followed by lessons learned from preclinical and clinical studies. The last part of the talk will summarize accomplishments to date, address commercialization issues and conclude with future developments in this field.