Topical and Transdermal Delivery of Therapeutic Peptides and Proteins : Science, Technology, and Clinical Translation

Topical and Transdermal Delivery of Therapeutic Peptides and Proteins is the first comprehensive single-authored book devoted to the challenge of non-invasive drug delivery. Across ten chapters, the volume follows the development pathway from molecular foundations through clinical translation.

Therapeutic peptides and proteins now treat conditions once considered untreatable, yet almost every approved biologic still reaches the patients through a needle. The significant burden of repeated injection, cold-chain expense, and reduced adherence among pediatric, geriatric, and needle-averse populations has made non-invasive drug delivery one of the most pressing unsolved problems in pharmaceutical sciences. Topical and Transdermal Delivery of Therapeutic Peptides and Proteins is the first comprehensive single-authored reference devoted to this challenge. Across ten chapters, the volume follows the development pathway from molecular foundations through clinical translation. Opening chapters present skin biology and the degradation kinetics of peptide and protein drugs. The middle chapters cover various formulation types (i.e., liposomes, transfersomes, microemulsions, nanoparticles, and hydrogels), physical enhancement technologies (i.e., microneedles, iontophoresis, electroporation, and sonophoresis), and chemical enhancement strategies (i.e., penetration enhancers, ionic liquids, cell-penetrating peptides, prodrug design, and PEGylation). Later chapters address therapeutic applications across growth factors, monoclonal antibodies, vaccines, and nucleic acids; manufacturing under Quality by Design; preclinical and clinical evaluation; international regulatory frameworks; specific case studies of clinical and commercial outcomes, including Zecuity sumatriptan iontophoresis and the Qtrypta regulatory failure; and emerging directions, including artificial intelligence in peptide design, glucose-responsive smart patches, and on-demand mRNA vaccine printers. Written in a single authorial voice with references current through 2026, the book offers pharmaceutical scientists, regulatory professionals, quality managers, clinical translational researchers, and graduate students a unified reference connecting the molecular, technological, regulatory, and clinical aspects of delivering therapeutic peptides and proteins into and across the skin. Key FeaturesAn in-depth exploration exclusively focused on topical and transdermal delivery of complex protein therapeutics. Explores the complexities of delivering peptides and proteins into and across the skin, providing a comprehensive coverage of this specialized area. Dedicates several chapters to manufacturing, clinical development, and regulatory requirements specifically tailored to topical and transdermal protein delivery systems. Balances theoretical knowledge with practical development considerations and addresses critical aspects of manufacturing, clinical development, and regulatory requirements. Covers different levels of complexity, from basic skin biology and protein structure to sophisticated delivery systems and regulatory requirements. This multi-level approach makes the book valuable for both newcomers and experienced professionals in the field.