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Lessons learned from the clinical development of oral peptides
Author(s) -
Karsdal Morten Asser,
Riis Bente Juul,
Mehta Nozer,
Stern William,
Arbit Ehud,
Christiansen Claus,
Henriksen Kim
Publication year - 2015
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.12557
Subject(s) - calcitonin , medicine , endocrinology
The oral delivery of peptides and proteins has been hampered by an array of obstacles. However, several promising novel oral delivery systems have been developed. This paper reviews the most advanced oral formulation technologies, and highlights key lessons and implications from studies undertaken to date with these oral formulations. Special interest is given to oral salmon calcitonin ( CT ), glucagon‐like peptide‐1 ( GLP ‐1), insulin, PYY ‐(3‐36), recombinant human parathyroid hormone ( rhPTH (1‐31)‐ NH 2 ) and PTH (1‐34), by different technologies. The issues addressed include (i) interaction with water, (ii) interaction with food, (iii) diurnal variation, (iv) inter‐ and intra‐subject variability, (v) correlation between efficacy and exposure and (vi) key deliverables of different technologies. These key lessons may aid research in the development of other oral formulations.