Lessons learned from the clinical development of oral peptides.
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)-NH2) 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.
['Karsdal|Morten Asser|MA|', 'Riis|Bente Juul|BJ|', 'Mehta|Nozer|N|', 'Stern|William|W|', 'Arbit|Ehud|E|', 'Christiansen|Claus|C|', 'Henriksen|Kim|K|']
D000284:Administration, Oral D004337:Drug Carriers D016503:Drug Delivery Systems D065569:Gastrointestinal Absorption D006801:Humans D010446:Peptide Fragments D011994:Recombinant Proteins D013678:Technology, Pharmaceutical
oral formulation calcitonin bone cartilage clinical trial diabetes