Lessons learned from the clinical development of oral peptides.

Abstract:

: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.

journal_name

Br J Clin Pharmacol

authors

Karsdal MA,Riis BJ,Mehta N,Stern W,Arbit E,Christiansen C,Henriksen K

doi

10.1111/bcp.12557

subject

Has Abstract

pub_date

2015-05-01 00:00:00

pages

720-32

issue

5

eissn

0306-5251

issn

1365-2125

journal_volume

79

pub_type

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