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Lessons learned from the clinical development of oral peptides
Morten Asser Karsdal1, Bente Juul Riis, Nozer Mehta
1Nordic Bioscience A/S, Herlev, Denmark.
British Journal of Clinical Pharmacology
|November 20, 2014
Summary
Novel oral delivery systems overcome challenges for peptide and protein drugs like insulin and GLP-1. This review highlights key lessons from advanced oral formulation technologies for improved drug development.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Oral delivery of peptides and proteins faces significant bioavailability challenges.
- Novel formulation technologies are emerging to address these obstacles.
Purpose of the Study:
- To review advanced oral formulation technologies for peptide and protein delivery.
- To highlight key lessons and implications from studies on oral formulations.
Main Methods:
- Review of current literature on advanced oral formulation technologies.
- Analysis of studies involving specific oral peptide/protein formulations (e.g., salmon calcitonin, GLP-1, insulin).
Main Results:
- Identified key issues: interaction with water/food, diurnal variation, subject variability, and efficacy-exposure correlation.
- Evaluated different technologies based on their deliverables and performance.
Conclusions:
- Key lessons learned from oral formulations can guide future research.
- Successful oral delivery of peptides and proteins is becoming increasingly feasible with advanced technologies.
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