Physicochemical and Formulation Developability Assessment for Therapeutic Peptide Delivery—A Primer

作者: Annette Bak , Dennis Leung , Stephanie E. Barrett , Seth Forster , Ellen C. Minnihan

DOI: 10.1208/S12248-014-9688-2

关键词:

摘要: Peptides are an important class of endogenous ligands that regulate key biological cascades. As such, peptides represent a promising therapeutic with the potential to alleviate many severe disease states. Despite their potential, frequently pose drug delivery challenges scientists. This review introduces physicochemical, biophysical, biopharmaceutical, and formulation developability aspects pertinent discovery-to-development interface. It relevance these properties respect modalities available for peptide pharmaceuticals, parenteral route being most prevalent administration. also presents characterization strategies oral aim illuminating issues candidate. A brief overview other routes administration, including inhaled, transdermal, intranasal routes, is provided as generally preferred by patients over injectables. Finally, this techniques mitigate some obstacles associated delivery. The authors emphasize opportunities thoughtful application pharmaceutical science development drugs general advancement pharmaceuticals.

参考文章(124)
S. P. Denyer, R. M. Baird, Guide to Microbiological Control in Pharmaceuticals ,(1991)
Y. John Wang, Rodney Pearlman, Stability and characterization of protein and peptide drugs : case histories Plenum Press. ,(1993)
Victor Tuan Giam Chuang, Ulrich Kragh‐Hansen, Masaki Otagiri, Pharmaceutical Strategies Utilizing Recombinant Human Serum Albumin Pharmaceutical Research. ,vol. 19, pp. 569- 577 ,(2002) , 10.1023/A:1015396825274
Glenn A. Brewer, Klaus Florey, Control Section, Analytical profiles of drug substances Academic Press. ,(1972)
D. Andrew Paterson, Robert A. Conradi, Allen R. Hilgers, Thomas J. Vidmar, Philip S. Burton, A non-aqueous partitioning system for predicting the oral absorption potential of peptides Quantitative Structure-activity Relationships. ,vol. 13, pp. 4- 10 ,(1994) , 10.1002/QSAR.19940130103
Joy Schramm, Samir Mitragotri, Transdermal drug delivery by jet injectors: energetics of jet formation and penetration. Pharmaceutical Research. ,vol. 19, pp. 1673- 1679 ,(2002) , 10.1023/A:1020753329492
Lars Hovgaard, Sven Frokjaer, Marco van de Weert, Pharmaceutical Formulation Development Of Peptides And Proteins ,(2009)
Alan C. Herman, Thomas C. Boone, Hsieng S. Lu, Characterization, formulation, and stability of Neupogen (Filgrastim), a recombinant human granulocyte-colony stimulating factor. Pharmaceutical biotechnology. ,vol. 9, pp. 303- 328 ,(2002) , 10.1007/0-306-47452-2_7