Improved intrapulmonary delivery of site-specific PEGylated salmon calcitonin: Optimization by PEG size selection

Journal of Controlled Release

Volumn 125, Issue 1, 2008, Pages 68-75

  Youn, Yu Seok ^a   Kwon, Min Jung ^b   Na, Dong Hee ^c   Chae, Su Young ^d   Lee, Seulki ^d   Lee, Kang Choon ^b  

^a Pusan National University   (South Korea)

^b Sungkyunkwan University   (South Korea)

^c Kyungsung University   (South Korea)

^d Korea Institute of Science and Technology   (South Korea)

Author keywords

Intrapulmonary delivery; PEGylation; Salmon calcitonin

Indexed keywords

INTRAPULMONARY DELIVERY; PEGYLATION; PROTEOLYTIC RESISTANCES; SALMON CALCITONIN;

AMINES; BIOACTIVITY; DERIVATIVES; PHARMACOKINETICS;

DRUG DELIVERY;

ENZYME; PEGYLATED CALCITONIN; SALCATONIN; UNCLASSIFIED DRUG;

AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG HALF LIFE; NONHUMAN; PRIORITY JOURNAL; RAT; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SALMON;

ADMINISTRATION, INHALATION; ANIMALS; BIOLOGICAL AVAILABILITY; BONE DENSITY CONSERVATION AGENTS; CALCITONIN; CALCIUM; CELL LINE, TUMOR; CYCLIC AMP; DRUG CARRIERS; DRUG STABILITY; HUMANS; LUNG; MALE; MOLECULAR STRUCTURE; MOLECULAR WEIGHT; POLYETHYLENE GLYCOLS; RATS; RATS, SPRAGUE-DAWLEY;

EID: 36649019135     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jconrel.2007.10.008     Document Type: Article

References (38)

1. Cleland J.L., Daugherty A., and Mrsny R. Emerging protein delivery methods. Curr. Opin. Biotechnol. 12 (2001) 212-219
2. Carino G.P., and Mathiowitz E. Oral insulin delivery. Adv. Drug Deliv. Rev. 35 (1999) 249-257
3. Lee V.H.L., and Yamamoto A. Penetration and enzymatic barriers to peptide and protein absorption. Adv. Drug Deliv. Rev. 4 (1990) 171-207
4. Wearley L.L. Recent progress in protein and peptide delivery by noninvasive routes. Crit. Rev. Ther. Drug Carrier Syst. 8 (1991) 331-394
5. Patton J.S., Fishburn C.S., and Weers J.G. The lungs as a portal of entry for systemic drug delivery. Proc. Am. Thorac. Soc. 1 (2004) 338-344
6. Agu R.U., Ugwoke M.I., Armand M., Kinget R., and Verbeke N. The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir. Res. 2 (2001) 198-209
7. Adjei A.L., and Gupta P.K. Inhalation delivery of therapeutic peptides and proteins 107 (1997), Marcel Dekker, New York
8. Baion P., and Berthold W. Polyethylene glycol-conjugated pharmaceutical proteins. Pharmaceut. Sci. Technol. Today 1 (1998) 352-356
9. Harris J.M., and Chess R.B. Effect of pegylation on pharmaceuticals. Nat. Rev. Drug Discov. 2 (2003) 214-221
10. Veronese F.M., and Pasut G. PEGylation, successful approach to drug delivery. Drug Discov. Today 10 (2005) 1451-1458
11. Caliceti P., and Veronese F.M. Pharmacokinetic and biodistribution properties of poly(ethylene glycol)-protein conjugates. Adv. Drug Deliv. Rev. 55 (2003) 1261-1277
12. Harris J.M., Martin N.E., and Modi M. Pegylation: a novel process for modifying pharmacokinetics. Clin. Pharmacokinet. 40 (2001) 539-551
13. Fineberg S.E., Kawabata T., Finco-Kent D., Liu C., and Krasner A. Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes, an analysis of initial phase II and III inhaled insulin (Exubera) trials and a two-year extension trial. J. Clin. Endocrinol. Metab. 90 (2005) 3287-3294
14. Lee K.C., Moon S.C., Park M.O., Lee J.T., Na D.H., Yoo S.D., Lee H.S., and DeLuca P.P. Isolation, characterization, and stability of positional isomers of mono-PEGylated salmon calcitonins. Pharm. Res. 16 (1999) 813-818
15. Lee K.C., Tak K.K., Park M.O., Lee J.T., Woo B.H., Yoo S.D., Lee H.S., and DeLuca P.P. Preparation and characterization of polyethylene glycol modified salmon calcitonins. Pharm. Dev. Technol. 4 (1999) 269-275
16. Na D.H., Youn Y.S., Park E.J., Lee J.M., Cho O.R., Lee K.R., Lee S.D., Yoo S.D., DeLuca P.P., and Lee K.C. Stability of PEGylated salmon calcitonin in nasal mucosa. J. Pharm. Sci. 93 (2004) 256-261
17. Yoo S.D., Jun H., Shin B.S., Lee H.S., Park M.O., DeLuca P.P., and Lee K.C. Pharmacokinetic disposition of polyethylene glycol-modified salmon calcitonin. Chem. Pharm. Bull. 48 (2000) 1921-1924
18. Shin B.S., Jung J.H., Lee K.C., and Yoo S.D. Nasal absorption and pharmacokinetic disposition of salmon calcitonin, modified with low molecular weight polyethylene glycol. Chem. Pharm. Bull. 52 (2004) 957-960
19. 18-amine specific PEGylation: stability, permeability, pharmacokinetic behavior and in vivo hypocalcemic efficacy. J. Control. Release 114 (2006) 334-342
20. 18) in rats: regional difference in stability and hypocalcemic effect. Pharm. Dev. Technol. 10 (2005) 389-396
21. Lee K.C., Park M.O., Na D.H., Youn Y.S., Lee S.D., Yoo S.D., Lee H.S., and DeLuca P.P. Intranasal delivery of PEGylated salmon calcitonins: hypocalcemic effects in rats. Calcif. Tissue Int. 73 (2003) 545-549
22. Youn Y.S., Na D.H., and Lee K.C. High-yield production of biologically active mono-PEGylated salmon calcitonin by site-specific PEGylation. J. Control. Release 117 (2007) 371-379
23. Youn Y.S., and Lee K.C. Site-specific PEGylation for high-yield preparation of Lys(21)-amine PEGylated growth hormone-releasing factor (GRF) (1-29) using a GRF(1-29) derivative FMOC-protected at Tyr(1) and Lys(12). Bioconjug. Chem. 18 (2007) 500-506
24. Katayama T., Furuya M., Yamaichi K., Konishi K., Sugiura N., Murafuji H., Magota K., Saito M., Tanaka S., and Oikawa S. Discovery of a non-peptide small molecule that selectively mimics the biological actions of calcitonin. Biochim. Biophys. Acta 1526 (2001) 183-190
25. Enna S.J., and Schanker L.S. Absorption of saccharides and urea from the rat lung. Am. J. Physiol. 222 (1972) 409-414
26. Kobayashi S., Kondo S., and Juni K. Study on pulmonary delivery of salmon calcitonin in rats: effects of protease inhibitors and absorption enhancer. Pharm. Res. 11 (1994) 1239-1243
27. Morita T., Yamamoto A., Takakura Y., Hashida M., and Sezaki H. Improvement of the pulmonary absorption of (Asu1,7)-eel calcitonin by various protease inhibitors in rats. Pharm. Res. 11 (1994) 909-913
28. Kobayashi S., Kondo S., and Juni K. Pulmonary delivery of salmon calcitonin dry powders containing absorption enhancers in rats. Pharm. Res. 13 (1996) 80-83
29. Niven R.W., Whitcomb K.L., Shaner L., Ip A.Y., and Kinstler O.B. The pulmonary absorption of aerosolized and intratracheally instilled rhG-CSF and monoPEGylated rhG-CSF. Pharm. Res. 12 (1995) 1343-1349
30. Hirai S., Yashiki T., and Mima H. Effect of surfactants to nasal absorption of insulin in rats. Int. J. Pharm. 9 (1981) 165-172
31. Patton J.S., Trinchero P., and Platz R.M. Bioavailability of pulmonary delivery of peptides and proteins: alpha-interferon, calcitonins, and parathyroid hormones. J. Control. Release 28 (1994) 79-85
32. Patton J.S. Mechanisms of macromolecular absorption by the lungs. Adv. Drug Deliv. Rev. 19 (1996) 3-36
33. Esposito P., Barbero L., Caccia P., Caliceti P., D'Antonio M., Piguet G., and Veronese F.M. PEGylation of growth hormone-releasing hormone (GRF) analogues. Adv. Drug Deliv. Rev. 55 (2003) 1279-1291
34. Youn Y.S., Chae S.Y., Lee S., Jeon J.E., Shin H.G., and Lee K.C. Evaluation of therapeutic potentials of site-specific PEGylated glucagon-like peptide-1 isomers as a type 2 anti-diabetic treatment: insulinotropic activity, glucose-stabilizing capability, and proteolytic stability. Biochem. Pharmacol. 73 (2007) 84-93
35. Foser S., Schacher A., Weyer K.A., Brugger D., Dietel E., Marti S., and Schreitmuller T. Isolation, structural characterization, and antiviral activity of positional isomers of monopegylated interferon alpha-2a (PEGASYS). Protein Expr. Purif. 30 (2003) 78-87
36. Hussain A., Arnold J.J., Khan M.A., and Ahsan F. Absorption enhancers in pulmonary protein delivery. J. Control. Release 94 (2004) 15-24
37. Deftos L.J., Nolan J.J., Seely B.L., Clopton P.L., Cote G.J., Whitham C.L., Florek L.J., Christensen T.A., and Hill M.R. Intrapulmonary drug delivery of salmon calcitonin. Calcif. Tissue Int. 61 (1997) 345-347
38. Kumar T.M., and Misra A. Pulmonary absorption enhancement of salmon calcitonin. J. Drug Target. 12 (2004) 135-144