Influence of stabilizers on the physicochemical characteristics of inhaled insulin powders produced by supercritical antisolvent process

Pharmaceutical Research

Volumn 26, Issue 1, 2009, Pages 61-71

  Kim, Yong Ho ^a   Sioutas, Constantinos ^a   Shing, Katherine S ^a  

^a University of Southern California   (United States)

Author keywords

Insulin; Pulmonary delivery; Stabilizer; Supercritical antisolvent

Indexed keywords

INSULIN; MANNITOL; STABILIZING AGENT; TREHALOSE;

AEROSOL; AEROSOL SOLVENT EXTRACTION SYSTEM; AIRFLOW; APPARATUS; ARTICLE; CHEMICAL REACTION; DRUG FORMULATION; DRUG STABILITY; DRUG STRUCTURE; PARTICLE SIZE; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; SOLVENT EXTRACTION; SUPERCRITICAL ANTISOLVENT PROCESS; SUPERCRITICAL FLUID;

ADMINISTRATION, INHALATION; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, SUPERCRITICAL FLUID; CRYSTALLIZATION; CRYSTALLOGRAPHY, X-RAY; EXCIPIENTS; HUMIDITY; HYPOGLYCEMIC AGENTS; INDICATORS AND REAGENTS; INSULIN; MANNITOL; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; POWDERS; SOLVENTS; SPECTROPHOTOMETRY, ULTRAVIOLET; SPECTROSCOPY, FOURIER TRANSFORM INFRARED;

EID: 57749172261     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-008-9708-y     Document Type: Article

References (44)

1. D. R. Owens B. Zinman G. Bolli 2003 Alternative routes of insulin delivery Diabet. Med. 20 886 898
2. R. K. Wolff 1998 Safety of inhaled proteins for therapeutic use J. Aerosol Med. 11 197 219
3. J. Kling 2008 Inhaled insulin's last gasp? Nat. Biotechnol. 26 479 480
4. W. T. Cefalu 2004 Concept, strategies, and feasibility of noninvasive insulin delivery Diabetes Care 27 239 246
5. J. S. Patton J. Bukar S. Nagarajan 1999 Inhaled insulin Adv. Drug Deliv. Reiv. 35 235 247
6. D. R. Owens 2002 New horizons-alternative routes for insulin therapy Nature Rev. 1 529 540
7. R. U. Agu M. I. Ugwoke M. Armand R. Kinget N. Verbeke 2001 The lung as a route for systemic delivery of therapeutic proteins and peptides Respir. Res. 2 198 209
8. S. J. Smith and J. A. Bernstein. Therapeutic uses of lung aerosols. In A. J. Hickey (ed.), Inhalation Aerosols: Physical and Biologic Basis for Therapy, Marcel Dekker, New York, 1996, pp. 233-269.
9. H.-C. Yeh R. G. Cuddihy R. F. Phalen I-Y. Chang 1996 Comparisons of calculated respiratory tract deposition of particles based on the proposed NCRP model and the new ICRP66 model Aerosol Sci. Tech. 25 134 140
10. S. P. Velaga R. Berger J. Carlfors 2002 Supercritical fluids crystallization of budesonide and flunisolide Pharm. Res. 19 1564 1571
11. B. Y. Shekunov J. C. Feeley A. H. L. Chow H. H. Y. Tong P. York 2003 Aerosolisation behaviour of micronised and supercritically-processed powders J. Aerosol Sci. 34 553 568
12. M. Rehman B. Y. Shekunov P. York D. Lechuga-Ballesteros D. P. Miller T. Tan P. Colthorpe 2004 Optimisation of powders for pulmonary delivery using supercritical fluid technology Eur. J. Pharm. Sci. 22 1 17
13. E. Reverchon A. Spada 2004 Erythromycin micro-particles produced by supercritical fluid atomization Powder Technol. 141 100 108
14. H. Steckel L. Pichert B. W. Müller 2004 Influence of process parameters in the ASES process on particle properties of budesonide for pulmonary delivery Eur. J. Pharmaceut. Biopharmaceut. 57 507 512
15. A. J. Hickey C. A. Dunbar 1997 A new millennium for inhaler technology Pharm. Technol. 21 116 125
16. X. M. Zeng, G. P. Martin, and C. Marriott. Particulate Interactions in Dry Powder Formulations for Inhalation. Taylor & Francis, London, 2001, pp. 12-26.
17. B. Subramaniam R. A. Rajewski K. Snavely 1997 Pharmaceutical processing with supercritical carbon dioxide J. Pharm. Sci. 86 885 890
18. R. E. Sievers U. Karst P. D. Milewski S. P. Sellers B. A. Miles J. D. Schaefer C. R. Stoldt C. Y. Xu 1999 Formation of aqueous small droplet aerosols assisted by supercritical carbon dioxide Aerosol Sci. Tech. 30 3 15
19. F. Dehghani N. R. Foster 2003 Dense gas anti-solvent processes for pharmaceutical formulation Curr. Opin. Solid State Mater. Sci. 7 363 369
20. A. Shariati C. J. Peters 2003 Recent developments in particle design using supercritical fluids Curr. Opin. Solid State Mater. Sci. 7 371 383
21. S.-A. Cryan 2005 Carrier-based strategies for targeting protein and peptide drugs to the lungs AAPS J. 7 E20 E41
22. H. Todo K. Iida H. Okamoto K. Danjo 2003 Improvement of insulin absorption from intratracheally administrated dry powder prepared by supercritical carbon dioxide process J. Pharm. Sci. 92 2475 2486
23. S. W. Stein B. J. Gabrio D. Oberreit P. Hairston P. B. Myrdal T. J. Beck 2002 An evaluation of mass-weighted size distribution measurements with the model 3320 aerodynamic particle sizer Aerosol Sci. Tech. 36 845 854
24. W. C. Hinds. Aerosol Technology-properties, Behavior, and Measurement of Airborne Particles. 2nd ed., Wiley, New York, 1999, pp. 42-110.
25. M. Jackson H. H. Mantsch 1995 The use and misuse of FTIR spectroscopy in the determination of protein structure Crit. Rev. Biochem. Mol. Biol. 30 95 120
26. R. T. Bustami H.-K. Chan F. Dehghani N. R. Foster 2000 Generation of micro-particles of proteins for aerosol delivery using high pressure modified carbon dioxide Pharm. Res. 17 1360 1366
27. N. Elvassore A. Bertucco P. Caliceti 2001 Production of insulin-loaded poly(ethylene glycol)/poly(l-lactide) (PEG/PLA) nanoparticles by gas antisolvent techniques J. Pharm. Sci. 90 1628 1636
28. W. Snavely B. Subramaniam R. Rajewski M. R. Defelippis 2002 Micronization of insulin from halogenated alcohol solution using supercritical carbon dioxide as an antisolvent J. Pharm. Sci. 91 2026 2039
29. N. Javanovi A. Bouchard G. W. Hofland G.-J. Witkamp D. J. A. Crommelin W. Jiskoot 2004 Stabilization of proteins in dry powder formulations using supercritical fluid technology Pharm. Res. 21 1955 1969
30. Y. H. Kim K. S. Shing 2008 Supercritical fluid-micronized ipratropium bromide for pulmonary drug delivery Powder Technol. 182 25 32
31. Y. H. Kim C. Sioutas P. Fine K. S. Shing 2008 Effect of albumin on physical characteristics of drug particles produced by supercritical fluid technology Powder Technol. 182 354 363
32. J. Wei Y.-Z. Lin J.-M. Zhou C.-L. Tsou 1991 FTIR studies of secondary structures of bovine insulin and its derivatives Biochim. Biophys. Acta 1080 29 33
33. L. Xie C.-L. Tsou 1993 Comparison of secondary structures of insulin and proinsulin by FTIR J. Protein Chem. 12 483 487
34. M. A. Winters B. L. Knutson P. G. Debenedetti H. G. Sparks T. M. Przybycien C. L. Stevenson S. J. Prestrelski 1996 Precipitation of proteins in supercritical carbon dioxide J. Pharm. Sci. 85 586 594
35. G. Vecchio A. Bossi P. Pasta C. Carrea 1996 Fourier-transform infrared conformational study of bovine insulin in surfactant solutions Int. J. Pept. Protein Res. 48 113 117
36. H.-K. Chan A. R. Clark J. C. feeley M.-C. Kuo S. R. Lehrman K. Pikal-Cleland D. P. Miller R. Vehring D. Lechuga-Ballesteros 2004 Physical stability of salmon calcitonin spray-dried powders for inhalation J. Pharm. Sci. 93 792 804
37. M. J. Pikal D. R. Rigsbee 1997 The stability of insulin in crystalline and amorphous solids: observation of greater stability for the amorphous form Pharm. Res. 14 1379 1387
38. B. Shenoy Y. Wang W. Shan A. L. Margolin 2001 Stability of crystalline proteins Biotechnol. Bioeng. 73 358 369
39. C. J. Roberts P. G. Debenedetti 2002 Engineering pharmaceutical stability with amorphous solids AIChE J. 48 6 1140 1144
40. B. C. Hancock M. Parks 2000 What is the true solubility advantage for amorphous pharmaceuticals? Pharm. Res. 17 4 397 404
41. B. C. Hancock G. Zografi 1997 Characteristics and significance of the amorphous state in pharmaceutical systems J. Pharm. Sci. 86 1 1 12
42. J. F. Carpenter J. H. Crowe 1989 An infrared spectroscopic study of the interactions of carbohydrates with dried proteins Biochemistry 28 3916 3922
43. T. Arakawa S. J. Prestrelski W. C. Kenney J. F. Carpenter 1993 Factors affecting short-term and long-term stabilities of proteins Adv. Drug Deliv. Reiv. 10 1 28
44. Powder diffraction file. Organic and Organometallic Phases. JCPDS International Center for Diffraction Data, Swarthmore, 1987.