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The effect of excipients on the stability and aerosol performance of salmon calcitonin dry powder inhalers prepared via the spray freeze drying process


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1. J. P. Meyer, J. T. Pelton, J. Hoflack and V. Saudek, Solution structure of salmon calcitonin, Biopolymers31 (1991) 233–241; DOI: 10.1002/bip.360310210.10.1002/bip.3603102102043752Search in Google Scholar

2. C. L. Stevenson, Advances in peptide pharmaceuticals, Cur. Pharm. Biotechnol.10 (2009) 122–137; DOI: 10.2174/138920109787048634.10.2174/13892010978704863419149594Search in Google Scholar

3. L. Jorgensen, E. H. Moeller, M. Van de Weert, H. M. Nielsen and S. Frokjaer, Preparing and evaluating delivery systems for proteins, Eur. J. Pharm. Sci.29 (2006) 174–182; DOI: 10.1016/j.eps.2006.05.008.Search in Google Scholar

4. Z. Antosova, M. Mackova, V. Kral and T. Macek, Therapeutic application of peptides and proteins: parenteral forever? Trends Biotech.27 (2009) 628–635; DOI: 10.1016/j.tibtech.2009.07.009.10.1016/j.tibtech.2009.07.00919766335Search in Google Scholar

5. A. Makhlof, M. Werle, Y, Tozuka and H. Takeuchi, Nanoparticles of glycol chitosan and its thiolated derivative significantly improved the pulmonary delivery of calcitonin, Int. J. Pharm.397 (2010) 92–95; DOI: 10.1016/j.ijpharm.2010.07.00.Search in Google Scholar

6. H. Yamamoto, Y. Kuno, S. Sugimoto, H. Takeuchi and Y. Kawashima, Surface-modified PLGA nanosphere with chitosan improved pulmonary delivery of calcitonin by mucoadhesion and opening of the intercellular tight junctions, J. Control. Release102 (2005) 373–381; DOI: 10.1016/j.conrel.2004010.010.Search in Google Scholar

7. J. Varshosaz, M. Minaiyan and M. Forghanian, Prolonged hypocalcemic effect by pulmonary delivery of calcitonin loaded poly (methyl vinyl ether maleic acid) bioadhesive nanoparticles, Biomed. Res. Int. 2014, 1–13; DOI: 10.1155/2014/932615.10.1155/2014/932615395049424701588Search in Google Scholar

8. S. A. Shoyele and S. Cawthorne, Particle engineering techniques for inhaled biopharmaceuticals, Adv. Drug. Deliv. Rev.58 (2006) 1009–1029; DOI: 10.1016/j.addr.2006.07.010.10.1016/j.addr.2006.07.01017005293Search in Google Scholar

9. Y. F. Maa, P. A. Nguyen, T. Sweeney, S. J. Shire and C. C. Hsu, Protein inhalation powders: spray drying vs. spray freeze drying, Pharm. Res.16 (1999) 249–254; DOI: 10.1023/A:1018828425184.10.1023/A:1018828425184Search in Google Scholar

10. D. A. Edwards, J. Hanes, G. Caponetti, J. Hrkach, A. Ben-Jebria, M. L. Eskew, J. Mintzes, D. Deaver, N. Lotan and R. Langer, Large porous particles for pulmonary drug delivery, Science276 (1997) 1868–1872; DOI: 10.1126/science.276.5320.1868.10.1126/science.276.5320.18689188534Search in Google Scholar

11. Z. Yu, K. P. Johnston and R. O. Williams III, Spray freezing into liquid versus spray-freeze drying: Influence of atomization on protein aggregation and biological activity, Eur. J. Pharm. Sci.27 (2006) 9–18; DOI: 10.1016/j.ejps.2005.08.010.10.1016/j.ejps.2005.08.01016188431Search in Google Scholar

12. F. Depreter, G. Pilcer and K. Amighi, Inhaled proteins: Challenges and perspectives, Int. J. Pharm.447 (2013) 251–280; DOI: 10.1016/j.ijpharm.2013.02.031.10.1016/j.ijpharm.2013.02.03123499756Search in Google Scholar

13. N. R. Maddux, S. B. Joshi, D. B. Volkin, J. P. Ralston and C. R. Middaugh, Multidimensional methods for the formulation of biopharmaceuticals and vaccines, J. Pharm. Sci.100 (2011) 4171–4197; DOI: 10.1002/jps.22618.10.1002/jps.22618394919921647886Search in Google Scholar

14. T. Serno, R. Geidobler and G. Winter, Protein stabilization by cyclodextrins in the liquid and dried state, Adv. Drug Deliv. Rev.63 (2011) 1086–1106; DOI: 1016/j/addr.2011.08.003.10.1016/j.addr.2011.08.003Search in Google Scholar

15. J. Iwai, N. Ogawa, H. Nagase, T. Endo, T. Loftsson and H. Ueda, Effects of various cyclodextrins on the stability of freeze dried lactate dehydrogenase, J. Pharm. Sci.96 (2007) 3140–3143; DOI: 10.1002/jps.20847.10.1002/jps.20847Search in Google Scholar

16. K. Izutsu, S. Yoshioka and T. Terao, Stabilization of [beta]-galactosidase by amphiphilic additives during freeze-drying, Int. J. Pharm.90 (1993) 187–194; DOI: 10.1016/0378-5173(93)90190-Q.10.1016/0378-5173(93)90190-QSearch in Google Scholar

17. H. R. Costantino, L. Firouzabadian, C. Wu, K. G. Carrasquillo, K. Griebenow, S. E. Zale and M. A. Tracy, Protein spray freeze drying. 2. Effect of formulation variables on particle size and stability, J. Pharm. Sci.91 (2002) 388–395; DOI: 10.1002/jps.10059.10.1002/jps.10059Search in Google Scholar

18. W. C. Johnson, Protein secondary structure and circular dichroism: a practical guide, Proteins7 (1990) 205–214; DOI: 10.1002/prot.340070302.10.1002/prot.340070302Search in Google Scholar

19. P. Manavalan and W. C. Johnson, Sensitivity of circular dichroism to protein tertiary structure class, Nature305 (1983) 831–832; DOI: 10.1038/305831a0.10.1038/305831a0Search in Google Scholar

20. H. R. Costantino, H. Culley, L. Chen, D. Morris, M. Houston, S. Roth, M. J. Phoenix, C. Foerder, J. S. Philo, T. Arakawa, L. Eideuschink, N. H. Andersen, G. Brandt and S. C. Quav, Development of calcitonin salmon nasal spray: similarity of peptide formulated in chlorobutanol compared to benzalkonium chloride as preservative, J. Pharm. Sci.98 (2009) 3691–3706; DOI: 10.1002/jps.21690.10.1002/jps.21690Search in Google Scholar

21. M. A. Capelle, R. Gurny and T. Arvinte, High throughput screening of protein formulation stability: practical considerations, Eur. J. Pharm. Biopharm.65 (2007) 131–148; DOI: 10.1016/j.ejpb.2006.09.009.10.1016/j.ejpb.2006.09.009Search in Google Scholar

22. J. T. Vivian and P. R. Callis, Mechanisms of tryptophan fluorescence shifts in proteins, Biophys. J.80 (2001) 2093–2109; DOI: 10.1016150006-349(01)76183-8.10.1016/S0006-3495(01)76183-8Search in Google Scholar

23. D. J. van Drooge, W. LJ. Hinrichs, B. H. J. Dickhoff, M. N. A. Elli, M. R. Visser, G. S. Zijlstra, W. Henddeik and H. W. Frijlink, Spray freeze drying to produce a stable Delta-9-tetrahydrocannabinol containing inulin-based solid dispersion powder suitable for inhalation, Eur. J. Pharm. Sci.26 (2005) 231–240; DOI: 10.1016/j.ejps.2005.06.007.10.1016/j.ejps.2005.06.00716084699Search in Google Scholar

24. S. A. Shoyele, N. Sivadas and S. A. Cryan, The effects of excipients and particle engineering on the biophysical stability and aerosol performance of parathyroid hormone (1-34) prepared as a dry powder for inhalation, AAPS Pharmscitech. 12 (2011) 304–311; DOI: 10.1208/s12249-011-9585-2.10.1208/s12249-011-9585-2306637521271316Search in Google Scholar

25. D. A. Edwards, G. Caponetti, J. S. Hrkach, N. Lotan, J. Hanes and A. A. Ben-Jebria, Aerodynamically light particles for pulmonary drug delivery, U.S. Pat. 5874064. 23 Feb. 1999.Search in Google Scholar

26. Y. Kato, T. Matsuda, N. Kato and R. Nakamura, Maillard reaction of disaccharides with protein: suppressive effect of nonreducing and pyranoside groups on browning and protein polymerization, J. Agri. Food Chem.37 (1989) 1077–1081; DOI: 10.1021/jf00088a057.10.1021/jf00088a057Search in Google Scholar

27. W. Wang, Y. J. Wang and D. Q. Wang, Dual effects of Tween 80 on protein stability, Int. J. Pharm.347 (2008) 31–38; DOI: 10161j.ijpharm.2007.06.042.10.1016/j.ijpharm.2007.06.04217692480Search in Google Scholar

28. N. B. Bam, J. L. Cleland and T. W. Randolph, Molten globule intermediate of recombinant human growth hormone: stabilization with surfactants, Biotechnol. Prog.12 (1996) 801–809; DOI: 10.1021/bp960068b.10.1021/bp960068b8983207Search in Google Scholar

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