Have a personal or library account? Click to login
The effect of excipients on the stability and aerosol performance of salmon calcitonin dry powder inhalers prepared via the spray freeze drying process Cover

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

Acta Pharmaceutica
Volume 66 (2016): Issue 2 (June 2016)
By: Narges Poursina,  Alireza Vatanara,  Mohammad Reza Rouini,  Kambiz Gilani and  Abdolhossein Rouholamini Najafabadi  
Open Access
|May 2016

References

  1. 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.3603102102043752
    Search in Google Scholar
  2. 2. C. L. Stevenson, Advances in peptide pharmaceuticals, Cur. Pharm. Biotechnol.10 (2009) 122–137; DOI: 10.2174/138920109787048634.10.2174/13892010978704863419149594
    Search in Google Scholar
  3. 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. 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.2009.07.00919766335
    Search in Google Scholar
  5. 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. 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. 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: 10.1155/2014/932615.10.1155/2014/932615395049424701588
    Search in Google Scholar
  8. 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.2006.07.01017005293
    Search in Google Scholar
  9. 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:1018828425184
    Search in Google Scholar
  10. 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.276.5320.18689188534
    Search in Google Scholar
  11. 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.2005.08.01016188431
    Search in Google Scholar
  12. 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.2013.02.03123499756
    Search in Google Scholar
  13. 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.22618394919921647886
    Search in Google Scholar
  14. 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.2011.08.003
    Search in Google Scholar
  15. 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.20847
    Search in Google Scholar
  16. 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-Q
    Search in Google Scholar
  17. 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.10059
    Search in Google Scholar
  18. 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.340070302
    Search in Google Scholar
  19. 19. P. Manavalan and W. C. Johnson, Sensitivity of circular dichroism to protein tertiary structure class, Nature305 (1983) 831–832; DOI: 10.1038/305831a0.10.1038/305831a0
    Search in Google Scholar
  20. 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.21690
    Search in Google Scholar
  21. 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.2006.09.009
    Search in Google Scholar
  22. 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)76183-8
    Search in Google Scholar
  23. 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.2005.06.00716084699
    Search in Google Scholar
  24. 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/s12249-011-9585-2306637521271316
    Search in Google Scholar
  25. 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. 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/jf00088a057
    Search in Google Scholar
  27. 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.2007.06.04217692480
    Search in Google Scholar
  28. 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/bp960068b8983207
    Search in Google Scholar
DOI: https://doi.org/10.1515/acph-2016-0012 | Journal eISSN: 1846-9558 | Journal ISSN: 1330-0075
Journal RSS Feed
Language: English
Page range: 207 - 218
Accepted on: Oct 15, 2015
Published on: May 28, 2016
Published by: Croatian Pharmaceutical Society
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
Keywords:
salmon calcitonin,
inhalation,
spray freeze drying,
hydroxypropyl-β-cyclodextrin,
fine particle fraction,
stability
Related subjects:
Pharmacy,
Pharmacy, other

© 2016 Narges Poursina, Alireza Vatanara, Mohammad Reza Rouini, Kambiz Gilani, Abdolhossein Rouholamini Najafabadi, published by Croatian Pharmaceutical Society
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Previous articleVolume 66 (2016): Issue 2 (June 2016)Next article