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Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation

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Abstract
A formulation and process development study was performed to formulate recombinant human deoxyribonuclease I as a powder for inhalation. First, excipient compatibility (with bovine DNase as a model substance) was examined with a stability study at stressed conditions (60 and 85 degrees C) while monitoring for occurrence of the Maillard reaction. Next, powders for inhalation were prepared by spray drying and spray freeze drying. We found that spray drying with inulin as stabilizer resulted in the best powder for inhalation. Finally, an ex-vivo test with the spray dried rhDNase I/inulin powder significantly decreased elastic and viscous moduli of sputum from five cystic fibrosis patients.
Keywords
PROTEIN, CYSTIC-FIBROSIS SPUTUM, RHDNASE I, AIR CLASSIFIER, ADHESIVE MIXTURES, AEROSOL DELIVERY, IGE MONOCLONAL-ANTIBODY, DE-AGGLOMERATION PRINCIPLE, HUMAN DNASE-I, SPRAY-DRIED POWDERS, Maillard reaction, rhDNase, DNase, sputum, dry powder inhalation, Protein, stabilization

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Citation

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Chicago
Zijlstra, Gerrit S, Bart J Ponsioen, Sylvia A Hummel, Niek Sanders, Wouter LJ Hinrichs, Anne H de Boer, and Henderik W Frijlink. 2009. “Formulation and Process Development of (recombinant Human) Deoxyribonuclease I as a Powder for Inhalation.” Pharmaceutical Development and Technology 14 (4): 358–368.
APA
Zijlstra, G. S., Ponsioen, B. J., Hummel, S. A., Sanders, N., Hinrichs, W. L., de Boer, A. H., & Frijlink, H. W. (2009). Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation. PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 14(4), 358–368.
Vancouver
1.
Zijlstra GS, Ponsioen BJ, Hummel SA, Sanders N, Hinrichs WL, de Boer AH, et al. Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation. PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY. 2009;14(4):358–68.
MLA
Zijlstra, Gerrit S, Bart J Ponsioen, Sylvia A Hummel, et al. “Formulation and Process Development of (recombinant Human) Deoxyribonuclease I as a Powder for Inhalation.” PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY 14.4 (2009): 358–368. Print.
@article{1849896,
  abstract     = {A formulation and process development study was performed to formulate recombinant human deoxyribonuclease I as a powder for inhalation. First, excipient compatibility (with bovine DNase as a model substance) was examined with a stability study at stressed conditions (60 and 85 degrees C) while monitoring for occurrence of the Maillard reaction. Next, powders for inhalation were prepared by spray drying and spray freeze drying. We found that spray drying with inulin as stabilizer resulted in the best powder for inhalation. Finally, an ex-vivo test with the spray dried rhDNase I/inulin powder significantly decreased elastic and viscous moduli of sputum from five cystic fibrosis patients.},
  author       = {Zijlstra, Gerrit S and Ponsioen, Bart J and Hummel, Sylvia A and Sanders, Niek and Hinrichs, Wouter LJ and de Boer, Anne H and Frijlink, Henderik W},
  issn         = {1083-7450},
  journal      = {PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY},
  keywords     = {PROTEIN,CYSTIC-FIBROSIS SPUTUM,RHDNASE I,AIR CLASSIFIER,ADHESIVE MIXTURES,AEROSOL DELIVERY,IGE MONOCLONAL-ANTIBODY,DE-AGGLOMERATION PRINCIPLE,HUMAN DNASE-I,SPRAY-DRIED POWDERS,Maillard reaction,rhDNase,DNase,sputum,dry powder inhalation,Protein,stabilization},
  language     = {eng},
  number       = {4},
  pages        = {358--368},
  title        = {Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation},
  url          = {http://dx.doi.org/10.1080/10837450802662820},
  volume       = {14},
  year         = {2009},
}

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