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Formulation and process development of (recombinant human) deoxyribonuclease I as a powder for inhalation.
- Source :
-
Pharmaceutical development and technology [Pharm Dev Technol] 2009; Vol. 14 (4), pp. 358-68. - Publication Year :
- 2009
-
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.
- Subjects :
- Administration, Inhalation
Animals
Cattle
Chemistry, Pharmaceutical methods
Deoxyribonuclease I chemistry
Deoxyribonuclease I pharmacology
Drug Stability
Drug Storage
Elastic Modulus drug effects
Humans
In Vitro Techniques
Inulin chemistry
Powders
Sputum chemistry
Temperature
Viscosity drug effects
Cystic Fibrosis drug therapy
Deoxyribonuclease I administration & dosage
Excipients chemistry
Sputum drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1097-9867
- Volume :
- 14
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Pharmaceutical development and technology
- Publication Type :
- Academic Journal
- Accession number :
- 19552563
- Full Text :
- https://doi.org/10.1080/10837450802662820