Quality by design approach in the optimization of the spray-drying process

Pharmaceutical Development and Technology

Volumn 17, Issue 4, 2012, Pages 389-397

  Baldinger, Arnaud ^a   Clerdent, Lucas ^a   Rantanen, Jukka ^a   Yang, Mingshi ^a   Grohganz, Holger ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Design of experiments; Multivariate analysis; Quality by design; Solid state characterization; Spray drying

Indexed keywords

MANNITOL; TREHALOSE;

AIRFLOW; ARTICLE; EXPERIMENTAL DESIGN; FACTORIAL DESIGN; LASER DIFFRACTION; NEAR INFRARED SPECTROSCOPY; PARTICLE SIZE; POWDER; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUALITY CONTROL; SPRAY DRYING; TEMPERATURE MEASUREMENT; X RAY POWDER DIFFRACTION;

CRYSTALLIZATION; DESICCATION; MANNITOL; MULTIVARIATE ANALYSIS; PARTICLE SIZE; POWDER DIFFRACTION; SPECTROSCOPY, NEAR-INFRARED; TEMPERATURE; TREHALOSE; X-RAY DIFFRACTION;

EID: 84862287073     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2010.550623     Document Type: Article

References (15)

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.Topic Q8(R1): Pharmaceutical Development, 2008.
2. Naelapää K, Veski P, Kristensen HG, Rantanen J, Bertelsen P.Building quality into a coating process.Pharm Dev Technol 2010;15:35-45.
3. Montgomery DC.Design and Analysis of Experiments.New York: John Wiley, 2005.
4. Hickey AJ.Pharmaceutical Inhalation Aerosol Technology.New York: Marcel Dekker Inc, 1996.
5. Vehring R.Pharmaceutical particle engineering via spray drying.Pharm Res 2008;25:999-1022.
6. Billon A, Bataille B, Cassanas G, Jacob M.Development of spraydried acetaminophen microparticles using experimental designs.Int J Pharm 2000;203:159-168.
7. Tewa-Tagne P, Degobert G, Briançon S, Bordes C, Gauvrit JY, Lanteri P et al.Spray-drying nanocapsules in presence of colloidal silica as drying auxiliary agent: formulation and process variables optimization using experimental designs.Pharm Res 2007;24:650-661.
8. Maltesen MJ, Bjerregaard S, Hovgaard L, Havelund S, van de Weert M.Quality by design - Spray drying of insulin intended for inhalation.Eur J Pharm Biopharm 2008;70:828-838.
9. Maury M, Murphy K, Kumar S, Shi L, Lee G.Effects of process variables on the powder yield of spray-dried trehalose on a laboratory spray-dryer.Eur J Pharm Biopharm 2005;59:565-573.
10. Burger A, Henck JO, Hetz S, Rollinger JM, Weissnicht AA, Stöttner H.Energy/temperature diagram and compression behavior of the polymorphs of D-mannitol.J Pharm Sci 2000;89:457-468.
11. Nunes C, Suryanarayanan R, Botez CE, Stephens PW.Characterization and crystal structure of D-mannitol hemihydrate.J Pharm Sci 2004;93:2800-2809.
12. Grohganz H, Fonteyne M, Skibsted E, Falck T, Palmqvist B, Rantanen J.Role of excipients in the quantification of water in lyophilised mixtures using NIR spectroscopy.J Pharm Biomed Anal 2009;49:901-907.
13. Barnes RJ, Dhanoa MS, Lister SJ.Standard normal variate transformation and de-trending of near-infrared diffuse reflectance spectra.Appl Spectrosc 1989;43:772-777.
14. Rinnan A, van den Berg F, Engelsen SB.Review of the most common pre-processing techniques for near-infrared spectra.Trends Anal Chem 2009;28:1201-1222.
15. Simperler A, Kornherr A, Chopra R, Bonnet PA, Jones W, Motherwell WD et al.Glass transition temperature of glucose, sucrose, and trehalose: an experimental and in silico study.J Phys Chem B 2006;110:19678-19684.