title: A user-friendly model for spray drying to aid pharmaceutical product development.
abstract: The aim of this study was to develop a user-friendly model for spray drying that can aid in the development of a pharmaceutical product, by shifting from a trial-and-error towards a quality-by-design approach. To achieve this, a spray dryer model was developed in commercial and open source spreadsheet software. The output of the model was first fitted to the experimental output of a Büchi B-290 spray dryer and subsequently validated. The predicted outlet temperatures of the spray dryer model matched the experimental values very well over the entire range of spray dryer settings that were tested. Finally, the model was applied to produce glassy sugars by spray drying, an often used excipient in formulations of biopharmaceuticals. For the production of glassy sugars, the model was extended to predict the relative humidity at the outlet, which is not measured in the spray dryer by default. This extended model was then successfully used to predict whether specific settings were suitable for producing glassy trehalose and inulin by spray drying. In conclusion, a spray dryer model was developed that is able to predict the output parameters of the spray drying process. The model can aid the development of spray dried pharmaceutical products by shifting from a trial-and-error towards a quality-by-design approach.
authors.affiliation: Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands.
authors.forename: Niels
authors.initials: N
authors.lastname: Grasmeijer
authors.forename: Hans
authors.initials: H
authors.lastname: de Waard
authors.forename: Wouter L J
authors.initials: WL
authors.lastname: Hinrichs
authors.forename: Henderik W
authors.initials: HW
authors.lastname: Frijlink
mesh_terms: D003890:Desiccation / Q000295:instrumentation*; D004339:Drug Compounding / Q000295:instrumentation*; D005079:Excipients / Q000737:chemistry; D006358:Hot Temperature; D006813:Humidity; D007444:Inulin / Q000737:chemistry; D015233:Models, Statistical; D014199:Trehalose / Q000737:chemistry
chemical_list: D005079:Excipients; D007444:Inulin; D014199:Trehalose
references.citation: Nat Protoc. 2010 Feb;5(2):267-81
references.pmid: 20134427
references.citation: J Pharm Innov. 2009 Sep;4(3):133-142
references.pmid: 20234866
references.citation: J Pharm Sci. 1998 Nov;87(11):1406-11
references.pmid: 9811498
references.citation: Mol Cell Biochem. 2004 Jan-Feb;256-257(1-2):319-27
references.pmid: 14977191
references.citation: Cryobiology. 2000 May;40(3):277-82
references.pmid: 10860627
references.citation: Biophys J. 1996 Oct;71(4):2087-93
references.pmid: 8889183
references.citation: Science. 2001 Dec 14;294(5550):2335-8
references.pmid: 11743196
references.citation: Phys Rev Lett. 2004 Jul 23;93(4):047801
references.pmid: 15323794
references.citation: J Am Chem Soc. 2008 Aug 6;130(31):10240-6
references.pmid: 18611016
references.citation: Int J Pharm. 2001 Mar 14;215(1-2):163-74
references.pmid: 11250102
references.citation: J Pharm Sci. 2009 Sep;98(9):2886-908
references.pmid: 19569054
references.citation: Pharm Res. 1995 Jun;12(6):799-806
references.pmid: 7667182
references.citation: Eur J Pharm Sci. 2009 Oct 8;38(3):224-9
references.pmid: 19631270
references.citation: Science. 1969 Mar 21;163(3873):1325-6
references.pmid: 17807813
references.citation: J Pharm Sci. 2005 Jul;94(7):1427-44
references.pmid: 15920775
references.citation: Biochim Biophys Acta. 2013 Apr;1834(4):763-9
references.pmid: 23360765
references.citation: Pharm Dev Technol. 2012 Jul-Aug;17(4):389-97
references.pmid: 21275777
references.citation: Chem Pharm Bull (Tokyo). 2004 Sep;52(9):1066-70
references.pmid: 15340191
references.citation: J Pharm Sci. 1999 May;88(5):489-500
references.pmid: 10229638
references.citation: Eur J Pharm Biopharm. 2012 Jan;80(1):226-34
references.pmid: 21983606
references.citation: AAPS J. 2010 Jun;12(2):215-22
references.pmid: 20195930
references.citation: Pharm Res. 2002 Dec;19(12):1847-53
references.pmid: 12523664
references.citation: Comput Methods Programs Biomed. 2001 Jun;65(3):191-200
references.pmid: 11339981