Statistical modeling of protein spray drying at the lab scale

• Published in: AAPS PharmSciTech Vol. 3; no. 1; pp. E4 - 39
• Main Authors: Prinn, Kristin B, Costantino, Henry R, Tracy, Mark
• Format: Journal Article
• Language: English
• Published: United States Springer-Verlag 01.03.2002
• Subjects: Chemistry, Pharmaceutical; Microscopy, Electron, Scanning - statistics & numerical data; Models, Statistical; Particle Size; Serum Albumin, Bovine - chemistry; Serum Albumin, Bovine - ultrastructure; Technology, Pharmaceutical - instrumentation; Technology, Pharmaceutical - methods; Temperature
• ISSN: 1530-9932; 1530-9932
• DOI: 10.1208/pt030104

The objective of this study was to examine the effects of formulation and process variables on particle size and other characteristics of a spray-dried model protein, bovine serum albumin (BSA), using a partial factorial design for experiments. Formulation variables tested include concentration and zinc:protein complexation ratio. Process variables explored were inlet temperature, liquid feed rate, drying air flow rate, and atomizing nitrogen pressure on a lab-scale spray dryer. Statistical data analysis was used to determine F ratios for each of the inputs, which provided a means of ranking the importance of variables relative to one another for each powder characteristic of interest. It was found that protein concentration and atomizing nitrogen pressure had the greatest effects on the particle size of the protein powder. For determining product yield, results showed that protein concentration was the critical variable. Finally, the outlet temperature was mostly influenced by inlet temperature and liquid feed rate. Mathematical models based on these input-output relationships were constructed; these models provide insight into some of the controllable variables of the spray-drying process.