title: The effect of operating and formulation variables on the morphology of spray-dried protein particles.
abstract: The purpose of this research was to investigate the shape and morphology of various spray-dried protein powders as a function of spray-drying conditions and protein formulations. A benchtop spray dryer was used to spray dry three model proteins in formulation with a sugar or a surfactant. Physical characterizations of the powder included morphology (scanning electron microscopy), particle size, residual moisture, and X-ray powder diffraction analyses. A significant change in particle shape from irregular (e.g., "donut") to spherical was observed as the outlet temperature of the dryer was decreased. The drying air outlet temperature was shown to depend on various operating parameters and was found to correlate with the drying rate of atomized droplets in the drying chamber. The morphology of spray-dried protein particles was also affected by formulation. In protein:sugar formulations, spray-dried particles exhibited a smooth surface regardless of the protein-to-lactose ratio, whereas roughness was observed when mannitol was present at > 30% of total solids, due to recrystallization. Protein particles containing trehalose at concentrations > 50% were highly agglomerated. The presence of surfactant resulted in noticeably smoother, more spherical particles. The shape and the morphology of spray-dried powders are affected by spray drying conditions and protein formulation. This study provides information useful for development of dry proteins for fine powder (e.g., aerosol) applications.
authors.affiliation: Genentech, Inc., South San Francisco, CA 94080, USA. maa.yuh-fun@gene.com
authors.forename: Y F
authors.initials: YF
authors.lastname: Maa
authors.forename: H R
authors.initials: HR
authors.lastname: Costantino
authors.forename: P A
authors.initials: PA
authors.lastname: Nguyen
authors.forename: C C
authors.initials: CC
authors.lastname: Hsu
mesh_terms: D000911:Antibodies, Monoclonal; D002626:Chemistry, Pharmaceutical; D003851:Deoxyribonucleases / Q000648:ultrastructure*; D005079:Excipients; D006358:Hot Temperature; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology*; D008353:Mannitol; D008855:Microscopy, Electron, Scanning; D010316:Particle Size; D011208:Powders; D011994:Recombinant Proteins; D012710:Serum Albumin, Bovine / Q000648:ultrastructure*; D013499:Surface Properties
chemical_list: D000911:Antibodies, Monoclonal; D005079:Excipients; D011208:Powders; D011994:Recombinant Proteins; D012710:Serum Albumin, Bovine; D007073:Immunoglobulin E; D008353:Mannitol; D003851:Deoxyribonucleases