Comparison of a laboratory and a production coating spray gun with respect to scale-up.
A laboratory spray gun and a production spray gun were investigated in a scale-up study. Two Schlick spray guns, which are equipped with a new antibearding cap, were used in this study. The influence of the atomization air pressure, spray gun-to tablet bed distance, polymer solution viscosity, and spray rate were analyzed in a statistical design of experiments. The 2 spray guns were compared with respect to the spray width and height, droplet size, droplet velocity, and spray density. The droplet size, velocity, and spray density were measured with a Phase Doppler Particle Analyzer. A successful scale-up of the atomization is accomplished if similar droplet sizes, droplet velocities, and spray densities are achieved in the production scale as in the laboratory scale. This study gives basic information for the scale-up of the settings from the laboratory spray gun to the production spray gun. Both spray guns are highly comparable with respect to the droplet size and velocity. The scale-up of the droplet size should be performed by an adjustment of the atomization air pressure. The scale-up of the droplet velocity should be performed by an adjustment of the spray gun to tablet bed distance. The presented statistical model and surface plots are convenient and powerful tools for scaling up the spray settings if the spray gun is changed from laboratory spray gun to the production spray gun.
Mueller
Ronny
R
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.
Kleinebudde
Peter
P
D020099:Coated Materials, Biocompatible / Q000737:chemistry*; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D065347:Hypromellose Derivatives; D007753:Laboratories; D008422:Materials Testing; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D010865:Pilot Projects; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods; D014783:Viscosity
D020099:Coated Materials, Biocompatible; D004337:Drug Carriers; D013607:Tablets; D065347:Hypromellose Derivatives; D008747:Methylcellulose