ABSTRACT
The purpose of this study was to investigate the influence of batch size during scale-up on the abrasion of biconvex tablets. Labelled tracer tablets of six different crushing forces (23-116 N) were mixed at different times and peripheral speeds in a laboratory (4 kg) and production (360 kg) perforated pan coater. The weight loss of these tracer tablets was determined. The main factor affecting the abrasion in both scales is the tablet crushing force as a nonlinear decrease in the abrasion was observed with increasing crushing force of the tablets. An increase in mixing time results in an increase in abrasion for the laboratory scale. In contrast to the production scale an influence of the peripheral speed on the abrasion could not be observed in laboratory scale. There is no difference in total abrasion for the laboratory scale and production scale for low peripheral speed. At higher peripheral speeds the abrasion in the production scale is slightly higher than in the laboratory scale.
Subject(s)
Chemistry, Pharmaceutical/methods , Surface Properties , Tablets , Technology, Pharmaceutical/methods , Absorption , Drug Compounding , Equipment Design , Hardness , Models, Statistical , Particle Size , Pressure , Solubility , Tablets, Enteric-Coated/chemistry , Time FactorsABSTRACT
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.
Subject(s)
Coated Materials, Biocompatible/chemistry , Drug Carriers/chemistry , Drug Compounding/instrumentation , Methylcellulose/analogs & derivatives , Nebulizers and Vaporizers , Tablets/chemistry , Technology, Pharmaceutical/instrumentation , Drug Compounding/methods , Equipment Design , Equipment Failure Analysis , Hypromellose Derivatives , Laboratories , Materials Testing , Methylcellulose/chemistry , Particle Size , Pilot Projects , Technology, Pharmaceutical/methods , ViscosityABSTRACT
The purpose of this study was to examine the influence of batch size during scale-up on the abrasion and edge splitting of flat faced lactose tablets. The weight loss of white tracer tablets in a batch of blue coated tablets was investigated in a laboratory scale pan coater and a pilot scale pan coater as a function of different pan speeds and mixing times. It was observed that increasing batch size resulted in a decreased weight loss due to less edge damaging. The higher number of tablet impacts at the pan wall in the laboratory scale compared to the pilot scale might be the reason for this phenomenon. The common assertion that an increase in batch size in scale-up leads to a higher abrasion or tablet damaging was not supported in the current study.
