چکیده (انگلیسی):

The purpose of this work was to develop a practical scaleup
model for a solvent-based pan-coating process. Practical
scale-up rules to determine the key parameters (pan load,
pan speed, spray rate, air flow) required to control the process
are proposed. The proposed scale-up rules are based
on a macroscopic evaluation of the coating process. Implementation
of these rules does not require complex experimentation
or prediction of model parameters. The proposed
scale-up rules were tested by conducting coating scale-up
and scale-down experiments on 24-inch and 52-inch Vector
Hi-coaters. The data demonstrate that using these rules led
to similar cumulative drug release profiles (f 2 99 50; and
P Analysis of Variance [PANOVA] 99 0.05 for cumulative
percentage of drug released after 12 hours [Cum12]) from
tablets made at 24- and 52-inch scales. Membrane characteristics
such as opacity and roughness were also similar
across the 2 scales. The effects of the key process variables
on coat weight uniformity and membrane characteristics were
also studied. Pan speed was found to be the most significant
factor related to coating uniformity. Spray droplet size
was found to affect the membrane roughness significantly,
whereas opacity was affected by the drying capacity.