Validation of an image analysis method for estimating coating thickness on pellets.
A digital image analysis method for the estimation of mean pellet size and coating thickness employing optical microscopy was evaluated. The coating thickness was expressed as the difference in mean projected area radius of the uncoated and the coated pellets. The repeatability, the intermediate precision and the robustness of the image analysis method were investigated. The repeatability and the intermediate precision of the image analysis method was excellent with a low degree of scatter between the measurements. The robustness investigation on the image analysis method illustrated the importance of controlling and monitoring the illumination technique utilised. Calibration of the image analysis equipment was of the highest importance. Using pellets with a high degree of sphericity and narrow size distribution, it was sufficient to use 1000 pellets to estimate the mean pellet size and the coating thickness with an accuracy of +/-1.2 microm. An equation is presented for an approximation of the number of pellets necessary to achieve a given accuracy in the estimation of mean pellet size and coating thickness.
Larsen
Crilles C
CC
Pharmaceutical Research and Development, H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark. Crilles@Crilles.dk
Sonnergaard
Jørn M
JM
Bertelsen
Poul
P
Holm
Per
P
D004343:Drug Implants / Q000032:analysis / Q000737:chemistry*; D013608:Tablets, Enteric-Coated; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D014743:Videotape Recording / Q000295:instrumentation / Q000379:methods / Q000592:standards
D004343:Drug Implants; D013608:Tablets, Enteric-Coated