Influence of neutron irradiation on Eudragit coated tablets: validation of neutron activation II.
The in vitro characteristics of enteric coated acetylsalicylic acid tablets and cores were compared before and after irradiation with thermal neutrons, 2, 4, 7 or 15 min at 1.1.1013 neutrons cm-2s-I. The irradiation procedure affected the coated formulation to a greater extent than the cores. Drug release from tablets was already affected after 2 min of exposure, whereas the cores showed no significant inhibition of release until after 15 min of irradiation, leading to the conclusion that the effects of irradiation were caused by a combination of changes both in the core and the coating. Both tablets and cores showed an increase in the disintegration time following irradiation. Scanning electron micrographs (SEM) of non-irradiated cores/tablets and cores/tablets irradiated for 15 min, showed clear differences in the structure of the surface. SEM of the tablets irradiated for 15 min, showed that the irradiation had caused the film to loosen from the core in several places. SEM of the cross-sections of both irradiated tablets and cores showed a partially melted surface above stacked layers with reduced porosity.
Waaler
T
T
Department of Pharmaceutics, Institute of Pharmacy, University of Oslo, P.O. Box 1068 Blindern, N-0316, Oslo, Norway.
Sande
S A
SA
Müller
B W
BW
Schüller Lisether
G
G
D000180:Acrylic Resins / Q000528:radiation effects*; D003116:Color; D006244:Hardness; D008855:Microscopy, Electron, Scanning; D009501:Neutron Activation Analysis; D009502:Neutrons; D011109:Polymethacrylic Acids; D015203:Reproducibility of Results; D020156:Salicylic Acid / Q000737:chemistry; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000528:radiation effects*; D013696:Temperature