Effect of X-ray exposure on the pharmaceutical quality of drug tablets using X-ray inspection equipment.
BACKGROUND
X-ray inspection equipment is widely used to detect missing materials and defective goods in opaque containers. Its application has been expanded to the pharmaceutical industry to detect the presence of drug tablets in aluminum foil press-through packaging. However, the effect of X-rays on the pharmaceutical quality of drug tablets is not well known.


OBJECTIVE
In this study, the effect of X-rays on the pharmaceutical quality of drug tablets was investigated.


METHODS
Exposure of acetaminophen, loxoprofen and mefenamic acid tablets to X-ray doses of 0.34 mGy (thrice the dose by X-ray scanning) to 300 Gy (maximum dose from our X-ray equipment) was demonstrated, and the samples were evaluated by formulation tests.


RESULTS
Exposure to X-rays did not affect the pharmaceutical quality of the drug content. The samples exposed to X-rays exhibited almost the same profile in formulation tests (dissolution test, disintegrating test and hardness test) as control samples (0 Gy). The combination of X-ray exposure with accelerated temperature and humidity tests (six months) also did not affect the pharmaceutical quality. The color change of light-sensitive drugs (nifedipine and furosemide tablets) after X-ray exposure was negligible (< 1.0). In contrast, tablet color was remarkably changed by light from a D65 lamp.


CONCLUSIONS
The X-ray scanning and X-ray exposure under our experimental conditions did not affect the pharmaceutical quality of drug tablets.
Drug Delivery and Nano Pharmaceutics, Graduate School of Pharmaceutical Sciences, Nagoya City University , Mizuho-ku, Nagoya, Aichi , Japan and.
Kazuaki
K
Uehara
Tatsuaki
T
Tagami
Itaru
I
Miyazaki
Norikazu
N
Murata
Yoshifumi
Y
Takahashi
Hiroshi
H
Ohkubo
Tetsuya
T
Ozeki
D003116:Color; D004345:Drug Industry / Q000379:methods*; D004349:Drug Packaging; D004355:Drug Stability; D006244:Hardness; D006813:Humidity; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011786:Quality Control; D012995:Solubility; D013607:Tablets; D013696:Temperature; D014965:X-Rays
D004364:Pharmaceutical Preparations; D013607:Tablets
Aluminum foil press-through packaging; X-ray inspection equipment; drug quality; drug stability; formulation test