医療薬学
Online ISSN : 1882-1499
Print ISSN : 1346-342X
ISSN-L : 1346-342X
速崩壊錠の崩壊試験法に関する検討
緒方 賢次高村 徳人柏木 さつき濱田 竜一郎児玉 裕文有森 和彦
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2001 年 27 巻 6 号 p. 553-558

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The present study was aimed at establishing a method to evaluate the disintegration of commercially available rapidly-disintegrating tablets. We performed disintegration tests using three procedures based on JP XIV : using an accessory disk on the usual basket, not using an accessory disk on the usual basket, and using the Distopper® which is an apparatus for recognizing the disintegration time using an electron sensor. The coefficient of variation (C.V.) values were over 20% in both the tests with and without an accessory disk on the usual basket, whereas those in the test using the Distopper® were less than 20%. We next investigated the disintegration time of the tablets put on the tongue in five healthy volunteers. A significant correlation between the in vitro test using the Distopper® and the in vivo test using the volunteers in the disintegration time was observed (r= 0.60, p< 0.05). The correlation increased when their disintegration times were limited to within 30 sec (r = 0.75, p< 0.001). These results suggest that the disintegration test of the rapidly-disintegrating tablets using the Distopper® accurately reflects the disintegration profiles in the oral cavity.

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© 一般社団法人 日本医療薬学会
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