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KMID : 0614020040190010052
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Journal of Pharmaceutical Sciences (C.N.U.)
2004 Volume.19 No. 1 p.52 ~ p.56
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Consideration on the Similarity in vitro Dissolution Profiles of Extended Release Commercial Tablets of Acetaminophen
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Kim Min-Soo
Lee Si-Beum
Lee Tae-Wan
Jun Jai-Il
Hwang Sung-Joo
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Abstract
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We have studied the dissolution kinetics of three extended release commercial tablets of acetaminoPhen in simulated gastric juice, and the dissolution profiles were compared. The applied methods for the comparison of in vitro dissolution profiles are model independent methods including difference factor (f₁) and similarity factor (f₂), and statistical methods based on the analysis of variance and in t-test. The comparison of the dissolution profile, using difference factor (f₁), and similarity factor (f₂), indicates that the three tablets are equivalent in their dissolution. But, statistical methods based on the analysis of variance and in t-test indicate that the three tablets are not equivalent in their dissolution. The results show that statistical methods are better indicator of discrimination than the f-factors.
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KEYWORD
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dissolution profiles, difference factor (f₁), similarity factor (f₂), ANOVA, t-test
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