市販カルバマゼピン錠のBioavailabilityと溶出試験

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Dissolution rates of carbamazepine (CBZ) in four preparations of commercial tablets (200 mg) were measured by the paddle method (pH 1.2,100rpm) using a cyclindrical vessel of 21,with a spherical bottom. Three tablet preparations (A, B, C) which showed different dissolution rates with each other, and a solution containing 200 mg of CBZ were chosen for the bioavailability test in eight healthy volunteers. The statistically significant differences were observed between a solution and three tablets for the serum levels of CBZ during 1 h after the administration. There was also a significant difference between tablets A and B, or A and C for the serum levels of CBZ at 1 and 2 h. However, there was no significantly difference for the extent of bioavailability. The absorption rate and mean dissolution time (MDT) were calculated by the Loo-Rigelman method and moment method, respectively. The log percent unabsorbed versus time plots of tablet A, B, and a solution yielded straight lines, respectively, but that of tablet C which was the slowest in vitro dissolution rate, was a biphasic curve with an inflexion at 4 h. The time required for 30,50,60 and 80% dissolved in vitro were well correlated with absorption rate constant obtained during the initial linear portion. Furthermore, the MDT values of tablet A, B, and C of in vitro were also correlated with those of in vivo, when tablet C is assumed to be absorbed completely with the absorption rate constant obtained during the initial portion. On the basis of these findings, it was suggested that the present in vitro dissolution test might be useful as a method to predict in vivo dissolution rate.
公益社団法人日本薬学会の論文
1984-01-25

市販カルバマゼピン錠のBioavailabilityと溶出試験

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