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KMID : 0869619990160040501
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Journal of Korean Society of Hospital Pharmacists
1999 Volume.16 No. 4 p.501 ~ p.506
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Evaluation for Enteric-coated Valproate Tablets in the Dissolution and Content-Uniformity Tests
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김명진/Kim, M.J.
정양희/김재연/조영환/노환성/Jung, Y.H./Kim, J.Y./Jo, Y.H./Rho, H.S.
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Abstract
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Valproate is an effective epileptic drug to control partial seizure and infantile spasm specially but the therapeutic range is narrow, so it is objective of TDM. The efficacy and safety of drug therapy depends on the bioavailability and the dissolution and content uniformity tests are very important procedures for the controlling of medication bioavailability. This study selected three enteric-coated valproate tablet that is administered to patients 2 or 3 times daily in Asan Medical Center and evaluated the bioavailability by the dissolution test and content uniformity test, attempted to estimate that the release of valproate in vivo is suitable for present drug therapy or not. The dissolution test was performed in the solution Ⅰ and the solution Ⅱ that was made by K.P. 7 for three hours and all sample were measured by HPLC. The results were as followed : (1) The mean dissolution amount in the solution I was higher in order of three different brands B (14.9%) > A (7.52%) > C (2.45%) (2) The mean dissolution amount in the solution Ⅱ was higher in order of three different brands B (114%) > A (102%) > C (22.2%). (3) The content uniformity was higher in order to B (117.6%) > A (110.3%) > C (85.8%). In conclusion, the dissolution of A and B in vivo seems to be suitable for present drug therapy but the release of C in vivo seems to be not.
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