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MATRIX-TYPE CONTROLLED RELEASE PREPARATION COMPRISING BASIC SUBSTANCE OR SALT THEREOF, AND PROCESS FOR PRODUCTION OF THE SAME
专利权人:
EISAI R&D MANAGEMENT CO.; LTD.
发明人:
UEKI, YOSUKE,FUJIOKA, SATOSHI
申请号:
EP05822550
公开号:
EP1832298A4
申请日:
2005.12.27
申请国别(地区):
EP
年份:
2012
代理人:
摘要:
A matrix type sustained-release preparation and a manufacturing method therefor are provided wherein dissolution with low pH dependence of a basic drug or a salt thereof at the early stage of dissolution can be ensured in a dissolution test, and wherein as the dissolution test proceeds, a ratio of a dissolution rate of the basic drug or the salt thereof in an acidic test solution to a dissolution rate of the basic drug or the salt thereof in a neutral test solution (dissolution rate in the acidic test solution /dissolution rate in the neutral test solution) decreases with dissolution time at the late stage of dissolution, as compared to the early stage of dissolution. According to the present invention, the matrix type sustained-release preparation contains a basic drug or a salt thereof and at least one enteric polymer, in which solubility of the basic drug or the salt thereof in a 0.1 N hydrochloric acid solution and a neutral aqueous solution, pH 6.0 is higher than in a basic aqueous solution, pH 8.0.
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