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PREPARATION OF PREGELATINIZED HIGH AMYLOSE STARCH AND DEBRANCHED STARCH USEFUL AS AN EXCIPIENT FOR CONTROLLED RELEASE OF ACTIVE AGENTS
PREPARATION OF PREGELATINIZED HIGH AMYLOSE STARCH AND DEBRANCHED STARCH USEFUL AS AN EXCIPIENT FOR CONTROLLED RELEASE OF ACTIVE AGENTS
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机译:用作活性药物控制释放的辅料的预糊化高淀粉淀粉和脱支淀粉的制备
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摘要
A process is disclosed for the manufacture of an excipient useful for the controlled release of an active agent. In this process, a starting material consisting of starch or high amylose starch is subjected to a gelatinization in an aqueous medium. When the starting material consists of starch having an amylose content of less than 50 % by weight, the gelatinized material is subjected to an enzymatic debranching treatment so as to obtain a gelatinized debranched starch having a short amylose chain content of at least 50 % by weight. When the starting material consists of starch having an amylose content of at least 50 % by weight or of a high amylose starch having an amylose content up to 80 % by weight, the gelatinized material is optionally subjected to an enzymatic debranching treatment so as to obtain a gelatinized debranched starch having a short amylose chain content of 20 % to 50 % by weight. The so obtained gelatinized and optionally debranched starch is further subjected to a thermal dehydration in order to obtain the requested excipient in form of a powder. Also disclosed is a dosage administration form for the sustained release of one or more active agents in the form of a powder. This form which is preferably a tablet, comprises the active agent(s) in admixture with the above excipient in such an amount as to achieve the requested sustained release.
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