PREPARATION OF PREGELATINIZED HIGH AMYLOSE STARCH AND DEBRANCHED STARCH USEFUL AS AN EXCIPIENT FOR CONTROLLED RELEASE OF ACTIVE AGENTS

摘要

A process is disclosed for the manufacture of an excipient useful for thecontrolled release of an active agent. In this process, a starting material consisting ofstarch 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 than50% by weight, the gelatinized material is subjected to an enzymatic debranchingtreatment so as to obtain a gelatinized debranched starch having a short amylosechain content of at least 50% by weigh. When the starting material consists of starchhaving an amylose content of at least 50% by weight or of a high amylose starchhaving an amylose content up to 80% by weight, the gelatinized material isoptionally subjected to an enzymatic debranching treatment so as to obtain agelatinized debranched starch having a short amylose chain content of 20% to 50%by weight. The so obtained gelatinized and optionally debranched starch is furthersubjected to a thermal dehydration in order to obtain the requested excipient in formof a powder. Also disclosed is a dosage administration form for the sustained releaseof one or more active agents in the form of a powder. This form which is preferably atablet, comprises the active agent(s) in admixture with the above excipient in such anamount as to achieve the requested sustained release.