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 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.