CROSS-LINKED HIGH AMYLOSE STARCH FOR USE IN CONTROLLED-RELEASE PHARMACEUTICAL FORMULATIONS AND PROCESSES FOR ITS MANUFACTURE
The present invention relates to a novel form of cross-linked high amylose starch and process for its manufacture. Such cross-linked high amylose starc h is useful as an excipient in a controlled-release pharmaceutical formulation when compressed with a pharmaceutical agent(s) in a tablet. Such cros...
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Zusammenfassung: | The present invention relates to a novel form of cross-linked high amylose starch and process for its manufacture. Such cross-linked high amylose starc h is useful as an excipient in a controlled-release pharmaceutical formulation when compressed with a pharmaceutical agent(s) in a tablet. Such cross-linke d high amylose starch is prepared by (a) cross-linking and chemical modificati on of high amylose starch, (b) gelatinization, and (c) drying to obtain a powde r of said controlled release excipient. In a preferred embodiment, such cross- linked high amylose starch is prepared in following steps: (1) granular cros s- linking and additionally chemical modification (e.g., hydroxypropylation) of high- amylose starch; (2) thermal gelatinization of the starch from step (1) ; and (3) drying the starch from step (2) to yield a powder capable of being used as a controlled release excipient. |
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