Cross-linked high amylose starch for use in...

C - Chemistry – Metallurgy – 08 – B

Patent

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Details

C08B 31/12 (2006.01) A61K 9/26 (2006.01) A61K 31/137 (2006.01) A61K 47/36 (2006.01) C08B 33/04 (2006.01) C08J 3/24 (2006.01) A61J 3/02 (2006.01) A61J 3/10 (2006.01) A61K 9/00 (2006.01)

Patent

CA 2414349

The present invention relates to a novel form of cross-linked high amylose starch and process for its manufacture. Such cross-linked high amylose starch is useful as an excipient in a controlled-release pharmaceutical formulation when compressed with a pharmaceutical agent(s) in a tablet. Such cross-linked high amylose starch is prepared by (a) cross-linking and chemical modification of high amylose starch, (b) gelatinization, and (c) drying to obtain a powder of said controlled release excipient. In a preferred embodiment, such cross- linked high amylose starch is prepared in following steps: (1) granular cross- 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.

L'invention concerne une nouvelle forme d'amidon réticulé à forte teneur en amylose et des procédés de fabrication associés. Cet amidon peut servir d'excipient dans une préparation pharmaceutique à libération prolongée lorsqu'il est compressé avec un/plusieurs agent(s) dans un comprimé. L'amidon décrit dans cette invention est préparé par (a) réticulation et modification chimique dudit amidon, (b) gélatinisation, et (c) séchage, de manière à obtenir une poudre dudit excipient à libération prolongée. Dans un mode de réalisation privilégié, un amidon réticulé à forte teneur en amylose est préparé selon les étapes suivantes: (1) réticulation granulaire et modification chimique supplémentaire (par exemple, hydroxypropylation) d'amidon à forte teneur en amylose; (2) gélatinisation thermique de l'amidon obtenu à l'étape (1); et (3) séchage de l'amidon obtenu à l'étape (2) afin d'obtenir une poudre pouvant être utilisée comme excipient à libération prolongée.

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