Abstract: The present invention relates to a novel form of cross-linked high amylose starch and processes for its manufacture. Such cross-linked high amylose starch is useful as an excipient in a controlled-release pharmaceutical formulation when compressed with 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 the following steps: (1) granular cross-linking and additional 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.

Abstract: The present invention relates to a novel form of cross-linked high amylose starch and processes for its manufacture. Such cross-linked high amylose starch is useful as an excipient in a controlled-release pharmaceutical formulation when compressed with 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 the following steps: (1) granular cross-linking and additional 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.

Abstract: A directly compressible starch consisting in an intense white free-flowing powder showing both excellent compression profile and extremely good disintegration properties. This starch is especially designed to be used as a binder in direct compression processes where it yields very hard white tablets at relatively low compression forces. Tablets resulting from the compression of the above mentioned starch disintegrate in an aqueous medium at a very high speed and they additionally exhibit low friability pattern. This free-flowing starch also brings advantages when used as filler and binder in the filling of some hard gelatine capsules especially for these which are filled by pre-compression of the ingredients. This starch is characterized by regular and smooth partially swollen granules which can be either birefringent or non-birefringent. It can be prepared by spray-drying of a partially cooked starch.