Cross-linked amylose material for enzymatically controlled...

A - Human Necessities – 61 – K

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Details

A61K 47/42 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 47/36 (2006.01)

Patent

CA 2140032

The present application is concerned with a solid slow release pharmaceutical dosage unit. More specifically, the invention is directed to a tablet form prepared by direct compression of cross-linked amylose (CLA) having a definite cross-linking degree, .alpha.-amylase and a pharmaceutical agent. The presence of the cross-linked amylose allows a sustained release of the drug, while the .alpha.-amylase permits the modulation of the release time. In other words, the release time of the drug is function of the amount of .alpha.-amylase in the tablet. The amount of amylase is defined in terms of Enzyme Units.

La présente application concerne une unité de dose pharmaceutique à libération lente solide. Plus précisément, il s'agit d'un comprimé préparé par compression pure d'une amylose réticulée ayant un degré de réticulation défini, d'une alpha-amylase et d'un agent pharmaceutique. La présence de l'amylose réticulée permet une libération prolongée du médicament, et l'alpha-amylase permet une modulation du temps de libération. En d'autres mots, le temps de libération du médicament est fonction de la quantité d'alpha-amylase dans le comprimé. La quantité d'amylase est définie selon le concept des unités enzymatiques.

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