Pregelatinized starch in a controlled release formulation

Details Pregelatinized starch in a controlled release formulation Pregelatinized starch in a controlled release formulation

A - Human Necessities

61

K

A61K 31/519 (2006.01) A61K 47/36 (2006.01) A61K 47/38 (2006.01) A61K 47/40 (2006.01)

Patent

CA 2371940

The present invention concerns the use of pregelatinized starch to prevent dose-dumping from a hydrophilic controlled release formulation. It also concerns a hydrophilic controlled release formulation, more in particular a hydrophilic controlled release matrix formulation, and solid dosage forms prepared therefrom, preferably for once daily oral administration. The hydrophilic controlled release formulation comprises pregelatinized starch, one or more active ingredients, one or more viscous hydrophilic polymers and optionally pharmaceutically acceptable formulating agents. Preferred hydrophilic polymers include hydroxypropyl cellulose and hydroxypropyl methylcellulose.

La présente invention concerne l'utilisation d'amidon prégélatinisé afin d'empêcher la libération massive d'un principe actif dans une formulation hydrophile à libération régulée. L'invention concerne également une formulation hydrophile à libération régulée et, plus particulièrement, une formulation hydrophile matricielle à libération régulée, ainsi que des formes pharmaceutiques solides préparées à partir de celle-ci, de préférence pour une seule administration orale journalière. La formulation hydrophile à libération régulée comprend de l'amidon prégélatinisé, un ou plusieurs principes actifs, un ou plusieurs polymères hydrophiles visqueux et, éventuellement, des agents de formulation acceptables d'un point de vue pharmaceutique. Parmi les polymères hydrophiles préférés se trouvent l'hydroxypropylcellulose et l'hydroxypropylméthylcellulose.

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