Diffusion-controlled dosage form and method of fabrication...

Details Diffusion-controlled dosage form and method of fabrication... Diffusion-controlled dosage form and method of fabrication...

A - Human Necessities

61

K

A61K 9/26 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/24 (2006.01) A61K 31/137 (2006.01)

Patent

CA 2483028

The invention includes a core-and-shell dosage form or unit in which the core contains API and in which the shell substantially governs the release such as by controlling diffusion of API through the shell. The shell may comprise a release-blocking polymer, and particles of a release-regulating polymer. The shell may be substantially impervious but the release-regulating polymer may become suitable to allow diffusion through it when activated. The core may include a buffer region between the shell and the API-containing portion of the core. The dosage form may include multiple units. The dosage form of the invention is capable of providing a release profile whose time scale can be adjusted by adjusting powder composition, and which may be approximately zero- order release. The invention further includes methods of manufacturing such a dosage form, such as three-dimensional printing.

L'invention concerne une forme posologique ou une unité du type noyau et enveloppe, dans laquelle le noyau contient une matière pharmaceutiquement active et l'enveloppe régule sensiblement la libération, par exemple par diffusion régulée de ladite matière à travers l'enveloppe. L'enveloppe peut comprendre un polymère bloquant la libération, et des particules d'un polymère régulant la libération. L'enveloppe peut être sensiblement imperméable, mais le polymère régulant la libération peut se transformer de manière à permettre une diffusion à travers lui-même lorsqu'il est activé. Le noyau peut comprendre une région tampon entre l'enveloppe et la partie du noyau contenant la matière pharmaceutiquement active. Cette forme posologique peut comprendre de multiples unités, et permet d'obtenir un profil de libération dont on peut régler l'échelle temporelle en ajustant la composition de poudre, la libération pouvant être approximativement d'ordre zéro. L'invention concerne de plus des procédés de fabrication de la forme posologique, p. ex. par impression tridimensionnelle.

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