Stable pharmaceutical formulations of zonisamide and methods...

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01) A61K 31/423 (2006.01) A61K 9/14 (2006.01)

Patent

CA 2595483

One of the embodiments of the present invention is directed toward a process for preparing a stable zonisamide pharmaceutical composition, comprising subjecting zonisamide to wet granulation with a granulation liquid to form a granulated mixture as the stable zonisamide pharmaceutical composition, wherein the granulation liquid is selected from purified water, alcohol and mixtures thereof. The stable zonisamide pharmaceutical composition can be used to fill capsule shells to prepare stable zonisamide capsules. Another embodiment of the invention concerns a for preparing a stable zonisamide pharmaceutical capsule, comprising (i) forming an intimate mixture with zonisamide powder and an effective amount of at least one pharmaceutically acceptable excipient by compressing, co-milling, co-micronization and/or co- compaction of the components, or subjecting the components to a similarly intensive process; and (ii) filling capsule shells with the intimate mixture to obtain the stable zonisamide pharmaceutical capsule.

Dans un mode de réalisation, l'invention concerne un procédé permettant de préparer une composition pharmaceutique stable de zonisamide. Ledit procédé consiste à soumettre un zonisamide à une granulation humide à l'aide d'un liquide de granulation afin de former un mélange granulé mixture, tel qu'une composition pharmaceutique stable de zonisamide, le liquide de granulation étant sélectionné dans le groupe constitué par de l'eau purifiée, un alcool et des mélanges de ceux-ci. La composition pharmaceutique stable de zonisamide peut être utilisée pour remplir des enveloppes de gélules afin de préparer des gélules de zonisamide stables. Dans un autre mode de réalisation, l'invention concerne un procédé permettant de préparer une gélule pharmaceutique stable de zonisamide, qui consiste: i) à former un mélange intime avec une poudre de zonisamide et une quantité efficace d'au moins un excipient pharmaceutiquement acceptable par compression, co-broyage, co-micronisation et/ou co-compaction des composants, ou à soumettre lesdits composants à un processus intensif similaire; et ii) à remplir des enveloppes de gélules à l'aide du mélange intime afin d'obtenir la gélule de zonisamide pharmaceutiquement stable.

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