Orally dispersible pharmaceutical composition and process...

A - Human Necessities – 61 – K

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A61K 9/20 (2006.01)

Patent

CA 2585940

A process for preparing an orally dispersible solid pharmaceutical form comprises the following steps: a) coating the active ingredient with at least one hydrophilic carboxylate polymer, b) granulating the coated active ingredient obtained in step (a) with at least one lipid compound having a melting point lower than that of the active ingredient, c) mixing the granulate obtained in step (b) with at least one hydrophilic natural polymer having high molecular weight, and d) mixing the granulate obtained in step (c) with ingredients suitable for obtaining an orally dispersible solid pharmaceutical form. An orally dispersible solid pharmaceutical form comprises an active ingredient coated with at least one hydrophilic carboxylate polymer and at least one lipid compound, in which the said coated active ingredient is embedded in a matrix comprising at least one hydrophilic natural polymer having high molecular weight.

Cette invention concerne un procédé de préparation d'une forme pharmaceutique solide orodispersible comprenant les étapes suivantes consistant: a) à enrober l'ingrédient actif d'au moins un polymère carboxylate hydrophile; b) à granuler l'ingrédient actif enrobé obtenu à l'étape (a) avec au moins un composé lipide dont le point de fusion est inférieur à celui de l'ingrédient actif; c) à mélanger le granulé obtenu à l'étape (b) avec au moins un polymère naturel hydrophile présentant un poids moléculaire élevé; et d) à mélanger le granulé obtenu à l'étape (c) avec des ingrédients appropriés afin de produire une forme pharmaceutique solide orodispersible. Une forme pharmaceutique solide orodispersible comprend un ingrédient actif enrobé d'au moins un polymère carboxylate hydrophile et au moins un composé lipide, lequel ingrédient actif enrobé est intégré dans une matrice comprenant au moins un polymère naturel hydrophile présentant un poids moléculaire élevé.

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