High dose film compositions and methods of preparation

A - Human Necessities – 61 – K

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A61K 9/70 (2006.01)

Patent

CA 2675356

This invention relates to films incorporating high amounts of pharmaceutical agents and methods for the preparation of the same. Moreover, the invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films contain a pharmaceutical and/or cosmetic active agent with no more than a 10 % variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.

La présente invention concerne des films incorporant des quantités élevées d'agents pharmaceutiques et leurs procédés de préparation. De plus, l'invention concerne les produits de films et leurs procédés de préparation qui présentent une hétérogénéité uniforme non auto-agglomérante. Idéalement, les films se désintègrent dans l'eau et peuvent être formés à l'aide d'un procédé de séchage contrôlé, ou d'un autre procédé qui maintienne l'uniformité requise du film. Idéalement, les films contiennent un agent actif pharmaceutique et/ou cosmétique dont la variance ne dépasse pas 10 % par unité de surface du film.

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