EP3829545A1 — Process for preparing rapidly or very rapidly dissolving tablets comprising freely soluble api

USPTO Abstract

The present invention relates to a process for preparing a rapidly or very rapidly dissolving tablet comprising an at least freely soluble solid form of an active pharmaceutically ingredient (API). The tablet comprises a granulate comprising said at least freely soluble solid form of an active pharmaceutically ingredient in form of granules, and a tablet base, with the granules exhibiting a certain minimum size, and the tablet base comprising a disintegrant. The process comprises a step of mixing the API-containing granulate with the tablet base, followed by a step of compressing the mixture to form the tablet. The present invention also relates to a rapidly or very rapidly dissolving tablet comprising an at least freely soluble solid form of an API, wherein said tablet comprises a mixture of API-containing granulate comprising API-containing granules, and a disintegrant-containing tablet base, with the granules exhibiting a certain minimum size. The amount of said API in the tablet is at least 10% w/w based on the weight of the tablet.