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The present invention relates to an orally disintegrating tablet (ODT) containing asenapine maleate and to a process for preparing the ODT. In a first aspect, the present invention relates to an ODT containing asenapine maleate and low substituted hydroxypropylcellulose. In a second aspect, the present invention relates to an ODT containing crystalline asenapine maleate and the ODT is prepared using conventional tabletting techniques as direct compression and granulation. In a third aspect, the present invention relates to an ODT containing asenapine maleate and a carboxylic acid, and to the use of a carboxylic acid for enhancing storage stability of an asenapine maleate containing ODT. Orally disintegrating tablet containing asenapine maleate, low substituted hydroxypropylcellulose (L-HPC) and/or a carboxylic acid, and a pharmaceutical excipient.
Orally disintegrating tablet according to claim 1, wherein the tablet is prepared by dry granulation. Orally disintegrating tablet claim 1, wherein the weight ratio of asenapine maleate to L-HPC is from 0.5 to 1.5, preferably 0.7 to 1.2, and more preferred 0.9 to 1.1. Orally disintegrating tablet according to claim 1, wherein the tablet is prepared by wet granulation.
Orally disintegrating tablet according to claim 4, wherein the weight ratio of asenapine maleate to L-HPC is from 0.5 to 3.5, preferably 1.5 to 3.5, and more preferred 2.5 to 3.0. Alice Madness Returns Activation Keygen Mac there. Orally disintegrating tablet according to claim 2, wherein the tablet contains asenapine maleate and L-HPC as intragranular components. Orally disintegrating tablet according to claim 1, wherein the carboxylic acid is selected from monocarboxylic acid, dicarboxylic acid, tricarboxylic acid, and mixtures thereof. Orally disintegrating tablet according to claim 1, wherein the carboxylic acid is a C 2− carboxylic acid optionally substituted with at least one of hydroxy, amino and mercapto. Orally disintegrating tablet according to claim 8, wherein the carboxylic acid is selected from glycolic acid, oxalic acid, malonic acid, succinic acid, maleic acid, fumaric acid, tartaric acid, malic acid, glutaric acid, citric acid and gluconic acid. Orally disintegrating tablet according to claim 8, wherein the carboxylic acid is a C 4 dicarboxylic acid optionally substituted with hydroxy, preferably tartaric acid. Orally disintegrating tablet according to claim 1, wherein the carboxylic acid is contained in the tablet in an amount of 0.2 to 2.0% by weight, preferably 0.5 to 1.5% by weight and more preferred 0.75 to 1.25% by weight, based on the total weight of the tablet.