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AssigneeAlfred E. Tiefenbacher (GmbH & Co. KG)
InventorsChaitanya Yogananda Gujjar, Bala Ramesha Chary Rallabandi, Pradip Shivraj Patwari, Ansgar Fitzner
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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.
An orally disintegrating tablet comprising asenapine maleate, a carboxylic acid in an amount of 0.2 to 2.0% by weight based on total weight of the tablet, and one or more pharmaceutical excipients, wherein said tablet is stable at 40° C. and 75% rH for at least 3 months compared to a tablet having no carboxylic acid.
An orally disintegrating tablet comprising asenapine maleate, a carboxylic acid in an amount of 0.75 to 2.5% by weight based on total weight of the tablet, and one or more pharmaceutical excipients, wherein said tablet is stable at 40° C. and 75% rH for at least 3 months compared to a tablet having no carboxylic acid.
Dependencies are inferred from the claim text.