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AssigneeBoehringer Ingelheim International GmbH
InventorsSara Abelaira, Daniel Bianchi, Francisco Gel, Victor Denker, Mabel Fernandez, Marta Cicconi de Vidal
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The present invention relates to novel oral pharmaceutical compositions comprising as pharmaceutically active compounds a combination of an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof and of a decongestant-effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof and further comprising suitable pharmaceutically acceptable carriers or excipients. The invention further relates to methods for the preparation these compositions and methods of using them in the treatment of allergic diseases and/or disorders.
A bilayer tablet consisting of a combination of an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof and a decongestant-effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof and additional pharmaceutically acceptable carriers or excipients and may additionally contain a tablet coating C consisting of pharmaceutically acceptable excipients, with the proviso that the composition does not contain a leukotriene antagonist, wherein a first layer A, providing for the sustained release of pseudoephedrine, comprises a decongestant-effective amount of pseudoephedrine or a pharmaceutically acceptable salt thereof in a matrix of a swellable hydrophilic polymer and wherein a second layer B, providing for the immediate release of epinastine, comprises an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof and wherein the epinastine layer is prepared by direct compression.
Dependencies are inferred from the claim text.