Multi-layer tablet comprising non-steroidal anti-inflammatory drugs decongestants and non-sedating antihistamines

摘要

Disclosed is a pharmaceutical composition comprising an effective amount of each of (a) a non-steroidal anti-inflammatory drug (NSAID), (b) a decongestant; and (c) an antihistamine, wherein the composition is a multi-layer tablet; at least one of the NSAID, the decongestant and the antihistamine is in each layer of the multi-layer tablet ; each of the NSAID, the decongestant and the antihistamine is in only one layer of the multilayer tablet; and optionally the multilayer tablet is surrounded by a coating. A method of preparing a pharmaceutical composition is also disclosed, wherein the method comprises: (a) selecting a non-steroidal anti-inflammatory drug (NSAID), a decongestant, and an antihistamine; (b) determining the duration profile of each of the NSAID, the decongestant and the antihistamine; (c) preparing at least one immediate release matrix comprising at least one of the NSAID, the decongestant and the antihistamine; (d) preparing at least one extended release matrix comprising at least one of the NSAID, the decongestant and the antihistamine and wherein the at least one of the NSAID, the decongestant and the antihistamine has been modified to extend the release profile; and (e) forming the at least one immediate release matrix and the at least one extended release matrix into a layered solid dosage form.