Rapidly disintegrating oral formulation of a cyclooxygenase-2 inhibitor

摘要

A molded article, such as a tablet, for administration to an oral cavity of a subject to treat of prevent a cyclooxygenase-2 mediated condition, disorder or disease, the molded article comprising a moldable blend of a selective cyclooxygenase-2 inhibitory drug which may have the structure of general formula (I), with a pharmaceutically acceptable excipient carrier system consisting predominantly of one or more carbohydrates, wherein: (a) the selective cyclooxygenase-2 inhibitory drug is present in a total amount of about 20% to about 60% by weight of the molded article; (b) ingredients and amounts thereof in the molded article and a process for preparing the molded article are selected such that the molded article exhibits rapid disintegration in the oral cavity; and (c) the moldable blend in prepared by a process step not requiring wet granulation; a process for preparing the molded article; and the use of the molded article in the manufacture of a medicament for treating a medical condition or disorder in a mammalian subject where treatment with a cyclooxygenase-2 inhibitor is indicated.