发明授权
EP1355631B1 ORAL FAST-MELT FORMULATION OF A CYCLOOXYGENASE-2 INHIBITOR 有权
在口腔中迅速崩解的口服药物制备含有环氧化酶-2抑制剂

ORAL FAST-MELT FORMULATION OF A CYCLOOXYGENASE-2 INHIBITOR
摘要:
A process is provided for preparing an oral fast-melt composition of a selective cyclooxygenase-2 inhibitory drug, the process comprising (a) a step of wet granulating the drug together with a binding agent comprising a saccharide of high moldability, and (b) a step of blending with the drug a saccharide of low moldability, wherein the above steps (a) and (b) occur in any order or simulatenously to result in formation of granules. The process optionally incorporates means to inhibit agglomeration of the drug, for example addition of a wetting agent. Optionally the process further comprises (c) a step of blending the granules with at least one of a lubricant, a sweetening agent and a flavoring agent to form a tableting blend, and (d) a step of compressing the tableting blend to form oral fast-melt tablets. Also provided is a composition prepared by such a process.
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