SUSTAINED RELEASE ANTIHISTAMINE AND DECONGESTANT COMPOSITION

摘要

A controlled-release, non-sedating antihistamine and decongestant composition which provides a 24-hour decongestant dissolution profile using standard ungranulated xanthan gum as the sole controlled-release agent and a process for preparing the same is provided. The pharmaceutical composition of the present invention typically includes: a compressed extended-release core comprising a pharmaceutically effective amount of decongestant, ungranulated xanthan gum, one or more binders, a flow agent, and a lubricant. An immediate-release coating composition is disposed on the core that typically includes a non-sedating antihistamine and at least one coating agent.