Euro-celtique S.a.

Helen Critchley

Stewart Thomas Leslie

Derek Allan Prater

Ronald Brown Miller

Sandra Therese Malkowska

Ian R Buxton

Adrian Brown

A controlled release composition including spheroid cores of diltiazem or a pharmaceutically acceptable salt thereof and optionally a spheronizing agent, the cores being coated with a controlled release layer, and a method of manufacturing the same, is disclosed. The spheronizing agent when present is preferably microcrystalline cellulose. Ethylcellulose is a preferred release coating. The controlled release coating preferably contains a plasticizer, a surfactant and a tack-modifier.

Pharmaceutical spheroid formulation

A controlled release composition including spheroid cores of diltiazem. or a pharmaceutically acceptable salt thereof and optionally a spheronizing agent, the cores being coated with a controlled release layer, and a method of manufacturing the same, is disclosed. The spheronizing agent when present is preferably microcrystalline cellulose. Ethylcellulose is a preferred release coating. The controlled release coating preferably contains a plasticizer, a surfactant and a tack-modifier.

A solid oral dosage form comprising diltiazem (or a pharmaceutically acceptable salt thereof) in controlled release form and hydrochlorothiazide in immediate release form. Preferably, the controlled release component comprises a plurality of spheroids comprising diltiazem and a spheronizing agent.

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Cambridge, United Kingdom

Helen Critchley