Oral preparation with controlled release

Abstract

A pharmaceutical pellet is disclosed, comprising a spherical core containing active ingredient with a smooth surface and a coating on the core which controls the release of the active ingredient in a pH-independent manner. With such a pellet the release of the active ingredient can follow a profile with a lag phase of 60 minutes to 840 minutes, a proportion of 5 wt. % or less of the active ingredient being released during the lag phase. The active ingredient can furthermore be released from the pellet with a profile such that after the lag phase the release of the active ingredient amounts to between 3 and 25 wt. % per hour.

1 - 19 . (canceled) 
     
     
         20 . A method for the production of a pellet as claimed in claim  1 , characterized in that the method comprises the following stages:
 (a) preparation of a pellet core containing the active substance, with a length-width ratio of less than about 1.4 and a mean roughness of less than 10 μm and/or a relative mean roughness of less than 2%;   (b) spraying-on of an aqueous or organic solution or dispersion containing a film-forming agent that controls the pH-independent release of the active substance.   
     
     
         21 . A method for the production of a tablet, comprising the following stages:
 (a) mixing of pharmaceutical pellets, comprising a spherical core containing the active substance with a smooth surface and a coating on the core, which controls pH-independent release of the active substance, characterized in that the core has a roughness of less than 10 μm with one or more ingredients, selected from fillers, binders, disintegrants, flow regulators and lubricants, with formation of a mixture; and   (b) compression of the mixture, with formation of a tablet.   
     
     
         22 . The method as claimed in  claim 21 , characterized in that during the compression stage some of the pellets are disrupted, so that the release of the active substance from the tablet does not exhibit a lag-phase. 
     
     
         23 . (canceled)