Process for the production of a pharmaceutical preparation containing IBP

2011 
Process for the production of a pharmaceutical preparation containing a PPI (proton-pump inhibitor) as spherical granules (pellets), and comprising the following steps: (a) granulating IBP, at least one component character basic, at least one pharmaceutically acceptable adjuvant, and at least one alcohol, preferably ethanol and / or isopropanol, especially isopropanol, using a fast mixer, for obtaining cores containing IBP, (b) drying the core, (c ) coating the dried cores with an inert intermediate layer, (d) coating the coated cores with an enteric layer in the form of film, and (e) drying the coated cores with the enteric film to a lower or equal residual moisture 1.5% by weight, preferably not exceeding 1% by weight, to obtain pellets of PPIs, the speed of the paddle speed mixer exceeding 50 rpm, preferential temente exceeding 65 rpm, is placed even more preferably in the range of 70 to 140 rpm, the granulation time preferably less than 20 minutes, more preferably less than or equal to 10 minutes, particularly preferably less than or equal to 8 minutes and more preferably 5 to 8 minutes, and granulation (a) it is preferably carried out in the absence of water.
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