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publicationDate 2006-12-13-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CZ-297446-B6
titleOfInvention A method for preparing an oral solid dosage form and an oral solid dosage form prepared by this method
abstract A process for the preparation of an oral solid dosage form capable of immediate release of an active ingredient which is an antiestrogen, in particular tamoxifen citrate. The antiestrogen is premixed with a water-insoluble and / or alcohol-insoluble filler and optionally with at least one other pharmaceutically acceptable excipient, wherein 80% of the filler particles or a mixture thereof with a pharmaceutically acceptable excipient has a particle size of less than 355 microns and no more than 10% of these particles. , whereupon the triturate obtained is mixed with a water-insoluble and / or alcohol-insoluble filler and a water-soluble and / or a water-soluble binder, wherein 80% of the filler / binder mixture particles are less than 355 microns in size and not more than 10% of these particles are less than 40 microns. the mixture is granulated in the presence of water and / or alcohol at a level not greater than 8% by weight, based on the total weight of the wet granulated mixture, after which the granulate is dried. The invention also relates to an oral solid dosage form thus prepared.
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