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publicationDate 2009-05-20-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CZ-300438-B6
titleOfInvention Method for immediate release oral solid dosage form of active substance containing polymorphic form of finasteride as active substance
abstract A process for the preparation of an immediate-release oral solid dosage form comprising as active ingredient a polymorphic form of finasteride, the essence of which consists in that an aqueous suspension containing 5 to 50% by weight of polymorphic form of finasteride, based on the total weight of the suspension, and 0.1 to 50% by weight of at least one anionic surfactant, based on the weight of the polymorphic form of finasteride, is ground to achieve a particle size distribution of the polymorphic form of finasteride such that at least 10% of the particles have a size of at most 2 .mu.m, at least 50% of the particles have a size of at most equal to 7 .mu.m and at least 90% of the particles have a size of at most 17 .mu.m, after which the aqueous suspension obtained is injected in a fluidized bed onto a solid particulate hydrophilic carrier having a particle size distribution such that at least 90% of the particles have a size greater than 40. .mi.m, not more than 10% of the particles have a size greater than 200 .mi.m and at least 99% of the particles have a size of at most 300 .mi.m.
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