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filingDate 2003-02-14-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_5cffd21355c95488af4f875086065ef1
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publicationDate 2005-01-26-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AR-038839-A1
titleOfInvention FORMULATION OF ATORVASTATIN STABILIZED WITH ALKALIN METAL ADDITIONS. METHOD FOR THEIR DEVELOPMENT
abstract A pharmaceutical formula that has better bioavailability and bioequivalence and includes amorphous and / or crystalline atorvastatin particles, whose particle size (d90) corresponds to less than 150 mm, with an average particle size (d50) of atorvastatin ranging between about 5 and 50 mm. Atorvastatin may correspond to one or more of the following: calcium atorvastatin, magnesium atorvastatin, aluminum atorvastatin, iron atorvastatin, and zinc atorvastatin. Atorvastatin formulas can be stabilized by mixing atorvastatin with an additive consisting of salts of an alkali metal that corresponds between about 1.2% and less than 5% water weight of the formula. The additive consisting of alkali metal salts may correspond to one or more of the following: sodium carbonate, sodium bicarbonate, sodium hydroxide, sodium silicate, disodium hydrogen orthophosphate, sodium dihydrogen phosphate, hydrogen phosphate disodium, sodium phosphate, sodium aluminate, calcium carbonate, calcium hydroxide, magnesium carbonate, magnesium hydroxide, magnesium silicate, magnesium aluminate, and magnesium hydroxide, magnesium silicate, magnesium aluminate, and hydroxide of aluminate magnesium Atorvastatin formulas can be used to treat medical conditions that include primary hypercholesterolemia, dysbetalpoproteinemia, and homozygous familial hypercholesterolemia. Claim 83: A method for processing amorphous atorvastatin in order to decrease the size of amorphous atorvastatin particles, the method comprises crushing amorphous atorvastatin particles by employing one or more of the following methods: air jet crushing , crushing with ball breaker, cad crushing and multi-crushing in order to reduce the size of amorphous atorvastatin particles such that the particles have a size (d90) of less than 150 mm and reach an average particle size (d50 ) between approximately 5 and 50 mm.
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