| abstract |
A pharmaceutical formulation having improved bioavailability and bioequivalencenincludes particles of amorphous and/or crystalline atorvastatin that have a particle sizen(d 90 ) less than 150 µm and a mean particle size (d 50 ) of the atorvastatin particles that isnbetween approximately 5 and 50 µm. The atorvastatin can be one or more of atorvastatinncalcium, atorvastatin magnesium, atorvastatin aluminum, atorvastatin iron, andnatorvastatin zinc. The formulations of atorvastatin can be stabilized by mixing atorvastatinnwith an alkali metal salt additive at between approximately 1.2% and less than 5% w/w ofnthe formulation. The alkali metal salt additive may be one or more of sodium carbonate,nsodium bicarbonate, sodium hydroxide, sodium silicate, disodium hydrogennorthophosphate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodiumnphosphate, sodium aluminate, calcium carbonate, calcium hydroxide, magnesiumncarbonate, magnesium hydroxide, magnesium silicate, magnesium aluminate, andnaluminum magnesium hydroxide. The atorvastatin formulations can be used to treatnmedical conditions, including primary hypercholesterolemia, dysbetalipoproteinemia, andnhomozygous familial hypercholesterolemia. |