A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 31/40 (2006.01) A61P 3/06 (2006.01) A61K 47/02 (2006.01)
Patent
CA 2475722
A pharmaceutical formulation having improved bioavailability and bioequivalence includes particles of amorphous and/or crystalline atorvastatin that have a particle size (d90) less than 150 m and a mean particle size (d50) of the atorvastatin particles that is between approximately 5 and 50 m. The atorvastatin can be one or more of atorvastatin calcium, atorvastatin magnesium, atorvastatin aluminum, atorvastatin iron, and atorvastatin zinc. The formulations of atorvastatin can be stabilized by mixing atorvastatin with an alkali metal salt additive at between approximately 1.2% and less than 5% w/w of the formulation. The alkali metal salt additive may be one or more of sodium carbonate, sodium bicarbonate, sodium hydroxide, sodium silicate, disodium hydrogen orthophosphate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium phosphate, sodium aluminate, calcium carbonate, calcium hydroxide, magnesium carbonate, magnesium hydroxide, magnesium silicate, magnesium aluminate, and aluminum magnesium hydroxide. The atorvastatin formulations can be used to treat medical conditions, including primary hypercholesterolemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia.
La présente invention concerne une formulation pharmaceutique présentant des qualités accrues de biodisponibilité et de bioéquivalence. Cette formulation comporte des particules d'atorvastatine amorphe et/ou cristalline d'un calibre particulaire (d90) inférieur à 150 ñm, le calibre particulaire moyen (d50) des particules d'atorvastatine se situant approximativement entre 5 et 50 ñm. L'atorvastatine peut être la forme calcique, magnésique, aluminique, ferrique ou zincique. Les formulations de l'atorvastatine peuvent se stabiliser en la mélangeant à un sel de métal alcalin représentant 1,2 % à 5 % en masse de la formulation. Ce sel de métal alcalin d'addition le carbonate de soude, le bicarbonate de soude, l'hydroxyde de sodium, le silicate de sodium, l'hydrogéno-orthophosphate de disodium, le phosphate mono-sodique, l'hydrogénophosphate de disodium, le phosphate de sodium, l'aluminate de sodium, le carbonate de calcium, l'hydroxyde de calcium, le carbonate de magnésium, l'hydroxyde de magnésium, le silicate de magnésium, l'aluminate de magnésium et l'hydroxyde double d'aluminium et de magnésium. Ces formulations d'atorvastatine conviennent au traitement d'états pathologiques tels que l'hypercholestérolémie primaire, la dysbêtalipoprotéinémie et l'hypercholestérolémie familiale homozygote.
Kumar Pananchukunnath Manoj
Malik Rajiv
Singh Romi Barat
Deeth Williams Wall Llp
Ranbaxy Laboratories Limited
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