Pharmaceutical formulation comprising atorvastatin calcium, method for the preparation and use

A pharmaceutical formulation comprising atorvastatin calcium as active ingredient and a pH adjusting substance, in which atorvastatin calcium is micronized amorphous atorvastatin calcium, and the amount of the pH adjusting substance is adjusted in the pharmaceutical formulation such that a single ad...

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Hauptverfasser: KERC JANEZ, BAVEC SASA, MATEJA SALOBIR
Format: Patent
Sprache:eng ; slo
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Zusammenfassung:A pharmaceutical formulation comprising atorvastatin calcium as active ingredient and a pH adjusting substance, in which atorvastatin calcium is micronized amorphous atorvastatin calcium, and the amount of the pH adjusting substance is adjusted in the pharmaceutical formulation such that a single administration of the formulation increases the pH in 900 ml of an aqueous 0.001 M HCl solution of pH 3 to pH equal to or greater than pKa+1 of atorvastatin calcium, wherein the pH adjusting substance is contained in the pharmaceutical formulation in an amount of 0.2 to 2.0 mmol and being MgO. Described is also a method for the preparation and use of a solid formulation. A pharmaceutical formulation comprising atorvastatin calcium as active ingredient and a pH adjusting substance, in which atorvastatin calcium is micronized amorphous atorvastatin calcium, and the amount of the pH adjusting substance is adjusted in the pharmaceutical formulation such that a single administration of the formulation increases the pH in 900 ml of an aqueous 0.001 M HCl solution of pH 3 to pH equal to or greater than pKa+1 of atorvastatin calcium, wherein the pH adjusting substance is contained in the pharmaceutical formulation in an amount of 0.2 to 2.0 mmol and being MgO. Described is also a method for the preparation and use of a solid formulation.