PHARMACEUTICAL COMPOSITIONS COMPRISING ATORVASTATIN MANUFACTURED WITHOUT GRANULATION

A unit dosage form comprising atorvastatin or a pharmaceutically acceptable salt thereof, prepared without a granulation step, wherein the measured atorvastatin potency of said dosage form shows a relative standard deviation (RSD) for atorvastatin potency per unit dosage form of not more than about...

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Bibliographische Detailangaben
Hauptverfasser: WATERMAN KENNETH CRAIG, BERCHIELLI ALFRED, DAUGHERITY PATRICK DAVID
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:A unit dosage form comprising atorvastatin or a pharmaceutically acceptable salt thereof, prepared without a granulation step, wherein the measured atorvastatin potency of said dosage form shows a relative standard deviation (RSD) for atorvastatin potency per unit dosage form of not more than about 7.8%, when said unit dosage form is prepared at a rate that greater than 10,000 unit dosage forms per hour per single unit dosage form per machine, as well as the unit dosage form in combination with at least one active drug, methods for preparing unit dosage form, kits for containing such compositions and the use of said compositions for the manufacture of a medicament for treating hypercholesterolemia and/or hyperlipidemia, osteoporosis, benign prostatic hyperplasia (BPH), and Alzheimer's Disease using a therapeutically effective amount of the unit dosage form.