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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1. Verfasser: DAUGHERITY, PATRICK, DAVID
Format: Patent
Sprache:eng ; spa
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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. Una forma farmaceutica unitaria que comprende atorvastatina o una de sus sales farmaceuticamente aceptable, prepara sin etapa de granulacion, en la que la potencia medida de la atorvastatina de dicha forma farmaceutica muestra una desviacion tipica relativa (RSD) para la potencia de la atorvastatina por forma farmaceutica unitaria, de no mas del 7.8% aproximadamente, cuando dicha forma farmaceutica unitaria se prepara a una velocidad que es mayor de 10,000 formas farmaceuticas unitarias por hora, por una sola forma farmaceutica unitaria, por maquina, asi como tambien la forma farmaceutica unitaria en combinacion con al menos un farmaco activo, metodos de preparacion de la forma farmaceutica unitaria, kits para contener tales composiciones y un metodo de tratamiento de la hipercolesterolemia y/o la hiperlipidemia, la osteoporosis, la hiperplasia prostatica benigna (BPH) y la enfermedad de Alzheimer, cuando un cantidad terapeuticamente eficaz de la forma farmaceutica unitaria.