GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS

• Main Authors: MAGGY BABIOLE SAUNIER, MARIERISTINE WOLF, BRUNO BUSS, PATRICE FRANCOIS KELLER, NICOLETTA LOGGIA, CHARU KOCHHAR, SHOUFENG LI, SABINE ADLER, HONG WEN, STEFAN HIRSCH, INDRAJIT GHOSH, JAY PARTHIBAN LAKSHMAN, CATHERINE CURDY, MICHAELA ANNA MARIA BOCK, JULIEN TAILLEMITE, AMOL SINGH MATHARU, JAMES KOWALSKI, RALF ALTENBURGER, NICOLE BARGENDA, WEI-QIN TONG, SUDHA VIPPAGUNTA
• Format: Patent
• Language: English; Spanish
• Published: 21.04.2010
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Valsartan, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component a) of 80% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component b) of 25% or more after 30 minutes, and 40% or more after 60 minutes at pH 4.5. La presente invenci?n se refiere a una combinaci?n farmac?utica de dosis oral fija, la cual comprende: a) una cantidad terap?uticamente efectiva de Alisquireno, o una sal farmac?uticamente aceptable del mismo, b) una cantidad terap?uticamente efectiva de Valsartan, o una sal farmac?uticamente aceptable del mismo, en donde la combinaci?n farmac?utica de dosis oral fija muestra una disoluci?n in vitro del componente a) del 80 por ciento o menos despu?s de 10 minutos, y del 98 por ciento o menos despu?s de 20 minutos, y un perfil de disoluci?n del componente b) del 25 por ciento o m?s despu?s de 30 minutos, y del 40 por ciento o m?s despu?s de 60 minutos, a un pH de 4.5.