MONARI, ELISA,CANTARELLI, ANNA MARIA,COCCONI, DANIELA,PASQUALI, IRENE
申请号：
PE0011662014
公开号：
PE17032014A1
申请日:
2013.01.23
申请国别(地区):
PE
年份:
2014
代理人:
摘要：
Refers to a dry powder Pharmaceutical formulation comprising: a) a fraction of Fine particles whose diameter is less than 20 MICRONS and is composed of a mixture of (i) between 90 and 99,5% by weight of particles in A physiologically acceptable excipient, and II) between 0,5 and 10% by weight of Magnesium Stearate (b) a fraction of coarse particles comprising a physiologically acceptable excipient with a diameter equal to or greater than 100 microns,Where the ratio between Fine particles and Coarse particles is between 1: 00 and 30: 70% in weight and (c) of formoterol fumarate Dihydrate in combination with beclomethasone Dipropionate (BDP) as active ingredients in the form of Micronized particles) where no more than 10% of the Beclomethasone Dipropionate as particles having a diameter of less than 0.6 micron(b) not more than 50% of these particles have a diameter of Volume between 1.5 and 2.0 microns and c) at least 90% of the particles have a diameter of smaller volume of 4.7 microns. This formulation is a dry powder Inhaler (DPI) is useful in the treatment of AsthmaSE REFIERE A UNA FORMULACION FARMACEUTICA SECA EN POLVO QUE COMPRENDE: A) UNA FRACCION DE PARTICULAS FINAS CUYO DIAMETRO ES MENOR DE 20 MICRONES Y ESTA COMPUESTA DE UNA MEZCLA DE i) ENTRE 90 Y 99,5% EN PESO DE PARTICULAS DE UN EXCIPIENTE FISIOLOGICAMENTE ACEPTABLE, Y ii) ENTRE 0,5 Y 10% EN PESO DE ESTEARATO DE MAGNESIO B) UNA FRACCION DE PARTICULAS GRUESAS COMPUESTA POR UN EXCIPIENTE FISIOLOGICAMENTE ACEPTABLE CON UN DIAMETRO MAYOR O IGUAL QUE 100 MICRONES, DONDE LA PROPORCION ENTRE LAS PARTICULAS FINAS Y LAS PARTICULAS GRUESAS ES DE ENTRE 1:99 Y 30:70 % EN PESO Y C) DIHIDRATO DEL FUMARATO DE FORMOTEROL EN COMBINACION CON DIPROPIONATO DE BECLOMETASONA (BDP) COMO INGREDIENTES ACTIVOS EN FORMA DE PARTICULAS MICRONIZADAS DONDE a) NO MAS DEL 10% DE DICHAS PARTICULAS DE DIPROPIONATO DE BECLOMETASONA TIENE UN DIAMETRO DE VOLUMEN MENOR DE 0,6 MICRONES, b) NO MAS DEL 50% DE DICHAS PARTICULAS TIENE UN DIAMETRO D
