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COMPOSICION COMBINADA DE BROMURO DE GLICOPIRRONIO Y FORMOTEROL EN SOLUCION ESTABLE PRESURIZADA PARA AEROSOL
专利权人:
CHIESI FARMACEUTICI S.P.A.
发明人:
BONELLI, Sauro,COPELLI, Diego,ZAMBELLI, Enrico,USBERTI, Francesca,DAGLI ALBERI, Massimiliano
申请号:
PE0009692016
公开号:
PE11322016A1
申请日:
2014.12.23
申请国别(地区):
PE
年份:
2016
代理人:
摘要:
Refers to a Pharmaceutical composition for use in Spray Solution with a pressurized Metered Dose Inhaler, comprising: (a) glycopyrronium bromide with a dosage between 5 and 26 UG Drive (b) formoterol, or a Salt thereof or a solvate of the Salt.With a Schedule between 1 and 25 ug Drive (c) a propellant consisting of a HFA (d) and (e) a cosolvent mineral acid as Stabilizer in a useful quantity. Said composition is contained in an aerosol container with a Metering Valve that has at least one Board of Butyl rubber.In a Preferred aspect, the mineral acid is hydrochloric acid in an amount between 1m and 0.28 0.15 ug \/ ul as a Stabilizer and the co Solvent is ethanol.In Another aspect, the composition comprises one or more pharmaceutically Active Ingredients selected from beta\u20132 agonists corticosteroids inhaled (beclomethasone Dipropionate, budesonide, Fluticasone propionate, triamcinolone, prednisone, among others) Agen Tes Antimuscarinics, inhibitors and fosfodiesterasa\u20134.The storage of said composition in aerosol containers fitted with a Metering Valve as has been pointed out previously, minimizes the amount of degradation products (particularly DP3) during its Shelf Life, even below the Threshold of Detection after Storage. In severe conditions of temperature and humiditySe refiere a una composicion farmaceutica en solucion para aerosol para utilizar con un inhalador presurizado de dosis medida, que comprende: a) bromuro de glicopirronio con una dosificacion entre 5 y 26 ug por accionamiento b) formoterol, o una sal del mismo o un solvato de dicha sal, con una dosificacion entre 1 y 25 ug por accionamiento c) un propelente que consiste en un HFA d) un cosolvente y e) un acido mineral como estabilizante en una cantidad util. Dicha composicion esta contenida en un envase de aerosol provisto de una valvula dosificadora que tiene por lo menos una junta de caucho butilico. En un aspecto preferido, el acido mineral es acido clorhidrico 1M, en una cantidad entre 0,
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