SAURO BONELLI,DIEGO COPELLI,MASSIMILIANO DAGLI ALBERI,FRANCESCA USBERTI,ENRICO ZAMBELLI
申请号：
ARP140104938
公开号：
AR098982A1
申请日:
2014.12.29
申请国别(地区):
AR
年份:
2016
代理人:
摘要：
1. Characteristic 1: the drug composition in aerosol used for pressure inhaler, the measurement standard of which is: (a) brominated glycerin used in the action dose range of 5-26 mg； (b) methanol, or its salt or solution； In the range of 1-25 mg of promoter dose； (c) a propellant composed of hydrofluorocarbons； (d) a solvent； (E) an effective amount of mineral acid stabilizer；This component is contained in the aerosol tank and is internally coated with a fluoroethylene propylene copolymer resin. Claim 2: according to claim 1, the pharmaceutical composition in the aerosol, which is characterized by the quantity of degradation product n - (3-bromine) n - [2-hydroxy-5 - [1-hydroxy-2 - [1 - (4-methoxy) propane-2-ethyl] phenyl] methylamine (DP3),It is less than 0.10% by weight with respect to the theoretical content of formoterol fumarate of 6 mg / drive, when stored under conditions of accelerated aging at 25 ° C and 60% relative humidity for at least 6 months. Claim 10: A pharmaceutical composition in aerosol solution according to claim 9 characterized in that the corticosteroid for inhalation is selected from the group of: beclomethasone dipropionate, budesonide or its 22R- epimer,Ciclosonida, fluxoda, fluticasone propionic acid, fluticasone sulfuric acid, mometasone fluvo, butixocot, acetone Trichloroacetone, trichloroacrylonitrile, methamphetamine, prednisone, Agave, agave and rovponda. Requirement 15: the aerosol tank is lined with a fluorine-containing ethylene propylene (FEP) resin, which is used for aerosol with aerosol drug composition and for pressure dose inhaler. Its characteristics are: (a) brominated diphenyl ether containing a fluorine-containing ethylene propylene copolymer； 2. In the range of 5 to 26 mg, apply the dose by action； (b) formaldehyde, salt or salt solution；with a dosage within the range between 1 and 25 mg per drive； (c) a propellant consisting of an HFA, (d) a co-solvent； (e) an amount useful as a mineral acid stabilizer, and, optionally,
