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Composition of glycopyrronium bromide and combined formoterol in stable pressurized Spray Solution
专利权人:
CHIESI FARMACEUTICI S.P.A.
发明人:
SAURO BONELLI,DIEGO COPELLI,MASSIMILIANO DAGLI ALBERI,FRANCESCA USBERTI,ENRICO ZAMBELLI
申请号:
ARP140104939
公开号:
AR098983A1
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; 1. A.2. A.2. A. has an actuating dose of 1 to 25 mg; (c) a propellant composed of hydrofluorocarbons; (d) a solvent; (E) an effective amount of mineral stabilizer;The composition is contained in an aerosol container containing at least one butyl rubber sealed valve. 2. Characteristic 2: drug composition in aerosol conforming to characteristic 1 car1. Because the content of N - [2-hydroxy-5 - [1-hydroxy-2 - [1 - (4-methoxy) propane-2-ethyl] phenyl], a degradation product of N - (3-bromo), is lower than the theoretical content of 6 mg / 0.10% (weight) of the active methanol nicotinic acidwhen stored under conditions of accelerated aging at 25 ° C and 60% relative humidity (RH) for at least 6 months. Claim 3: A pharmaceutical composition in aerosol solution according to claim 1 or 2 characterized in that the amount of mineral acid useful as a stabilizer is acantidad de cido equivalente a cido clorh drico 1M dentro del rango entre 0 15 y 0 28 mg 2Fml Reivindicaci n 9 Una composici n farmac utica en soluci n para aerosol de acuerdo con la reivindicaci n 8 caracterizada porque el corticoesteroide para inhalaci n se selecciona entre Buddha or his book name 22rCiclosonida, flunisoda, fluticasone propionic acid, fluticasone sulfuric acid, mometasone furan, butixoort, acetonida triamcinolone, methylprednisone, predinosa, lotprednol and rofleponida. Claim 14: an aerosol container equipped with at least one butyl rubber sealing valve for aerosol with pharmaceutical ingredients, used for a pressurized dose inhaler, which is characterized by: (a) a dose of brominated glycerin (b) A solution of formaldehyde, salt, or salt in the range of 5 to 26 mg;with a dosage within the range between 1 and 25 mg per drive; (c) a propellant consisting of an HFA, (d) a co-solve
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