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Free Liquid formulation comprising a drug antimuscarinica propellant
专利权人:
CHIESI FARMACEUTICI S.P.A.
发明人:
SOLIANI RASCHINI ANNAMARIA,LUTERO EMILIO
申请号:
ARP120100539
公开号:
AR085273A1
申请日:
2012.02.16
申请国别(地区):
AR
年份:
2013
代理人:
摘要:
Pharmaceutical Formulation for Liquid propellant free Administration Antimuscarinic drugs by nebulisation comprising as an active ingredient. Process for preparing the formulation and its use in the Prevention and / or treatment of a wide range of conditions including Respiratory disorders.Claim 1: a Pharmaceutical formulation free of liquid propellant for Administration via nebulisation, characterized in that it comprises a compound of General formula (1) wherein: R1 is a group of the formula (CH2) P - - - - - - - - - W P where p is 0 or an integer Number 1 And 4, p is absent or is selected from the group consisting of o, S, so,SO2 and CO; W is selected from the group consisting of H, aryl and heteroaryl, aryl and heteroaryl where are optionally substituted with one or more substituents are selected from the group consisting of halogen ATOMS, Oh, sh, NO2, NS,NH2 and COOH, - represents a physiologically acceptable anion; wherein Said Compound is dissolved in a Solvent comprising at least 75% V / V and an optional Water Co Solvent miscible with water; and where the PH of the solution was formed is between 3.0 and 5.5.Claim 3: Formulation according to claim 1 or 2, wherein the compound of General formula (1) is present in a concentration that is between 0.001 and 7 mg / ml.Claim 7: Formulation according to any of the preceding Claims, wherein the PH is adjusted by the use of a buffering Agent is Citric Acid. Claim 8: the formulation according to any one of claims 1 to 6, wherein the cosolvent ethanol is optional.Claim: The 9 formulation according to any one of claims 1 to 6, wherein the cosolvent is optional, Propylene Glycol or glycerol. Claim 1: the formulation according to claim 10, wherein Said additional Therapeutic Agent is selected from the group consisting of B2 agonists, corticosteroids, or inhibitors of phosphodiesterase-4 (PDE4).Claim: a set of 15 components, characterized in that it comprises: (a) a formulation according to any one of claims 1 to 11 stu
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