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Pharmaceutical formulations of formoterol or ta2005 in stable solution for Pressurised Metered Dose Measurement

机译:用于加压计量剂量的稳定溶液中的福莫特罗或ta2005的药物制剂

摘要

A composition comprising a drug spray type amino Functional Group wherein has a sensitive oxidation Reactions and / or hydrolysis in a solution of a Liquefied HFA propellant, a pharmaceutically acceptable co Solvent selected from alcohols, where the P H of the solution was adjusted to between 2.5 and 50 by addition of small amounts of a Mineral acid such as hydrochloric acid, nitric acid, fosfu00f3rico.una composition according to clause 2, wherein the PH of the solution was adjusted to 3.0 and 3.5.A composition in accordance with the clauses on 1 - 2, wherein the solution comprises a component with a Low Volatility to low vapour pressure of not more than 0,1kpa, preferably not more than 0,05kpa.A composition according to any preceding clause, wherein the solution comprises at least 0.2% by weight of the component of Low Volatility and no more than 10% by weight. A composition agreement with clauses 1 to 4, wherein the co Solvent is an alcohol, Preferably ethanol.A composition according to any preceding clause, wherein the low volatile component is selected from one or a glycol Ester. A composition according to clause 2, wherein the component of Low Volatility is Isopropyl Myristate.A composition according to any preceding clause, characterized in that the propellant comprises one or more hfas / s selected among the Group comprising HFA 134a or HFA 227.
机译:包含药物喷雾型氨基官能团的组合物,其中在液化HFA推进剂,选自醇的药学上可接受的共溶剂的溶液中具有敏感的氧化反应和/或水解,其中溶液的PH调节至2.5 50.根据条款2,通过添加少量的无机酸,例如盐酸,硝酸,fosf 3组合物,其中溶液的pH调节至3.0和3.5。 1-2。根据权利要求1-2的组合物,其中所述溶液包含对挥发性低的蒸气压低至不大于0.1kpa,优选不大于0.05kpa的组分。根据前述条款中任一项的组合物,其中所述溶液包含至少0.2kPa。低挥发性组分的重量百分比不超过10重量%。根据条款1-4所述的组合物,其中所述助溶剂为醇,优选为乙醇。根据前述条款中任一项的组合物,其中所述低挥发性组分选自一种或二醇酯。 3.根据条款2的组合物,其中低挥发性的组分是肉豆蔻酸异丙酯。根据任何前述条款的组合物,其特征在于所述推进剂包含选自HFA 134a或HFA 227的一种或多种hfa / s。

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