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公开(公告)号：US20200000925A1
公开(公告)日：2020-01-02
申请号：US16515653
申请日：2019-07-18
摘要： The present invention relates to an aqueous composition comprising: (i) a steroidal neuromuscular blocking agent that is a Rocuronium salt, further wherein the steroidal neuromuscular blocking agent is present at a concentration ranging from 5 mg/mL to 20 mg/mL based on the total volume of the aqueous composition; and (ii) an excipient that includes D-gluconic acid, D-glucono-delta-lactone, or a combination thereof, where the steroidal neuromuscular blocking agent and the excipient are dissolved in a solution consisting of water. Furthermore the present invention relates to a liquid pharmaceutical composition comprising or consisting of said aqueous composition and a method for producing said aqueous composition.
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公开(公告)号：US11998605B2
公开(公告)日：2024-06-04
申请号：US16515653
申请日：2019-07-18
CPC分类号： A61K47/26 , A61K9/0019 , A61K31/58 , A61K45/06 , A61K47/12
摘要： The present invention relates to an aqueous composition comprising:
(i) a steroidal neuromuscular blocking agent that is a Rocuronium salt, further wherein the steroidal neuromuscular blocking agent is present at a concentration ranging from 5 mg/mL to 20 mg/mL based on the total volume of the aqueous composition; and
(ii) an excipient that includes D-gluconic acid, D-glucono-delta-lactone, or a combination thereof, where the steroidal neuromuscular blocking agent and the excipient are dissolved in a solution consisting of water.
Furthermore the present invention relates to a liquid pharmaceutical composition comprising or consisting of said aqueous composition and a method for producing said aqueous composition.-
公开(公告)号：US20150216979A1
公开(公告)日：2015-08-06
申请号：US14420684
申请日：2013-09-19
CPC分类号： A61K47/26 , A61K9/0019 , A61K31/58 , A61K45/06 , A61K47/12
摘要： The present invention relates to an aqueous composition comprising: (i) a quaternary ammonium neuromuscular blocking agent; and (ii) an excipient selected from a polyhydroxy acid of the following formula: HO—CH2—[CH(OH)]n—COOH, wherein n is an integer from 1 to 8, an intramolecular lactone of said polyhydroxy acid or a mixture thereof. Furthermore the present invention relates to a liquid pharmaceutical composition comprising or consisting of said aqueous composition and a method for producing said aqueous composition comprising the steps of: a) providing a quaternary ammonium neuromuscular blocking agent wherein said quaternary ammonium neuromuscular blocking agent is optionally freeze-dried, b) providing an excipient selected from a polyhydroxy acid of the following formula: HO—CH2—[CH(OH)]n—COOH, wherein n is an integer from 1 to 8, an intramolecular lactone of said polyhydroxy acid or a mixture thereof, wherein said excipient is optionally freeze-dried, c) mixing the quaternary ammonium neuromuscular blocking agent of step a) and the excipient of step b) in water to give an aqueous composition. In addition, the present invention relates to the use of a polyhydroxy carboxylic acid of the following formula: HO—CH2—[CH(OH)]n—COOH, wherein n is an integer from 1 to 8, an intramolecular lactone of said polyhydroxy acid or a mixture thereof for stabilizing an aqueous composition comprising a quaternary ammonium neuromuscular blocking agent. The present invention also refers to a container containing the aqueous composition or the liquid pharmaceutical composition of the present invention. It furthermore relates to a kit comprising said compositions. Preferred embodiments are apparent from the dependent claims.
摘要翻译： 本发明涉及含水组合物，其包含：（i）季铵神经肌肉阻滞剂; 和（ii）选自下式的多羟基酸的赋形剂：HO-CH 2 - [CH（OH）] n -COOH，其中n为1至8的整数，所述多羟基酸的分子内内酯或混合物 其中。 此外，本发明涉及包含所述水性组合物或由所述水性组合物组成的液体药物组合物和用于制备所述水性组合物的方法，其包括以下步骤：a）提供季铵神经肌肉阻滞剂，其中所述季铵神经肌肉阻滞剂任选地冷冻干燥， 干燥，b）提供选自下式的多羟基酸的赋形剂：HO-CH 2 - [CH（OH）] n -COOH，其中n为1至8的整数，所述多羟基酸的分子内内酯或 其中所述赋形剂任选地冷冻干燥，c）将步骤a）的季铵神经肌肉阻滞剂和步骤b）的赋形剂混合在水中，得到含水组合物。 此外，本发明涉及下式的多羟基羧酸的用途：HO-CH 2 - [CH（OH）] n -COOH，其中n为1至8的整数，所述多羟基的分子内酯 酸或其混合物，用于稳定包含季铵神经肌肉阻滞剂的水性组合物。 本发明还涉及含有本发明的水性组合物或液体药物组合物的容器。 此外，它还涉及包含所述组合物的试剂盒。 优选的实施方案从从属权利要求中显而易见。
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