JP2021152047A5 - - Google Patents

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JP2021152047A5
JP2021152047A5 JP2021100791A JP2021100791A JP2021152047A5 JP 2021152047 A5 JP2021152047 A5 JP 2021152047A5 JP 2021100791 A JP2021100791 A JP 2021100791A JP 2021100791 A JP2021100791 A JP 2021100791A JP 2021152047 A5 JP2021152047 A5 JP 2021152047A5
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Prior art keywords
salt
filter
buffer
brimonidine
production method
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JP2021100791A
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Japanese (ja)
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JP2021152047A (en
JP7002692B2 (en
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Priority claimed from JP2020191883A external-priority patent/JP6901619B2/en
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Priority claimed from JP2021100791A external-priority patent/JP7002692B2/en
Priority to JP2021100791A priority Critical patent/JP7002692B2/en
Publication of JP2021152047A publication Critical patent/JP2021152047A/en
Publication of JP2021152047A5 publication Critical patent/JP2021152047A5/ja
Priority to JP2021212111A priority patent/JP7447072B2/en
Publication of JP7002692B2 publication Critical patent/JP7002692B2/en
Application granted granted Critical
Priority to JP2022160514A priority patent/JP7269425B2/en
Priority to JP2024028248A priority patent/JP2024052871A/en
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Claims (24)

フィルターを通過させる水性液剤に、For aqueous liquids that pass through the filter
ブリモニジン及び/又はその塩と、With brimonidine and / or its salt,
緩衝剤と、With a buffer,
ポリヘキサニド及び/又はその塩とWith polyhexanide and / or its salt
を含有させる、ブリモニジン及び/又はその塩のフィルターへの吸着抑制方法。A method for suppressing the adsorption of brimonidine and / or a salt thereof on a filter.
前記ブリモニジン及び/又はその塩が、ブリモニジン酒石酸塩である、請求項1に記載の吸着抑制方法。The adsorption suppression method according to claim 1, wherein the brimonidine and / or a salt thereof is brimonidine tartrate. 前記水性液剤におけるブリモニジン及び/又はその塩の濃度が、0.05〜0.2w/v%である、請求項1又は2に記載の吸着抑制方法。The adsorption suppression method according to claim 1 or 2, wherein the concentration of brimonidine and / or a salt thereof in the aqueous solution is 0.05 to 0.2 w / v%. 前記緩衝剤が、ホウ酸緩衝剤、リン酸緩衝剤、トリス緩衝剤、及びクエン酸緩衝剤よりなる群から選択される少なくとも1種である、請求項1〜3のいずれかに記載の吸着抑制方法。The adsorption inhibition according to any one of claims 1 to 3, wherein the buffer is at least one selected from the group consisting of a boric acid buffer, a phosphate buffer, a Tris buffer, and a citric acid buffer. Method. 前記緩衝剤が、ホウ酸緩衝剤である、請求項1〜4のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 4, wherein the buffer is a boric acid buffer. 前記ポリヘキサニド及び/又はその塩が、塩酸ポリヘキサニドである、請求項1〜5のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 5, wherein the polyhexanide and / or a salt thereof is polyhexanide hydrochloride. 前記水性液剤におけるポリヘキサニド及び/又はその塩の濃度が0.00001〜0.1w/v%である、請求項1〜6のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 6, wherein the concentration of polyhexanide and / or a salt thereof in the aqueous solution is 0.00001 to 0.1 w / v%. 前記水性液剤が粘稠剤を含まない、請求項1〜7のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 7, wherein the aqueous liquid does not contain a viscous agent. 前記水性液剤が、点眼液である、請求項1〜8のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 8, wherein the aqueous liquid is an eye drop. 前記フィルターの素材が、ポリエーテルスルホン、又はポリフッ化ビニリデンである、請求項1〜9のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 9, wherein the material of the filter is polyether sulfone or polyvinylidene fluoride. 前記フィルターが、ろ過滅菌工程で使用されるフィルターである、請求項1〜10のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 10, wherein the filter is a filter used in a filtration sterilization step. 前記水性液剤が、製造時にろ過滅菌工程でフィルターを通過させる水性液剤であって、ろ過滅菌工程後にフィルターを備えていないマルチドーズ型容器に収容して提供される、請求項1〜11のいずれかに記載の吸着抑制方法。One of claims 1 to 11, wherein the aqueous liquid is an aqueous liquid that passes through a filter in a filtration sterilization step at the time of manufacture, and is provided by being housed in a multi-dose type container not provided with a filter after the filtration sterilization step. The adsorption suppression method according to. 前記フィルターが、フィルター付き容器のフィルターである、請求項1〜12のいずれかに記載の吸着抑制方法。The adsorption suppression method according to any one of claims 1 to 12, wherein the filter is a filter of a container with a filter. ブリモニジン及び/又はその塩と、緩衝剤と、ポリヘキサニド及び/又はその塩とを含む水性液剤を調製する工程、並びにA step of preparing an aqueous solution containing brimonidine and / or a salt thereof, a buffer, and polyhexanide and / or a salt thereof, and
前記工程で得られた水性液剤を、フィルターを用いたろ過滅菌工程に供する工程、A step of subjecting the aqueous liquid obtained in the above step to a filtration sterilization step using a filter,
を含む、水性液剤の製造方法。A method for producing an aqueous liquid preparation including.
前記ブリモニジン及び/又はその塩が、ブリモニジン酒石酸塩である、請求項14に記載の製造方法。The production method according to claim 14, wherein the brimonidine and / or a salt thereof is brimonidine tartrate. 前記水性液剤におけるブリモニジン及び/又はその塩の濃度が、0.05〜0.2w/v%である、請求項14又は15に記載の製造方法。The production method according to claim 14 or 15, wherein the concentration of brimonidine and / or a salt thereof in the aqueous solution is 0.05 to 0.2 w / v%. 前記緩衝剤が、ホウ酸緩衝剤、リン酸緩衝剤、トリス緩衝剤、及びクエン酸緩衝剤よりなる群から選択される少なくとも1種である、請求項14〜16のいずれかに記載の製造方法。The production method according to any one of claims 14 to 16, wherein the buffer is at least one selected from the group consisting of a boric acid buffer, a phosphate buffer, a Tris buffer, and a citric acid buffer. .. 前記緩衝剤が、ホウ酸緩衝剤である、請求項14〜17のいずれかに記載の製造方法。The production method according to any one of claims 14 to 17, wherein the buffer is a boric acid buffer. 前記ポリヘキサニド及び/又はその塩が、塩酸ポリヘキサニドである、請求項14〜18のいずれかに記載の製造方法。The production method according to any one of claims 14 to 18, wherein the polyhexanide and / or a salt thereof is polyhexanide hydrochloride. 前記水性液剤におけるポリヘキサニド及び/又はその塩の濃度が0.00001〜0.1w/v%である、請求項14〜19のいずれかに記載の製造方法。The production method according to any one of claims 14 to 19, wherein the concentration of polyhexanide and / or a salt thereof in the aqueous solution is 0.00001 to 0.1 w / v%. 前記水性液剤が粘稠剤を含まない、請求項14〜20のいずれかに記載の製造方法。The production method according to any one of claims 14 to 20, wherein the aqueous liquid does not contain a viscous agent. 前記水性液剤が、点眼液である、請求項14〜21のいずれかに記載の製造方法。The production method according to any one of claims 14 to 21, wherein the aqueous liquid is an eye drop. 前記フィルターの素材が、ポリエーテルスルホン、又はポリフッ化ビニリデンである、請求項14〜22のいずれかに記載の製造方法。The production method according to any one of claims 14 to 22, wherein the material of the filter is polyether sulfone or polyvinylidene fluoride. 前記水性液剤が、ろ過滅菌工程後にフィルターを備えていないマルチドーズ型容器に収容して提供される、請求項14〜23のいずれかに記載の製造方法。The production method according to any one of claims 14 to 23, wherein the aqueous liquid agent is provided in a multi-dose type container not provided with a filter after the filtration sterilization step.
JP2021100791A 2020-11-18 2021-06-17 Aqueous liquid Active JP7002692B2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2021100791A JP7002692B2 (en) 2020-11-18 2021-06-17 Aqueous liquid
JP2021212111A JP7447072B2 (en) 2020-11-18 2021-12-27 aqueous liquid
JP2022160514A JP7269425B2 (en) 2020-11-18 2022-10-04 aqueous solution
JP2024028248A JP2024052871A (en) 2020-11-18 2024-02-28 Water-based liquid

Applications Claiming Priority (2)

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JP2020191883A JP6901619B2 (en) 2019-09-30 2020-11-18 Aqueous solution
JP2021100791A JP7002692B2 (en) 2020-11-18 2021-06-17 Aqueous liquid

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JP2021152047A5 true JP2021152047A5 (en) 2021-11-18
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US20050026924A1 (en) 2000-07-14 2005-02-03 Allergan, Inc. Compositions containing alpha-2-adrenergic agonist components
JP2013523828A (en) 2010-04-07 2013-06-17 アラーガン インコーポレイテッド Preservative combinations for ophthalmic compositions
CA3047279A1 (en) 2016-12-15 2018-06-21 Harrow Health, Inc. Pharmaceutical formulations for treating glaucoma and methods for fabricating and using thereof

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