CN116981761A - 隐形眼镜处理溶液 - Google Patents
隐形眼镜处理溶液 Download PDFInfo
- Publication number
- CN116981761A CN116981761A CN202280018795.1A CN202280018795A CN116981761A CN 116981761 A CN116981761 A CN 116981761A CN 202280018795 A CN202280018795 A CN 202280018795A CN 116981761 A CN116981761 A CN 116981761A
- Authority
- CN
- China
- Prior art keywords
- contact lens
- treatment solution
- lens treatment
- total weight
- antimicrobial agents
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 57
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- IHPKGUQCSIINRJ-UHFFFAOYSA-N β-ocimene Natural products CC(C)=CCC=C(C)C=C IHPKGUQCSIINRJ-UHFFFAOYSA-N 0.000 description 1
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Abstract
一种隐形眼镜处理溶液包含(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠、氯化钾或其任何组合;以及(e)一种或多种缓冲液。
Description
优先权声明
本申请要求于2021年3月10日提交的题为“眼用溶液(Ophthalmic Solutions)”的美国临时专利申请序列号63/159,097的优先权,所述美国临时专利申请的内容通过引用整体并入本文。
背景技术
在正常使用期间,隐形眼镜会被各种各样的可能降低镜片的性能的化合物染污或污染。例如,隐形眼镜将被泪液中存在并粘附到镜片表面的生物材料,如蛋白质或脂质染污。而且,通过操作隐形眼镜,皮脂(皮肤油)、化妆品或其它材料可能会染污隐形眼镜。这些生物和外部污染物可能影响视力和患者的舒适度。因此,有利的是从镜片表面去除任何碎屑,以便与镜片护理溶液一起继续舒适使用。
发明内容
根据一说明性实施例,提供了一种隐形眼镜处理溶液,其包括(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠和氯化钾中的一种或多种;以及(e)一种或多种缓冲液。
根据另一说明性实施例,一种清洁和消毒隐形眼镜的方法,所述方法包括:将所述隐形眼镜在隐形眼镜处理溶液中浸泡至少约两小时,其中所述隐形眼镜处理溶液包括:(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠和氯化钾中的一种或多种;以及(e)一种或多种缓冲液。
根据另外的说明性实施例,一种重新润湿隐形眼镜的方法,所述方法包括在佩戴在眼睛上时向隐形眼镜施用隐形眼镜处理溶液,其中所述隐形眼镜处理溶液包括(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠和氯化钾中的一种或多种;以及(e)一种或多种缓冲液。
根据又另外的说明性实施例,一种隐形眼镜处理溶液的用途,其用于将隐形眼镜清洁和消毒至少两小时,所述隐形眼镜处理溶液包括(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠和氯化钾中的一种或多种;以及(e)一种或多种缓冲液。
根据仍又另外的说明性实施例,一种隐形眼镜处理溶液的用途,其用于在佩戴在眼镜上时重新润湿隐形眼镜,所述隐形眼镜处理溶液包括:(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠和氯化钾中的一种或多种;以及(e)一种或多种缓冲液。
具体实施方式
本文所描述的说明性实施例涉及眼用溶液,包含例如隐形眼镜处理溶液、重新润湿滴液、滴眼液和其用途。本文所描述的各种说明性实施例包含眼用溶液,如可用于例如处理隐形眼镜的旨在与身体组织或流体直接接触的表面的隐形眼镜处理溶液。因此,本文所描述的说明性实施例可以涉及用于清洁、消毒、储存和/或重新润湿隐形眼镜的旨在与身体组织或流体直接接触的表面的隐形眼镜处理溶液。
许多生物聚合物对常见的灭菌程序敏感,例如热灭菌。热灭菌通常可能导致生物聚合物的物理化学特性发生显著变化,从而使所得无菌生物聚合物不适合其预期用途。
目前应用于医疗材料的灭菌方法包含例如热处理、高压蒸汽灭菌(例如,高压灭菌器灭菌)、环氧乙烷气体(EOG)灭菌、超临界二氧化碳灭菌和辐射灭菌。可用的灭菌方法通常关于要灭菌的特定生物聚合物的稳健性进行评估。例如,仅在生物聚合物能够承受高温和高压的范围内,高压蒸气灭菌才能用于生物聚合物。然而,包含透明质酸在内的极少数生物聚合物能够承受如此高温和高压。
透明质酸是一种非免疫原性物质,并且由于其粘弹特性和亲水特性,透明质酸多年来一直被用作眼睛玻璃体或关节液的替代品,或眼科手术中的支持介质。在关节液中,透明质酸溶液用作润滑剂,以为细胞提供保护环境,并且因此,其用于治疗发炎的膝关节。消费者使用包含透明质酸的产品需要制造商对消费品进行灭菌,并且如果用作开放式多剂量调配物,则必须采取另外的步骤来保存调配物产品。
已知透明质酸是一种对热灭菌过程相对敏感的生物聚合物。已知透明质酸的热灭菌会加速透明质酸的水解或氧化,由此导致生物聚合物的平均分子量显著且通常有害地降低。对于许多药物应用,调配物中相对低分子量形式的透明质酸是不期望的。通常,低分子量形式的透明质酸不能提供高分子量形式的透明质酸所期望的流变特性。为了补偿透明质酸在上述热灭菌方法中的分解,可以从具有比期望的分子量更高的分子量的透明质酸开始。然而,这种调节导致工艺效率低下,这是因为透明质酸的产物产率随着生物聚合物的平均分子量的增加而降低。
本文所描述的说明性实施例通过调配透明质酸或其盐的改善的无菌隐形眼镜处理溶液克服了这一问题和其它问题,所述溶液可以在透明质酸或其盐没有实质降解的情况下进行灭菌。具体地,通过在本文所公开的眼用溶液中将透明质酸或其盐与赤藓糖醇组合,当经受灭菌条件,如高压灭菌时,透明质酸或其盐随时间推移的分子量损失在统计学上显著好于在不存在赤藓糖醇的情况下含有透明质酸或其盐的隐形眼镜处理溶液。因此,本文所公开的其中透明质酸或其盐的分子量损失得到改善的隐形眼镜处理溶液将有利地表现出更少的pH问题、更少的功效问题、改善的粘度和更少的氧化和热降解,由此导致更高的稳定性和更长的保质期。另外,本文所公开的隐形眼镜处理溶液还有利地对用于制备溶液的水中所含的任何铁表现出更高的耐受性,这是通过将透明质酸或其盐与赤藓糖醇组合来实现的,并且由此提供更稳健的溶液。
在一个或多个非限制性说明性实施例中,一种隐形眼镜处理溶液包括(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠和氯化钾中的一种或多种;以及(e)一种或多种缓冲液。
本文所公开的隐形眼镜处理溶液将包含基于所述隐形眼镜处理溶液的总重量,至少约0.005wt.%至约2wt.%的透明质酸或其盐。透明质酸是一种众所周知的天然水溶性生物可降解聚合物,由两种交替连接的糖,D-葡萄糖醛酸和N-乙酰葡糖胺构成,通过交替的β-(1,4)和β-(1,3)糖苷键连接。透明质酸与其它糖胺聚糖不同,因为其与蛋白质和磺酰基没有共价连接。透明质酸在动物体内普遍存在,其中发现在软结缔组织中浓度最高。透明质酸对于身体的机械和运输目的两者都发挥着重要作用,例如,其赋予关节弹性和脊椎动物椎间盘刚性,并且也是眼睛玻璃体的重要组成。
透明质酸聚合物在相对低的溶质浓度的水溶液中具有亲水性和高粘性。其通常以钠盐、透明质酸钠的形式天然存在。制备可商购获得的透明质酸和其盐的方法是众所周知的。透明质酸可以从以下购买:例如,生化学工业株式会社公司(Seikagaku Company);清液生物技术有限公司(Clear Solutions Biotech,Inc.);法玛西亚有限公司(PharmaciaInc.);西格玛有限公司(Sigma Inc.);HTL生物技术公司(HTL Biotechnology);Contipro公司;华熙生物科技公司(Bloomage Biotechnology Corporation)以及许多其它供应商。透明质酸具有由下式表示的结构的重复单元:
因此,透明质酸中的重复单元可以如下:
通常,透明质酸或其盐,如透明质酸钠和透明质酸钾的二糖单元可以为约2个至约1,500,000个。在一实施例中,透明质酸或其盐的重均分子量可以在约10,000至约3,000,000道尔顿(Da)的范围内,其中下限为约10,000、约20,000、约30,000、约40,000、约50,000、约60,000、约70,000、约80,000、约90,000、约100,000、约200,000、约300,000、约400,000、约500,000或约600,000Da,并且上限为约200,000、约300,000、约400,000、约500,000、约600,000、约700,000、约800,000、约900,000、约1,000,000或约至多2,800,000Da,其中任何下限可以与任何上限组合。
在一说明性实施例中,基于隐形眼镜处理溶液的总重量,透明质酸或其盐以范围为约0.005wt.%至约2wt.%的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,透明质酸或其盐以范围为约0.01wt.%至约0.2wt.%的量存在于本文所公开的隐形眼镜处理溶液中。
本文所公开的隐形眼镜处理溶液进一步含有赤藓糖醇。在一说明性实施例中,基于隐形眼镜处理溶液的总重量,赤藓糖醇以范围为约0.01wt.%至约1wt.%的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,赤藓糖醇以范围为约0.05wt.%至约0.5wt.%的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,赤藓糖醇以范围为约0.08wt.%至约0.4wt.%的量存在于本文所公开的隐形眼镜处理溶液中。
本文所公开的隐形眼镜处理溶液进一步含有一种或多种非离子表面活性剂。在说明性实施例中,合适的一种或多种非离子表面活性剂包含例如一种或多种末端官能化的表面活性剂。合适的非离子表面活性剂举例来说包含一种或多种聚醚。有用的末端官能化的聚醚包括一个或多个链或聚合物组分,其具有一个或多个(-O-R-)重复单元,其中R是具有2个至约6个碳原子的亚烷基或亚芳基。聚醚可以衍生自由不同比率组分的环氧乙烷(EO)和环氧丙烷(PO)形成的嵌段共聚物。此类聚醚和其相应组分区段可以包含不同的连接的疏水性和亲水性化学官能团部分和区段。
可以末端官能化的合适的聚醚的一个非限制性代表性实例是泊洛沙姆嵌段共聚物(poloxamer block copolymer)。一类特定的泊洛沙姆嵌段共聚物是可以商标普朗尼克(Pluronic)(密歇根州怀恩多特的BASF怀恩多特公司)获得的那些。泊洛沙姆包含普朗尼克类和反向普朗尼克类。普朗尼克类是一系列ABA嵌段共聚物,由聚(环氧乙烷)-聚(环氧丙烷)-聚(环氧乙烷)嵌段构成,如通常由式(I)所示:
HO(C2H4O)a(C3H6O)b(C2H4O)aH(I),
其中a独立地是至少1并且b是至少1。
反向普朗尼克类是一系列BAB嵌段共聚物,分别由聚(环氧丙烷)-聚(环氧乙烷)-聚(环氧丙烷)嵌段构成,如通常由式(II)所示:
HO(C3H6O)b(C2H4O)a(C3H6O)bH(II),
其中a是至少1并且b独立地是至少1。聚(环氧乙烷)PEO嵌段是亲水性的,而聚(环氧丙烷)PPO嵌段本质上是疏水性的。每个系列中的泊洛沙姆具有不同比率的PEO和PPO,这最终决定了材料的亲水-亲脂性平衡(HLB),即,变化的HLB值基于a和b的变化值,a表示存在于分子中的亲水性聚(环氧乙烷)单元(PEO)的数量,并且b表示存在于分子中的疏水性聚(环氧丙烷)单元(PPO)的数量。
泊洛沙姆和反向泊洛沙姆具有可以末端官能化的末端羟基。末端官能化的泊洛沙姆并且如下文所讨论的一个实例是泊洛沙姆二甲基丙烯酸酯(例如,F127二甲基丙烯酸酯),如美国专利申请公开第2003/0044468号和美国专利第9,309,357号中所公开的。其它实例包含聚乙二醇和聚丙二醇的缩水甘油基封端的共聚物,如美国专利第6,517,933号中所公开的。
合适的聚醚的另一个非限制性代表性实例是泊洛沙明嵌段共聚物(poloxamineblock copolymer)。虽然泊洛沙姆和反向泊洛沙姆被认为是双官能分子(基于末端羟基),但泊洛沙明是四官能形式,即分子是终止于伯羟基并通过中心二胺连接的四官能嵌段共聚物。一类特定的泊洛沙明嵌段共聚物是可以商标特窗酸(Tetronic)(BASF)获得的那些。泊洛沙明包含特窗酸和反向特窗酸。泊洛沙明具有下式(III)的一般结构:
其中a独立地是至少1并且b独立地是至少1。
泊洛沙姆和/或泊洛沙明可以被官能化以在分子的末端处提供期望的反应性。官能度可以变化,并且基于官能化的含PEO和PPO的嵌段共聚物的预期用途来确定。如本文所使用的,术语嵌段共聚物应理解为意指在其聚合物主链中具有两个或更多个嵌段的泊洛沙姆和/或泊洛沙明。
在一说明性实施例中,本文所公开的隐形眼镜处理溶液含有泊洛沙姆和泊洛沙明中的一种或多种作为所述一种或多种非离子表面活性剂。在一说明性实施例中,本文所公开的隐形眼镜处理溶液含有分子量为约7,500至约27,000的泊洛沙明,如泊洛沙明1107(特窗酸1107),以及泊洛沙姆,如泊洛沙姆181,其中至少约40重量%的加合物是聚(氧乙烯)。
在一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种非离子表面活性剂以范围为约0.05wt.%至约5wt.%的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种非离子表面活性剂以范围为约0.1wt.%至约2wt.%的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种非离子表面活性剂以范围为约0.1wt.%至约1.5wt.%的量存在于本文所公开的隐形眼镜处理溶液中。
本文所公开的隐形眼镜处理溶液进一步含有有效量的一种或多种张力调节组分。合适的张力调节组分包含例如隐形眼镜护理产品中常规使用的组分,如各种无机盐。在一说明性实施例中,合适的张力调节组分包含氯化钠、氯化钾和其组合。所述一种或多种张力调节组分的量是有效地为溶液提供期望张力程度的量。
在一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种张力调节组分以范围为约0.01wt.%至约5wt.%的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种张力调节组分以范围为约0.01wt.%至约1wt.%的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种张力调节组分以范围为约0.01wt.%至约0.08wt.%的量存在于本文所公开的隐形眼镜处理溶液中。
本文所公开的隐形眼镜处理溶液进一步含有一种或多种缓冲液。术语“缓冲液”和“缓冲液系统”被理解为意指单独或与至少一种其它化合物组合在溶液中提供缓冲系统的化合物,所述缓冲系统表现出缓冲能力,即在其中原始pH变化相对较小或没有变化的一定范围内中和酸或碱(base/alkali)的能力。术语“缓冲能力”被理解为意指当添加到一升(标准单位)缓冲溶液中时,将pH值改变一个单位所需的强酸或强碱(或分别为氢或氢氧根离子)的毫摩尔(mM)。缓冲容量将取决于缓冲组分的类型和浓度。缓冲容量是在约6至约8、或约7.4至约8.4的起始pH下测量的。
合适的缓冲液包含例如硼酸和其盐,如硼酸钠或硼酸钾。硼酸盐缓冲液还包含缓冲化合物,如例如在溶液中产生硼酸或其盐的四硼酸钾或偏硼酸钾。已知硼酸盐缓冲液增强某些聚合双胍的功效。例如,美国专利第4,758,595号描述了一种含有聚(六亚甲基双胍),也称为PHMB或PAPB的隐形眼镜溶液,如果与硼酸盐缓冲液组合,其可以表现出增强的功效。其它合适的缓冲液包含双甘肽(双甘氨肽)和柠檬酸钠。
在一说明性实施例中,所述一种或多种缓冲液以范围为约0.1%至约10%(w/w)的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,所述一种或多种缓冲液以范围为约0.5%至约5%(w/w)的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,所述一种或多种缓冲液以范围为约0.75%至约2%(w/w)的量存在于本文所公开的隐形眼镜处理溶液中。
在说明性实施例中,本文所公开的隐形眼镜处理溶液含有一种或多种抗微生物剂。已知在眼用组合物中用作防腐剂的各种抗微生物剂。例如,合适的已知的眼用可接受的抗微生物剂包含双胍或其盐或其游离碱;季铵化合物或其盐或者其游离碱;萜烯或其衍生物;支化的甘油单烷基醚;支化的甘油单烷基胺;支化的甘油单烷基硫化物;脂肪酸单酯,其中所述脂肪酸单酯包括具有六个至十四个碳原子的脂肪族脂肪酸部分和脂肪族羟基部分;酰氨基胺化合物等以及其组合。
用于本文所公开的隐形眼镜处理溶液的合适的双胍抗微生物剂包含例如本领域已知的任何双胍或其盐。在一说明性实施例中,双胍的代表性实例包含非聚合物双胍、聚合物双胍、其盐、其游离碱等和其混合物。在一说明性实施例中,非聚合物双胍的代表性实例包含双(双胍),如阿来西定(alexidine)、氯己定、阿来西定盐,例如阿来西定HCl、氯己定盐、阿来西定游离碱等和其混合物。阿来西定和氯己定的盐可以是有机的或无机的,并且通常是消毒硝酸盐、乙酸盐、磷酸盐、硫酸盐、卤化物等。
在一说明性实施例中,聚合物双胍的代表性实例包含聚合物六亚甲基双胍(PHMB)(可从特拉华州威尔明顿的泽尼卡商购获得)、其聚合物和水溶性盐。在一实施例中,用于本文的水溶性聚合物双胍的数均分子量可以是至少约1,000或数均分子量是约1,000至约50,000。合适的游离碱的水溶性盐包含例如盐酸盐、硼酸盐、乙酸盐、葡萄糖酸盐、磺酸盐、酒石酸盐和柠檬酸盐。通常,六亚甲基双胍聚合物,也称为聚氨基丙基双胍(PAPB)的数均分子量可以为至多约100,000。此类化合物是已知的,并且公开于例如美国专利第4,758,595号中,所述美国专利通过引用并入本文。
PHMB或聚六甲基双胍最好描述为包括至少三种且优选地至少六种双胍聚合物的聚合物双胍组合物,我们称之为PHMB-A、PHMB-CG和PHMB-CGA,其一般化学结构描绘如下。
对于这些聚合物中的每一种,“n”表示重复基团的平均数量。对于所示的聚合物中的每一种,都存在聚合物长度的分布。PHMB的先前合成路线提供了聚合物双胍组合物,其中约50重量%的聚合物组合物作为PHMB-CGA,即在一端上具有氰基胍端帽并且在另一端上具有胺,约25重量%PHMB-A和约25重量%PHMB-CG。给定上述三种主要PHMB聚合物的此近似重量比,氰基胍端帽的百分比也为末端基团总数的约50%。在本申请中,将这种常规的聚合物双胍组合物称为聚(六亚甲基双胍)或PHMB。
还可以使用如通过13C NMR测量的包括小于18摩尔%的末端胺基团的聚合物双胍组合物。聚合物双胍组合物的特征还可以在于末端胍基或末端氰基胍基的摩尔浓度的相对增加。例如,在一说明性实施例中,双胍组合物包括小于约18摩尔%的末端胺基团和约40mol%或更多的末端胍基。在另一说明性实施例中,双胍组合物包括小于约18摩尔%的末端胺基团和约55mol%或更多的末端胍基。
在本申请中,这种双胍组合物被称为PHMB-CG*。另外,一般意义上的聚合双胍组合物被称为“六亚甲基双胍”,本领域普通技术人员将认识到其包含PHMB以及PHMB-CG*两者。
在一说明性实施例中,基于隐形眼镜处理溶液的总重量,双胍抗微生物剂可以以约0.5ppm至约10ppm的量存在于隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,双胍抗微生物剂可以以约0.5ppm至约5ppm的量存在于隐形眼镜处理溶液中。
用于本文所公开的隐形眼镜处理溶液的合适的季铵化合物包含例如聚[(二甲基亚氨基)-2-丁烯-1,4-二酰氯]和[4-三(2-羟乙基)铵]-2-丁烯-w-[三(2-羟乙基)铵]-二氯化物(化学注册号75345-27-6)等以及其混合物,其通常可以商品名M(伊利诺伊州诺思菲尔德的斯泰潘公司(Stepan Company,Northfield,Ill))的聚季铵盐-1形式获得。季铵化合物在本领域中通常被称为“聚季铵盐”消毒剂,并且在名称后面用特定的数字来标识,如聚季铵盐-1、聚季铵盐-10、聚季铵盐-42等。
在一说明性实施例中,基于隐形眼镜处理溶液的总重量,季铵化合物可以以约0.5ppm至约10ppm的量存在于隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,季铵化合物可以以约0.5ppm至约3ppm的量存在于隐形眼镜处理溶液中。
用于本文所公开的隐形眼镜处理溶液的合适的萜烯抗微生物剂包含例如任何单萜、倍半萜和/或二萜或其衍生物。可以使用非环、单环和/或双环单萜、倍半萜和/或二萜,以及那些具有更高环数的那些。如本文所使用的萜烯的“衍生物”应理解为意指具有一个或多个官能团的萜烯烃,如萜烯醇、萜烯醚、萜烯酯、萜烯醛、萜烯酮等和其组合。此处,反式异构体和顺式异构体两者都是合适的。衍生物中的萜烯以及萜烯部分可以含有6个至约100个碳原子或约10个至约25个碳原子。
用于本文所公开的隐形眼镜处理溶液中的合适的萜烯醇抗微生物剂包含例如马鞭草烯醇、反式松香芹醇、顺式-2-蒎烷醇、诺卜醇(nopol)、异冰片、卡比醇(carbeol)、胡椒醇、百里酚、α-萜品醇、萜品-4-醇(terpinen-4-ol)、薄荷醇、1,8-萜品(1,8-terpin)、二氢-萜品醇、橙花醇、香叶醇、芳樟醇、香茅醇、羟基香茅醇、3,7-二甲基辛醇、二氢-月桂烯醇、四氢别罗勒烯醇(tetrahydro-alloocimenol)、紫苏醇、法卡林二醇(falcarindiol)等和其混合物。
用于本文所公开的隐形眼镜处理溶液的合适的萜烯醚和萜烯酯抗微生物剂包含例如1,8-桉树脑、1,4-桉树脑、异冰片基甲基醚、玫瑰吡喃、α-松油基甲基醚、薄荷呋喃、反式茴香脑、甲基胡椒酚、二环氧别罗勒烯(allocimene diepoxide)、柠檬烯单环氧化物、乙酸异冰片酯、乙酸壬酯、乙酸α-松油酯、乙酸芳樟酯、乙酸香叶酯、乙酸香茅酯、乙酸二氢松油酯、乙酸甲酯等和其混合物。
用于本文所公开的隐形眼镜处理溶液中的合适的萜烯醛和萜烯酮抗微生物剂包含例如桃金娘烯醛、樟脑醛、紫苏醛、香茅醛、柠檬醛、羟基香茅醇、樟脑、马鞭草烯酮、香芹烯酮、二氢-香芹酮、香芹酮、胡椒酮、薄荷酮、香叶基丙酮、假-紫罗酮、α-紫罗酮、异-假-甲基紫罗兰酮、正-假-甲基紫罗兰酮、异-甲基紫罗兰酮、正-甲基紫罗兰酮等和其混合物。本领域已知的任何其它具有官能团的萜烯烃可以在本文中用于本发明的组合物中。
在一实施例中,作为抗微生物剂的合适的萜烯或其衍生物包含但不限于三环烯、α-蒎烯、萜品油烯、香苇醇、戊醇、橙花醇、β-檀香醇、柠檬醛、蒎烯、橙花醇、b-紫罗兰酮、石竹烯(来自丁香)、愈创木醇、茴香醛、雪松醇、芳樟醇、d-柠檬烯(橙油、柠檬油)、长叶烯、茴香醇、广藿香醇、α-杜松萜烯、1,8-桉树脑、ρ-伞花烃、3-蒈烯、ρ-8-明坦(ρ-8-mentane)、反式薄荷酮、龙脑、α-葑醇、乙酸异戊酯、萜品、肉桂醛、紫罗兰酮、香叶醇(来自玫瑰和其它花朵)、月桂烯(来自杨梅蜡、月桂油和马鞭草)、橙花醇、香茅醇、香芹醇、丁香酚、香芹酮、α-萜品醇、茴香脑、樟脑、薄荷醇、柠檬烯、橙花叔醇、法尼醇、植醇、胡萝卜素(维生素A1)、鲨烯、百里酚、生育三烯醇、紫苏醇、龙脑、西蒙(simene)、蒈烯、萜烯、芳樟醇、1-萜烯-4-醇、姜烯(来自生姜)等和其混合物。
在一说明性实施例中,抗微生物剂可以包含支化的甘油单烷基醚。在另一说明性实施例中,抗微生物剂可以包含支化的甘油单烷基胺。在另一实施例中,抗微生物剂可以包含支化的甘油单烷基硫化物。在仍另一实施例中,抗微生物剂可以包含支化的甘油单烷基醚、支化的甘油单烷基胺或支化的甘油单烷基硫化物的任何一种混合物。
在一实施例中,支化的甘油单烷基醚是3-[(2-乙基己基)氧基]-1,2-丙二醇(EHOPD)。在另一实施例中,支化的甘油单烷基胺是3-[(2-乙基己基)氨基]-1,2-丙二醇(EHAPD)。在另一实施例中,支化的甘油单烷基硫化物是3-[(2-乙基己基)硫代]-1,2-丙二醇(EHSPD)。在仍另一实施例中,隐形眼镜处理溶液包括EHOPD、EHAPD和EHSPD的任何一种混合物。EHOPD、EHAPD和EHSPD的化学结构提供如下。
EHOPD也被称为辛氧基甘油,并且以商品名SC50(Schülke&Mayr)出售。EHOPD是支化的甘油单烷基醚,已知对皮肤温和,并对多种革兰氏阳性细菌表现出抗微生物活性,如滕黄微球菌(Micrococcus luteus)、水生棒杆菌(Corynebacterium aquaticum)、淡黄棒状杆菌(Corynebacterium flavescens)、帚石南棒状杆菌(Corynebacteriumcallunae)和肾棒状杆菌(Corynebacterium nephredi)。因此,EHOPD以约0.2重量%至3重量%的浓度用于各种皮肤除臭剂制剂中。EHAPD可以使用本领域普通技术人员熟知的化学方法由2-乙基己胺和2,3-环氧基-1-丙二醇制备。EHSPD可以使用本领域普通技术人员熟知的化学方法由2-乙基己基硫醇和2,3-环氧基-1-丙二醇制备。
用于本文所公开的隐形眼镜处理溶液的合适的脂肪酸单酯包含例如包括具有六个至十四个碳原子的脂族脂肪酸部分和脂肪族羟基部分的那些脂肪酸单酯。
术语“脂肪族”是指具有六个至十四个碳原子的直链或支链饱和或不饱和烃。在一实施例中,脂肪族脂肪酸部分是具有八个至十个碳的直链饱和或不饱和烃。在另一实施例中,脂肪族脂肪酸部分是具有八个至十个碳的直链饱和或不饱和烃。
脂肪酸单酯的脂肪族羟基部分可以是具有至少一个羟基的任何脂肪族化合物。在说明性实施例中,脂肪族羟基部分将具有三个至九个碳。脂肪族羟基部分可以包含但不限于丙二醇;甘油;聚亚烷基二醇,例如聚乙二醇或聚丙二醇;环状多元醇,例如山梨醇、葡萄糖、甘露糖、蔗糖、果糖、岩藻糖和肌糖和其衍生物;以及直链多元醇,例如甘露醇和山梨醇和其衍生品等和其混合物。
用于本文所公开的隐形眼镜处理溶液的合适的酰氨基胺包含例如以下通式的氨基胺:
R15-(OCH2CH2)m-X-(CH2)n-Y
其中R15是C6-C30饱和或不饱和烃,包含举例来说直链或支链、经取代或未经取代的烷基、烷基芳基或烷氧基芳基;m是零至16;n是2至16;X是-C(O)-NR16-或-R16N-C(O)-;Y是-N(R17)2,其中R16和R17中的每一个独立地是氢、C1-C8饱和或不饱和烷基或羟烷基或其药学上可接受的盐。
本文中使用的一些酰氨基胺可从商业来源获得。例如,肉豆蔻酰胺丙基二甲胺可从爱尔康公司(Alcon Inc.)(德克萨斯州福特沃斯(Fort Worth,TX))以商品名获得;月桂酰胺丙基二甲胺可从伊洛克斯化学公司(Inolex Chemical Company)(宾西法尼亚州费城(Philadelphia,PA))以商品名/>L-13获得;并且硬脂酰胺丙基二甲胺也来自伊洛克斯化学公司,作为/>S-13。上述酰氨基胺可以根据已知技术合成,包含美国专利第5,573,726号中描述的技术。
所述一种或多种抗微生物剂的量可以根据所使用的具体药剂而变化。在一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种抗微生物剂以范围为约0.5ppm至约10ppm的量存在于本文所公开的隐形眼镜处理溶液中。在另一说明性实施例中,基于隐形眼镜处理溶液的总重量,所述一种或多种抗微生物剂以范围为约1ppm至约5ppm的量存在于本文所公开的隐形眼镜处理溶液中。当使用隐形眼镜处理溶液,例如以将隐形眼镜消毒时,这些抗微生物剂包含在内。
期望抗微生物剂的用量将至少部分地减少所使用的调配物中的微生物群体。如果期望,可以以消毒量使用抗微生物剂,这将在四小时内将微生物生物负荷减少至少两个对数级,并且更优选地在一小时内减少一个对数级。在一实施例中,消毒量是当在推荐浸泡时间的方案中使用时将消除隐形眼镜上的微生物负荷的量(FDA化学消毒功效测试-1985年7月隐形眼镜溶液草案指南)。
除上述组分外,本文所公开的隐形眼镜处理溶液可以进一步含有一种或多种两性表面活性剂、舒适剂、pH调节剂、螯合剂、粘度调节剂、缓和剂等。两性表面活性剂是具有酸性和碱性特性两者的表面活性化合物。用于本文的两性表面活性剂包含一类称为甜菜碱的化合物。甜菜碱的特征在于完全季铵化的氮原子,并且在碱性溶液中不表现出阴离子特性,这意味着甜菜碱在接近中性的pH下仅以两性离子的形式存在。在一实施例中,合适的两性表面活性剂由式(IV)的结构表示:
其中R1是任选地被羟基或-(CH2)n-NHC(O)R取代的C8至C30烷基,其中R是任选地被羟基取代的C8至C30烷基,并且n是2、3或4;R2和R3各自独立地是氢或C1至C4烷基;R4是任选地被羟基取代的C2至C8亚烷基;并且Y是CO2 -或SO3 -。
甜菜碱的特征在于完全季铵化的氮。在烷基甜菜碱中,季铵化氮的烷基之一是具有八个到三十个碳原子的烷基链。一类甜菜碱是磺基甜菜碱或羟基磺基甜菜碱,其中烷基甜菜碱的羧基被磺酸盐替代。在羟基磺基甜菜碱中,羟基位于从季铵化氮延伸到磺酸盐的亚烷基碳之一上。在烷基氨基甜菜碱中,酰胺基团被插入作为疏水性C8至C30烷基链与季铵化氮之间的连接。
在一说明性实施例中,式IV的两性表面活性剂可以是式(V)的磺基甜菜碱:
其中R1是C8到C30烷基;R2和R3各自独立地是C1至C4烷基;并且R4是C2至C8亚烷基。某些通式V的磺基甜菜碱比其它磺基甜菜碱更优选。例如,可从Calbiochem公司获得的93-10是式V的磺基甜菜碱,其中R1是具有十(10)个碳的直链饱和烷基,R2和R3各自是甲基,并且R4 i是-CH2CH2CH2-(三个碳,(3))。可用于隐形眼镜处理组合物中的其它磺基甜菜碱包含例如对应的/>3-08(即,R1是具有八个碳的直链饱和烷基)、3-12(即,R1是具有十二个碳的直链饱和烷基)、/>3-14(即,R1是具有十四个碳的直链饱和烷基)和/>3-16(即,R1是具有十六个碳的直链饱和烷基)。在一实施例中,磺基甜菜碱具有式V,并且R1是C8至C16烷基;并且R2和R3是甲基。
在另一个实施例中,式IV的两性表面活性剂是式(VI)的羟基磺基甜菜碱:
其中R1是被至少一个羟基取代的C8至C30烷基;R2和R3各自独立地是C1至C4烷基;并且R4是被至少一个羟基取代的C2至C8亚烷基。
在另一个实施例中,两性表面活性剂是式(VII)的烷基氨基甜菜碱:
其中R1是C8至C30烷基,并且m和n独立地选自2、3、4或5;R2和R3各自独立地是任选地被羟基取代的C1到C4烷基;R4是任选地被羟基取代的C2至C8亚烷基;并且Y是CO2 -或SO3 -。在一说明性实施例中,烷基氨基甜菜碱的代表性实例包含烷基氨基丙基甜菜碱,例如椰油氨基丙基二甲基甜菜碱和月桂酰氨基丙基二甲基甜菜碱。
本文所公开的隐形眼镜处理溶液可以进一步含有一种或多种舒适组分或缓冲组分。舒适组分可以增强和/或延长表面活性剂组分的清洁和润湿活性和/或调节镜片表面,使其更亲水(不太亲脂性)和/或对眼睛充当缓和剂。舒适组分被认为在放置镜片期间缓冲对眼睛表面的影响,并且还用于减轻眼睛刺激。
合适的舒适组分包含例如水溶性天然树胶、纤维素衍生聚合物等。有用的天然树胶包含瓜尔胶、黄芪胶等。有用的纤维素衍生的舒适组分包含纤维素衍生的聚合物,如羟丙基纤维素、羟丙基甲基纤维素、羧甲基纤维素、甲基纤维素、羟乙基纤维素等。一些非纤维素舒适组分包含丙二醇或甘油。舒适组分可以以约0.01%至约1%(w/w)的量存在于溶液中。
在一实施例中,据信维持水合角膜表面的舒适剂是聚乙烯吡咯烷酮(PVP)。PVP是线性均聚物或基本上包括至少90%衍生自1-乙烯基-2-吡咯烷酮单体的重复单元的线性均聚体,单体组合物的其余部分可以包含中性单体,例如乙烯基或丙烯酸盐。PVP的其它同义词包含聚维酮(povidone/polyvidone)、1-乙烯基-2-吡咯烷酮和1-乙烯基-2-吡咯烷酮(CAS注册号9003-39-8)。PVP的重均分子量可以为约10,000至约250,000或约30,000至约100,000。此类材料由多家公司销售,包含ISP技术有限公司,商标为K-29/32;BASF公司,商标为/>例如/>K-30或K-90。还优选地使用药物级PVP。
本文所公开的隐形眼镜处理溶液还可以包含一种或多种螯合组分,以帮助在日常使用后从镜片表面去除脂质和蛋白质沉积物。通常,隐形眼镜处理溶液将包含相对少量,例如约0.005%至约0.05%(w/w)的乙二胺四乙酸(EDTA)或其对应金属盐,如二钠盐Na2EDTA。
在一说明性实施例中,本文所公开的隐形眼镜处理溶液的渗透压的范围可以在至少约200mOsmol/kg到至多约400mOsmol/kg,例如至少约250或至少约300或约350,各自至多约400mOsmol/kg。隐形眼镜处理溶液是基本上等渗的或高渗的(例如,轻微高渗的),并且是眼用可接受的。
在一实施例中,本文所公开的隐形眼镜处理溶液包含间接滴注在眼睛中的溶液,如用于在将隐形眼镜插入在眼睛上之前处理隐形眼镜的隐形眼镜处理溶液。通常,本文所公开的隐形眼镜处理溶液可以用于清洁和消毒隐形眼镜。例如,隐形眼镜溶液可以作为日常护理方案使用或本领域中已知的“无摩擦”方案每隔一天使用。此程序包含将隐形眼镜从眼睛上取下,用几毫升隐形眼镜处理溶液冲洗镜片的两侧,并将镜片放置在含有本文所公开的隐形眼镜处理溶液或不同隐形眼镜处理溶液的镜片储存盒中。镜片可以在镜片储存盒中的新鲜溶液中浸泡至少约两小时。将镜片从盒中取出,任选地用更多的溶液冲洗,并且重新放置在眼睛上。
可替代地,可以执行摩擦方案,在所述方案中,上述步骤中的每个步骤加上向镜片的每一侧添加几滴溶液的步骤,然后将表面在手指间轻轻摩擦约3秒至约25秒或约3秒至约10秒。然后可以任选地冲洗镜片,并随后将其在镜片储存盒中的溶液中浸没至少两小时。将镜片从镜片收纳盒中取出,并且重新放置在眼睛上。
与本文所公开的隐形眼镜处理溶液接触的镜片的类型不是关键的,并且可以设想任何镜片。此类镜片的代表性实例包含但不限于软性隐形眼镜,例如软性水凝胶镜片;软性非水凝胶镜片等,硬性隐形眼镜,例如,硬性可透气镜片材料等,刚性可透气(RGP)镜片、人工晶状体、重叠镜片等。如本领域技术人员所理解的,如果镜片可以折回其自身而不破裂,则认为所述镜片是“软性的”。本文可以使用任何已知的产生隐形眼镜的材料。例如,隐形眼镜处理溶液可以用于(1)由通过丙烯酸酯聚合,如聚(甲基丙烯酸甲酯)(PMMA)制备的材料形成的硬性镜片;(2)由硅酮丙烯酸酯和氟硅酮甲基丙烯酸脂形成的RGP镜片;以及(3)由水凝胶聚合材料,如硅酮水凝胶制成的软性水凝胶隐形眼镜,其中水凝胶被定义为含有处于平衡状态的水的交联聚合物系统。
通常,水凝胶表现出优异的生物相容性特性,即通过不在活组织中产生毒性、损伤性或免疫应答而具有生物或生化相容性特性。代表性常规水凝胶隐形眼镜材料是通过使包括至少一种亲水性单体的单体混合物聚合而制备的,所述亲水性单体如(甲基)丙烯酸、甲基丙烯酸2-羟乙酯(HEMA)、甲基丙烯酸甘油酯、N,N-二甲基丙烯酰胺和N-乙烯基吡咯烷酮(NVP)。在硅酮水凝胶的情况下,制备共聚物的单体混合物除亲水性单体外,进一步包含含硅酮的单体。通常,单体混合物还将包含交联单体,如乙二醇二甲基丙烯酸酯、四甘醇二甲基丙烯酸酯和碳酸甲基丙烯酰氧酯乙酯。可替代地,含硅酮的单体或亲水性单体可以充当交联剂。
在另一实施例中,本文所公开的隐形眼镜处理溶液包含用于直接滴注在眼睛中的溶液,包含直接在眼睛中蒸馏的隐形眼镜处理溶液,如用于在佩戴时重新润湿隐形眼镜的溶液,以及也符合多用途溶液的溶液。
本文所公开的隐形眼镜处理溶液在生理上是相容的。具体地,溶液与隐形眼镜一起使用必须是“眼用安全的”,这意味着用溶液处理的隐形眼镜通常适于且安全地直接放置在眼睛上而无需冲洗,也就是说,溶液对于通过用隐形眼镜处理溶液润湿的隐形眼镜与眼睛的日常接触是安全且舒适的。眼用安全溶液具有与眼睛相容的张力和pH,并且包括根据ISO(国际标准组织)标准和美国FDA规定的非细胞毒性的材料和其量。溶液应是无菌的,因为在释放之前,必须在统计学上证明此类产品中不存在微生物污染物,达到此类产品所需的程度。
本文所公开的隐形眼镜处理溶液可以成液滴的形式,并且可用作隐形眼镜的含此类材料的清洁、消毒或调节组合物的组分。在一实施例中,本文所公开的组合物和/或溶液可以被调配成“多用途溶液”。多用途溶液可用于清洁、消毒、储存和冲洗镜片,尤其是软性隐形眼镜。多用途溶液并不排除这样的可能性,即一些佩戴者,例如对化学消毒剂或其它化学剂特别敏感的佩戴者,可能更喜欢在插入镜片之前用另一种溶液,例如无菌盐水溶液冲洗或润湿隐形眼镜。术语“多用途溶液”也不排除这样的可能性,不每天使用定期清洁剂或用于进一步去除蛋白质的补充清洁剂,例如通常每周使用的酶清洁剂。术语“清洁”意指溶液中含有一种或多种浓度足以松动和去除松散保持在隐形眼镜的表面上的镜片沉积物和其它污染物的试剂,其可以与数字操纵(例如,用溶液手动摩擦镜片)或与搅拌与镜片接触的溶液,例如机械清洁助剂的辅助装置结合使用。
传统上,市场上的多用途溶液需要一种涉及用多用途溶液机械摩擦镜片的方案,以提供所需的消毒和清洁。对于不符合化学消毒溶液资格的化学消毒系统,政府监管机构(如FDA或美国食品和药物管理局(FDA))要求采用这种方案。在一实施例中,有可能调配清洁和消毒产品,其一方面能够在不存在摩擦方案的情况下提供改善的清洁和消毒,并且另一方面足够温和以用作润湿剂,例如,用作滴眼液。例如,符合化学消毒溶液资格的产品必须符合FDA为隐形眼镜护理产品制定的杀菌性能标准(1997年5月1日),所述标准不涉及镜片的摩擦。在本发明的一实施例中,组合物被调配成符合FDA或ISO独立程序针对隐形眼镜消毒产品的要求。类似地,本文所公开的组合物可以被调配成在不使用摩擦方案的情况下提供增强的清洁。与传统的多用途消毒和清洁产品相比,此类调配物可以确保更高的患者依从性和更大的普遍吸引力。多用途溶液的粘度可以小于约75cps、或约1cps至约50cps或约1cps至约25cps,或者所述多用途溶液在总组合物中具有至少约95重量(体积)%的水。
本文所公开的隐形眼镜处理溶液和/或组合物的pH可以保持在约4.0至约9.0、或约5.0至约8.0、或约6.0至约8.0或约6.5至约7.8的pH范围内。在一实施例中,pH值至多大于或等于约7。
在一说明性实施例中,一种清洁和消毒隐形眼镜的方法包含将隐形眼镜在本文所公开的隐形眼镜处理溶液中浸泡至少两小时。在一实施例中,一种隐形眼镜盒,包括用于储存隐形眼镜的镜片储存部分,其中隐形眼镜浸没在本文所公开的隐形眼镜处理溶液中,其中镜片储存部分用适当的盖密封。隐形眼镜可以在隐形眼镜盒中储存两小时,并且至多例如48小时。隐形眼镜处理溶液可以含有如上文所讨论的任何相应量的组分。
在另一说明性实施例,提供了一种重新润湿隐形眼镜的方法,所述方法包括在佩戴在眼睛上时向隐形眼镜施用隐形眼镜处理溶液,其中所述隐形眼镜处理溶液包括(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)一种或多种非离子表面活性剂;(d)氯化钠、氯化钾或其任何组合;以及(e)一种或多种缓冲液。如本领域技术人员将容易理解,隐形眼镜处理溶液可以在必要时佩戴在眼睛上时周期性地应用于隐形眼镜。隐形眼镜处理溶液可以含有如上文所讨论的任何相应量的组分。
提供以下实例以使本领域技术人员能够实践本发明,并且以下实例仅是说明性的。实例不应被认为限制如权利要求中所限定的本发明的范围。
实例1
适于清洁和消毒隐形眼镜的隐形眼镜处理溶液的制备。量是基于溶液的总重量的wt%或ppm,其中纯化水用于q.s至100wt.%。
第一溶液通过添加硼酸(0.9wt.%)、硼酸钠(0.34wt.%)、双甘氨肽(0.3wt.%)、氯化钾(0.05wt.%)、乙二胺四乙酸(EDTA)(0.1wt.%)、赤藓糖醇(0.2wt.%)、泊洛沙明1107(1.0wt.%)和泊洛沙姆181(0.006wt.%)来制备。然后将溶液在121℃下高压灭菌,持续三个循环30分钟。
第二溶液通过添加透明质酸钠(0.0125wt.%)和柠檬酸钠(0.6wt.%)来制备。溶液未进行高压灭菌。
将第一溶液添加到第二溶液中。接下来,将聚(六亚甲基双胍)(PAPB)(0.5ppm)、聚季铵-1(PQ-1)(1.5ppm)和阿来西定(2.5ppm)添加到组合的溶液中以形成隐形眼镜处理溶液。
比较实例1
类似于实例1制备溶液,但缺少赤藓糖醇。
透明质酸分子量损失研究
向实例1和比较实例1的隐形眼镜处理溶液的样品中添加5ppm过氧化氢,并且然后在40℃下高压灭菌20小时和48小时。过氧化氢的加标是为了使调配物受到氧化应激,并评估赤藓糖醇预防氧化应激的作用,特别是对透明质酸的作用。在20小时和48小时高压灭菌时间段,与比较实例1的隐形眼镜处理溶液相比,实例1的隐形眼镜处理溶液显示出统计学上显著更低的透明质酸的分子量损失量。
为了简洁起见,在单个实施例的上下文中描述的本文所公开的隐形眼镜处理溶液的各种特征也可以单独地或以任何合适的子组合提供。说明性实施例具体涵盖实施例的所有组合,并且在本文中公开,就好像每个和每个组合被单独和明确地公开一样。另外,描述这些变量的实施例中列出的所有子组合也被明确地涵盖在本发明组合物中,并且在本文中公开,如同每个此类子组合在本文中单独和明确地公开一样。
将理解,可对本文中所公开的实施例进行各种修改。因此,以上说明不应该被解释为限制性的,但是仅作为优选实施例的例示。例如,上文所描述的并且实施为用于操作本发明的最佳模式的功能仅用于说明目的。在不脱离本发明的范围和精神的情况下,本领域技术人员可以实施其它布置和方法。此外,所属领域技术人员将构想出在所附特征和优点的范围和精神内的其它修改。
Claims (55)
1.一种隐形眼镜处理溶液,其包括:
(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;
(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;
(c)一种或多种非离子表面活性剂;
(d)氯化钠、氯化钾或其任何组合;以及
(e)一种或多种缓冲液。
2.根据权利要求1所述的隐形眼镜处理溶液,其中所述透明质酸或其盐的重均分子量在约100,000至约3,000,000道尔顿(Da)的范围内。
3.根据权利要求1或2所述的隐形眼镜处理溶液,其包括:
(a)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及
(b)基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇。
4.根据权利要求1或2所述的隐形眼镜处理溶液,其包括:
基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及
基于所述隐形眼镜处理溶液的总重量,约0.08wt.%至约0.4wt.%的赤藓糖醇。
5.根据权利要求1至4所述的隐形眼镜处理溶液,其包括基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约5wt.%的所述一种或多种非离子表面活性剂。
6.根据权利要求1至5所述的隐形眼镜处理溶液,其包括基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合。
7.根据权利要求1至4所述的隐形眼镜处理溶液,其包括:
基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约5wt.%的所述一种或多种非离子表面活性剂;
基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合;以及
约0.1%至约10%(w/w)的所述一种或多种缓冲液。
8.根据权利要求1至7所述的隐形眼镜处理溶液,其中所述一种或多种非离子表面活性剂包括泊洛沙姆(poloxamer)和泊洛沙明(poloxamine)中的一种或多种。
9.根据权利要求1至8所述的隐形眼镜处理溶液,其中所述一种或多种缓冲液包括双甘氨肽、硼酸、硼酸钠和硼酸钾中的一种或多种。
10.根据权利要求1至9所述的隐形眼镜处理溶液,其进一步包括以下中的一种或多种:两性表面活性剂、抗微生物剂、舒适剂、pH调节剂、螯合剂、粘度调节剂和缓和剂。
11.根据权利要求10所述的隐形眼镜处理溶液,其中所述一种或多种抗微生物剂包括双胍或其盐或其游离碱;季铵化合物或其盐或者其游离碱;萜烯或其衍生物;支化的甘油单烷基醚;支化的甘油单烷基胺;支化的甘油单烷基硫化物;脂肪酸单酯,其中所述脂肪酸单酯包括具有六个至十四个碳原子的脂肪族脂肪酸部分和脂肪族羟基部分;酰氨基胺化合物以及其组合。
12.根据权利要求11所述的隐形眼镜处理溶液,其中所述双胍是聚合物双胍和非聚合物双胍中的一种或多种。
13.根据权利要求12所述的隐形眼镜处理溶液,其包括基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述双胍。
14.根据权利要求11所述的隐形眼镜处理溶液,其中所述季铵化合物是聚季铵化合物。
15.根据权利要求14所述的隐形眼镜处理溶液,其包括基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述季铵化合物。
16.根据权利要求1至9所述的隐形眼镜处理溶液,其进一步包括一种或多种双胍抗微生物剂和一种或多种季铵抗微生物剂。
17.根据权利要求16所述的隐形眼镜处理溶液,其中所述一种或多种双胍抗微生物剂包括聚(六亚甲基双胍)和阿来西定(alexidine),并且所述一种或多种季铵抗微生物剂包括聚季铵-1。
18.根据权利要求16所述的隐形眼镜处理溶液,其包括:
基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述一种或多种双胍抗微生物剂;以及
基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述一种或多种季铵抗微生物剂。
19.根据权利要求1至18所述的隐形眼镜处理溶液,其中所述隐形眼镜处理溶液满足消毒产品的独立程序的杀生物要求。
20.根据权利要求1至19所述的隐形眼镜处理溶液,其呈眼部护理产品或隐形眼镜护理产品的形式,所述隐形眼镜护理产品选自由以下组成的组:隐形眼镜防腐剂溶液、隐形眼镜清洁溶液、隐形眼镜重新润湿溶液和隐形眼镜多用途溶液。
21.一种清洁和消毒隐形眼镜的方法,所述方法包括:将所述隐形眼镜在隐形眼镜处理溶液中浸泡至少约两小时,其中所述隐形眼镜处理溶液包括:
(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;
(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;
(c)一种或多种非离子表面活性剂;
(d)氯化钠、氯化钾或其任何组合;以及
(e)一种或多种缓冲液。
22.根据权利要求21所述的方法,其中所述透明质酸或其盐的重均分子量在约100,000至约3,000,000道尔顿(Da)的范围内。
23.根据权利要求21或22所述的方法,其中所述隐形眼镜处理溶液包括:
(a)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及
(b)基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇。
24.根据权利要求21或22所述的方法,其中所述隐形眼镜处理溶液包括:
基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及
基于所述隐形眼镜处理溶液的总重量,约0.08wt.%至约0.4wt.%的赤藓糖醇。
25.根据权利要求21至24所述的方法,其中所述隐形眼镜处理溶液包括基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约5wt.%的所述一种或多种非离子表面活性剂。
26.根据权利要求21至25所述的方法,其中所述隐形眼镜处理溶液包括基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合。
27.根据权利要求21至24所述的方法,其中所述隐形眼镜处理溶液包括:
基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约5wt.%的所述一种或多种非离子表面活性剂;
基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合;以及
约0.1%至约10%(w/w)的所述一种或多种缓冲液。
28.根据权利要求21至27所述的方法,其中所述一种或多种非离子表面活性剂包括泊洛沙姆和泊洛沙明中的一种或多种。
29.根据权利要求21至28所述的方法,其中所述一种或多种缓冲液包括双甘氨肽、硼酸、硼酸钠和硼酸钾中的一种或多种。
30.根据权利要求21至29所述的方法,其中所述隐形眼镜处理溶液进一步包括以下中的一种或多种:两性表面活性剂、抗微生物剂、舒适剂、pH调节剂、螯合剂、粘度调节剂和缓和剂。
31.根据权利要求30所述的方法,其中所述一种或多种抗微生物剂包括双胍或其盐或其游离碱;季铵化合物或其盐或者其游离碱;萜烯或其衍生物;支化的甘油单烷基醚;支化的甘油单烷基胺;支化的甘油单烷基硫化物;脂肪酸单酯,其中所述脂肪酸单酯包括具有六个至十四个碳原子的脂肪族脂肪酸部分和脂肪族羟基部分;酰氨基胺化合物以及其组合。
32.根据权利要求21至28所述的方法,其中所述隐形眼镜处理溶液进一步包括一种或多种双胍抗微生物剂和一种或多种季铵抗微生物剂。
33.根据权利要求32所述的方法,其中所述一种或多种双胍抗微生物剂包括聚(六亚甲基双胍)和阿来西定,并且所述一种或多种季铵抗微生物剂包括聚季铵-1。
34.根据权利要求32所述的方法,其中所述隐形眼镜处理溶液包括:
基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述一种或多种双胍抗微生物剂;以及
基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述一种或多种季铵抗微生物剂。
35.根据权利要求21至34所述的方法,其中所述隐形眼镜处理溶液满足消毒产品的独立程序的杀生物要求。
36.根据权利要求21至35所述的方法,其中所述隐形眼镜处理溶液呈眼部护理产品或隐形眼镜护理产品的形式,所述隐形眼镜护理产品选自由以下组成的组:隐形眼镜防腐剂溶液、隐形眼镜清洁溶液、隐形眼镜重新润湿溶液和隐形眼镜多用途溶液。
37.根据权利要求21至36所述的方法,其中将所述隐形眼镜在所述隐形眼镜处理溶液中浸泡包括将所述隐形眼镜在所述隐形眼镜处理溶液中浸泡约两小时至约二十四小时。
38.一种重新润湿隐形眼镜的方法,所述方法包括在佩戴在眼睛上时向隐形眼镜施用隐形眼镜处理溶液,其中所述隐形眼镜处理溶液包括:
(a)基于所述隐形眼镜处理溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;
(b)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;
(c)一种或多种非离子表面活性剂;
(d)氯化钠、氯化钾或其任何组合;以及
(e)一种或多种缓冲液。
39.根据权利要求38所述的方法,其中所述透明质酸或其盐的重均分子量在约100,000至约3,000,000道尔顿(Da)的范围内。
40.根据权利要求38或39所述的方法,其中所述隐形眼镜处理溶液包括:
(a)基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及
(b)基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇。
41.根据权利要求38或39所述的方法,其中所述隐形眼镜处理溶液包括:
基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及
基于所述隐形眼镜处理溶液的总重量,约0.08wt.%至约0.4wt.%的赤藓糖醇。
42.根据权利要求38至41所述的方法,其中所述隐形眼镜处理溶液包括基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约5wt.%的所述一种或多种非离子表面活性剂。
43.根据权利要求38至42所述的方法,其中所述隐形眼镜处理溶液包括基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合。
44.根据权利要求38至41所述的方法,其中所述隐形眼镜处理溶液包括:
基于所述隐形眼镜处理溶液的总重量,约0.05wt.%至约5wt.%的所述一种或多种非离子表面活性剂;
基于所述隐形眼镜处理溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合;以及
约0.1%至约10%(w/w)的所述一种或多种缓冲液。
45.根据权利要求38至44所述的方法,其中所述一种或多种非离子表面活性剂包括泊洛沙姆和泊洛沙明中的一种或多种。
46.根据权利要求38至45所述的方法,其中所述一种或多种缓冲液包括双甘氨肽、硼酸、硼酸钠和硼酸钾中的一种或多种。
47.根据权利要求38至46所述的方法,其中所述隐形眼镜处理溶液进一步包括以下中的一种或多种:两性表面活性剂、抗微生物剂、舒适剂、pH调节剂、螯合剂、粘度调节剂和缓和剂。
48.根据权利要求47所述的方法,其中所述一种或多种抗微生物剂包括双胍或其盐或其游离碱;季铵化合物或其盐或者其游离碱;萜烯或其衍生物;支化的甘油单烷基醚;支化的甘油单烷基胺;支化的甘油单烷基硫化物;脂肪酸单酯,其中所述脂肪酸单酯包括具有六个至十四个碳原子的脂肪族脂肪酸部分和脂肪族羟基部分;酰氨基胺化合物以及其组合。
49.根据权利要求38至46所述的方法,其中所述隐形眼镜处理溶液进一步包括一种或多种双胍抗微生物剂和一种或多种季铵抗微生物剂。
50.根据权利要求49所述的方法,其中所述一种或多种双胍抗微生物剂包括聚(六亚甲基双胍)和阿来西定,并且所述一种或多种季铵抗微生物剂包括聚季铵-1。
51.根据权利要求49所述的方法,其中所述隐形眼镜处理溶液包括:
基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述一种或多种双胍抗微生物剂;以及
基于所述隐形眼镜处理溶液的总重量,约0.5ppm至约10ppm的所述一种或多种季铵抗微生物剂。
52.根据权利要求38至51所述的方法,其中所述隐形眼镜处理溶液满足消毒产品的独立程序的杀生物要求。
53.根据权利要求38至52所述的方法,其中所述隐形眼镜处理溶液呈眼部护理产品或隐形眼镜护理产品的形式,所述隐形眼镜护理产品选自由以下组成的组:隐形眼镜防腐剂溶液、隐形眼镜清洁溶液、隐形眼镜重新润湿溶液和隐形眼镜多用途溶液。
54.一种根据权利要求1至20所述的隐形眼镜处理溶液的用途,其用于将隐形眼镜在所述隐形眼镜处理溶液中清洁和消毒至少两小时。
55.一种根据权利要求1至20所述的隐形眼镜处理溶液的用途,其用于在佩戴在眼镜上时重新润湿隐形眼镜。
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- 2022-03-10 JP JP2023554392A patent/JP2024508961A/ja active Pending
- 2022-03-10 CA CA3212305A patent/CA3212305A1/en active Pending
- 2022-03-10 WO PCT/EP2022/056158 patent/WO2022189557A1/en active Application Filing
- 2022-03-10 WO PCT/EP2022/056144 patent/WO2022189552A1/en active Application Filing
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JP2024508961A (ja) | 2024-02-28 |
BR112023017725A2 (pt) | 2023-10-03 |
EP4305142A1 (en) | 2024-01-17 |
WO2022189548A1 (en) | 2022-09-15 |
WO2022189552A1 (en) | 2022-09-15 |
CN116963720A (zh) | 2023-10-27 |
AU2022233951A1 (en) | 2023-09-14 |
US20220288107A1 (en) | 2022-09-15 |
CA3212315A1 (en) | 2022-09-15 |
MX2023010373A (es) | 2023-09-12 |
US20220290073A1 (en) | 2022-09-15 |
JP2024508986A (ja) | 2024-02-28 |
MX2023010375A (es) | 2023-09-12 |
AU2022231886A1 (en) | 2023-09-14 |
CA3212309A1 (en) | 2022-09-15 |
JP2024509214A (ja) | 2024-02-29 |
KR20230156932A (ko) | 2023-11-15 |
KR20230156748A (ko) | 2023-11-14 |
WO2022189557A1 (en) | 2022-09-15 |
US20220290072A1 (en) | 2022-09-15 |
CN116940662A (zh) | 2023-10-24 |
EP4305143A1 (en) | 2024-01-17 |
BR112023017375A2 (pt) | 2023-10-03 |
AU2022235192A1 (en) | 2023-09-14 |
US11944638B2 (en) | 2024-04-02 |
CA3212305A1 (en) | 2022-09-15 |
BR112023017376A2 (pt) | 2023-10-03 |
EP4304555A1 (en) | 2024-01-17 |
MX2023010372A (es) | 2023-09-12 |
KR20230156747A (ko) | 2023-11-14 |
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