CN112533615A - 次氯酸基眼睑清洁剂 - Google Patents
次氯酸基眼睑清洁剂 Download PDFInfo
- Publication number
- CN112533615A CN112533615A CN201980029518.9A CN201980029518A CN112533615A CN 112533615 A CN112533615 A CN 112533615A CN 201980029518 A CN201980029518 A CN 201980029518A CN 112533615 A CN112533615 A CN 112533615A
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- Prior art keywords
- composition
- eyelid
- cleanser composition
- surfactants
- eyelid cleanser
- Prior art date
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Abstract
一种抗菌眼睑清洁剂组合物，包含：(a)次卤酸；(b)一种或多种表面活性剂，所述一种或多种表面活性剂具有5至18的HLB值；和(c)水性载体，所述水性载体包括：(i)一种或多种张力调节剂；(ii)一种或多种渗透压调节剂以用于调节组合物的渗透压；和(iii)一种或多种pH调节剂以用于将组合物的pH维持于约4.5至约8.0之间。组合物可以泡沫、液体、喷雾剂、雾剂、凝胶或洗剂形式进行分配。组合物可通过移除过量的油、碎屑和脱落皮肤而促进长期的眼睑卫生，并且可缓解眼睛炎症。
Description
技术领域
本发明整体涉及眼睑和皮肤清洁组合物，并且涉及制备和使用此类组合物的方法。
背景技术
眼部健康针对的是眼睛以及眼睛相关的结构，例如眼睑。眼睑对于整体眼部健康尤为重要，因为它们保护眼睛免于危险(诸如接近物体)或免于气载污染物(诸如花粉、灰尘颗粒或其它异物)。眼睑包括必要腺体：泪腺和睑板腺，它们产生多层的泪膜，这些泪膜对于健康眼睛是至关重要的。当人眨眼时，新泪膜形成并且眼泪分布横跨角膜以润滑眼睛的表面。该眨眼动作还“冲洗”眼睛的异物。
然而，眼睑受某些问题的影响，这些问题尽管极其常见但依然令人烦恼，尤其是对于隐形眼镜佩戴者，并且可导致其它更严重的并发症。一种并发症为睑炎。睑炎为眼睑的常见慢性炎症，其特征在于睑缘上的鳞状结痂。该病症可由细菌感染引起，并且其可起源于过敏或可与面部和头皮的皮脂溢相关联。治疗通常涉及定期清洁眼睑，以移除可成问题的过量的油、碎屑和脱落皮肤。
通常与睑炎相关联或继发的是睑边缘处皮肤表面的细菌感染，已知为内睑腺炎。其它此类感染包括外睑腺炎(通常称为麦粒肿)，该外睑腺炎为沿着眼睑的边缘(围绕睫毛)的微油分泌睑板腺的感染。麦粒肿开始为红色触痛隆起，并且通常在三天内完全发育。此类病症伴有眼睑(或睑)缘的疼痛、红肿和触痛。尽管麦粒肿通常为复发的，但是眼睑缘的定期清洁可使此类病症最小化。
第二问题为霰粒肿，该霰粒肿为眼睑内的睑板腺的炎症。霰粒肿通常在2周至3周内缓慢地生长，尽管它们通常不引起疼痛，但是在不加以治疗的情况下，它们通常需要手术治疗。
由于上文所描述问题的任一者以及其它医疗并发症(诸如红斑痤疮和皮脂溢)，利用眼睑清洁剂所带来的适当眼睑卫生可使爆发严重度最小化，或如果发现得早，可完全防止这种问题。眼睑清洁剂还可用于清洁睫毛、眼睑或眼周区域，并且可用作术前擦洗剂以协助降低有害细菌的存在，该有害细菌可引起患者的感染、炎症或甚至眼内炎。
发明内容
包含次氯酸和水的组合物连同其它眼睑护理组合物一起已成功地用于促进长期眼睑卫生，如申请人的美国专利号9833399已描述的。然而，申请人已确定，需要单一等渗(isotonic)/等渗透压(isoosmolar)和生理上兼容的抗菌制剂，该抗菌制剂也可提供基于表面活性剂制剂的清洁效果。
在一个实施方案中，眼睑清洁剂组合物包含：(a)次卤酸；(b)一种或多种表面活性剂，所述一种或多种表面活性剂具有5至18的HLB值；和(c)水性载体，所述水性载体包括：(i)一种或多种张力调节剂；(ii)一种或多种渗透压调节剂，该渗透压调节剂配置成调节组合物的渗透压；和(iii)一种或多种pH改性剂以用于将组合物的pH调节为约4.5至约8.0之间。组合物可以泡沫、液体、喷雾剂(spray)、雾剂(mist)、凝胶或洗剂形式进行分配。组合物可通过移除过量的油、碎屑和脱落皮肤而促进长期的眼睑卫生，并且还可缓解眼睛炎症。
在一个优选实施方案中，次卤酸为次氯酸。组合物可包含10ppm至1000ppm的次氯酸。在某些实施方案中，组合物包含50ppm至300ppm的次氯酸。
优选地，组合物具有一种或多种表面活性剂，该一种或多种表面活性剂具有10至18的HLB值。当组合物包括表面活性的组合时，至少第一表面活性剂具有10至18的HLB值并且第二表面活性剂具有5至10的HLB值。一种或多种表面活性剂选自由以下项组成的组：非离子表面活性剂和两性表面活性剂。在某些实施方案中，一种或多种表面活性剂选自由以下项组成的组：山梨醇酐、失水山梨醇单月桂酸酯、聚氧乙烯或聚乙二醇(PEG)改性分子(诸如PEG-改性表面活性剂、PEG-改性磷脂、PEG-改性糖)、氧化胺、嵌段共聚物及其混合物。组合物中的一种或多种表面活性剂的总浓度在0.01％w/w至20％w/w总组合物的范围内。在某些实施方案中，组合物中的一种或多种表面活性剂的总浓度在0.01％w/w至5％w/w的范围内。
组合物为生理兼容的和等渗的/等渗透压的。张力调节剂可选自由以下项组成的组：氯化钠、氯化钾、氯化钙、氯化镁、乳酸钠、乳酸钾、乳酸钙及其混合物。
渗透压调节剂配置成将组合物的渗透压从100mOsm/kg调节至500mOsm/kg。渗透压调节剂可选自由以下项组成的组：糖、甘油、丙二醇及其混合物。
在一个或多个实施方案中，组合物包含泡沫稳定剂。泡沫稳定剂可为甲基葡萄糖聚乙二醇二酯和脂肪酸。
在一个或多个实施方案中，组合物包括0.01％w/w至5％w/w的一种或多种成分，该一种或多种成分选自由以下项组成的组：丙二醇、甘油、液体多元醇、坚果油和衍生物、花卉提取物、水果提取物、海藻酸钠、透明质酸、甘油二酸酯、甘油三酸酯、PEG-75羊毛脂、矿物油、硅油及其混合物。
在一个或多个实施方案中，组合物包括0.01％w/w至5％w/w的一种或多种成分，该一种或多种成分选自由以下项组成的组：抗氧化剂、抗刺激剂、冷却剂、粘度改性剂及其混合物。
在另一实施方案中，用于维护眼睑卫生的试剂盒基本上由涂敷器和本文所公开的眼睑清洁剂组合物组成。涂敷器可包括低敏性非织造亲水材料。
在又一实施方案中，用于维护眼睑卫生的试剂盒基本上由涂敷器组成，该涂敷器采用有效量的本文所公开的眼睑清洁剂组合物进行预湿润。涂敷器可包括一个或多个织物垫，其中每个垫独立地包装于可密封的包装中。
在另一实施例中，用于管理眼睑护理的方法包括将有效量的本文所公开的眼睑清洁剂组合物施用至眼睑及其周围区域。组合物在施用之后可留置或洗掉。
具体实施方式
如本发明所用，术语和短语“发明”、“本发明”、“当前发明”和类似术语和短语为非限制性的，并且非旨在将本主题限制于任何单个实施方式，而是涵盖所描述的所有可能实施方式。
如本发明所用，所有重量百分比(wt％)都是基于皮肤护理组合物的总wt％，除非另行指明。此外，所有组合物百分比基于等于100wt％的总数，除非另行指明。
组合物及其使用的方法可“包括(comprise)”、“基本上由……组成(consistessentially of)”或“由……组成(consist of)”说明书通篇所公开的成分或步骤的任一者。如本说明书和一项或多项权利要求所用，词语“包括(comprising)”(及其任何形式，诸如“包括(comprise)”和“包括(comprises)”)、“具有(having)”(及其任何形式，诸如“具有(have)”和“具有(has)”)、“包括(including)”(及其任何形式，诸如“包括(inludes)”和“包括(include)”)或“含有(containing)”(及其任何形式，诸如“含有(contains)”和“含有(contain)”)为包容性的或开放性的，并且可包含本发明的成分并且不排除本发明所描述的其它成分或元素。当结合权利要求和/或说明书中的术语“包括”使用时，词语“一(a)”或“一(an)”的使用可意指“一者(one)”，但其还符合“一者或多者”、“至少一者”和“一者或一者以上”的含义。如本发明所用，“基本上组成”意指，本发明可包括权利要求所列举那些之外的成分，只要这些额外成分本质上未更改所要求保护发明的本质和新颖特性。一般来讲，此类添加剂可根本不存在或仅以痕量存在。然而，可能的是包括至多约10重量％的材料(这些材料可实质性更改本发明的本质和新颖特性)，只要组合物的实用性(相对于实用性的程度)得以维持。
本发明所列举的所有范围包括端值(包括列举两个值“之间”的范围的那些)。诸如“约”、“通常”、“基本上”等的术语应理解为修饰术语或值，使得其不是绝对值。此类术语将由它们修饰的情况和术语进行定义，因为那些术语由本领域的技术人员来理解。在一个非限制性实施方案中，这些术语定义为在5％范围内。术语“基本上”及其变型定义为如本领域的技术人员所理解的很大程度上但是非必然完整地指定的事项，并且在一个非限制性实施方案中，“基本上”是指0.01％至5％内的范围。
如本发明所用，组合物的术语“有效量”是指足以引出期望的生物响应的量。如本领域的技术人员将理解，物质的有效量可根据诸如期望生物端值、患者等因素而改变。术语有效量和临床效果可在本发明中互换地使用。例如，组合物的有效量/临床有效量为可用于促进长期眼睑卫生同时还基本上降低炎症并促使眼睑的创伤愈合的量。
尽管说明书以特别地指明和区别地要求保护本发明的权利要求书进行总结，但是应当相信，本发明根据下述描述将得到更充分的理解。
眼睑清洁剂组合物为眼科/眼部组合物，该组合物可清洁眼睑和眼睛并且从眼睑和周围区域移除过量的油、碎屑和脱落皮肤，同时降低炎症并促进创伤愈合。组合物包含次卤酸、一种或多种表面活性剂和水性载体；该一种或多种表面活性剂具有在10和18之间范围内的亲水亲脂平衡(HLB)值，该水性载体包含用于调节组合物的pH、张力、渗透压的一种或多种组分。
次卤酸中的“卤”为卤素，该卤素选自由以下项组成的组：氯、溴、碘和氟。优选地，卤素为氯并且次卤酸为次氯酸。组合物包含至少10ppm至1000ppm的次氯酸。在某些实施方案中，组合物包含50ppm至300ppm的次氯酸。
一种或多种非离子或两性表面活性剂可用于制剂中以实现期望的发泡能力和/或清洁能力。表面活性剂的包含将增强组合物用以溶解和移除油、碎屑和脱落皮肤的能力。可优选表面活性剂具有发泡能力，并且包括具有10和18之间的HLB值的非离子或两性表面活性剂。如果使用一种以上的表面活性剂，那么至少一种表面活性剂应具有10和18之间的HLB值，并且其它一种或多种表面活性剂应具有10和18之间的HLB值或5和10之间的HLB值。可使用的合适的表面活性剂包括但不限于山梨醇酯(诸如但不限于Span 20或失水山梨醇单月桂酸酯，或山梨醇酯的聚氧乙烯衍生物)、聚乙二醇(PEG)改性表面活性剂(诸如但不限于聚山梨酸酯80、Brij 52、PEG-75羊毛脂)、改性磷脂、改性糖(诸如但不限于烷基糖苷、脂肪酸葡糖酰胺)、氧化胺和/或嵌段共聚物，诸如Pluronic(Pluronic 120、Poloxamer 188)。最终制剂中的表面活性剂的总浓度可在0.01％w/w至20％w/w的范围内，但更优选地在0.01％至5％范围内。
水性载体可为去离子水或纯化水USP。组合物为生理兼容的和等渗的/等渗透压的。根据需要，水性载体包括一种或多种组分以用于调节张力、渗透压和pH。优选张力调节剂包括一种或多种盐，诸如钠、钾、钙和镁的氯化物，和钠/钾/钙乳酸盐。渗透压可利用糖、甘油、丙二醇和类似成分进行调节。组合物的渗透压可从约100mOsm/kg调节至约500mOsm/kg。在某些实施方案中，组合物的渗透压维持于约180mOsm/kg至约400mOsm/kg。渗透压调节剂可包括糖、甘油、丙二醇及其混合物，以及其它类似成分。
最佳地，组合物的pH保持在4.5和8.5之间，或优选地保持地5.0和7.0之间的pH范围内。该pH的调节不使用传统pH调节剂，传统pH调节剂会对眼睛产生刺激。例如，在制备水性载体时，通过添加缓冲组分(诸如磷酸盐、柠檬酸盐、三盐，和限定比率的对应酸/碱)来锁定目标pH，或通过在搅拌条件下添加渐增量的酸或碱直至当所有成分已溶解/分散时达到期望pH，以调节组合物的pH。
次氯酸使组合物具有抗菌活性。根据次氯酸的浓度、一种或多种表面活性剂的存在和组合物的pH，抗菌活性有所不同。维持组合物的pH还将优化次氯酸、其抗菌活性的稳定性，以及在施用至眼睑或皮肤之后未洗掉的情况下降低与皮肤或眼睑的负面反应。
尽管任选，泡沫稳定剂可添加至组合物，并且可包括但不限于甲基葡萄糖聚乙二醇二酯和脂肪酸。脂肪酸可选自由以下项组成的组：油酸、硬脂酸、月桂酸、辛酸和癸酸。优选地，一种或多种泡沫稳定剂包括PEG-120甲基葡萄糖二油酸酯。
组合物还可包括占组合物至多5％w/w的量的额外组分。这些组分包括通常也添加至组合物且在本文中通常称为湿润剂的一种或多种湿润剂、柔润剂、保湿剂、或润滑剂。合适湿润剂为丙二醇、甘油、聚乙二醇(例如，PEG 300,400,600)，或通常为液体多元醇、坚果油和衍生物、花卉提取物(诸如玫瑰提取物)、水果提取物(诸如黄瓜提取物)、海藻酸钠、透明质酸、中链甘油二酸酯、中链甘油三酸酯、PEG-75羊毛脂、矿物油、硅油及其混合物。
组合物进一步包括至多5％w/w的一种或多种任选组分，该一种或多种任选组分包括作为抗氧化剂的化合物(诸如但不限于维生素E及其衍生物、绿茶提取物、维生素C及其衍生物)、抗刺激/平滑剂(诸如但不限于尿囊素、芦荟、茶树油)、冷却剂(诸如但不限于山梨醇、木糖醇、薄荷醇、百里酚)和粘度改性剂(诸如但不限于羧甲基纤维素、羟丙基甲基纤维素、
)。组合物的粘度优选地大于10cps。在某些实施方案中，粘度还可在1cps至10cps的范围内。
在一个实施方案中，公开了一种制备组合物的方法。该方法涉及将本发明所公开的成分混合于水性载体中以在恒定混合(低剪切力)条件下增加浓度，直至所有水可混溶/水可溶成分均匀地溶解/分散于载体内。在涉及油可溶成分的实施方案中，可制备(在30℃至70℃下)分离的油相，然后在30℃至70℃下的剧烈搅拌条件下(取决于成分的稳定性)添加至水相，直至形成均匀分散。
眼睑清洁剂组合物通常以喷雾剂、雾剂、泡沫或凝胶的形式施用至眼睑和周围区域的表面。在某些实施方案中，组合物可施用由医生所规定的时间/频率。在使用之后，组合物可留置于眼睑或周围区域的表面上，或可擦除。每当组合物用作擦除剂型时，推荐低敏性非织造亲水材料以实现最佳结果。组合物可配置为无残留剂型。组合物不得用于开放创伤、伤疤，或可见迹象的炎症、湿疹和过敏性皮疹上。在外观上，组合物可为透明至半透明的，无色至淡黄色的。
眼睑清洁剂组合物可由合适容器/分配器进行容纳和分配。在某些实施方案中，容器为泵分配器，该泵分配器配置成容纳并递送眼睑清洁剂组合物，所述眼睑清洁剂组合物作为预发泡泡沫。眼睑清洁剂组合物可选自由以下项组成的组：溶液、泡沫、凝胶、喷雾剂、洗剂、悬浮液、乳液、微乳液、膏剂及其组合。在某些实施方案中，组合物可为双相的，即，在容器内具有两个不同的独立层，该容器在施用之前必须摇晃。
在某些实施方案中，眼睑清洁试剂盒可包括采用临床有效量的眼睑清洁剂组合物浸渍/预湿润的一个或多个织物垫或擦拭巾。术语“垫”是指厚件的织物，该织物能够保持或吸收眼睑清洁剂组合物。例如，织物可为无绒织物，诸如人造丝或另一种合适材料。在某些实施方案中，织物垫可为棉垫。垫可为单次使用的一次性垫。试剂盒还可包括1个至100个之间的垫。垫可单独地密封或可包裹于任何合适的包装内。
在某些实施方案中，试剂盒可包括一个或多个一次性的干垫。然后，在利用干垫来清洁眼睑之前，可以将期望量的眼睑清洁剂组合物施用至该干垫。在另一实施方案中，试剂盒可包括采用期望量的眼睑清洁剂组合物浸透的药签或另一合适涂敷器/系统。
对本领域的技术人员将显而易见的是，可对本发明做出各种修改和变型而不脱离本发明的范围或精神。考虑到说明书和本发明所公开本发明的实践，本发明的其它实施方案对本领域的技术人员将为显而易见的。据预期，说明书和实例仅视为示例性的。
Claims (22)
1.一种眼睑清洁剂组合物，包括：
(a)次卤酸；
(b)一种或多种表面活性剂，所述一种或多种表面活性剂具有5至18的HLB值；和
(c)水性载体，所述水性载体包括：
(i)一种或多种张力调节剂；
(ii)一种或多种渗透压调节剂以用于调节组合物的渗透压；和
(iii)一种或多种pH改性剂以用于将组合物的pH调节至约4.5至约8.0之间。
2.根据权利要求1所述的眼睑清洁剂组合物，其中所述次卤酸为次氯酸，并且其中组合物包含10ppm至1000ppm的次氯酸。
3.根据权利要求1所述的眼睑清洁剂组合物，其中所述次卤酸为次氯酸，并且其中组合物包含50ppm至300ppm的次氯酸。
4.根据权利要求1所述的眼睑清洁剂组合物，其中所述一种或多种表面活性剂具有10-18的HLB值。
5.根据权利要求1所述的眼睑清洁剂组合物，其中组合物包括表面活性剂的组合，其中第一表面活性剂具有10至18的HLB值，第二表面活性剂具有5-10的HLB值。
6.根据权利要求1所述的眼睑清洁剂组合物，其中所述一种或多种表面活性剂选自由以下项组成的组：非离子表面活性剂和两性表面活性剂。
7.根据权利要求6所述的眼睑清洁剂组合物，其中所述一种或多种表面活性剂选自由以下项组成的组：山梨醇酐、失水山梨醇单月桂酸酯、诸如PEG-改性表面活性剂、PEG-改性磷脂、PEG-改性糖的聚氧乙烯或聚乙二醇(PEG)改性分子、氧化胺、嵌段共聚物及其混合物。
8.根据权利要求1所述的眼睑清洁剂组合物，其中组合物中的一种或多种表面活性剂的总浓度在0.01％w/w至20％w/w的范围内。
9.根据权利要求8所述的眼睑清洁剂组合物，其中组合物中的一种或多种表面活性剂的总浓度在0.01％w/w至5％w/w的范围内。
10.根据权利要求1所述的眼睑清洁剂组合物，其中所述张力调节剂选自由以下项组成的组：氯化钠、氯化钾、氯化钙、氯化镁、乳酸钠、乳酸钾、乳酸钙及其混合物。
11.根据权利要求1所述的眼睑清洁剂组合物，其中所述一种或多种渗透压调节剂配置成将组合物的渗透压从约100mOsm/kg调节至约500mOsm/kg。
12.根据权利要求1所述的眼睑清洁剂组合物，其中所述一种或多种渗透压调节剂选自由以下项组成的组：糖、甘油、丙二醇及其混合物。
13.根据权利要求1所述的眼睑清洁剂组合物，其中所述组合物的形式为泡沫、液体、喷雾剂、雾剂、凝胶或洗剂。
14.根据权利要求1所述的眼睑清洁剂组合物，进一步包括泡沫稳定剂。
15.根据权利要求14所述的眼睑清洁剂组合物，其中所述泡沫稳定剂为甲基葡萄糖聚乙二醇二酯和脂肪酸。
16.根据权利要求1所述的眼睑清洁剂组合物，进一步包括0.01％w/w至5％w/w的一种或多种成分，所述一种或多种成分选自由以下项组成的组：丙二醇、甘油、液体多元醇、坚果油和衍生物、花卉提取物、水果提取物、海藻酸钠、透明质酸、甘油二酸酯、甘油三酸酯、PEG-75羊毛脂、矿物油、硅油及其混合物。
17.根据权利要求1所述的眼睑清洁剂组合物，进一步包括0.01％w/w至5％w/w的一种或多种成分，所述一种或多种成分选自由以下项组成的组：抗氧化剂、抗刺激剂、冷却剂、粘度改性剂及其混合物。
18.一种用于维护眼睑卫生的试剂盒，其中所述试剂盒基本上由涂敷器和权利要求1所述的眼睑清洁剂组合物组成。
19.根据权利要求18所述的试剂盒，其中所述涂敷器包括低敏性非织造亲水材料。
20.一种用于维护眼睑卫生的试剂盒，其中所述试剂盒基本上由涂敷器组成，所述涂敷器采用临床有效量的权利要求1所述的眼睑清洁剂组合物进行预湿润。
21.根据权利要求20所述的用于维护眼睑卫生的试剂盒，其中所述涂敷器包括一个或多个织物垫，其中每个垫独立地包装于可密封的包装中。
22.一种用于管理眼睑护理的方法，所述方法包括将有效量的权利要求1所述的眼睑清洁剂组合物施用至眼睑及其周围区域。
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| JP2021523124A (ja) | 2021-09-02 |
| EP3787641A4 (en) | 2022-02-23 |
| GB2589225B (en) | 2023-03-15 |
| CA3099166A1 (en) | 2019-11-07 |
| WO2019213266A1 (en) | 2019-11-07 |
| GB2589225A (en) | 2021-05-26 |
| AU2019262032A1 (en) | 2021-01-07 |
| TW202002949A (zh) | 2020-01-16 |
| EP3787641A1 (en) | 2021-03-10 |
| MX2020011605A (es) | 2022-10-13 |
| KR20210005936A (ko) | 2021-01-15 |
| US20190336415A1 (en) | 2019-11-07 |
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