CN113950319A - 免洗型口腔护理组合物 - Google Patents
免洗型口腔护理组合物 Download PDFInfo
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- CN113950319A CN113950319A CN202080043608.6A CN202080043608A CN113950319A CN 113950319 A CN113950319 A CN 113950319A CN 202080043608 A CN202080043608 A CN 202080043608A CN 113950319 A CN113950319 A CN 113950319A
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- oral care
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- toothpaste
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Abstract
本发明公开了一种用于促进牙龈健康的免洗型口腔护理组合物,该免洗型口腔护理组合物包含透明质酸和牙龈强化多元醇。
Description
技术领域
本发明涉及用于促进使用者的牙龈健康的免洗型口腔护理组合物。特别地,包含透明质酸和牙龈强化多元醇的此类口腔护理组合物可用于为使用者提供改善的屏障功能/保护和感官体验。
背景技术
牙龈疾病诸如齿龈炎和/或牙周炎在口腔中引起急性和慢性牙龈炎症。“齿龈炎”是该疾病的较轻微的形式。齿龈炎的症状可能包括:齿龈出血;和发红、肿胀或牙龈浮肿。如果不及时处理,齿龈炎会发展成“牙周炎”。对于牙周炎,牙龈从牙齿上脱落并形成称为“牙周腔洞”的空间,其可被病原菌感染。细菌作为生物膜存在于牙根表面上。生物膜中的细菌可能攻击齿龈和下面的牙槽骨,该牙槽骨用于支撑牙齿。这些攻击可能对支撑牙齿的软组织和骨骼造成严重损害。在牙龈疾病的后期阶段(即“重度牙周炎”),可能出现更严重的牙齿松动和最终牙齿缺失的问题。
患有牙龈问题的使用者通常限于在家中用抗菌牙膏刷牙作为解决方案。这种机制可有助于清洁和控制宿主上的菌斑和细菌以及相关毒素攻击。然而,由于刷洗的停留时间有限即2分钟,因此几乎没有时间来修复或甚至强化宿主组织。因此,使用者期望可施用于宿主组织更长的时间并修复、强化和焕新牙龈的方案。为了满足此类使用者的期望,已开发出多种可施用于口腔的凝胶或膏剂产品以提供此类有益效果。例如,使用者可将凝胶制剂产品施用到口腔组织例如牙龈区域上,并且在吐出之前保留一段时间,或另选地,不吐出或冲洗掉。所期望的产品需要足够的亲和性和粘度,以使其能够施用到口腔中,粘附到口腔组织上,并且在延长的时间段内释放所包含的口腔护理有益剂。所期望的产品还需要向使用者提供改善的牙龈健康有益效果(例如,屏障功能/保护或齿龈伤口愈合有益效果)。
因此,持续需要提供一种免洗型组合物,其不仅具有良好的铺展性和粘附性以向使用者提供良好的感官有益效果,而且还向使用者提供期望的牙龈健康有益效果(例如,屏障保护有益效果或齿龈伤口愈合等)。
发明内容
发明人开发了一种用于配制免洗型口腔护理组合物的新型技术以满足上述需要中的至少一些需要。特别地,令人惊讶的发现是,包含透明质酸和牙龈强化多元醇的免洗型口腔护理组合物向使用者提供改善的牙龈健康有益效果,尤其是良好的屏障功能/保护有益效果。同时,本文所述的此类口腔护理组合物向使用者提供期望的感官感觉。
有利的是,含有透明质酸和牙龈强化多元醇的免洗型口腔护理组合物可向使用者提供改善的牙龈健康有益效果,诸如牙龈屏障保护有益效果。
不受任何理论的约束,据信表现出改善的伤口愈合有益效果和屏障功能有益效果的本发明的免洗型口腔护理组合物可继而有助于减轻齿龈疼痛、促进齿龈再生、加速粘膜/齿龈损伤的修复和齿龈出血伤口的愈合、和/或增强齿龈免疫力/抵抗力。免洗型口腔护理组合物还可有助于在由不贴合义齿造成的损伤和刺激上形成保护性膜。免洗型口腔护理组合物还可有助于修复或愈合牙根脱屑/刨削或牙龈移植后的齿龈损伤。免洗型口腔护理组合物可甚至进一步有助于改善对粘膜的水合作用,并且甚至有助于缓解或减轻口干。
还有利的是免洗型口腔护理组合物具有最佳的粘度特征,以便提供良好的铺展性。
仍有利的是免洗型口腔护理组合物不重、过度粘稠/发粘,并且为使用者提供愉悦的体验,诸如清新、安全和有效的感觉。
进一步有利的是,为使用者提供长期使用的舒适口感和味道,这被认为是亲和性、粘附性和粘度之间的平衡作用。
还有利的是在刷牙后或作为口腔卫生方案的最后步骤施用免洗型口腔护理组合物。有利的是将免洗型口腔护理组合物施用到口腔的软组织上,停留超过2分钟,优选地超过10分钟,并且不被冲洗掉或吐出。
进一步有利的是,通过递送载体将免洗型口腔护理组合物施用到牙龈,其中递送载体可包括贴条、材料膜、牙托、矫治器、海绵材料、施用装置或它们的混合物。
在一个方面,本发明涉及一种口腔护理组合物,该口腔护理组合物包含:a)按组合物的重量计30%至85%的总水含量;b)按组合物的重量计约0.01%至约10%的透明质酸或其盐;c)按组合物的重量计约0.1%至约20%的牙龈强化多元醇。优选地,口腔护理组合物基本上不含磨料。优选地,口腔护理组合物为免洗型组合物。优选地,牙龈强化多元醇选自海藻糖、棉子糖、水苏糖、毛蕊花糖、异麦芽酮糖醇、麦芽糖醇、乳糖醇、麦芽三糖醇、麦芽四糖醇、聚葡萄糖醇、以及它们的组合。优选地,牙龈强化多元醇以按组合物的重量计约0.5%至约18%、优选地约1%至约15%的量存在。
在另一方面,本发明涉及一种口腔护理组合物,该口腔护理组合物包含:(a)按组合物的重量计约0.2%至约2%的透明质酸或其盐;b)按组合物的重量计约0.5%至约5%的聚丙烯酸;c)按组合物的重量计约0.5%至约5%的附加聚合物;d)按组合物的重量计约0.5%至约15%的海藻糖;和d)按组合物的重量计约30%至约75%的总水含量;其中所述口腔护理组合物基本上不含磨料;并且其中口腔护理组合物为凝胶形式的免洗型组合物。
在本发明的另一方面,提供了使用如本文所定义的口腔护理组合物改善受试者的牙龈健康的方法,该方法包括将口腔护理组合物施用到受试者的口内组织上的步骤,在该口内组织上该口腔护理组合物保留1分钟至1000分钟、优选地2分钟至200分钟的持续时间而不移除;任选地,所述施用步骤可作为口腔卫生方案的最后步骤进行。
在本发明的另一方面,提供了改善受试者的牙龈健康的方法,该方法包括至少两个步骤:(a)用牙膏刷牙,该牙膏优选地为抗菌牙膏,更优选地为含亚锡的牙膏,甚至更优选地为含亚锡离子源和氨基酸的牙膏;以及随后,优选地紧接着(b)将如本文所定义的口腔护理组合物立即施用到受试者的口内组织上,优选地沿齿龈缘、龈沟或龈袋施用,在其上该口腔护理组合物保留1分钟至1000分钟的持续时间而不移除。
在本发明的另一方面,提供了一种包含本发明的口腔护理组合物和递送载体的套盒,其中该递送载体包括贴条、材料膜、牙托、矫治器、海绵材料、施用装置或它们的混合物。在一个优选的示例中,该套盒包括本发明的口腔护理组合物和具有柄部和头部的施用装置。还提供了包括牙膏和本发明的口腔护理组合物的套盒。在一个优选的示例中,该套盒包括抗菌牙膏和本发明的口腔护理组合物,其中牙膏优选地为含亚锡的牙膏,更优选地为含亚锡离子源和氨基酸的牙膏。优选地,单独地且顺序地施用牙膏和口腔护理组合物以改善牙龈健康。
当结合所附权利要求书阅读以下具体实施方式时,本发明的这些和其它特征对于本领域的技术人员而言将变得显而易见。
具体实施方式
定义
如本文所用,当用于权利要求中时,包括“一个”和“一种”的冠词应被理解为是指一种或多种受权利要求书保护或所描述的物质。
如本文所用,术语“包括”是指可添加除具体提及的那些之外的步骤和成分。该术语涵盖术语“由…组成”和“基本上由…组成”。本发明的组合物可包含、由并基本上由本文所述的本发明的基本成分和限制条件、以及本文所述的任何附加的或任选的成分、组分、步骤或限制条件组成。
如本文所使用,单词“优选的”、“优选”和它们的变体是指在特定环境下能够提供特定有益效果的本发明的实施方案。然而,其它的实施方案在相同或其它的环境下也可为优选的。此外,一个或多个优选实施方案的表述并不表示其它实施方案是不可用的,并且不旨在从本发明的范围中排除其它的实施方案。
如本文所用,术语“齿龈凝胶”或“牙龈凝胶”意指旨在主要施用于受试者的牙龈的凝胶形式的产品或组合物,优选地将超过50%的产品或组合物施用于牙龈。
如本文所用,“免洗型”意指产品或组合物被采用或施用到表面上持续一定量的时间,例如超过一分钟,优选地超过两分钟。优选地,“免洗型”凝胶意指旨在不被冲洗掉或吐出的凝胶产品或组合物。
术语“牙龈护理”意指旨在缓解牙龈疾病(即齿龈炎)的早期阶段的一种或多种症状的那些有益效果,其包括:缓解发红、肿胀或牙龈浮肿;和/或干牙龈出血。
如本文所用,术语“牙龈健康”是指口腔护理组合物提供“牙龈护理”有益效果的固有或促进有益效果,其包括至少改善齿龈伤口愈合,以及提供附加的改善细菌活性的减少以减轻细菌的有害影响,因为它与牙龈疾病包括齿龈炎、牙周炎或两者有关。
如本文所用,术语“促进”是指促进和/或增强与在口腔中使用本发明的口腔护理组合物相关联的牙龈健康有益效果。
如本文所用,术语“基本上不含”是指在组合物中存在按此类组合物的总重量计不超过0.05%、优选地不超过0.01%并且更优选地不超过0.001%的指定材料。
如本文所用,术语“实质上不含”是指所指示的材料不是被有意加入到组合物,或者优选地不以分析可检测的水平存在。这是指包括其中指示的材料仅作为有意加入的其它材料中的一种中的杂质而存在的组合物。
术语“口腔卫生方案”或“方案”意指使用两个或更多个单独且不同的口腔健康处理步骤,例如牙膏、漱口水、牙线、牙签、喷剂、冲水器、按摩器。
如本文所用,术语“总水含量”是指游离水和不结合口腔护理组合物中其它成分的水。
除非另外说明,否则所有百分比、份数和比率均基于本发明的组合物的总重量。除非另外指明,否则所有此类涉及所列成分的重量均基于活性物质水平计,并且因此不包括可包含于可商购获得的材料中的溶剂或副产物。
除非另外指明,否则本文涉及的所有测量均在25℃(即室温)下进行。
口腔护理组合物
本发明所述的口腔护理组合物被构造成用于施用在受试者口腔内的齿龈组织以及其他软组织(例如,颊粘膜)上。已令人惊讶地发现,具有最佳粘度和良好的粘附和保留功效两者的口腔护理组合物为使用者提供更好的感官有益效果,并且还特别可用于促进使用者的牙龈健康有益效果。
其中所述的口腔护理组合物为免洗型组合物。将免洗型组合物施用于齿龈组织,例如牙龈线区域,并且保留超过2分钟,优选地超过10分钟。在一些示例中,将组合物施用于齿龈组织并且保留超过15分钟、或超过30分钟、或甚至超过60分钟或更长。优选地,将本发明的组合物施用于齿龈组织而不冲洗掉。优选地,将免洗型组合物作为口腔卫生方案的最后步骤施用于齿龈组织。例如,在刷牙之后,并且任选地在使用漱口水和/或牙线之后施用本发明的免洗型组合物。
在一个方面,本发明涉及凝胶形式的口腔护理组合物。希望具有一种用于本发明的凝胶,该凝胶能够容易地施加、形成薄层并均匀地铺展到龈沟/龈袋内以及沿牙龈线铺展。口腔护理组合物具有约50Pa·s至约250Pa·s的粘度稠度系数K,如通过本文所述的流变学测试方法测量的。优选地,口腔护理组合物具有约50Pa·s至约200Pa·s、优选地约50Pa·s至约150Pa·s、更优选地约50Pa·s至约120Pa·s的粘度稠度系数K。该最佳粘度特征范围为使用者提供了更好的铺展性感官体验。如果产品太粘稠,则使用者将难以将其均匀地铺展到齿龈组织上。如果产品具有过低的粘度,则它是流动的并且难以通过手指或施用装置保持在适当的区域上。
在一个方面,本发明的口腔护理组合物具有期望的粘膜粘附特性。粘膜粘附可被定义为两个表面之间通过界面力持续给定的时段、随后表面能降低的粘合相互作用,其中一个表面至少为黏膜。用于口腔护理应用的粘膜粘附聚合物应理想地(1)易于保持亲水性和亲脂性活性成分并且不妨碍它们的释放;(2)促进活性成分渗透和吸收,(3)尽可能快地粘附到生物基底上并保持一段时间,(4)为安全的,(5)为高性价比的以及(6)提供使用者可接受的应用。
本发明的口腔护理组合物具有在不小于约0.6FI%范围内的粘膜粘附指数,如通过本文所述的粘膜粘附测试方法测量的。优选地,口腔护理组合物具有不小于约0.8FI%、更优选地不小于约1.0FI%的粘膜粘附指数。例如,口腔护理组合物可具有不小于约1.2FI%、或不小于约1.3FI%、或不小于约1.5FI%、或不小于约1.8FI%、或不小于约2.0FI的粘膜粘附指数。优选地,口腔护理组合物具有小于约20FI%、优选地小于约15FI%、更优选地小于约10FI%的粘膜粘附指数。
透明质酸和盐
本发明的口腔护理组合物包含透明质酸或其盐。透明质酸是存在于脊椎动物结缔组织中的多糖,一种葡糖醛酸和N-乙酰葡糖胺的聚合物,并且是具有高分子量Mw的葡糖胺家族的成员。透明质酸(玻尿酸)是完整、健康的齿龈和口腔粘膜组织的必不可少组分。它具有许多特性,使得其成为用于通过诱导早期肉芽组织形成、抑制炎症、促进上皮更新以及结缔组织血管生成而有助于伤口愈合的潜在理想分子。优选地,用于本发明的透明质酸具有约900,000道尔顿至约5,000,000道尔顿、优选地约900,000道尔顿至约3,000,000道尔顿、更优选地约900,000道尔顿至约2,000,000道尔顿的重均分子量(M.W.)。透明质酸的分子量可使用凝胶电泳方法来测量。本发明的透明质酸以按组合物的重量计0.01%至5.0%的量存在。优选地,透明质酸以按组合物的重量计0.1%至2%、更优选地0.2%至0.8%的量存在。例如,透明质酸以按组合物的重量计约0.2%、或约0.3%、或约0.4%、或约0.5%、或约0.6%、或约0.7%、或约0.8%、或约0.9%、或约1.0%的量存在。适用于口腔护理产品的透明质酸的任何盐均可用于本发明。优选地,透明质酸盐可为透明质酸钠。
牙龈强化多元醇
本发明的口腔护理组合物包含牙龈强化多元醇。申请人已发现,牙龈强化多元醇已显示出另外强化口腔中上皮细胞的屏障功能。
术语“牙龈强化多元醇”可为糖醇、二糖、多糖,并且优选地非还原糖。糖醇是一类多元醇,其可通过具有式(CHOH)nH2(其中n为七或更大)的糖化合物的氢化获得,诸如异麦芽酮糖醇、麦芽糖醇、乳糖醇、麦芽三糖醇、麦芽四糖醇、聚葡萄糖醇或它们的组合。优选地,n为约7至约12。甚至更优选地,牙龈强化多元醇是异麦芽酮糖醇、麦芽糖醇、乳糖醇或它们的组合。
非还原糖是一类不生成任何包含醛或酮官能团的化合物的糖。非还原糖在水中是稳定的,并且不与弱氧化剂反应产生糖醇。非还原糖不能向其他分子提供电子,并且通常为二糖、三糖、四糖、五糖,诸如蔗糖、海藻糖、棉子糖、水苏糖、毛蕊花糖或它们的组合。优选地,牙龈强化多元醇为海藻糖。牙龈屏障特性可从多元醇的组合混合物获得,由此全部具有七个或更多个羟基官能团。
口腔护理组合物可包含按该口腔护理组合物的重量计0.025%至约20%、约0.1%至约18%、约0.2%至约15%、约0.5%至约15%、或约1%至约12%的牙龈强化多元醇。
牙龈强化特性可通过如下文所述的屏障保护能力来表征。例如,在浓度为0.5重量%时表现出超过10%的屏障保护的多元醇可被认为是牙龈强化多元醇。在其他示例中,牙龈强化多元醇可包括具有五个或更多个羟基官能团的多元醇,只要其能够提供上文提到的屏障保护能力。
粘膜粘附聚合物
本发明的口腔护理组合物包含作为粘膜粘附聚合物的聚丙烯酸。聚丙烯酸(PAA)聚合物是丙烯酸的合成高分子量聚合物的通用术语。这些可以是与烯丙基醚季戊四醇、蔗糖的烯丙基醚或丙烯的烯丙基醚交联的丙烯酸均聚物。而且,在中性pH的水溶液中,PAA为阴离子聚合物,即PAA的许多侧链将失去它们的质子并获得负电荷。这使得PAA聚电解质具有吸收和保持水并溶胀至其初始体积的许多倍的能力。聚丙烯酸商品名也被称为卡波姆。例如,型聚合物,诸如和是与聚烯基醚或二乙烯基二醇交联的丙烯酸聚合物。卡波姆商业代码例如940TM指示聚合物的分子量和具体组分。
优选地,用于本发明的聚丙烯酸以按口腔护理组合物的重量计约0.1%至约10%的量存在。例如,聚丙烯酸以按口腔护理组合物的重量计约0.2%至约5%、或约0.5%至约8%、或约1.0%至约5%的量存在。
附加聚合物
本发明的口腔护理组合物可包含附加聚合物。优选地,口腔护理组合物包含按组合物的重量计约0.1%至约10%、优选地约0.5%至约6%、更优选地约1%至约5%、还更优选地约1.3%至约2.6%的附加聚合物。附加聚合物选自天然树胶、直链硫酸化多糖、阴离子纤维素、非离子纤维素衍生物、聚乙烯吡咯烷、包含至少聚羧化乙烯主链的聚合物、以及它们的组合。
优选地,天然树胶选自刺梧桐树胶、阿拉伯树胶(也称为金合欢树胶)、黄蓍胶、黄原胶、以及它们的组合。更优选地,天然树胶为黄原胶。黄原胶为由细菌野油菜黄单胞菌(Xanthomonas camestris)分泌的多糖。一般来讲,黄原胶由戊糖重复单元构成,戊糖重复单元分别包含摩尔比为2:2:1的葡萄糖、甘露糖和葡糖醛酸。化学式(单体的)为C35H49O29。在一个示例中,黄原胶得自CP Kelco Inc(Okmulgee,US)。
优选地,直链硫酸化多糖为角叉菜胶。角叉菜胶的示例包括κ-角叉菜胶、ι-角叉菜胶、λ-角叉菜胶、以及它们的组合。在一个示例中,直链硫酸化多糖为ι-角叉菜胶。
优选地,阴离子纤维素为羧甲基纤维素(“CMC”)。在一个示例中,CMC通过用碱和一氯乙酸或其钠盐处理而由纤维素制备。不同种类的商业特征为粘度。一个可商购获得的示例是AqualonTM品牌CMC,得自Ashland Special Ingredients(例如AqualonTM 7H3SF;AqualonTM 9M3SF AqualonTM TM9A;AqualonTM TM12A)。
优选地,非离子纤维素或其衍生物具有50,000道尔顿至1,300,000道尔顿的重均分子量范围以及优选地300至4,800的平均聚合度。更优选地,非离子纤维素或其衍生物为羟乙基纤维素(“HEC”)。在其他示例中,非离子纤维素可为羟丙基纤维素或羟甲基纤维素。
优选地,至少包含多羧化乙烯主链的聚合物选自:马来酸酐与甲基乙烯基醚的共聚物,该共聚物具有30,000道尔顿至1,000,000道尔顿的重均分子量;以及马来酸和丙烯酸或甲基丙烯酸的共聚物。
在示例中,GANTREZTM系列聚合物为马来酸酐与甲基乙烯基醚的共聚物,该共聚物具有30,000道尔顿至1,000,000道尔顿的重均分子量(M.W.)。这些共聚物可以例如GANTREZTM AN139(M.W.500,000道尔顿)、AN119(M.W.250,000道尔顿)和S-97医药级(M.W.70,000道尔顿)从Ashland Chemicals(Kentucky,USA)购得。
在另一示例中,ACUSOLTM和SOKALAN系列聚合物包括丙烯酸的均聚物以及马来酸和丙烯酸或甲基丙烯酸的共聚物。示例为具有约2,000至约1,000,000的重均分子量(M.W.)的0:1000至1000:0的马来酸与丙烯酸的共聚物。这些共聚物可以ACUSOLTM 445和445N、ACUSOLTM 531、ACUSOLTM 463、ACUSOLTM 448、ACUSOLTM 460、ACUSOLTM 465、ACUSOLTM 497、ACUSOLTM 490从Dow Chemicals(Michigan,USA)商购获得,以及以CP 5、CP 7、CP 45和CP 12 S从BASF(New Jersey,USA)商购获得。
在一些示例中,本发明的口腔护理组合物中的粘膜粘附聚合物和附加聚合物的比率为约5:1至约1:5、优选地约3:1至约1:3。例如,按重量计,本发明的口腔护理组合物中聚丙烯酸和附加聚合物的比率为约4:1、或约3:1、或约2:1、或约1.5:1、或约1:1、或约1:1.5、或约1:2、或约1:2.5、或约1:3、或约1:4、或约1:5。
水
如本文所用,术语“口服用载体”是指用于包含本发明活性成分并且将它们递送到口腔中的液体或半固体媒介物,诸如糊剂或凝胶。水通常因其多种有益效果而用作口腔组合物中的载体材料。例如,水可用作加工助剂,对口腔温和并且有助于牙膏快速发泡。水可作为一种成分以其自身的方式添加,或可作为载体存在于其他普通的原材料诸如例如山梨醇和月桂基硫酸钠中。如本文所用,术语“总水含量”是指口腔护理组合物中存在的水的总量,无论是单独地添加还是作为其它原材料的溶剂或载体添加,但是排除某些无机盐中存在的结晶水。
本发明的口腔护理组合物包含至少约30%的总水含量。优选地,口腔护理组合物包含超过约35%至约85%的总水含量。在其他实施方案中,组合物包含约40%至约80%、另选地约45%至约75%、另选地约50%至约70%、另选地约50%至约60%、另选地约45%至约55%、另选地约55%至约65%、另选地约65%至约75%、另选地它们的组合的总水含量。
不含磨料
优选地,本发明的口腔护理组合物基本上不含磨料。出于本发明的目的,术语“磨料”包括含钙磨料和二氧化硅磨料。含钙磨料可选自碳酸钙、磷酸二钙、磷酸三钙、正磷酸钙、偏磷酸钙、聚磷酸钙、氧磷灰石钙、碳酸钠、以及它们的组合。在含钙磨料为碳酸钙的一个实施方案中,碳酸钙可选自细磨天然白垩、研磨碳酸钙、沉淀碳酸钙、以及它们的组合。二氧化硅磨料一般具有0.1μm至30μm并且优选地5μm至15μm范围内的平均粒度。二氧化硅磨料可为沉淀二氧化硅或硅胶,诸如以商品名“Syloid”由W.R.Grace&Company,DavisonChemical分部市售的二氧化硅干凝胶,以及沉淀二氧化硅材料诸如以商品名由J.M.Huber Corporation市售的那些,尤其是具有命名119、 109和129的二氧化硅。
优选地,本发明的口腔护理组合物包含低含量的磨料。例如,口腔护理组合物可包含按组合物的重量计0%至约5%、另选地按组合物的重量计0%至约3%、另选地0%至2%、另选地0%至约1%、另选地小于约3%、或小于约2%、或小于约1%、或小于约0.5%的磨料。优选地,组合物实质上不含磨料,更优选地不含磨料。
湿润剂
本文的口腔护理组合物可包含湿润剂。湿润剂用于防止口腔护理组合物在暴露于空气时变硬,给口腔带来湿润感觉,并且对于特定湿润剂,赋予期望的甜味。
用于本发明的合适湿润剂包括可食用的多元醇,诸如甘油、山梨醇、木糖醇、赤藓糖醇、丁二醇、聚乙二醇、丙二醇、以及它们的组合。在一个实施方案中,湿润剂选自山梨醇、甘油、以及它们的组合。在另一个实施方案中,湿润剂为甘油。在另一个实施例中,所述湿润剂为山梨醇。在一个实施方案中,口腔护理组合物包含按组合物的重量计约1%至小于约50%、优选地约10%至约40%的湿润剂。在另一个实施方案中,口腔护理组合物含有按口腔护理组合物的重量计约15%至约30%的甘油。
在一个示例中,本发明的口腔护理组合物基本上不含乙醇,优选地实质上不含乙醇。在一些情况下,乙醇是不可取的,因为其可对使用者造成刺激感觉。
风味剂
本文的口腔护理组合物可包含按口腔护理组合物的重量计约0.001%至约5%、另选地约0.01%至约4%、另选地约0.1%至约3%、另选地约0.5%至约2%、另选地它们的组合的风味剂。在最广泛的意义上,使用术语风味剂组合物以包括风味剂成分、或感觉剂、或感觉试剂、或它们的组合。风味剂成分可包括描述于美国公布2012/0082630A1第39段中的那些;并且感觉剂和感觉剂成分可包括描述于第40段至第45段中的那些,其以引用方式并入本文。
风味剂组合物或风味剂成分的示例包括:薄荷油、冬青油、丁香芽油、桂皮、鼠尾草、欧芹油、牛至属植物、柠檬、橙、丙烯基乙基愈创木酚、洋茉莉醛、4-顺式-庚烯醛、二乙酰、对叔丁基苯基乙酸甲酯、水杨酸甲酯、水杨酸乙酯、乙酸1-薄荷酯、噁烷酮、α-紫罗兰酮、肉桂酸甲酯、肉桂酸乙酯、肉桂酸丁酯、丁酸乙酯、乙酸乙酯、邻氨基苯甲酸甲酯、乙酸异戊酯、丁酸异戊酯、己酸烯丙酯、丁子香酚、桉树脑、百里酚、肉桂醇、辛醇、辛醛、癸醇、癸醛、苯乙醇、苄醇、α-萜品醇、里哪醇、柠檬烯、柠檬醛、橙花醛、香叶醛、香叶醇橙花醇、麦芽酚、乙基麦芽酚、茴香脑、二氢茴香脑、香芹酮、薄荷酮、β-大马酮、紫罗酮、γ-癸内酯、γ-壬内酯、γ-十一烷酸内酯、或它们的组合。一般来讲,合适的风味剂成分是结构特征和官能团较不倾向于发生氧化还原反应的化学品。这些包括饱和的或含有稳定的芳族环或酯基的风味剂成分的衍生物。
感觉剂诸如凉爽剂、加温剂和麻刺剂可用于向使用者递送信号。最熟知的凉爽剂为薄荷醇,尤其是薄荷油中天然存在的1-薄荷醇。在合成的凉爽剂中,许多是薄荷醇的衍生物或者是与薄荷醇结构上相关的,即包含环己烷部分,以及是官能团衍生的,该官能团包括羧酰胺、缩酮、酯、醚和醇。示例包括对薄荷烷甲酰胺化合物,诸如N-乙基-对薄荷烷-3-甲酰胺(商业上称为“WS-3”)。结构上与薄荷醇不相关的合成羧酰胺清凉剂的示例为N,2,3-三甲基-2-异丙基丁酰胺。附加的示例性合成凉爽剂包括醇衍生物,诸如3-1-薄荷氧基-丙烷-1,2-二醇、异蒲勒醇、对薄荷烷-3,8-二醇;薄荷酮甘油缩醛(商业上称为“MGA”);薄荷酯,诸如乙酸薄荷酯、乙酰乙酸薄荷酯、乳酸薄荷酯和琥珀酸单薄荷酯。
结构上与薄荷醇无关但是已经被报导具有相似生理清凉效果的附加试剂包括描述于美国专利6,592,884中的α-酮基烯胺衍生物,包括3-甲基-2-(1-吡咯烷基)-2-环戊烯-1-酮(3-MPC)、5-甲基-2-(1-吡咯烷基)-2-环戊烯-1-酮(5-MPC);2,5-二甲基-4-(1-吡咯烷基)-3(2H)-呋喃酮(DMPF);icilin(也称为AG-3-5,化学名142-羟基苯基]-4-[2-硝基苯基]-1,2,3,6-四氢嘧啶-2-酮)。
加温剂的一些示例包括乙醇;烟酸酯,如烟酸苄酯;多元醇;壬酰基香草酰胺;壬酸香草醚;香草醇烷基醚衍生物,如香草乙醚、香草丁醚、香草戊醚和香草己醚;异香草醇烷基醚;乙基香草醇烷基醚;藜芦醇衍生物;取代的苄醇衍生物;取代的苄醇烷基醚;香草醛丙二醇缩醛;乙基香草醛丙二醇缩醛;生姜提取物;生姜油;姜醇;姜油酮;或它们的组合。
一些麻刺剂的示例包括辣椒碱;同型辣椒碱、金钮扣油树脂、日本山椒提取物、山椒素-I、山椒素II、山椒酰胺、胡椒碱、哌啶、千日菊素、4-(1-甲氧基甲基)-2-苯基-1,3-二氧杂环戊烷、或它们的组合。
本文的口腔护理组合物还可包含草本植物成分,诸如春黄菊、橡树树皮、蜜蜂花、迷迭香和鼠尾草的提取物。这些以及一些草本来源的风味剂组分可以刚好足以向风味剂提供贡献的含量被包含,或者它们可以更高的含量诸如1%或更高被添加,以便提供更大的治疗效果。
防腐剂
本发明的口腔护理组合物可包含防腐剂。防腐剂可为苄醇、苯氧基乙醇、脱水山梨糖醇辛酸酯(Velsan)、1-2己二醇和辛乙二醇(Symediol)、对羟基苯甲酸酯和/或它们的组合。对羟基苯甲酸酯可包括对羟基苯甲酸甲酯或对羟基苯甲酸丙酯或它们的组合。苄醇或苯氧基乙醇的含量可以按组合物的重量计大于约0.10%至约0.40%、优选地约0.15%至约0.30%、更优选地约0.17%至约0.23%、另选地约0.18%至约0.22%、另选地约0.19%至约0.21%、另选地约0.20%的量存在。Velsan的含量可以约0.10%至约0.50%、优选地约0.20%至约0.40%、更优选地约0.25%至约0.30%的量存在。Symdiol的含量可以约0.10%至约0.80%、优选地约0.10%至约0.50%并且更优选地约0.20%至约0.30%存在。对羟基苯甲酸酯的含量可以按组合物的重量计约0.01%至约0.11%、优选地约0.02%至约0.10%、更优选地约0.03%至约0.09%的量存在。在一个实施方案中,组合物包含按组合物的重量计约0.005%至约0.1%、优选地约0.01%至约0.08%、另选地约0.01%至约0.05%的对羟基苯甲酸丙酯。在另一个实施方案中,组合物包含按组合物的重量计约0.01%至约0.1%、优选地约0.02%至约0.07%、另选地约0.03%至约0.05%的对羟基苯甲酸甲酯。
在另一个实施方案中,对羟基苯甲酸酯包括对羟基苯甲酸甲酯和对羟基苯甲酸丙酯的组合,其中存在更大的对羟基苯甲酸甲酯与对羟基苯甲酸丙酯的重量比。在另一个实施方案中,对羟基苯甲酸酯为对羟基苯甲酸甲酯和对羟基苯甲酸丙酯,其中对羟基苯甲酸甲酯与对羟基苯甲酸丙酯的重量比为约5:3至约30:3、优选地大于约5:3至约20:3、更优选约6:3至约15:3。
在一个实施方案中,本发明的口腔护理组合物基本上不含三氯生(即,5-氯-2-(2,4-二氯苯氧基)苯酚),优选地不含三氯生。
甜味剂
本文的口腔护理组合物可包含甜味剂。这些包括甜味剂诸如糖精、右旋糖、蔗糖、乳糖、木糖醇、麦芽糖、左旋糖、天冬甜素、环己氨基磺酸钠、D-色氨酸、二氢查尔酮、丁磺氨、三氯蔗糖、纽甜、以及它们的混合物。甜味剂通常以按组合物的重量计约0.005%至约5%、另选地约0.01%至约1%、另选地约0.1%至约0.5%、另选地它们的组合的含量用于口腔护理组合物中。
着色剂
本文的口腔护理组合物可包含着色剂(即颜料、染料和遮光剂)。着色剂可为水性溶液的形式,优选地1%着色剂的水溶液。也可将二氧化钛添加到本发明的口腔护理组合物中。二氧化钛是给口腔护理组合物增加不透明度的白色粉末。二氧化钛的含量按所述组合物的重量计一般为约0.25%至约5%。应当理解,所选择的组合物组分必须是化学上和物理上彼此相容的。
抗牙结石剂
口腔护理组合物可包含有效量的抗牙结石剂,其在一个实施方案中可以约0.05%至约50%、另选地约0.75%至约25%、另选地约0.1%至约15%存在。非限制性示例包括描述于美国专利公布号2011/0104081A1第64段中的那些,和描述于美国专利公布号2012/0014883A1第63至68段中的那些,以及本文所引用的参考文献。一个示例是作为焦磷酸根离子源的焦磷酸盐。在一个实施方案中,组合物包含焦磷酸四钠(TSPP)或焦磷酸二钠或它们的组合,优选地包含按组合物的重量计约0.01%至约2%、更优选地约0.1%至约1%的焦磷酸盐。不受理论的束缚,TSPP可不仅提供钙螯合作用,从而减少牙斑形成,而且还可提供附加的单氟磷酸盐稳定有益效果(在包含单氟磷酸盐的那些制剂中)。
其它成分
本发明的口腔护理组合物可包含其它口腔护理活性物质。例如,口腔护理组合物还可包含选自维生素C、维生素E、维生素B5、以及它们的组合的维生素。本文术语“维生素”意指所述维生素及其所有衍生物。这些成分可为口腔护理组合物提供附加有益效果。使用细胞外抗氧化剂例如抗坏血酸盐或α-生育酚作为链断裂或自由基清除抗氧化剂有助于控制和调节可导致宿主组织损伤的细胞内反应性氧物质(ROS)。使用右旋泛醇可改善上皮化并诱导受损组织的伤口愈合中的增殖阶段。
在一些实施方案中,口腔护理组合物可包含按组合物的重量计约0.1%至约10%、优选地约0.5%至约8%、或约0.5%至约5%的维生素,该维生素选自维生素C、维生素E、维生素B5、或它们的组合。本发明所述的维生素意指所述维生素及其所有衍生物。
本发明的口腔护理组合物还可包含常见和常规的辅助组分,诸如表面活性剂、抗微生物剂、氟离子、以及本领域技术人员已知的其它成分。应当理解,所选择的口腔护理组合物组分必须是化学上和物理上彼此相容的。
使用方法
本发明还涉及用于治疗口腔的方法,该方法包括向受试者口腔的口内组织(例如,口腔粘膜、齿龈)、尤其是牙龈组织施用,保留超过2分钟,优选地超过10分钟,更优选地超过30分钟,或超过60分钟或更长。本文的使用方法包括使受试者的口腔粘膜(例如齿龈缘或龈沟/龈袋)与根据本发明的口腔护理组合物接触。
本发明还涉及使用本文所述的口腔护理组合物改善受试者的牙龈健康的方法,该方法包括将口腔护理组合物施用到受试者的口内组织上的步骤,优选地,沿齿龈缘或龈沟施用每天至少一次,优选地施用每天至少两次,更优选地在每次刷牙之后立即施用。本文术语“立即”意指在1小时内,优选地在30分钟内,更优选地在15分钟内,另选地在10分钟内。优选地,可通过使用施用装置将口腔护理组合物施用到受试者的口内组织上,该施用装置具有柄部和头部,以使口腔护理组合物沿受试者的齿龈缘或龈沟铺展。优选地,口腔护理组合物在施用到口内组织上之前被施用在施用装置的头部上。
本发明还涉及改善受试者的牙龈健康的方法,该方法包括至少两个步骤:(a)用抗菌牙膏、优选地含亚锡的牙膏刷牙,并且紧接着(b)将如本文所定义的口腔护理组合物施用到受试者的口内组织上,优选地沿齿龈缘、龈沟或龈袋施用。
测试方法
测试1:流变学测试方法
描述了用于评估粘度特征(并根据制造说明书运行)的流变学测试方法。通过使用洁牙剂宏观流变学测试程序,在TA AR2000流变仪(购自TA Instruments,New Castle,United States)上测试粘度特征。所用的几何形状为具有溶剂捕集器的40mm钢平行板。将洁牙剂放置在AR2000流变仪的Peltier板上,并且间隙设置为1000微米。洁牙剂宏观流变学测试由应力扫描振荡、频率扫描振荡和稳态流动测试组成。列出了关键参数设置:(a)应力扫描步骤:振荡应力(Pa):0.01-500;(b)频率(Hz):1.0;(c)频率扫描步骤:频率(Hz):0.1-10,以及受控振荡应力(Pa):1.5;(d)稳态流动步骤1:剪切速率(s-1):0.01-100;和(e)稳态流动步骤2:剪切速率(s-1):100-0.01。
剪切流动测试是在不同剪切速率下测量粘度的粘度测试模式。稳态流动测试是其中每个点处的速度不随时间而变化的流动。该测试中的三个主要参数为粘度、剪切速率和剪切应力。幂律模型是熟知的用于表征在非牛顿流体中发生剪切致稀的情况下剪切速率范围内粘度或剪切应力与剪切速率之间的关系的模型。它量化了总体粘度范围和与牛顿行为的偏差程度。幂律模型被描述为η=Kγn-1,其中η=粘度并且γ=剪切速率。K被称为粘度稠度系数,其描述了跨越正在被建模的流动曲线的部分的粘度的总体范围。指数“n”被称为速率指数。K和η能够通过幂律模型拟合来确定。基于速率指数n,幂律模型描述了流动的三种基本类型:
n=1 牛顿行为
n<1 剪切致稀(或假塑性)
n>1 剪切增稠
本文组合物的粘度特征由通过幂律模型拟合以0.1-10s-1的剪切速率范围确定的粘度稠度系数K(Pa·s)表示。
测试2:粘膜粘附测试方法
本发明提供了粘膜粘附测试方法。将测试样品用异硫氰酸荧光素(FITC)在室温处标记1小时。将所得溶液在磷酸盐缓冲盐水(PBS)中透析48h,以去除游离的FITC分子。将二氧化硅晶片用乙醇/(3-氨基丙基)三乙氧基硅烷(APTES)/氨溶液(20:4:1,v/v/v)的混合物处理8小时,然后用乙醇和水冲洗,并干燥以获得胺官能化二氧化硅晶片(NH2-SW)。将NH2-SW在粘蛋白溶液中在室温处温育8小时。将粘蛋白改性的二氧化硅晶片与测试样品在PBS缓冲液中于37℃处在振荡器中温育12小时,然后用去离子水冲洗。粘蛋白改性的二氧化硅晶片的荧光图像通过荧光显微镜拍摄,并且用于在ImageJ软件(National Institutes ofHealth,USA,(https://imagej.nih.gov/ij/))中测量荧光强度(FI)。用于描述“粘膜粘附指数”的荧光强度百分比(“FI%”)是相对于归一化图像场中的总像素的荧光像素。因此,具有较高FI%的第一测试样品与具有较低FI%的第二测试样品相比具有较强的粘膜粘附。
测试3:粘附性测试方法
使用质构分析仪(TA Plus/30,Stable Micro System(Surrey,UK))测试样品的粘附性。程序描述如下:
1.样品制备:以'0.03±0.005g'的量从包装中取出凝胶或膏剂样品至测试板。
2.制定TA序列以启用仪器动作:将探针压入每个样品中,遵循所确定的编程序列(对于阶段2,速度为10mm/sec,力为5g;对于阶段4,速度为1mm/sec,力为200g,并且对于阶段5时间为1sec)。
3.仪器和附件设置:
3.1用可用的探针选项尝试测试:金属圆板
3.2 TA设置为'压缩'
4.所有分析应进行5次平行测定。
5.测量:粘附性:克服样品表面与探针表面之间的吸引力所需的功。
6.数据计算:利用编程的TTA数据分析宏(例如,力5g)。
粘附性值(单位:gf*sec)描述了克服样本表面与探针表面之间的吸引力所需的能量。
实施例
下列实施例和描述进一步阐明了本发明范围内的实施方案。所给出的这些实施例仅是例证的目的,并且不应被理解为对本发明的限制,因为在不脱离本发明的实质和范围的情况下,可对其进行许多改变。
实施例1:实施例A和B
实施例A和B为下表1中所示的免洗型口腔护理凝胶组合物,其中组分的量以重量百分比(“wt%”)描述。这些实施例通过常规方法制备。实施例A为含有透明质酸钠(作为透明质酸源)但不含海藻糖的比较凝胶组合物。实施例B为本发明的含有透明质酸钠和10重量%海藻糖的凝胶组合物。
表1:实施例A-B--凝胶组合物
*重均分子量为约1,400,000Da的透明质酸钠。
实施例2:屏障保护测试
此处描述了屏障保护测试。该测试通过使用辣椒碱处理被样品覆盖的细胞来评估免洗型口腔护理组合物的屏障保护能力。
细胞培养:
将人齿龈上皮(HGE)细胞维持在37℃培养箱中,CO2饱和度为5%。向达尔伯克改良伊格尔培养基(DMEM,Gibco)中添加10重量%胎牛血清和1重量%青霉素-链霉素,以制备这些细胞的完全培养基,每2-3天更换一次。
通过实时细胞分析仪(RTCA)进行的屏障保护分析:
使用基于阻抗测量的实时细胞分析仪(RTCA)xCELLigence RTCA DP(ACEABioscience Inc.,San Diego,CA)设备监测样品的屏障保护。将50ul完全培养基添加到E-板以获得背景读数,然后添加100ul细胞悬浮液。将含有28000个细胞/孔的E-板在37℃、5%CO2处温育22h-24h,直到细胞铺满。将培养基换成DMEM或含有50倍稀释样品的DMEM(样品信息如下表2),并在37℃、5%CO2处温育2h。将屏障破坏剂(在这种情况下,辣椒碱的最终浓度为75uM)添加到E-板的孔中。阻抗反映为细胞指数(“CI”)并且连续记录16-24小时,并且报告为CI曲线。
表2:样品信息:
CI曲线在恰好添加样品之前的时间点归一化。记录在添加屏障破坏剂后3小时的归一化CI与空白对照的比较。通过以下公式计算屏障保护百分比。
屏障保护百分比=(样品的归一化CI-辣椒碱的归一化CI)/空白的归一化CI。
表3:屏障保护结果
样品(稀释) | 屏障保护百分比 |
对照辣椒碱(75uM) | 0% |
C(对照) | 0% |
D(比较例) | 22% |
E(本发明) | 67% |
表3中的结果显示,与对照辣椒碱(即屏障破坏剂)相比,样品C(即,最终浓度为0.2重量%的仅海藻糖对照)未显示任何屏障保护。样品D(即,含有透明质酸但不含海藻糖的比较例A)在22%下表现出一定水平的屏障保护。值得注意的是,含有透明质酸和海藻糖的样品E(即,本发明实施例B)在67%下表现出比样品D高三倍以上的显著屏障保护。这些结果显示那些组合了透明质酸和牙龈强化多元醇诸如海藻糖的免洗型口腔护理组合物的显著增量的屏障保护。
本文所公开的量纲和值不应理解为严格限于所引用的精确数值。相反,除非另外指明,否则每个此类量纲旨在表示所述值以及围绕该值功能上等同的范围。例如,公开为“40mm”的量纲旨在表示“约40mm”。
除非明确排除或以其它方式限制,本文中引用的每一篇文献,包括任何交叉引用或相关专利或专利申请以及本申请对其要求优先权或其有益效果的任何专利申请或专利,均据此全文以引用方式并入本文。对任何文献的引用不是对其作为与本发明的任何所公开或本文受权利要求书保护的现有技术的认可,或不是对其自身或与任何一个或多个参考文献的组合提出、建议或公开任何此类发明的认可。此外,当本发明中术语的任何含义或定义与以引用方式并入的文献中相同术语的任何含义或定义矛盾时,应当服从在本发明中赋予该术语的含义或定义。
虽然已举例说明和描述了本发明的具体实施方案,但是对于本领域技术人员来说显而易见的是,在不脱离本发明的实质和范围的情况下可作出各种其它变化和修改。因此,本文旨在于所附权利要求中涵盖属于本发明范围内的所有此类变化和修改。
Claims (15)
1.一种口腔护理组合物,包含:
a) 按所述组合物的重量计30%至85%的总水含量;
b) 按所述组合物的重量计0.01%至10%的透明质酸或其盐;
c) 按所述组合物的重量计0.5%至20%的牙龈强化多元醇;
其中所述口腔护理组合物基本上不含磨料;
其中所述口腔护理组合物为免洗型组合物。
2.根据权利要求1所述的口腔护理组合物,其中所述牙龈强化多元醇选自海藻糖、棉子糖、水苏糖、毛蕊花糖、异麦芽酮糖醇、麦芽糖醇、乳糖醇、麦芽三糖醇、麦芽四糖醇、聚葡萄糖醇、以及它们的组合;优选地,其中所述牙龈强化多元醇以按所述组合物的重量计0.5%至18%、优选地1%至15%的量存在。
3.根据权利要求1或权利要求2所述的口腔护理组合物,其中所述牙龈强化多元醇为海藻糖或异麦芽酮糖醇,优选地海藻糖。
4.根据前述权利要求中任一项所述的口腔护理组合物,所述口腔护理组合物还包含按所述组合物的重量计0.1%至10%、优选地0.5%至5%、更优选地1%至4%的聚丙烯酸。
5.根据前述权利要求中任一项所述的口腔护理组合物,其中所述透明质酸具有900,000道尔顿至5,000,000道尔顿、优选地900,000道尔顿至3,000,000道尔顿、更优选地900,000道尔顿至2,000,000道尔顿的重均分子量;优选地所述透明质酸以按所述组合物的重量计0.1%至5.0%、更优选地0.2%至0.8%的量存在。
6.根据前述权利要求中任一项所述的口腔护理组合物,所述口腔护理组合物还包含附加聚合物,所述附加聚合物选自天然树胶、直链硫酸化多糖、阴离子纤维素和非离子纤维素衍生物、马来酸酐与甲基乙烯基醚的共聚物、聚乙烯吡咯烷、以及它们的组合;优选地,所述附加聚合物选自黄原胶、角叉菜胶、羧甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟甲基纤维素、羟丙基纤维素、羟甲基纤维素、聚乙烯吡咯烷、具有30,000道尔顿至1,000,000道尔顿重均分子量的马来酸酐与甲基乙烯基醚的共聚物、以及它们的组合;优选地,所述附加聚合物以按所述组合物的重量计0.1%至10%、优选地0.5%至5%、更优选地1%至4%的量存在。
7.根据前述权利要求中任一项所述的口腔护理组合物,其中所述总水含量为按所述组合物的重量计40%至80%、优选地45%至75%、更优选地50%至75%。
8.根据前述权利要求中任一项所述的口腔护理组合物,所述口腔护理组合物还包含湿润剂,所述湿润剂选自甘油、山梨醇、木糖醇、赤藓糖醇、丁二醇、聚乙二醇、丙二醇、以及它们的组合;优选地,所述湿润剂以按所述组合物的重量计1%至50%、优选地15%至30%的量存在。
9.根据前述权利要求中任一项所述的口腔护理组合物,其中所述口腔护理组合物基本上不含乙醇,优选地实质上不含乙醇。
10.根据前述权利要求中任一项所述的口腔护理组合物,所述口腔护理组合物还包含维生素;优选地,所述维生素选自维生素C、维生素E、维生素B5、以及它们的组合。
11.一种使用如前述权利要求中任一项所定义的口腔护理组合物改善受试者的牙龈健康的方法,所述方法包括将所述口腔护理组合物施用到所述受试者的口内组织上的步骤,在所述口内组织上所述口腔护理组合物保留1分钟至1000分钟、优选地2分钟至200分钟的持续时间而不移除;任选地,所述施用步骤可作为口腔卫生方案的最后步骤进行。
12. 一种改善受试者的牙龈健康的方法,所述方法包括至少两个步骤:
(a) 用牙膏刷洗所述受试者的牙齿,所述牙膏优选地为抗菌牙膏,更优选地为含亚锡的牙膏,并且最优选地为含亚锡离子源和氨基酸的牙膏;以及
(b) 随后,将如权利要求1至10中任一项所定义的口腔护理组合物施用、优选地立即施用到所述受试者的口内组织上,优选地沿齿龈缘、龈沟或龈袋施用,在所述齿龈缘、龈沟或龈袋上所述口腔护理组合物保留1分钟至1000分钟、优选地2分钟至200分钟的持续时间而不移除。
13.根据权利要求11或权利要求12所述的方法,其中通过使用具有柄部和头部的施用装置将所述口腔护理组合物施用到所述受试者的口内组织上,以将所述口腔护理组合物铺展到所述受试者的所述口内组织上。
14.一种套盒,所述套盒包括牙膏和由权利要求1至10中任一项所定义的口腔护理组合物,其中优选地所述牙膏为抗菌牙膏,更优选地所述牙膏为含亚锡的牙膏,并且最优选地所述牙膏为含亚锡离子源和氨基酸的牙膏。
15.一种套盒,所述套盒包括如权利要求1至10中任一项所定义的口腔护理组合物和递送载体,其中所述递送载体包括贴条、材料膜、牙托、矫治器、海绵材料、施用装置、或它们的混合物。
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