CN115551467B - 包含锡的再矿化口腔护理组合物 - Google Patents
包含锡的再矿化口腔护理组合物 Download PDFInfo
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- CN115551467B CN115551467B CN202180033244.8A CN202180033244A CN115551467B CN 115551467 B CN115551467 B CN 115551467B CN 202180033244 A CN202180033244 A CN 202180033244A CN 115551467 B CN115551467 B CN 115551467B
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Abstract
本发明提供具有低RDA值的洁牙剂组合物,该洁牙剂组合物包含锡、单齿配体、多齿配体。本发明提供洁牙剂组合物,该洁牙剂组合物具有单齿配体与多齿配体的独特比率以稳定锡。本发明提供口腔护理组合物,该口腔护理组合物包含在较低RDA值处具有出乎意料地低色斑的锡。本发明提供具有出乎意料的低色斑和RDA值的洁牙剂组合物,该洁牙剂组合物包含锡和二氧化硅。
Description
技术领域
本发明涉及口腔护理组合物,所述口腔护理组合物包含在较低RDA值处具有出乎意料地低色斑的锡。本发明还涉及洁牙剂组合物,所述洁牙剂组合物包含具有出乎意料低色斑和RDA值的锡和二氧化硅。
背景技术
口腔护理组合物已经包含抗微生物剂,如锡离子,以对抗口腔细菌并预防和治疗由口腔中细菌引起的病状,如牙斑的形成、恶臭和牙龈疾病。牙斑的形成以及不能阻止其增殖是龋齿、齿龈炎、牙周病和牙缺失的主要原因。另外,锡离子可以沉积在口腔内的表面上以提供保护功能,诸如抗侵蚀、抗菌和/或抗敏感性有益效果。
牙结石和牙斑以及行为和环境因素导致牙齿色斑的形成,严重影响了牙齿的美观。有助于牙齿变色倾向的行为和环境因素包括定期使用包含牙齿变色化学物质或发色体的产品诸如咖啡、茶、可乐或烟草,以及使用促色斑口腔产品诸如包含阳离子抗微生物剂的那些。
已知引起牙齿变色的阳离子抗微生物剂中最常见的是季铵化合物诸如西吡氯铵以及金属离子源诸如氟化亚锡和氯化亚锡。这些阳离子材料的牙齿变色潜力早已有所记载。在许多方法中,已提出通过使用漂白剂或氧化剂诸如过氧化物来减少和控制牙齿变色并美白牙齿。基本上,漂白剂通过氧化发色体和现有的色斑而起作用。然而,由于稳定性和安全限制,添加到口腔护理产品中的漂白剂通常以低浓度存在。在这些低浓度下,漂白剂诸如过氧化物通常在控制色斑和美白牙齿方面是无效的。此外,漂白剂在功能上不能用于防止色斑采集。
阴离子配体,特别是聚合物配体的使用也已用于减轻阳离子诱导变色的倾向。然而,当与阴离子色斑缓解剂一起配制时,阳离子抗微生物成分的稳定性和生物利用率经常受到损害。例如,多磷酸盐在减轻CPC和亚锡诱导的变色方面是有效的,但它们在使用期间影响两种抗微生物剂进入牙斑的可用性。
减轻阳离子抗微生物剂变色的另一种策略是使用高度研磨材料,如二氧化硅。高度研磨材料可以去除这些色斑,但如果大量使用,也可以去除牙齿表面的层。因此,需要一种包含锡的洁牙剂组合物,但不需要具有高RDA值的磨料。
发明内容
本文公开了一种洁牙剂组合物,所述洁牙剂组合物包含(a)锡、(b)磨料、(c)单齿配体;(d)多齿配体;以及(e)至少约6的pH,其中所述洁牙剂组合物的RDA值小于约150。
本文还公开了一种洁牙剂组合物,所述洁牙剂组合物包含(a)锡、(b)二氧化硅磨料、(c)包括羧酸的单齿配体;(d)多齿配体;以及(e)至少约6的pH,其中所述洁牙剂组合物的RDA值小于约150。
附图说明
图1示出了实施例1-实施例3的体内色斑和RDA。
具体实施方式
本发明涉及含有Sn的口腔护理组合物,所述口腔护理组合物具有用于防止Sn色斑积聚而不使用刺激性化学清洁剂(例如,多磷酸盐)的最佳稳定体系,或高清洁磨料体系(例如,具有高RDA的组合物)。所得的发明提供了有效的口腔硬组织有益效果,而不会在稳定性差的体系中观察到牙齿色斑的聚积。
已知稳定性差的Sn在牙斑中聚积。当此类不稳定的Sn聚积时,它可以从亚锡离子转化成锡离子,其可以是深黄棕色色调。这种牙齿色斑可能难以去除,并且可能需要由牙科专业人员去除。受牙齿色斑困扰的消费者可以选择不含Sn的不同牙膏,从而可能缺少由生物可利用亚锡离子提供的重要牙齿和牙龈健康益处。传统上,使用高度研磨材料,诸如特定二氧化硅部分来处理具有不充分稳定的Sn的牙膏中的色斑,或者牙齿色斑的聚积是可能的。
适当稳定口腔护理组合物中的亚锡以确保功效,同时防止色斑形成需要使用螯合剂。螯合效应假定多齿配体与金属的络合物比齿状归一化当量的单齿配体稳定的金属络合物(例如,1摩尔二齿配体相比于2摩尔类似结构化的单齿配体)更稳定,因为二齿螯合物相对于单齿络合物的摩尔熵减小。
虽然不希望受理论束缚,但在金属在混合的多齿/单齿溶液中形成络合物的情况下,当使用常规稳定剂(例如,柠檬酸根阴离子)时常常导致键合几何形状的构型限制,这因此有利于金属-单齿-多齿络合物的形成。考虑亚锡金属离子被柠檬酸根阴离子螯合的情况。Sn2+优选四面体键合几何形状。由于空间限制,三齿柠檬酸根阴离子在这种几何结构中只能占据具有亚锡的四个配位位点中的两个位点。因此,单齿配体(例如,葡萄糖酸盐)可以在第三配位位点处参与络合物。然后将过量的电子密度(来自三个配位的羧酸根阴离子中的每个阴离子的一个电子减去2+形式锡价)在Sn键合轨道内分布到第四配位位点,所述第四配位位点在溶液中时可以获得氢键合的水或水合氢离子。
虽然不希望受理论束缚,但相反如果在先前的实施例中,柠檬酸盐的摩尔比从1增加到2并且不存在单齿配体,则金属螯合物将过度稳定,导致Sn生物利用度降低和口腔护理益处损失。这是螯合效应的直接结果。另外,如果在仅混合或多齿配体的情况下使用太少的多齿配体,则金属络合物不充分稳定,这也导致口腔护理益处的损失或不充分稳定的Sn的沉积,从而导致牙齿色斑的聚积。由于亚锡离子在溶液中的独特几何性质(具有2+形式化合价的四面体键合几何)和在混合单齿/多齿配体的存在下,Sn2+优选混合齿络合物。这是因为,尽管两个多齿配体可以形成螯合络合物,但所得的电子密度分布并不有利,从而为络合物的形成提供焓罚分。
最后,在仅单齿稳定的金属络合物的情况下,不存在螯合效应,并且稳定配体可以容易地被具有较高结合亲和力的化学部分替代。这导致组合物中的不充分稳定的亚锡和随时间推移损失到配方组分(例如,二氧化硅)或口腔中的不充分稳定的Sn的沉积,导致牙齿色斑的聚积。出乎意料地,需要单齿配位配体和多齿配位配体的最佳混合物以适当地稳定来确保功效并有助于防止色斑形成。因此,本发明涉及含有Sn但在低RDA值处提供异常色斑控制的口腔护理组合物。
定义
为了更清楚地定义本文所用的术语,提供了以下定义。除非另外指明,以下定义均适用于本公开。如果在本公开中使用术语但未在本文中具体定义,则可应用来自IUPACCompendium of Chemical Terminology第2版(1997)的定义,只要该定义不与本文应用的任何其他公开或定义相冲突,或者不使应用该定义的任何权利要求不确定或不能实现。
如本文所用,术语“口腔护理组合物”包括在普通使用过程中不是用于吞咽以用于特定治疗剂的全身给药的目的,而是在口腔中保留足够长的时间以接触牙齿表面或口腔组织的产品。口腔护理组合物的示例包括洁牙剂、牙胶、龈下凝胶、漱口水、摩丝、泡沫、口喷剂、锭剂、咀嚼片、口香糖、牙齿美白条、牙线和牙线涂层、口气清新可溶性条、或者义齿护理或粘合剂产品。口腔护理组合物还可掺入条或膜上以用于直接施用或附接到口腔表面。
除非另外指明,否则如本文所用,术语“洁牙剂组合物”包括牙齿或龈下糊剂、凝胶或液体制剂。洁牙剂组合物可以是单相组合物,或可以是两种或更多种单独洁牙剂组合物的组合。洁牙剂组合物可呈任何期望的形式,如深条纹的、浅条纹的、多层的、糊剂周围有凝胶的、或它们的任意组合。在包括两种或更多种单独洁牙剂组合物的洁牙剂中,每种洁牙剂组合物均可被包含于物理上独立的分配器隔室中,并且并排分配。
可用于本文中的活性成分和其他成分可根据其美容和/或治疗有益效果或其假定的作用或运行模式来在本文中分类或描述。然而应当理解,在一些情况下,可用于本文的活性物质和其他成分可提供多于一种美容和/或治疗有益效果,或者经由不止一种作用模式起作用或运行。因此,本文的分类只是为了方便起见,而并不旨在将成分限制在所列的具体指定的功能或活性。
术语“口部可接受的载体”包括一种或多种适用于局部口腔给药的相容的固体或液体赋形剂或稀释剂。如本文所用,所谓“相容的”是指组合物的组分能够混合但不相互作用,所述相互作用会显著降低组合物的稳定性和/或功效。本发明的载体或赋形剂可包括漱口水或漱口液的常见和常规组分,如下文中更全面描述:漱口水或漱口液载体材料通常包括但不限于水、醇、湿润剂、表面活性剂和接受改善剂(诸如调味剂、甜味剂、着色剂和/或凉爽剂)中的一种或多种。
如本文所用,术语“基本上不含”是指按此类组合物的总重量计,组合物中存在不超过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他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”可用于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。
出于本发明的目的,待使用的相关分子量(MW)是在制备组合物时添加的材料的相关分子量,例如,如果螯合剂是柠檬酸盐物质,则其可以以柠檬酸、柠檬酸钠或实际上其他盐形式提供,所用的MW是添加到组合物中的特定盐或酸的MW,但忽略可能存在的任何结晶水。
术语RDA是指FDI-ISO 11609中定义的相对牙本质磨蚀性放射性牙本质磨蚀性。
虽然本文以“包括”各种组分或步骤的方式描述组合物和方法,但除非另外指明,所述组合物和方法也可“基本上由”或“由”各种组分或步骤组成。
如本文所用,词语“或”当用作两个或更多个元素的连词时,是指包括单独的所述元素或所述元素的组合;例如X或Y,是指X或Y或两者。
如本文所用,冠词“一个”和“一种”被理解为受权利要求书保护的或描述的一种或多种材料,例如,“口腔护理组合物”或“漂白剂”。
除非另外指明,否则本文提及的所有测量均在约23℃(即室温)处进行。
一般来讲,使用Chemical and Engineering News,63(5),27,1985中公布的元素周期表的版本中所示的编号方案来指示元素族。在一些情况下,元素族可使用分配到该族的通用名称指示;例如,对于1族的碱金属元素、对于2族的碱土金属元素,诸如此类。
本发明公开了几种类型的范围。当公开或以权利要求书保护任何类型的范围时,其目的在于单独公开或以权利要求书保护此类范围可合理涵盖的每个可能数值,包括该范围的端点以及其中涵盖的任何子范围和子范围的组合。
术语“约”意指数量、尺寸、配方、参数以及其他数量和特性不是且不必是精确的,但可根据需要为近似和/或更大或更小,从而反映公差、转换因子、四舍五入、测量误差等等,以及本领域技术人员已知的其他因素。一般来讲,无论是否进行此类明确表述,数量、尺寸、配方、参数或其他量或特性均为“约”或“近似”。术语“约”还涵盖由于由特定初始混合物产生的对于组合物的不同平衡条件而不同的量。无论是否由术语“约”修饰,权利要求均包括数量的等同量。术语“约”可意指在报告数值10%内的值,优选在报告数值5%内的值。
口腔护理组合物可为任何合适的形式,诸如固体、液体、粉末、糊剂或它们的组合。口腔护理组合物可为洁牙剂、牙胶、龈下凝胶、漱口液、摩丝、泡沫、口喷剂、锭剂、咀嚼片、口香糖、牙齿美白条、牙线和牙线涂层、口气清新可溶性条、洁牙膏或者义齿护理或粘合剂产品。可将口腔护理组合物的组分掺入到膜、条、泡沫或纤维基洁牙剂组合物中。
如本文所述,口腔护理组合物包含锡、单齿配体和多齿配体。另外,口腔护理组合物可以包括其他任选的成分,如下文所述。仅出于方便提供下面的部分标题。在一些情况下,化合物可以落入一个或多个部分内。例如,氟化亚锡可以是锡化合物和/或氟化物化合物。另外,例如,草酸或其盐可以是二羧酸、多齿配体和/或美白剂。
锡
本发明的口腔护理组合物包含锡,其可以由锡离子源提供。锡离子源可为任何合适的化合物,当将口腔护理组合物施用到口腔中时,该化合物可在口腔护理组合物中提供锡离子和/或将锡离子递送到口腔中。锡离子源可包含一种或多种含锡化合物,诸如氟化亚锡、氯化亚锡、溴化亚锡、碘化亚锡、氧化亚锡、草酸亚锡、硫酸亚锡、硫化亚锡、氟化锡、氯化锡、溴化锡、碘化锡、硫化锡和/或它们的混合物。锡离子源可以包含氟化亚锡、氯化亚锡和/或它们的混合物。锡离子源也可以是不含氟的锡离子源,诸如氯化亚锡。
口腔护理组合物可以包含按该口腔护理组合物的重量计约0.0025%至约5%、约0.01%至约10%、约0.2%至约1%、约0.4%至约1%、或约0.3%至约0.6%的锡和/或锡离子源。
单齿配体
口腔护理组合物包含单齿配体,该单齿配体具有小于1000g/mol的分子量(MW)。单齿配体具有可以与中心原子如锡离子相互作用的单个官能团。单齿配体必须适合用于口腔护理组合物中,可以包括在美国食品和药品管理局公认为安全的(GRAS)列表或所关注管辖范围内的其他合适列表中列出所述口腔护理组合物。
如本文所述,单齿配体可以包含可以与锡螯合、缔合和/或键合的单个官能团。可以与锡螯合、缔合和/或键合的合适官能团包括羰基、胺以及本领域普通技术人员已知的其他官能团。合适的羰基官能团可以包括羧酸、酯、酰胺或酮。
单齿配体可以包含单个羧酸官能团。包含羧酸的合适的单齿配体可以包括具有式R-COOH的化合物,其中R是任何有机结构。包含羧酸的合适的单齿配体还可以包括脂族羧酸、芳族羧酸、糖酸、它们的盐和/或它们的组合。
脂族羧酸可以包含连接到直链烃链、支链烃链和/或环状烃分子的羧酸官能团。脂族羧酸可以是完全饱和或不饱和的并且具有一个或多个烯烃和/或炔烃官能团。其他官能团可以存在并键合到烃链,包括烃链的卤代变体。脂族羧酸还可以包括羟基酸,其为相对于羧酸官能团在α、β或γ位置具有醇官能团的有机化合物。合适的α羟基酸包括乳酸和/或其盐。
芳族羧酸可以包含连接到至少一个芳族官能团的羧酸官能团。合适的芳族羧酸基团可以包括苯甲酸、水杨酸和/或它们的组合。
羧酸可以包括甲酸、乙酸、丙酸、丁酸、戊酸、己酸、庚酸、辛酸、抗坏血酸、苯甲酸、辛酸、胆酸、甘氨酸、丙氨酸、缬氨酸、异亮氨酸、亮氨酸、苯丙氨酸、亚油酸、烟酸、油酸、丙酸、山梨酸、硬脂酸、葡萄糖酸、乳酸、碳酸、氯乙酸、二氯乙酸、三氯乙酸、它们的盐和/或它们的组合。
单齿配体还可以包括磷酸根作为官能团以与锡相互作用。合适的磷酸化合物包括磷酸盐、有机磷酸或它们的组合。合适的磷酸盐包括正磷酸盐、磷酸氢盐、磷酸二氢盐、烷基化磷酸盐和它们的组合。
口腔护理组合物可以包含按组合物的重量计约0.01%至约10%、约0.1%至约15%、约1%至约5%、或约0.0001%至约25%的单齿配体。
多齿配体
口腔护理组合物包含分子量(MW)小于1000g/mol或小于2500g/mol的多齿配体。多齿配体具有至少两个可以与中心原子如锡离子相互作用的官能团。另外,多齿配体必须适合用于口腔护理组合物中,可以包括在美国食品和药品管理局公认为安全的(GRAS)列表或所关注管辖范围内的另一个合适列表中列出所述口腔护理组合物。
如本文所述,多齿配体可以包含至少两个可以与锡螯合、缔合和/或键合的官能团。多齿配体可以包括二齿配体(即,具有两个官能团)、三齿(即,具有三个官能团)、四齿(即,具有四个官能团)等。
可以与锡螯合、缔合和/或键合的合适官能团包括羰基、磷酸根、硝酸根、胺以及本领域普通技术人员已知的其他官能团。合适的羰基官能团可以包括羧酸、酯、酰胺或酮。
多齿配体可以包含两个或更多个羧酸官能团。包含羧酸的合适的多齿配体可以包括具有式HOOC-R-COOH的化合物,其中R是任何有机结构。包含两种或更多种羧酸的合适的多齿配体还可以包括二羧酸、三羧酸、四羧酸等。
其他合适的多齿配体包括包含至少两个磷酸官能团的化合物。因此,如本文所述,多齿配体可以包括多磷酸盐。
其他合适的多齿配体包括啤酒花β酸,诸如蛇麻酮、合蛇麻酮、聚蛇麻酮和/或它们的组合。啤酒花β酸可以合成衍生和/或从天然来源提取。
多齿配体可以包括草酸、草酸、丙二酸、琥珀酸、戊二酸、己二酸、庚二酸、辛二酸、壬二酸、癸二酸、十一烷二酸、十二烷二酸、十三烷二酸、十六烷二酸、日本蜡酸、软木原酸、木贼二酸、苹果酸、酒石酸、柠檬酸、植酸、焦磷酸、三聚磷酸、四聚磷酸、六偏磷酸、它们的盐和/或它们的组合。
口腔护理组合物可以包含按组合物的重量计约0.01%至约10%、约0.1%至约15%、约1%至约5%、或约0.0001%至约25%的多齿配体。
锡与单齿配体与多齿配体的比率
如本文所述,口腔护理组合物包括锡与单齿配体与多齿配体的比率,其提供出人意料地高量的可溶性锡和/或优异的氟化物摄取。锡与单齿配体与多齿配体的合适比率可以是约1:0.5:0.5至约1:5:5、约1:0.5:0.75至约1:5:5、约1:1:1至约1:5:5、约1:1:0.5至约1:2.5:2.5、约1:1:1至约1:2:2、约1:0.5:0.5至约1:3:1、或约1:0.5:0.5至约1:1:3。
本文期望具有至少约1000ppm、2000ppm、4000ppm、至少约4500ppm、至少约5000ppm、至少约6000ppm和/或至少约8000ppm的可溶性Sn的口腔护理组合物。本文还期望在至少约9天、30天、65天、75天、100天、200天、365天和/或400天的时间段后具有至少约6.5μg/cm2、至少约7.0μg/cm2、至少约8.0μg/cm2或至少约9.0μg/cm2的氟化物摄取的口腔护理组合物。
总之,虽然不希望受理论束缚,但据信,可溶性Sn量与生物可用Sn相关,因为它可以自由利用以提供口腔健康有益效果。完全结合的Sn(即,过螯合的Sn)或沉淀的Sn(即不溶性锡盐,诸如Sn(OH)2和/或Sn基色斑可以在Sn过螯合时形成)将不包括在可溶性Sn的测量中。另外,虽然不希望受理论束缚,但据信,Sn与单齿配体和多齿配体的仔细平衡的比率可以提供大量的生物可用的氟化物和Sn离子,而无需使用阳离子抗微生物剂,诸如表面染色。因此,进行另外的筛选实验以定量并鉴定单齿配体和多齿配体的范围和身份。
二羧酸
多齿配体可以包括二羧酸。二羧酸包括具有两个羧酸官能团的化合物。二羧酸可以包括由式I定义的化合物或其盐。
R可以是空的、烷基、烯基、烯丙基、苯基、苄基、脂族、芳族、聚乙二醇、聚合物、O、N、P或它们的组合。
二羧酸可以包括草酸、丙二酸、琥珀酸、戊二酸、己二酸、庚二酸、辛二酸、壬二酸、癸二酸、十一烷二酸、十二烷二酸、十三烷二酸、十六烷二酸、日本蜡酸、软木原酸、木贼二酸、苹果酸、酒石酸、它们的盐或它们的组合。二羧酸可以包括二羧酸的合适盐,诸如单碱金属草酸盐、二碱金属草酸盐、单氢草酸单钾、草酸二钾、单氢草酸单钠、草酸二钠、草酸钛和/或草酸盐的其他金属盐。二羧酸还可以包括二羧酸的水合物和/或二羧酸的盐的水合物。
口腔护理组合物可以包含按口腔护理组合物的重量计约0.01%至约10%、约0.1%至约15%、约1%至约5%、或约0.0001%至约25%的二羧酸。
三羧酸
多齿配体可以包括三羧酸。三羧酸包括具有三个羧酸官能团的化合物。三羧酸可以包括由式II定义的化合物或其盐。
R可以是烷基、烯基、烯丙基、苯基、苄基、脂族、芳族、聚乙二醇、聚合物、O、N、P和/或它们的组合。
三羧酸可以包括柠檬酸、异柠檬酸、乌头酸、丙烷-1,2,3-三羧酸、三苯均三酸、柠檬酸循环或Krebs循环中的任何三羧酸、它们的盐或它们的组合。三羧酸可以包括合适的三羧酸的盐,例如柠檬酸钠。
口腔护理组合物可以包含按口腔护理组合物的重量计约0.01%至约10%、约0.1%至约15%、约1%至约5%、或约0.0001%至约25%的三羧酸。
多磷酸盐
多齿配体可以包括多磷酸盐,其可以由多磷酸盐源提供。多磷酸盐源可包含一个或多个多磷酸盐分子。多磷酸盐是一类通过正磷酸盐脱水和缩合生成不同链长的直链和环状多磷酸盐而获得的物质。因此,多磷酸盐分子通常以多磷酸盐分子的平均数(n)来标识,如下所述。尽管可存在一些环状衍生物,但通常认为多磷酸盐由主要以线性构型排列的两个或更多个磷酸盐分子组成。
优选的多磷酸盐是那些具有平均两个或更多个磷酸基团的多磷酸盐,以使得有效浓度的表面吸附产生足够的未结合的磷酸根官能团,这增强了阴离子表面电荷以及表面的亲水特性。本发明中优选的是具有下式的直链多磷酸盐:XO(XPO3)nX,其中X为钠、钾、铵或任何其他碱金属阳离子,并且n平均为约2至约21、约2至约14、或约2至约7。碱土金属阳离子(诸如钙)不是优选的,因为它们趋于由包含氟离子和碱土金属阳离子的水溶液形成不溶性氟化物盐。因此,本文公开的口腔护理组合物可以不含或基本上不含焦磷酸钙。
合适的多磷酸盐分子的一些示例包括例如焦磷酸盐(n=2)、三聚磷酸盐(n=3)、四聚磷酸盐(n=4)、多磷酸钠磷(n=6)、六聚磷酸盐(n=13)、苯多磷酸盐(n=14)、六偏磷酸盐(n=21),其还被称为Glass H.多磷酸盐,可包括由FMC Corporation、ICLPerformance Products和/或Astaris生产的那些多磷酸盐化合物。
口腔护理组合物可包含按该口腔护理组合物的重量计约0.01%至约15%,约0.1%至约10%,约0.5%至约5%,约1%至约20%或约10%或更少的多磷酸盐源。或者,口腔护理组合物可以基本上不含、实质上不含或不含多磷酸盐。口腔护理组合物可以基本上不含、实质上不含或不含环状多磷酸盐。口腔护理组合物可以基本上不含、实质上不含或不含植酸。
氟化物
口腔护理组合物可以包含氟,其可以由氟离子源提供。氟化物离子源可包含一种或多种含氟化物的化合物,诸如氟化亚锡、氟化钠、氟化钾、氟化胺、单氟磷酸钠、氟化锌和/或它们的混合物。
氟离子源和锡离子源可为相同的化合物,例如,氟化亚锡,其可生成锡离子和氟离子。另外,氟离子源和锡离子源可为单独的化合物,诸如当锡离子源为氯化亚锡并且氟离子源为单氟磷酸钠或氟化钠时。
氟离子源和锌离子源可为相同的化合物,例如,氟化锌,其可生成锌离子和氟离子。另外,氟离子源和锌离子源可为单独的化合物,诸如当锌离子源为磷酸锌并且氟离子源为氟化亚锡时。
氟离子源可实质上不含或不含氟化亚锡。因此,口腔护理组合物可包含氟化钠、氟化钾、氟化胺、单氟磷酸钠、氟化锌和/或它们的混合物。
口腔护理组合物可包含能够提供约50ppm至约5000ppm并且优选地约500ppm至约3000ppm的游离氟离子的氟离子源。为递送所期望量的氟离子,氟离子源可以按口腔护理组合物的重量计约0.0025%至约5%、约0.01%至约10%、约0.2%至约1%、约0.5%至约1.5%、或约0.3%至约0.6%的量存在于口腔护理组合物中。另选地,口腔护理组合物可包含小于0.1%、小于0.01%、实质上不含、基本上不含或不含氟化物离子源。
金属
如本文所述的口腔护理组合物可以包含金属,所述金属可以由包含一种或多种金属离子的金属离子源提供。如本文所述,金属离子源可包含锡离子源和/或锌离子源或除锡离子源和/或锌离子源之外。合适的金属离子源包括具有金属离子的化合物,诸如但不限于Sn、Zn、Cu、Mn、Mg、Sr、Ti、Fe、Mo、B、Ba、Ce、Al、In和/或它们的混合物。金属离子源可为具有合适的金属和任何相伴配体和/或阴离子的任何化合物。
可与金属离子源配对的合适配体和/或阴离子包括但不限于乙酸根、硫酸铵、苯甲酸根、溴离子、硼酸根、碳酸根、氯离子、柠檬酸根、葡糖酸根、甘油磷酸根、氢氧根、碘离子、草酸根、氧化物、丙酸根、D-乳酸根、DL-乳酸根、正磷酸根、焦磷酸根、硫酸根、硝酸根、酒石酸根、和/或它们的混合物。
口腔护理组合物可以包含约0.01%至约10%、约1%至约5%、或约0.5%至约15%的金属和/或金属离子源。
锌
口腔护理组合物可以包含锌,其可以由锌离子源提供。锌离子源可包含一种或多种含锌化合物,诸如氟化锌、乳酸锌、氧化锌、磷酸锌、氯化锌、乙酸锌、六氟锆酸锌、硫酸锌、酒石酸锌、葡萄糖酸锌、柠檬酸锌、苹果酸锌、甘氨酸锌、焦磷酸锌、偏磷酸锌、草酸锌和/或碳酸锌。锌离子源可以是不含氟锌离子源,诸如磷酸锌、氧化锌和/或柠檬酸锌。
锌和/或锌离子源可以按洁牙剂组合物的重量计约0.01%至约10%、约0.2%至约1%、约0.5%至约1.5%、或约0.3%至约0.6%的量存在于总口腔护理组合物中。特别地,锌可能对再矿化过程有害。因此,口腔护理组合物可以基本上不含、实质上不含或不含锌。
pH
如本文所述的口腔护理组合物的pH可以是约4至约7.5、约4.5至约6.5、或约4.5至约5.5。如本文所述,口腔护理组合物的pH也可以是至少约6、至少约6.5、或至少约7。漱口水溶液的pH可被确定为纯溶液的pH。洁牙剂组合物的pH可被确定为浆料pH,其为洁牙剂组合物与水的混合物(诸如洁牙剂组合物与水的1:4、1:3或1:2混合物)的pH。如本文所述的口腔护理组合物的pH具有约4至约10、约5至约9、约6至约8、或约7的优选pH。
口腔护理组合物可包含一种或多种缓冲剂。如本文所用,缓冲剂是指可用于调节口腔护理组合物的浆液pH的试剂。这些缓冲剂包括碱金属氢氧化物、碳酸盐、倍半碳酸盐、硼酸盐、硅酸盐、磷酸盐、咪唑以及它们的混合物。具体的缓冲剂包括磷酸一钠、磷酸三钠、氢氧化钠、氢氧化钾、碱金属碳酸盐、碳酸钠、咪唑、焦磷酸盐、柠檬酸和柠檬酸钠。口腔护理组合物可包含一种或多种缓冲剂,每种缓冲剂的含量为按本发明组合物的重量计约0.1%至约30%、约1%至约10%或约1.5%至约3%。
表面活性剂
口腔护理组合物可包含一种或多种表面活性剂。表面活性剂可用于使组合物在美容上更可接受。表面活性剂优选地为赋予组合物去污和发泡性质的去污材料。合适的表面活性剂是安全有效量的阴离子、阳离子、非离子、两性离子、两性甜菜碱表面活性剂,诸如:月桂基硫酸钠、月桂基羟乙基磺酸钠、月桂酰甲基羟乙基磺酸钠、椰油基谷氨酸钠、十二烷基苯磺酸钠、月桂酰肌氨酸、肉豆寇酰肌氨酸、棕榈酰肌氨酸、硬脂酰肌氨酸和油酰肌氨酸的碱金属盐或铵盐、聚氧乙烯山梨醇单硬脂酸酯、异硬脂酸酯和月桂酸酯、月桂基磺基乙酸钠、N-月桂酰肌氨酸、N-月桂酰基、N-肉豆蔻酰基或N-棕榈酰基肌氨酸的钠盐、钾盐和乙醇胺盐,烷基酚的聚环氧乙烷缩合物、椰油酰氨基丙基甜菜碱、月桂酰氨基丙基甜菜碱、棕榈基甜菜碱、椰油基谷氨酸钠等。月桂基硫酸钠是优选的表面活性剂。口腔护理组合物可包含一种或多种表面活性剂,每种表面活性剂的含量为按口腔护理组合物的重量计约0.01%至约15%、约0.3%至约10%或约0.3%至约2.5%。
增稠剂
口腔护理组合物可包含一种或多种增稠剂。增稠剂可用于口腔护理组合物中以提供凝胶状结构使牙膏稳定防止相分离。合适的增稠剂包括多糖、聚合物和/或二氧化硅增稠剂。多糖的一些非限制性示例包括淀粉;淀粉甘油;树胶,诸如卡拉牙树胶(刺梧桐树胶)、黄蓍胶、阿拉伯胶、茄替胶、阿拉伯树胶、黄原胶、瓜尔胶和纤维素胶;硅酸镁铝(胶体硅酸镁铝);角叉菜胶;藻酸钠;琼脂;果胶;明胶;纤维素化合物,诸如纤维素、羧甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟甲基纤维素、羟甲基羧丙基纤维素、甲基纤维素、乙基纤维素和硫酸化纤维素;天然和合成粘土,例如锂蒙脱石粘土;以及它们的混合物。
增稠剂可包括多糖。适用于本文的多糖包括角叉菜胶、结冷胶、刺槐豆胶、黄原胶、卡波姆、泊洛沙姆、改性纤维素、以及它们的混合物。角叉菜胶是衍生自海藻的多糖。存在几种类型的角叉菜胶,这些角叉菜胶可通过它们的海藻源和/或通过它们的硫酸化程度和位置来区分。增稠剂可包括κ角叉菜胶、改性的κ角叉菜胶、ι角叉菜胶、改性的ι角叉菜胶、λ角叉菜胶、以及它们的混合物。适用于本文的角叉菜胶包括可以系列名称“Viscarin”从FMC公司(FMC Company)商购获得的那些,包括但不限于Viscarin TP 329、Viscarin TP 388和Viscarin TP 389。
增稠剂可包含一种或多种聚合物。聚合物可为聚乙二醇(PEG)、聚乙烯吡咯烷酮(PVP)、聚丙烯酸、来源于至少一种丙烯酸单体的聚合物、马来酸酐和甲基乙烯基醚的共聚物、交联的聚丙烯酸聚合物,其具有占口腔护理组合物的各种重量百分比以及各种范围的平均分子范围。聚合物可以包括聚丙烯酸酯交联聚合物,诸如聚丙烯酸酯交联聚合物-6。聚丙烯酸酯交联聚合物-6的合适来源可以包括可从Seppic商购获得的Sepimax ZenTM。
增稠剂可包括无机增稠剂。合适的无机增稠剂的一些非限制性示例包括胶态硅酸镁铝、二氧化硅增稠剂。可用二氧化硅增稠剂的非限制性示例包括例如无定形沉淀二氧化硅,诸如165二氧化硅。其他非限制性二氧化硅增稠剂包括/>153、163和167以及/>177和265二氧化硅产品(均购自赢创公司(EvonikCorporation)),以及/>热解法二氧化硅。
口腔护理组合物可包含0.01%至约15%、0.1%至约10%、约0.2%至约5%或约0.5%至约2%的一种或多种增稠剂。
磨料
本发明的口腔护理组合物可包含研磨剂。可将磨料添加到口腔护理制剂中,以有助于去除牙齿上的表面污渍。优选地,磨料为钙磨料或二氧化硅磨料。
钙磨料可为任何合适的磨料化合物,当将口腔护理组合物施用到口腔中时,该磨料化合物可在口腔护理组合物中提供钙离子和/或将钙离子递送到口腔中。口腔护理组合物可包含约5%至约70%、约10%至约60%、约20%至约50%、约25%至约40%或约1%至约50%的钙磨料。钙磨料可包含一种或多种钙磨料化合物,诸如碳酸钙、沉淀碳酸钙(PCC)、研磨碳酸钙(GCC)、白垩、磷酸二钙、焦磷酸钙和/或它们的混合物。
口腔护理组合物还可包含二氧化硅磨料,诸如硅胶(自身或任何结构)、沉淀二氧化硅、无定形沉淀二氧化硅(自身或任何结构)、二氧化硅水合物和/或它们的组合。口腔护理组合物可包含约5%至约70%、约10%至约60%、约10%至约50%、约20%至约50%、约25%至约40%或约1%至约50%的二氧化硅磨料。
口腔护理组合物还可包含另一种磨料,诸如膨润土、珍珠岩、二氧化钛、氧化铝、氧化铝水合物、煅烧氧化铝、硅酸铝、不溶性偏磷酸钠、不溶性偏磷酸钾、不溶性碳酸镁、硅酸锆、颗粒状热固性树脂以及其他合适的研磨材料。口腔护理组合物可包含约5%至约70%、约10%至约60%、约10%至约50%、约20%至约50%、约25%至约40%或约1%至约50%的另一种磨料。
氨基酸
口腔护理组合物可包含氨基酸。单齿和/或多齿配体可以包括氨基酸。氨基酸是单齿配体还是多齿配体可以基于存在多少能够螯合锡、与锡缔合和/或与锡键合的官能团和/或口腔护理组合物的pH。如本文所述,氨基酸可以包括一个或多个氨基酸、肽和/或多肽。
如式II所示,氨基酸是含有胺官能团、羧基官能团和每个氨基酸特有的侧链(式II中的R)的有机化合物。合适的氨基酸包括例如具有正或负侧链的氨基酸、具有酸性或碱性侧链的氨基酸、具有极性不带电荷侧链的氨基酸、具有疏水侧链的氨基酸和/或它们的组合。合适的氨基酸还包括例如精氨酸、组氨酸、赖氨酸、天冬氨酸、谷氨酸、丝氨酸、苏氨酸、天冬酰胺、谷氨酰胺、半胱氨酸、硒代半胱氨酸、甘氨酸、脯氨酸、丙氨酸、缬氨酸、异亮氨酸、亮氨酸、甲硫氨酸、苯丙氨酸、酪氨酸、色氨酸、瓜氨酸、鸟氨酸、肌酸、二氨基丁酸、二氨基丙酸、它们的盐和/或它们的组合。
合适的氨基酸包括由式III、天然存在的或合成衍生的化合物。基于R基团和环境,氨基酸可以是两性离子、中性的、带正电的或带负电的。氨基酸的电荷以及特定官能团是否可以在特定pH条件下与锡相互作用,这是本领域普通技术人员众所周知的。
式III.氨基酸。R是任何合适的官能团
合适的氨基酸包括一种或多种碱性氨基酸、一种或多种酸性氨基酸、一种或多种中性氨基酸或它们的组合。
口腔护理组合物可包含按口腔护理组合物的重量计约0.01%至约20%、约0.1%至约10%、约0.5%至约6%或约1%至约10%的氨基酸。
如本文所用,术语“中性氨基酸”不仅包括天然存在的中性氨基酸,诸如丙氨酸、天冬酰胺、半胱氨酸、谷氨酰胺、甘氨酸、异亮氨酸、亮氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、苏氨酸、色氨酸、酪氨酸、缬氨酸,还包括等电点在pH 5.0至7.0范围内的生物学上可接受的氨基酸。生物学优选的可接受的中性氨基酸在分子或其功能衍生物中具有单个氨基基团和羧基基团,诸如具有改变的侧链的功能衍生物,尽管具有相似或基本上相似的物理化学特性。在另一个实施方案中,中性氨基酸将至少是部分水溶性的,并且在25℃下1g/1000ml的水性溶液中提供小于7的pH。
因此,适用于本发明的中性氨基酸包括但不限于丙氨酸、氨基丁酸、天冬酰胺、半胱氨酸、胱氨酸、谷氨酰胺、甘氨酸、羟脯氨酸、异亮氨酸、亮氨酸、甲硫氨酸、苯丙氨酸、脯氨酸、丝氨酸、牛磺酸、苏氨酸、色氨酸、酪氨酸、缬氨酸、它们的盐、或它们的混合物。优选地,用于本发明的组合物中的中性氨基酸可包括天冬酰胺、谷氨酰胺、甘氨酸、它们的盐、或它们的混合物。中性氨基酸在25℃下的水性溶液中可具有如下等电点:5.0、或5.1、或5.2、或5.3、或5.4、或5.5、或5.6、或5.7、或5.8、或5.9、或6.0、或6.1、或6.2、或6.3、或6.4、或6.5、或6.6、或6.7、或6.8、或6.9、或7.0。优选地,中性氨基酸选自脯氨酸、谷氨酰胺或甘氨酸,更优选地为其游离形式(即,未配合的)。如果中性氨基酸为其盐形式,则合适的盐包括本领域已知的药学上可接受的盐,该盐在所提供的量和浓度下被认为是生理上可接受的。
美白剂
口腔护理组合物可包含按口腔护理组合物的重量计约0.1%至约10%、约0.2%至约5%、约1%至约5%、或约1%至约15%的美白剂。美白剂可为适于美白口腔中的至少一颗牙齿的化合物。美白剂可以包括过氧化物、金属亚氯酸盐、过硼酸盐、过碳酸盐、过氧酸、过硫酸盐、二羧酸以及它们的组合。合适的过氧化物包括固体过氧化物、过氧化氢、过氧化脲、过氧化钙、过氧化苯甲酰、过氧化钠、过氧化钡、无机过氧化物、氢过氧化物、有机过氧化物、以及它们的混合物。适宜的金属亚氯酸盐包括亚氯酸钙、亚氯酸钡、亚氯酸镁、亚氯酸锂、亚氯酸钠和亚氯酸钾。其他合适的美白剂包括过硫酸钠、过硫酸钾、Peroxydone复合物(聚乙烯吡咯烷酮和过氧化氢)、6-苯二甲酰亚氨基过氧己酸、邻苯二甲酰亚胺过氧己酸、或者它们的混合物。
湿润剂
口腔护理组合物可以包含一种或多种湿润剂,具有低含量的湿润剂,或不含湿润剂。湿润剂用于增加口腔护理组合物或洁牙剂的稠度或“口感”以及防止洁牙剂变干。合适的湿润剂包括聚乙二醇(具有多种不同的分子量)、丙二醇、甘油(glycerin、glycerol)、赤藓醇、木糖醇、山梨醇、甘露糖醇、丁二醇、乳糖醇、氢化淀粉水解物和/或它们的混合物。口腔护理组合物可包含一种或多种湿润剂,每种湿润剂的含量为按该口腔护理组合物的重量计0%至约70%、约5%至约50%、约10%至约60%或约20%至约80%。
水
本发明的口腔护理组合物可为无水洁牙剂组合物、低水制剂或高水制剂。总体而言,口腔护理组合物可包含按组合物的重量计0%至约99%、约20%或更多、约30%或更多、约50%或更多、至多约45%或至多约75%的水。优选地,水为USP水。
在高水洁牙剂制剂中,洁牙剂组合物包含按组合物的重量计约45%至约75%的水。高水洁牙剂组合物可包含按组合物的重量计约45%至约65%、约45%至约55%或约46%至约54%的水。可将水添加到高水洁牙剂制剂中,并且/或者水可因包含其他成分而进入组合物中。
在低水洁牙剂制剂中,洁牙剂组合物包含按组合物的重量计约10%至约45%的水。低水洁牙剂组合物可包含按组合物的重量计约10%至约35%、约15%至约25%或约20%至约25%的水。可将水添加到低水洁牙剂制剂中,并且/或者水可因包含其他成分而进入组合物中。
在无水洁牙剂制剂中,洁牙剂组合物包含按组合物的重量计小于约10%的水。无水洁牙剂组合物包含按组合物的重量计小于约5%、小于约1%或0%的水。可将水添加到无水制剂中,并且/或者水可因包含其他成分而进入洁牙剂组合物中。
洁牙剂组合物还可包含其他口腔可接受载体材料,诸如醇、湿润剂、聚合物、表面活性剂和接受改善剂(诸如调味剂、甜味剂、着色剂和/或凉爽剂)。
口腔护理组合物还可为漱口水制剂。漱口液制剂可包含约75%至约99%、约75%至约95%或约80%至约95%的水。
其他成分
口腔护理组合物可包含多种其他成分,诸如调味剂、甜味剂、着色剂、防腐剂、缓冲剂或适用于口腔护理组合物中的其他成分,如下所述。
还可将调味剂添加到口腔护理组合物中。合适的调味剂包括冬青油、胡椒薄荷油、留兰香油、丁香芽油、薄荷醇、对丙烯基茴香醚、水杨酸甲酯、桉油精、肉桂、乙酸1-薄荷酯、鼠尾草、丁子香酚、欧芹油、羟苯基丁酮、α-紫罗兰酮、甘牛至草、柠檬、橙、丙烯基乙基愈创木酚、桂皮、香兰素、乙基香兰素、天芥菜精、4-顺式-庚烯醛、丁二酮、对叔丁基苯乙酸甲酯、以及它们的混合物。冷却剂也可以是调味剂体系的一部分。本发明组合物中优选的冷却剂是对孟烷氨基甲酰试剂,诸如N-乙基-对孟烷-3-甲酰胺(商业上称为“WS-3”)或N-(乙氧羰基甲基)-3-对薄荷烷甲酰胺(商业上称为“WS-5”)以及它们的混合物。调味剂体系通常以按口腔护理组合物的重量计约0.001%至约5%的含量用于组合物中。这些调味剂通常包含醛、酮、酯、酚、酸以及脂族、芳族和其他醇的混合物。
可将甜味剂添加到口腔护理组合物中以赋予产品令人愉悦的味道。合适的甜味剂包括糖精(如糖精钠、糖精钾或糖精钙)、环磺酸盐(如钠盐、钾盐或钙盐)、安赛蜜-K、非洲甜果素、新橙皮苷二氢查耳酮、氨化甘草素、右旋糖、左旋糖、蔗糖、甘露糖、三氯蔗糖、甜菊糖和葡萄糖。
添加着色剂以改善产品的美学外观。合适的着色剂包括但不限于由相应监管机构诸如FDA批准的那些着色剂和欧洲食品和药品指令中列出的那些着色剂,并且包括色素诸如TiO2,以及颜色诸如FD&C和D&C染料。
还可将防腐剂添加到口腔护理组合物中以防止细菌生长。可以安全有效量添加被批准用于口腔组合物中的合适防腐剂,诸如对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、苯甲酸和苯甲酸钠。
二氧化钛也可添加到本发明的组合物中。二氧化钛是能给组合物增加不透明度的白色粉末。二氧化钛通常占按口腔护理组合物的重量计约0.25%至约5%。
口腔护理组合物中可使用其他成分,诸如脱敏剂、康复剂、其他防龋剂、螯合剂/多价螯合剂、维生素、氨基酸、蛋白质、其他抗牙斑/抗牙结石剂、遮光剂、抗生素、抗酶、酶、pH控制剂、氧化剂、抗氧化剂等。
口腔护理组合物形式
用于递送锡、单齿配体和/或多齿配体的合适组合物包括乳液组合物如美国专利申请公开2018/0133121(该专利申请公开以引用的方式整体并入本文)的乳液组合物、单位剂量组合物如美国专利申请公开2019/0343732(该专利申请公开以引用的方式整体并入本文)的单位剂量组合物、免洗型口腔护理组合物、堵塞乳液、洁牙剂组合物、口腔冲洗组合物、漱口水组合物、牙胶、龈下凝胶、漱口水、摩丝、泡沫、口腔喷雾剂、锭剂、咀嚼片剂、口香糖、牙齿美白条、牙线和牙线涂层、口气清新可溶解条、义齿护理产品、义齿粘合剂产品或它们的组合。
方法
如本文所述,口腔护理组合物当施用于口腔时可以产生口腔健康益处,诸如牙齿的再矿化。例如,使用者可以将至少一英寸的如本文所述的合适的口腔护理组合物条分配到口腔护理器具如牙刷、涂敷器和/或牙托上,并施用到口腔和/或牙齿。
可以指示使用者每天至少一次、至少两次或至少三次彻底刷牙至少30秒、至少一分钟、至少90秒或至少两分钟。还可以指示使用者在刷牙过程完成后吐出口腔护理组合物。还可以指示使用者在完成刷牙程序后用包含治疗量的氟化物的漱口水组合物和/或包含治疗量的氟化物的口腔冲洗组合物进行冲洗。除了包含治疗量的氟化物的组合物之外,还可以指示使用者不用任何液体(包括自来水或瓶装水)冲洗。由于口腔护理组合物的施用可能导致口腔健康益处,诸如牙齿的再矿化,在施用和口腔护理组合物的吐出之后冲洗口腔可以从牙齿表面去除残留的氟化物,从而至少部分地减少口腔健康益处。
在口腔中使用口腔护理组合物(诸如将口腔护理组合物施用于牙齿)可以产生的其他口腔健康益处包括增加牙齿的密度,防止牙齿的钙损失,修复牙釉质的结构弱点,延长使用者牙齿的寿命,增加牙釉质的结构密度,用重建矿物质涂覆牙釉质,和/或牙齿的再矿化。
本文公开了用于增加牙齿密度、预防牙齿的钙损失、修复牙釉质的结构弱点、延长使用者牙齿的寿命、增加牙釉质的结构密度、用重建矿物质涂覆牙釉质和/或牙齿再矿化的方法,所述方法包括指示使用者每天两次施用如本文所述的口腔护理组合物至少1分钟。该方法还可以包括指示使用者吐出口腔护理组合物并且不冲洗口腔或仅用包含治疗量的氟化物的组合物冲洗口腔。
实施例
以下实施例进一步说明了本发明,这些实施例不应以任何方式被理解为对本发明的范围施加限制。在阅读本文的说明书之后,在不脱离本发明的精神或所附权利要求书的范围的下,可向本领域的普通技术人员提出它们自己的各种其他方面、修改和其等同形式。
人体内色斑
本研究的目的是评价两种含有氟化亚锡的实验洁齿剂相对于两种参考配方的色斑聚积潜力。此处呈现的结果来自随机、平行组、双盲、单中心研究,其中四个治疗组由健康成人志愿者组成。进一步优选的是,志愿者在其基线访视时存在聚积的天然色斑,并且每天饮用至少一杯咖啡,更优选每天两杯咖啡。在基线访视时,受试者根据Lobene等人(JADA,77:849-855,1968)发表的方法接受口腔检查和Lobene色斑检查,随后对十二颗前牙进行预防性清洁。然后将受试者随机分配到四种洁牙剂治疗中的一种。然后给予受试者研究试剂盒,包括软手动牙刷(Oral-B Indicator,Soft,Procter&Gamble,OH,USA)、适当的牙膏、定时器和书面说明。在整个研究的5周持续时间期间,对要求刷牙一分钟、每天两次(早晨和晚上)的受试者口头审查说明书。在基线、第2周和第5周评估安全性和功效测量。
第5周的Lobene复合色斑、色斑面积和色斑强度评分是主要关注的;第2周结果是次要关注的。使用协方差分析(ANCOVA)分析每对治疗组。ANCOVA模型包括作为因子的治疗和作为协变量的基线色斑评分。在统计学上显著违反参数分析的正态性或等方差假设的情况下,使用数据转换和/或非参数方法。统计学比较为双侧,显著性水平为0.05。
相对牙本质磨蚀(RDA)
通常进行相对牙质磨耗(RDA)测试以确认洁牙剂组合物例如牙膏对于消费者使用是安全的,其中测试的推荐上限设定为250。表2和表3中的RDA值通过使用FDIS-ISO 11609,Annexure,第三版Annex B:Determination ofrelative dentifrice abrasivity toenamel and dentine by a surface profile method中所概述的工业公布的标准进行确定,所述文献以引用方式并入本文。
表1.口腔护理组合物
实施例1 | 实施例2 | 实施例3 | |
甘油 | 27.013 | 27.013 | |
山梨醇 | 34.900 | 34.900 | 48.0000 |
水 | 8.186 | 8.186 | 20.8311 |
氟化亚锡 | 0.454 | 0.454 | 0.4540 |
氯化亚锡(10%二氧化硅) | 0.4400 | 0.4400 | 0.5619 |
柠檬酸锌 | - | - | 0.5330 |
葡萄糖酸钠 | 1.020 | 1.020 | 1.3000 |
柠檬酸钠 | 1.220 | 1.220 | - |
二氧化硅Z109 | - | 7.500 | 17.5000 |
二氧化硅Z119 | 15.000 | 7.500 | - |
角叉菜胶 | 1.050 | 1.050 | 1.5000 |
黄原胶 | 0.6125 | 0.6125 | 0.8750 |
月桂基硫酸钠28%溶液 | 5.625 | 5.625 | 5.0000 |
甜菜碱(30%溶液) | 1.500 | 1.500 | |
调味剂 | 1.100 | 1.100 | 1.1750 |
NaOH50% | 0.720 | 0.720 | 0.8700 |
糖精 | 0.500 | 0.500 | 0.4000 |
三氯蔗糖液体 | 0.160 | 0.160 | 0.2000 |
二氧化钛 | 0.500 | 0.500 | 0.5000 |
染料 | - | - | 0.3000 |
表2.第2周的色斑和RDA
表3.第3周的色斑和RDA
表1示出实施例1至实施例3。实施例1和实施例2是具有合适的锡与单齿配体与多齿配体的摩尔比,诸如大于1:0:5:0.5的本发明实施例,如本文所述。实施例3是锡与单齿配体与多齿配体的摩尔比低于1:0:5:0.5的比较例。
将实施例1-实施例3与Gum Care(CGC)、已知引起牙齿变色的氟化亚锡基牙膏(即阳性对照)进行比较。CGC的锡与单齿配体与多齿配体的摩尔比为1:1:0。使用CGC(RDA为110)2周导致平均色斑面积为0.414,平均色斑强度为0.485。5周后,CGC(RDA为100)的平均变色面积为0.798,并且平均变色强度为0.918。
相比之下,实施例3,具有183的高得多RDA的组合物在2周后具有0.252的平均色斑面积和0.262的平均色斑强度,并且在5周后具有0.332的平均色斑面积和0.326的平均色斑强度。虽然改善了该色斑面积和色斑强度,但它需要高得多的RDA。长期使用具有高RDA值(诸如>200)的牙膏可以导致牙釉质和牙齿损失。因此,期望口腔护理组合物具有CGC的RDA值,但具有实施例3的变色潜力。
如表2和表3所示,实施例1和实施例2提供了优于实施例3的变色性能,具有出乎意料的低RDA值。实施例1(RDA为98)在2周后具有0.244的平均色斑面积和0.237的平均色斑强度,并且在五周后具有0.319的平均色斑面积和0.288的平均色斑强度。实施例1出乎意料地优于实施例3,但具有低得多的RDA值。
实施例2(RDA为143)在2周后具有0.354的平均色斑面积和0.372的平均色斑强度,并且在五周后具有0.313的平均色斑面积和0.334的平均色斑强度。实施例2出乎意料地类似于实施例3进行,但具有低得多的RDA值。
虽然不希望受理论束缚,但据信这种优异的变色性能在较低的RDA值处是可行的,因为锡离子被适当地螯合,从而使可溶性锡离子的量最大化而不有助于变色。
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他方式限制,否则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他变化和修改。因此,本文旨在于所附权利要求书中涵盖属于本发明范围内的所有此类变化和修改。
Claims (23)
1.一种洁牙剂组合物,所述洁牙剂组合物包含:
(a)锡;
(b)磨料;
(c)单齿配体,其中所述单齿配体包括包含能够螯合锡的单个官能团的化合物;
(d)多齿配体,其中所述多齿配体包括包含至少两个能够螯合锡的官能团的化合物;和
(e)至少6的pH,
其中所述洁牙剂组合物的RDA值小于150,且
其中所述洁牙剂组合物具有1:1:1至1:2.5:2.5的锡与单齿配体与多齿配体摩尔比。
2.根据权利要求1所述的洁牙剂组合物,其中所述锡包括氟化亚锡、氯化亚锡或它们的组合。
3.根据权利要求1所述的洁牙剂组合物,其中所述磨料包括二氧化硅磨料、钙磨料或它们的组合。
4.根据权利要求1所述的洁牙剂组合物,其中所述洁牙剂组合物的RDA值小于125。
5.根据权利要求1所述的洁牙剂组合物,其中所述洁牙剂组合物包含按所述组合物的重量计至多0.05%的锌。
6.根据权利要求1所述的洁牙剂组合物,其中所述洁牙剂组合物包含按所述组合物的重量计至多0.01%的锌。
7.根据权利要求1所述的洁牙剂组合物,其中所述洁牙剂组合物不含锌。
8.根据权利要求1至7中任一项所述的洁牙剂组合物,其中所述洁牙剂组合物包含氟化物。
9.根据权利要求8所述的洁牙剂组合物,其中所述氟化物包括氟化亚锡、氟化钠、单氟磷酸钠、氟化胺或它们的组合。
10.根据权利要求1至7中任一项所述的洁牙剂组合物,其中所述洁牙剂组合物不包含添加的水或者包含水。
11.根据权利要求10所述的洁牙剂组合物,其中所述洁牙剂组合物包含按所述组合物的重量计至多45%的水。
12.根据权利要求1至7中任一项所述的洁牙剂组合物,其中所述单齿配体包括羧酸或其盐。
13.根据权利要求12所述的洁牙剂组合物,其中所述羧酸包括脂族羧酸、芳族羧酸、糖酸、它们的盐或它们的组合。
14.根据权利要求13所述的洁牙剂组合物,其中所述糖酸包括醛糖酸、乌索酸、糖醛酸、醛糖二酸、葡萄糖酸、它们的盐或它们的组合。
15.根据权利要求13所述的洁牙剂组合物,其中所述脂族羧酸包括直链饱和羧酸、直链不饱和羧酸、α羟基酸、β羟基酸、γ羟基酸、氨基酸、它们的盐或它们的组合。
16.根据权利要求15所述的洁牙剂组合物,其中所述氨基酸包括甘氨酸、丙氨酸、缬氨酸、异亮氨酸、色氨酸、苯丙氨酸、脯氨酸、甲硫氨酸、亮氨酸、丝氨酸、苏氨酸、酪氨酸、天冬酰胺、谷氨酰胺、半胱氨酸、瓜氨酸、天冬氨酸、谷氨酸、赖氨酸、精氨酸、组氨酸或它们的组合。
17.根据权利要求15所述的洁牙剂组合物,其中所述α羟基酸包括乳酸。
18.根据权利要求1至7中任一项所述的洁牙剂组合物,其中所述多齿配体包括羧酸、多磷酸盐、它们的盐或它们的组合。
19.根据权利要求18所述的洁牙剂组合物,其中所述羧酸包括二羧酸、三羧酸、它们的盐或它们的组合。
20.根据权利要求19所述的洁牙剂组合物,其中所述二羧酸包括具有式HO2C-R-CO2H的化合物,其中R为脂族、芳族或它们的组合。
21.根据权利要求19所述的洁牙剂组合物,其中所述二羧酸包括草酸、丙二酸、琥珀酸、戊二酸、己二酸、庚二酸、辛二酸、壬二酸、癸二酸、十一烷二酸、十二烷二酸、十三烷二酸、十六烷二酸、日本蜡酸、软木原酸、木贼二酸、它们的盐或它们的组合。
22.根据权利要求19所述的洁牙剂组合物,其中所述三羧酸包括柠檬酸、异柠檬酸、乌头酸、丙烷-1,2,3-三羧酸、苯均三酸、它们的盐或它们的组合。
23.根据权利要求18所述的洁牙剂组合物,其中所述多磷酸盐包括焦磷酸盐、三聚磷酸盐、四聚磷酸盐、六偏磷酸盐或它们的组合。
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US6350436B1 (en) * | 1996-11-21 | 2002-02-26 | The Procter & Gamble Company | Method of reducing staining of stannous in dentifrice compositions |
US6685920B2 (en) * | 1999-11-12 | 2004-02-03 | The Procter & Gamble Company | Method of protecting teeth against erosion |
ES2606342T3 (es) * | 2005-11-23 | 2017-03-23 | Colgate-Palmolive Company | Composiciones para el cuidado bucal de sal estannosa y tripoli-fosfato de sodio y métodos |
EP1962787A2 (en) * | 2005-12-20 | 2008-09-03 | The Procter and Gamble Company | Oral care compositions comprising zinc and phytate |
US8007771B2 (en) * | 2006-07-07 | 2011-08-30 | The Procter & Gamble Company | Flavors for oral compositions |
EP2281543A1 (en) * | 2009-07-27 | 2011-02-09 | The Procter & Gamble Company | Oral care compositions which comprise stannous and potassium salts |
CN109890465A (zh) | 2016-10-26 | 2019-06-14 | 宝洁公司 | 牙齿美白 |
CN111936114B (zh) * | 2018-03-29 | 2023-11-17 | 宝洁公司 | 用于促进牙龈健康的口腔护理组合物 |
AU2018415261B2 (en) * | 2018-03-29 | 2021-11-04 | The Procter & Gamble Company | Oral care compositions for promoting gum health |
WO2019222126A1 (en) | 2018-05-14 | 2019-11-21 | The Procter & Gamble Company | Oral care compositions comprising metal ions |
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JP2023523308A (ja) | 2023-06-02 |
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WO2021226158A1 (en) | 2021-11-11 |
MX2022013041A (es) | 2022-11-09 |
AU2021268653A1 (en) | 2022-11-10 |
CA3181915A1 (en) | 2021-11-11 |
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