CN107648070A - 水性口腔护理组合物 - Google Patents
水性口腔护理组合物 Download PDFInfo
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- CN107648070A CN107648070A CN201710963346.5A CN201710963346A CN107648070A CN 107648070 A CN107648070 A CN 107648070A CN 201710963346 A CN201710963346 A CN 201710963346A CN 107648070 A CN107648070 A CN 107648070A
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Abstract
本文描述包含以下的水性口腔护理组合物及制备和使用所述水性口腔护理组合物的方法：(a)有效量的游离或口腔可接受的盐形式的碱性氨基酸，和(b)聚合物系统，所述聚合物系统包含(i)纤维素聚合物、(ii)树胶聚合物和(iii)聚丙烯酸酯聚合物或共聚物。
Description
本申请是申请日为2011年12月15日、申请号为201180075496.3、发明名称为“水性口腔护理组合物”的中国专利申请的分案申请。
技术领域
本申请涉及水性口腔护理组合物。
背景技术
常规的漱口水产品可含有抗菌剂和/或氟化物，但是它们通常不预防或修复酸槽，或者增强活性剂的传递和保留。有效保护免于对牙齿表面的这种酸侵蚀，理想地应提供针对酸侵蚀的物理屏障，以及增强可中和酸和/或强化牙釉质的活性剂的传递和保留。
发明内容
在一些实施方案中，本发明提供水性口腔护理组合物，所述组合物包含有效量的游离或口腔可接受的盐形式的碱性氨基酸，以及聚合物系统，所述聚合物系统包含(i)纤维素聚合物，(ii)树胶聚合物，和(iii)聚丙烯酸酯聚合物或共聚物，例如，其中漱口水呈现：(i)可测量程度的粘弹性，弹性与粘性组分的比率G′/G″大于0.5；和(ii)剪切稀化特性，流速指数n小于0.85。在一些实施方案中，组合物为粘弹性漱口水。在一些实施方案中，漱口水任选地进一步包含有效量的氟源(fluoride source)。
制剂的高粘弹性(G′/G″＞0.5)有助于在牙齿表面形成聚合物膜，和活性物质比如氟化物、精氨酸或缓冲剂在牙釉质表面的保留更多。剪切稀化性质(n＜0.85)进一步把漱口水表征为粘弹性的和非牛顿的(non-Newtonian)，并且助于驱动漱口水的消费者可接受性。
如经以下实施例证实的那样，本发明的组合物提供改善的耐牙釉质侵蚀。不受理论的束缚，据信以溶液中的聚合物足以明显叠盖并形成网络的浓度使用粘膜粘附性聚合物，导致在使用时聚合物膜在口腔的硬和软组织上沉积。这种聚合物膜用作抗腐蚀性酸的物理屏障，以及增强氟和/或碱性氨基酸比如精氨酸在牙釉质表面的传递和保留的载体，因此提供抗酸诱导的侵蚀和去矿化作用的优良的牙釉质保护。此外，据信增强碱性氨基酸例如精氨酸的摄取，因为碱性氨基酸比如精氨酸荷正电。在主要荷负电的聚合物网络存在下，电荷和电荷相互作用增强碱性氨基酸向口腔表面的沉积。
本发明其它的适用性领域自下文提供的详述将变得显而易见。应该理解，详述和具体实例，尽管表明本发明的优选实施方案，旨在仅用于说明的目的，并且不旨在限制本发明的范围。
具体实施方式
以下优选实施方案的描述本质上仅为示例性的，并且决不旨在限制本发明、其应用或用途。
本发明的一些实施方案提供水性口腔护理组合物，所述组合物包含有效量的游离或口腔可接受的盐形式的碱性氨基酸，以及聚合物系统，所述聚合物系统包含(i)纤维素聚合物、(ii)树胶聚合物和(iii)聚丙烯酸酯聚合物或共聚物，其中组合物具有小于0.85的流速指数。
一些实施方案进一步包含氟源，其中氟源。在一些实施方案中，氟源以有效提供约90-约500ppm氟的量存在。在其它的实施方案中，氟源以有效提供约225ppm氟的量存在。
在一些实施方案中，氟源选自氟化亚锡、氟化钠、氟化钾、单氟磷酸钠、氟硅酸钠、氟硅酸铵、氟化胺(例如N’-十八烷基三亚甲基二胺-N，N，N’-三(2-乙醇)-二氢氟酸盐)、氟化铵、氟化钛、六氟硫酸盐及其两种或更多种的组合。
在一些实施方案中，氟源选自氟化钠、单氟磷酸钠及其组合。在其它的实施方案中，氟源包含氟化钠。
在一些实施方案中，碱性氨基酸包含游离或口腔可接受的盐形式的L-精氨酸。在一些实施方案中，碱性氨基酸选自精氨酸游离碱、精氨酸盐酸盐、磷酸精氨酸、精氨酸碳酸氢盐及其组合。在一些实施方案中，游离或口腔可接受的盐形式的碱性氨基酸的有效量按制剂的重量计占0.05-2％(当为口腔可接受的盐形式时，作为游离碱当量的重量测量)。
一些实施方案进一步包含缓冲剂。在一些实施方案中，缓冲剂为磷酸钠缓冲剂(例如磷酸二氢钠和磷酸氢二钠)。
其它的实施方案进一步包含例如选自以下的湿润剂：甘油、山梨醇、丙二醇及其两种或更多种的组合。
仍然其它的实施方案进一步包含抗菌剂，例如三氯生或氯化十六烷基吡啶。
前述权利要求中的任一项的组合物，其中所述纤维素聚合物选自羟烷基甲基纤维素、羧烷基甲基纤维素、羟烷基纤维素、烷基纤维素、羧烷基纤维素及其两种或更多种的组合。
一些实施方案提供水性口腔护理组合物，所述组合物包含：按重量计约0.5％-约2％的游离或口腔可接受的盐形式的碱性氨基酸；聚合物系统，所述聚合物系统包含(i)纤维素聚合物、(ii)树胶聚合物和(iii)聚丙烯酸酯聚合物或共聚物；和按重量计约0.01-约0.5％的氟源；
其中组合物具有小于0.85的流速指数；和其中当使用Hooper方案评估时，组合物递送有效提供小于0.25微米的阶梯高度(step height)差的一定量的氟。
在一些实施方案中，氟源以按组合物的重量计约0.02％-约0.2％的量存在。在一些实施方案中，氟源以按组合物的重量计约0.03％-约0.08％的量存在。其它实施方案提供其中氟源以按组合物的重量计约0.05％的量存在的组合物。在一些实施方案中，氟源以按组合物的重量计0.5％的量存在。
本发明的一些实施方案提供一种减少牙釉质侵蚀的方法，所述方法包括给予有需要的受试者的口腔本文描述的任何一种组合物。在一些实施方案中，给予包括漱洗(rinsing)约15-约60秒。在一些实施方案中，给予包括漱洗约30秒。
本发明的一些实施方案因此提供粘弹性漱口水(漱口水1)，所述漱口水包含(a)有效量的游离或口腔可接受的盐形式的碱性氨基酸，和(b)聚合物系统，所述聚合物系统包含(i)纤维素聚合物、(ii)树胶聚合物和(iii)聚丙烯酸酯聚合物或共聚物。
在一些实施方案中，纤维素聚合物选自羟烷基甲基纤维素(比如羟丙基甲基纤维素、羟丁基甲基纤维素、羟乙基甲基纤维素、羟甲基甲基纤维素和羟乙基丙基甲基纤维素)、羧烷基甲基纤维素(比如羧丙基甲基纤维素、羧丁基甲基纤维素、羧乙基甲基纤维素、羧甲基甲基纤维素和羧乙基丙基甲基纤维素)、羟烷基纤维素(比如羟丙基纤维素、羟丁基纤维素、羟乙基纤维素、羟甲基纤维素和羟乙基丙基纤维素)、烷基纤维素(比如丙基纤维素、丁基纤维素、乙基纤维素、甲基纤维素)、羧烷基纤维素(比如羧丙基纤维素、羧丁基纤维素、羧乙基纤维素、羧甲基纤维素和羧乙基丙基纤维素)及其组合。
在一些实施方案中，纤维素聚合物包含羧甲基纤维素。
在一些实施方案中，树胶聚合物选自角叉菜胶、黄原胶及其组合。在一些实施方案中，树胶聚合物包含黄原胶。在一些实施方案中，聚丙烯酸酯聚合物或共聚物为卡波姆。在一些实施方案中，聚丙烯酸酯聚合物或共聚物选自丙烯酸与聚烯基聚醚交联的均聚物和共聚物。
在一些实施方案中，组合物包含在表1(以下)中提供的浓度范围的成分。
表1
在以下共同待审的申请PCT/US 2010/061962、PCT/US 2010/061956和PCT/US2010/061959(全部在2010年12月23日提交)中描述了粘弹性漱口水制剂，这些申请的内容通过参照以其整体结合到本文中。
本发明的组合物用正确组合和浓度的聚合物精心制备，形成具有独特的流变性但是仍然类似于一般漱口水的流动性的粘弹性、低粘度水溶液。
本文使用的术语“粘弹性流体”指呈现弹性(固体样例如橡胶)和粘性(液体样，可流动的例如水)两方面的机械性质的复杂流体。粘弹性流体组合物将在所施加的剪切应力的影响下(例如在口中摇动或发出嗖嗖声)变形和流动，但是当去除应力时，组合物将从变形恢复。粘弹行为的弹性部分用弹性模量(G′)量化，而粘性部分用粘性模量(G″)量化。
本文使用的术语“剪切稀化”指其中粘度随着剪切应力的速率增大而降低的性质。呈现剪切稀化性质的材料称为假塑性体。
本文使用的“结构化流体”和“结构化组合物”可互换使用，并且指在应变扫描测量的线性粘弹性区域内呈现大于G″值的G′值(即G’与G”的比率为＞0.5)的流体。G’与G”的比率确定为结构参数。
可用于本发明组合物的碱性氨基酸不仅包括天然存在的碱性氨基酸，比如精氨酸、赖氨酸和组氨酸，而且包括在分子中具有羧基和氨基的任何碱性氨基酸。因此，碱性氨基酸非限制性地包括精氨酸、赖氨酸、瓜氨酸(citrullene)、鸟氨酸、肌酸、组氨酸、二氨基丁酸、二氨基丙酸、其盐或其组合。在具体的实施方案中，碱性氨基酸选自精氨酸、瓜氨酸(citrullene)和鸟氨酸，优选地为精氨酸，例如L-精氨酸。
本发明的组合物旨在局部用于口腔，并且因此用于本发明的盐应为口腔可接受的，就是说，对于以所提供的量和浓度局部用于口腔为安全的。合适的盐包括本领域已知为药学上可接受的盐的盐，其通常认为以所提供的量和浓度用于该目的为口腔可接受的。口腔可接受的盐包括源于药学上可接受的无机或有机酸或碱的那些盐，例如用形成生理学上可接受的阴离子的酸形成的酸加成盐，例如盐酸盐，和用形成生理学上可接受的阳离子的碱形成的碱加成盐，例如源于碱金属比如钾和钠或碱土金属比如钙和镁的那些盐。生理学上可接受的盐可使用本领域已知的标准程序得到，例如通过使足够碱性的化合物比如胺与提供生理学上可接受的阴离子的合适酸反应。
在一些实施方案中，组合物进一步包含一种或多种选自以下的组分：氟离子源、牙垢控制剂、缓冲剂、磨料及其两种或更多种的组合。在一些实施方案中，所述一种或多种组分中的至少一种为选自以下的氟离子源：氟化亚锡、氟化钠、氟化钾、单氟磷酸钠、氟硅酸钠、氟硅酸铵、氟化胺、氟化铵及其两种或更多种的组合。
称为卡波姆的合成的高分子量丙烯酸聚合物可为丙烯酸与季戊四醇烯丙基醚、蔗糖的烯丙基醚或丙烯的烯丙基醚交联的均聚物。卡波姆具有“A型卡波姆均聚物”的USP类别。卡波姆具有吸附、保留水并膨胀至其初始体积的许多倍的能力。卡波姆代码(910、934、940、941、971、974和934P)表明聚合物的分子量和具体组分。卡波姆可以商品名市售得自Lubrizol和其它公司。
本文有用的湿润剂包括多元醇，比如甘油、山梨醇、木糖醇或低分子量PEG、亚烷基二醇比如聚乙二醇或丙二醇。在多种实施方案中，湿润剂对于防止糊状或凝胶组合物在暴露于空气时硬化为切实可行的。在多种实施方案中湿润剂也起甜味剂作用。在一些实施方案中，湿润剂以按重量计各约1-约40％的量存在。在一些实施方案中，湿润剂为山梨醇。在一些实施方案中，山梨醇以按重量计约5-约25％的浓度存在。在一些实施方案中，山梨醇以按重量计约5-约15％的浓度存在。在一些实施方案中，山梨醇以按重量计约10％的浓度存在。本文提到山梨醇，指一般地以70％水溶液可市售得到的材料。在一些实施方案中，总的湿润剂浓度为按重量计约1-约60％。在一些实施方案中，湿润剂为甘油。在一些实施方案中，甘油以按重量计约5-约15％的浓度存在。在一些实施方案中，甘油以按重量计约7.5％的浓度存在。在一些实施方案中，湿润剂为丙二醇。在一些实施方案中，丙二醇以按重量计约5-约15％的浓度存在。在一些实施方案中，丙二醇以按重量计约7％的浓度存在。
一些实施方案提供其中存在防腐剂的组合物。在一些实施方案中，防腐剂选自对羟基苯甲酸酯类、山梨酸钾、苄醇、苯氧乙醇、聚氨丙基双胍、辛酸、苯甲酸钠和氯化十六烷基吡啶。在一些实施方案中，防腐剂以按重量计约0.0001-约1％的浓度存在。在一些实施方案中，防腐剂以按重量计约0.01-约1％的浓度存在。在一些实施方案中，防腐剂以按重量计约0.5％的浓度存在。
着色剂比如染料可为目前以美国食品、药品和化妆品法案(Food Drug&CosmeticAct)认证用于食物和摄入药物的食品色素添加剂，包括染料比如FD&C Red No.3(四碘荧光素的钠盐)、Food Red 17(6-羟基-5-{(2-甲氧基-5-甲基-4-磺基苯基)偶氮}-2-萘磺酸的二钠盐)、Food Yellow 13(喹酞酮(quinophtalone)或2-(2-喹啉基)茚满二酮的单和二磺酸的混合物的钠盐)、FD&C Yellow No.5(4-对-磺基苯基偶氮-1-对-磺基苯基-5-羟基吡唑-3-羧酸的钠盐)、FD&C Yellow No.6(对-磺基苯基偶氮-B-萘酚-6-单磺酸酯的钠盐)、FD&C Green No.3(4-{[4-(N-乙基-对-磺基苄基氨基)-苯基]-(4-羟基-2-硫鎓(sulfonium)苯基)-亚甲基}-[1-(N-乙基-N-对-磺基苄基)-δ-3，5-环己二烯亚胺(cyclohexadienimine)]的二钠盐)、FD&C Blue No.1(二苄基二乙基-二氨基-三苯基甲醇三磺酸酸酐(anhydrite)的二钠盐)、FD&C Blue No.2(靛蓝的二磺酸的钠盐)及其各种比例的混合物。一般地，着色剂(如果包含的话)以非常小的量存在。
调味剂为已知的，比如天然和人工调味剂。这些调味剂可选自合成的调味油和调味香料和/或油类、油性树脂以及源于植物、叶、花、果实等的提取物，及其组合。代表性的调味油包括：留兰香油、肉桂油、薄荷油、丁香油、月桂叶油、百里香油、雪松叶油、肉豆蔻油、鼠尾草油和苦杏仁油。这些调味剂可单独或混合使用。常用的调味剂包括薄荷比如胡椒薄荷、人工香草精、肉桂衍生物和各种果味调味剂，无论单独还是混合使用。通常，可使用任何调味剂或食品添加剂，比如在用于食品加工的化学品(Chemicals Used in FoodProcessing)，美国国家科学院(the National Academy of Sciences)的出版物1274，第63-258页中描述的那些调味剂或食品添加剂。一般地，调味剂(如果包含的话)以按重量计0.01-1％存在。在一些实施方案中，调味剂可以按重量计约0.2％存在。
甜味剂包括天然和人工甜味剂两者。合适的甜味剂包括水溶性甜味剂比如单糖、二糖和多糖类，比如木糖、核糖、葡萄糖(右旋葡萄糖)、甘露糖、半乳糖、果糖(左旋糖)、蔗糖(糖)、麦芽糖；水溶性人工甜味剂比如可溶性的糖精盐，即糖精钠或钙盐、环己基氨基磺酸盐二肽基甜味剂，比如L-天冬氨酸衍生的甜味剂，比如L-天冬氨酰-L-苯丙氨酸甲酯(阿斯巴甜)。通常，有效量的甜味剂用于提供对具体组合物期望的甜味水平，并随着所选择的甜味剂而变化。该量通常为按组合物的重量计约0.001％-约5％。在一些实施方案中，甜味剂为糖精钠，并以按组合物的重量计约0.01％存在。
可提供任选的口气清新剂。可使用任何口腔可接受的口气清新剂，非限制性地包括锌盐比如葡萄糖酸锌、枸橼酸锌和亚氯酸锌、α-紫罗兰酮及其混合物。一种或多种口气清新剂任选地以口气清新有效的总量存在。
任选地，组合物可包含牙垢控制(抗牙垢)剂。本文有用的那些当中的牙垢控制剂包括磷酸盐和多磷酸盐(例如焦磷酸盐)、聚氨基丙磺酸(AMPS)、聚烯烃磺酸盐、聚烯烃磷酸盐；二膦酸盐，比如氮杂环烷烃-2，2-二膦酸盐(例如氮杂环庚烷-2，2-二膦酸)、N-甲基氮杂环戊烷2，3-二膦酸、乙烷-1-羟基-1，1-二膦酸(EHDP)和乙烷-1-氨基-1，1-二膦酸盐；膦酰基链烷羧酸和这些试剂中任何一种的盐，例如其碱金属盐和铵盐。有用的无机磷酸盐和多磷酸盐包括磷酸二氢钠、磷酸氢二钠和磷酸三钠、三聚磷酸钠、四聚磷酸盐、焦磷酸一钠、焦磷酸二钠、焦磷酸三钠和焦磷酸四钠、三偏磷酸钠、六偏磷酸钠及其混合物，其中钠可任选地被钾或铵替代。其它有用的抗牙垢剂包括聚羧酸盐(酯)聚合物和聚乙烯基甲醚/马来酸酐(PVME/MA)共聚物，比如可以GantrezTM商标得自ISP，Wayne，N.J的那些聚合物。
在一些实施方案中，牙垢控制剂以按重量计约0.01-10％的浓度存在。在一些实施方案中，牙垢控制剂以按重量计约1％的浓度存在。在一些实施方案中，牙垢控制剂也起缓冲剂作用。例如，在磷酸盐缓冲剂系统中，磷酸二氢钠以按重量计约0.01-约5％的浓度存在，和磷酸氢二钠以按重量计约0.01-约5％的浓度存在，精确比率取决于制剂中的其它赋形剂和期望的pH。
其它任选的添加剂包括抗微生物(例如抗菌)剂。可使用任何口腔可接受的抗菌剂，包括三氯生(5-氯-2-(2，4-二氯苯氧基)苯酚)、锌和亚锡离子源、季铵化合物比如氯化十六烷基吡啶(CPC)、双胍类比如氯己定以及苯扎氯铵。在GafTar等的美国专利第5776435号中提供了有用的抗菌剂的其它说明性列表。在一些实施方案中，抗菌剂以按重量计约0.001-约1％的浓度存在。在一些实施方案中，抗菌剂为氯化十六烷基吡啶。在一些实施方案中，氯化十六烷基吡啶以按重量计约0.05％的浓度存在。
抗氧化剂为另一类任选的添加剂。可使用任何口腔可接受的抗氧化剂，包括丁羟茴香醚(BHA)、丁羟甲苯(BHT)、维生素A、类胡罗卜素、维生素E、类黄酮、多酚类、抗坏血酸、草本抗氧化剂、叶绿素、褪黑激素及其混合物。
还可包含用于例如改善口干的任选的唾液刺激剂。可使用任何口腔可接受的唾液刺激剂，非限制性地包括食品酸，比如枸橼酸、乳酸、苹果酸、琥珀酸、抗坏血酸、己二酸、富马酸和酒石酸及其混合物。一种或多种唾液刺激剂任选地以唾液刺激有效的总量存在。
任选地，可包含抗菌斑(例如菌斑破坏)剂。可使用任何口腔可接受的抗菌斑剂，非限制性地包括亚锡、铜、镁和锶的盐；二甲硅油共聚醇，比如十六烷基二甲硅油共聚醇；木瓜蛋白酶、葡糖淀粉酶、葡萄糖氧化酶、尿素、乳酸钙、甘油磷酸钙、聚丙烯酸锶及其混合物。
任选的减敏剂包括枸橼酸钾、氯化钾、酒石酸钾、碳酸氢钾、草酸钾、硝酸钾、锶盐及其混合物。在一些实施方案中，可使用局部或全身性镇痛剂比如阿司匹林、可待因、对乙酰氨基酚、水杨酸钠或水杨酸三乙醇胺盐。
在一些实施方案中，方法包括用如本文描述的组合物漱洗口腔的步骤。在一些实施方案中，当在口腔内搅动时，组合物的剪切稀化性质增加流动，并因此增加所覆盖的面积。在一些实施方案中，在排掉组合物之后在口腔的表面形成聚合物膜，这导致减轻口干症状。在一些实施方案中，含漱5ml或更多的组合物。在一些实施方案中，使用10ml或者更多。在一些实施方案中，使用10-50ml。在一些实施方案中，使用15-25ml或者更多。在一些实施方案中，使用15ml或者更多。在一些实施方案中，个体每天用组合物含漱多次。在一些实施方案中，个体用组合物含漱多天。在一些实施方案中，个体每天每4-6小时用组合物含漱最多6次。
在全文所用，范围用作用于描述处于该范围内的每个数值的简写形式。该范围内的任何数值可选择作为范围的端点。另外，本文引用的所有参考文献通过参照以其整体结合到本文中。
如果本公开的定义与所引用的参考文献的定义发生冲突，以本公开为准。
除非另外规定，本文和说明书中别处表示的所有百分数和量应理解为指按重量计的百分数。所给出的量基于材料的有效重量。
实施例
实施例1
目的是提供含有聚合物系统加上活性物质(精氨酸，优选地含有氟化物)的粘弹性漱口水，用于针对酸诱导的去矿化作用的牙釉质的优良保护作用。制备具有以下成分的漱口水制剂：
表2
| 漱口水1：成分 | 浓度(％wt/wt) |
| 水 | 71.05 |
| 湿润剂 | 17.5 |
| 表面活性剂 | 1 |
| 磷酸二氢钠 | 1 |
| 磷酸氢二钠 | 0.15 |
| 防腐剂 | 0.5 |
| 调味剂 | 0.2 |
| 羧甲基纤维素 | 0.083 |
| 黄原胶 | 0.083 |
| 丙烯酸酯共聚物 | 0.05 |
| 氟化钠 | 0.02 |
| 精氨酸(Arg HCO3) | 1.3 |
| 甜味剂 | 0.01 |
| 氯化十六烷基吡啶 | 0.05 |
表3
表4
| 漱口水3：成分 | 理论重量(％) |
| 水 | 71.22 |
| 山梨醇(70％溶液) | 10 |
| 甘油 | 7.5 |
| 丙二醇 | 7 |
| L-精氨酸 | 0.8 |
| 泊洛沙姆407(Poloxamer 407) | 1 |
| 磷酸二氢钠 | 1 |
| FD&C GREEN NO.3 | 0.000375 |
| 氯化十六烷基吡啶 | 0.05 |
| 苯甲酸钠 | 0.5 |
| 调味剂 | 0.2 |
| 磷酸氢二钠 | 0.15 |
| 糖精钠 | 0.01 |
| 黄原胶 | 0.083 |
| 羧甲基纤维素钠 | 0.083 |
| 聚丙烯酸酯共聚物 | 0.05 |
| 三甲基甘氨酸 | 0.3 |
| 氟化钠 | 0.05 |
实施例2
本发明的示例性组合物可按照以下程序制备：
向小的容器中加入约1/3的水，并在强烈混合下缓慢加入丙烯酸酯共聚物。
向主混合罐中加入剩余的水。
加入泊洛沙姆407并混合，直到完全溶解。
加入适量的山梨醇。
加入磷酸二氢钠、苯甲酸钠、无水磷酸氢二钠、糖精钠、Betafin BP20和L-精氨酸，并在各进行混合后加入下一个。
加入CPC和染料。混合10分钟，以确保整个批次完全溶解。
使黄原胶和CMC在丙二醇中浆化。
向主混合罐中加入丙烯酸酯共聚物和水混合物。
向主混合罐中加入黄原胶和CMC浆料，并混合15分钟。
加入调味剂，并混合5分钟。
实施例3
与水、唾液和3种市售的漱口水相比较，评价实施例1的三聚合物漱口水制剂的流变性质。3种市售的漱口水为简单的含氟漱洗型漱口水(比较制剂1)、基于聚合物的高含氟漱口水(比较制剂2)和具有不同于在该情况下所描述的聚合物系统的常规聚合物系统的漱口水(漱口水3)。制剂的流变性质使用应力控制的AR2000ex流变仪(TA Instruments)和cuette式几何量化。产生流量曲线并拟合幂律模型，以量化流速指数n。实施应变扫描，以量化弹性模量G′和损耗模量G″。结果描述在表5(以下)中。
表5
在表5(以上)中描述的数据证实，本发明的组合物为粘弹性的(更像唾液)，而比较实施例为牛顿的(更像水)。
实施例4
然后将三聚合物漱口水与市售漱口水比较其保护免受牙釉质损失的能力。基于由S.M.Hooper，R.G.Newcombe，R.Faller，S.Eversole，M.Addy，N.X.West，Journal ofDentistry，35(2007)，476-481发表的方案，使用体外方法学，比较三聚合物漱口水原型与水和3种市售实施例的牙釉质损失。每一种制剂进行4-6次平行测试，以得到统计学上有意义的结果。
将牛门牙用70％乙醇清洗和灭菌。每个样本使用特氟隆(Teflon)模具嵌入环氧树脂中，形成20mm X 10mm X 5mm块。牙釉质表面使用600和1200粒度碳化硅纸连续打磨，获得有光泽的平整表面。每个牙釉质表面用胶带掩盖，仅留下暴露的中心区域(约0.5mm宽)。将所掩盖的牙釉质块用5％枸橼酸溶液预蚀刻30秒，以产生预先存在的(初始)损伤。在试验之前，把所有的牙釉质样品在37℃下的人工唾液中保持至少12小时。人工唾液在1000mL去离子水中含有以下成分：25g来自猪胃的粘蛋白、466mg NH4Cl、420mg CaCl2·H2O、86mgMgCl2·6H2O、2314mg KCl、708mg KH2PO4、444mg KCNS、1070mg NaHCO3、750mg NaH2PO4、26mg枸橼酸钠·2H2O、50mg白蛋白(BSA)、346mg尿素和900mg甘氨酸。
侵蚀研究通过循环的去矿化作用和再矿化作用程序进行。将每个牙釉质基底早上用指定的MW制剂或无处理的H2O对照处理1分钟，并然后使用以NaOH滴定至pH 3.8的1％枸橼酸溶液去矿化两次2分钟。下午重复相同的程序，并把这种每天处理方案重复5天。除了在去矿化作用和MW处理期间以外，牙釉质基底总是储存于37℃下的人工唾液中。轮廓测定法通过测量未掩盖的中心相对于所掩盖区域的阶梯高度，用于量化由于酸暴露引起的牙釉质损失。使用循环研究之前和之后的阶梯高度差计算牙釉质损失。
与使用市售的比较制剂所见到的相比较，使用基于粘弹性三聚合物的原型导致牙釉质损失的明显和出乎意料的减少，如在表6(以下)中所见。
表6
在表6(以上)中描述的数据证实，当使用本文描述的Hooper方案评估时，本发明的组合物出乎意料地提供小于0.25微米的阶梯高度差，而不含有本文描述的本发明组合的类似配制的组合物不能提供相同水平的针对牙釉质损失的保护。
以下内容对应于母案申请中的原始权利要求书，现作为说明书的一部分并入此处：
1.一种水性口腔护理组合物，所述组合物包含
a)有效量的游离或口腔可接受的盐形式的碱性氨基酸；和
b)聚合物系统，所述聚合物系统包含(i)纤维素聚合物、(ii)树胶聚合物和(iii)聚丙烯酸酯聚合物或共聚物。
2.项1的组合物，所述组合物进一步包含氟源，其中氟源以有效提供约90-约500ppm氟的量存在。
3.项2的组合物，其中所述氟源以有效提供约225ppm氟的量存在。
4.项2或3的组合物，其中所述氟源选自氟化钠、单氟磷酸钠及其组合。
5.项2-4中任一项的组合物，其中所述氟源包含氟化钠。
6.任一项前述项的组合物，其中所述碱性氨基酸包含游离或口腔可接受的盐形式的L-精氨酸。
7.任一项前述项的组合物，其中所述游离或口腔可接受的盐形式的碱性氨基酸的有效量按制剂的重量计占0.05-2％(当以口腔可接受的盐形式存在时，作为游离碱当量的重量测量)。
8.任一项前述项的组合物，所述组合物进一步包含缓冲剂。
9.任一项前述项的组合物，所述组合物进一步包含湿润剂。
10.任一项前述项的组合物，所述组合物进一步包含抗菌剂。
11.前述项中任一项的组合物，其中所述纤维素聚合物选自羟烷基甲基纤维素、羧烷基甲基纤维素、羟烷基纤维素、烷基纤维素、羧烷基纤维素及其两种或更多种的组合。
12.前述项中任一项的组合物，其中所述纤维素聚合物包含羧甲基纤维素。
13.前述项中任一项的组合物，其中所述树胶聚合物选自角叉菜胶、黄原胶及其组合。
14.前述项中任一项的组合物，其中所述聚丙烯酸酯聚合物或共聚物为卡波姆。
15.前述项中任一项的组合物，其中所述聚丙烯酸酯聚合物或共聚物选自丙烯酸与聚烯基聚醚交联的均聚物和共聚物。
16.一种水性口腔护理组合物，所述组合物包含：
a)按重量计约0.5％-约2％的游离或口腔可接受的盐形式的碱性氨基酸；
b)包含以下的聚合物系统：(i)纤维素聚合物，(ii)树胶聚合物，和(iii)聚丙烯酸酯聚合物或共聚物；和
c)按重量计约0.01-约0.5％的氟源；
其中当使用Hooper方案评估时，所述组合物递送有效提供小于0.25微米的阶梯高度差的一定量的氟。
17.项16的组合物，其中所述氟源以按组合物的重量计约0.05％的量存在。
18.任一项前述项的组合物，其中所述组合物具有小于0.85的流速指数。
19.任一项前述项的组合物，其中所述组合物具有大于或等于0.5的G′/G″比率。
20.一种减少牙釉质侵蚀的方法，所述方法包括给予有需要的受试者的口腔前述项中任一项的组合物。
21.项20的方法，其中所述给予包括漱洗约15-约60秒。
Claims (16)
1.一种水性口腔护理组合物，所述组合物包含
a)有效量的游离或口腔可接受的盐形式的碱性氨基酸；和
b)聚合物系统，所述聚合物系统包含(i)纤维素聚合物、(ii)树胶聚合物和(iii)聚丙烯酸酯聚合物或共聚物，所述纤维素聚合物为羧甲基纤维素，所述树胶聚合物为黄原胶，
其中所述纤维素聚合物、树胶聚合物和聚丙烯酸酯聚合物或共聚物各自存在的量为组合物重量的0.01-0.5％，所述组合物具有小于0.85的流速指数，且具有大于或等于0.5的G′/G″比率，所述碱性氨基酸是精氨酸且量相当于占组合物的0.05-2％重量的游离碱的量，所述组合物进一步包含氟源，其中氟源以有效提供90-500ppm氟的量存在。
2.权利要求1的组合物，其中所述氟源选自氟化钠、单氟磷酸钠及其组合。
3.权利要求1或2的组合物，其中所述氟源包含氟化钠。
4.权利要求1或2的组合物，其中所述碱性氨基酸包含游离或口腔可接受的盐形式的L-精氨酸。
5.权利要求1或2的组合物，所述组合物进一步包含缓冲剂。
6.权利要求1或2的组合物，所述组合物进一步包含湿润剂。
7.权利要求1或2的组合物，所述组合物进一步包含抗菌剂。
8.权利要求1或2的组合物，其中所述组合物进一步包含选自羟烷基甲基纤维素、羧烷基甲基纤维素、羟烷基纤维素、烷基纤维素、羧烷基纤维素及其两种或更多种的组合的另外的纤维素聚合物。
9.权利要求1或2的组合物，其进一步包含角叉菜胶。
10.权利要求1或2的组合物，其中所述聚丙烯酸酯聚合物或共聚物为卡波姆。
11.权利要求1或2的组合物，其中所述聚丙烯酸酯聚合物或共聚物选自与聚烯基聚醚交联的丙烯酸的均聚物和共聚物。
12.权利要求1的水性口腔护理组合物，所述组合物包含：
a)按重量计0.5％-2％的游离或口腔可接受的盐形式的碱性氨基酸；
b)包含以下的聚合物系统：(i)纤维素聚合物，(ii)树胶聚合物，和(iii)聚丙烯酸酯聚合物或共聚物；和
c)按重量计0.01-0.5％的氟源；
其中当使用Hooper方案评估时，所述组合物递送有效提供小于0.25微米的阶梯高度差的一定量的氟。
13.权利要求12的组合物，其中所述氟源以按组合物的重量计0.05％的量存在。
14.前述权利要求中任一项的组合物在制备药物中的用途，所述药物用于通过给予有需要的受试者的口腔所述组合物来减少牙釉质侵蚀。
15.权利要求14的用途，其中所述给予包括漱洗15-60秒。
16.权利要求1或2的组合物，所述组合物用于在减少牙釉质侵蚀的方法中使用。
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| PCT/US2011/065125 WO2013089734A1 (en) | 2011-12-15 | 2011-12-15 | Aqueous oral care compositions |
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| CN103260600B (zh) * | 2010-12-23 | 2015-12-02 | 高露洁-棕榄公司 | 包含黄原胶、纤维素胶和卡波姆的水性口腔护理组合物 |
| CN104039369B (zh) | 2011-07-20 | 2017-06-16 | 布莱阿姆青年大学 | 疏水性塞拉集宁化合物和包含该化合物的装置 |
| US20140363780A1 (en) * | 2011-12-21 | 2014-12-11 | Brigham Young University | Oral care compositions |
| CA2872399C (en) | 2012-05-02 | 2021-01-12 | Brigham Young University | Ceragenin particulate materials and methods for making same |
| US10568893B2 (en) | 2013-03-15 | 2020-02-25 | Brigham Young University | Methods for treating inflammation, autoimmune disorders and pain |
| US11524015B2 (en) | 2013-03-15 | 2022-12-13 | Brigham Young University | Methods for treating inflammation, autoimmune disorders and pain |
| JP6518230B2 (ja) | 2013-03-15 | 2019-05-22 | ブリガム・ヤング・ユニバーシティＢｒｉｇｈａｍ Ｙｏｕｎｇ Ｕｎｉｖｅｒｓｉｔｙ | 炎症、自己免疫疾患、および疼痛を治療する方法 |
| US11690855B2 (en) | 2013-10-17 | 2023-07-04 | Brigham Young University | Methods for treating lung infections and inflammation |
| EP3076920B1 (en) | 2013-12-03 | 2019-04-17 | Colgate-Palmolive Company | Oral care compositions |
| US20150203527A1 (en) | 2014-01-23 | 2015-07-23 | Brigham Young University | Cationic steroidal antimicrobials |
| CA2844321C (en) | 2014-02-27 | 2021-03-16 | Brigham Young University | Cationic steroidal antimicrobial compounds |
| US10220045B2 (en) | 2014-03-13 | 2019-03-05 | Brigham Young University | Compositions and methods for forming stabilized compositions with reduced CSA agglomeration |
| US10238665B2 (en) | 2014-06-26 | 2019-03-26 | Brigham Young University | Methods for treating fungal infections |
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| US10155788B2 (en) | 2014-10-07 | 2018-12-18 | Brigham Young University | Cationic steroidal antimicrobial prodrug compositions and uses thereof |
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| RU2713948C2 (ru) * | 2014-12-23 | 2020-02-11 | Колгейт-Палмолив Компани | Композиция для ухода за полостью рта |
| US10370403B2 (en) | 2015-04-22 | 2019-08-06 | Brigham Young University | Methods for the synthesis of ceragenins |
| US10226550B2 (en) | 2016-03-11 | 2019-03-12 | Brigham Young University | Cationic steroidal antimicrobial compositions for the treatment of dermal tissue |
| BR112017019268A2 (pt) | 2016-06-24 | 2018-07-17 | Colgate-Palmolive Company | composições para higiene bucal e métodos de uso. |
| CN115350117A (zh) * | 2016-11-08 | 2022-11-18 | 高露洁-棕榄公司 | 口腔护理组合物 |
| US10959433B2 (en) | 2017-03-21 | 2021-03-30 | Brigham Young University | Use of cationic steroidal antimicrobials for sporicidal activity |
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| WO2020081049A1 (en) * | 2018-10-16 | 2020-04-23 | Colgate-Palmolive Company | Oral care compositions and methods for the same |
| US11154487B2 (en) | 2018-10-16 | 2021-10-26 | Colgate-Palmolive Company | Oral care compositions and methods for the same |
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- 2011-12-15 AU AU2011383326A patent/AU2011383326B2/en not_active Ceased
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| CN101938978A (zh) * | 2008-02-08 | 2011-01-05 | 高露洁-棕榄公司 | 口腔护理产品及其使用和制造方法 |
| CN102223921A (zh) * | 2008-11-25 | 2011-10-19 | 宝洁公司 | 抗敏性口腔护理组合物 |
| CN102245157A (zh) * | 2008-12-09 | 2011-11-16 | 葛兰素集团有限公司 | 新用途 |
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| WO2013089734A1 (en) | 2013-06-20 |
| JP2015504040A (ja) | 2015-02-05 |
| MX342833B (es) | 2016-10-14 |
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| AU2011383326A1 (en) | 2014-05-22 |
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| CN103974691A (zh) | 2014-08-06 |
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| US10722446B2 (en) | 2020-07-28 |
| TW201338798A (zh) | 2013-10-01 |
| US20140305461A1 (en) | 2014-10-16 |
| HK1200706A1 (zh) | 2015-08-14 |
| PH12014501213B1 (en) | 2014-09-08 |
| BR112014014315A2 (pt) | 2017-06-13 |
| CA2855732A1 (en) | 2013-06-20 |
| AR089268A1 (es) | 2014-08-13 |
| CA2855732C (en) | 2016-06-28 |
| RU2609862C2 (ru) | 2017-02-06 |
| PH12014501213A1 (en) | 2014-09-08 |
| AU2011383326B2 (en) | 2016-01-28 |
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