CN105530999B - 口腔组合物、牙齿结构以及递送口腔组合物的方法 - Google Patents
口腔组合物、牙齿结构以及递送口腔组合物的方法 Download PDFInfo
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- CN105530999B CN105530999B CN201480049754.4A CN201480049754A CN105530999B CN 105530999 B CN105530999 B CN 105530999B CN 201480049754 A CN201480049754 A CN 201480049754A CN 105530999 B CN105530999 B CN 105530999B
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Abstract
本发明描述了一种口腔组合物以及一种将口腔组合物递送至牙齿结构的方法。所述口腔组合物可包含溶剂;酸性共聚物,所述酸性共聚物具有酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;中性共聚物,所述中性共聚物具有中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及任选的活性剂。酸性共聚物和中性共聚物可溶解在口腔组合物中,并且口腔组合物在与水性溶液接触时可在表面上形成膜。
Description
相关申请的交叉引用
本申请要求2013年9月11日提交的美国临时申请No.61/876599、61/876435、61/876602和61/876606的权益,该临时申请全文以引用方式并入本文中。
技术领域
本公开整体涉及口腔组合物,如水性或非水性口服涂层组合物,以及递送口腔组合物的方法。本公开的一些方面整体涉及牙齿结构。
背景技术
已采用了基于预防性活性物质的口服材料,诸如牙齿密封剂、清漆、凝胶、牙膏、口服漱口液、和延长接触清漆,经由不同的递送载体释放各种量的活性剂(如,氟化物离子、钙离子和磷酸盐离子、抗过敏剂、抗微生物剂、和生物膜破坏剂),以提供进入口腔组织的潜在摄取量或生物活性。这些材料利用几种不同的施用技术并且适用于不同患者。例如,密封剂和延长接触清漆通常需要固化以针对延长耐久性和保持性提供交联。另选地,氟化物漱口液和凝胶提供简化的氟化物递送。
牙齿制品用于治疗多种牙齿疾病。已采用了牙齿制品递送口服活性剂。已采用了基于预防性活性物质的口服材料,诸如牙齿密封剂、清漆、凝胶、牙膏、口服漱口液、和延长接触清漆,经由不同的递送载体释放各种量的活性剂(如,氟化物离子、钙离子和磷酸盐离子、抗过敏剂、抗微生物剂、和生物膜破坏剂),以提供进入口腔组织的潜在摄取量或生物活性。这些材料利用几种不同的施用技术并且适用于不同患者。例如,密封剂和延长接触清漆通常需要固化以针对延长耐久性和保持性提供交联。另选地,氟化物漱口液和凝胶提供简化的氟化物递送。
发明内容
现有的基于预防性活性物质的牙齿材料一般分为两类:a)交联/固化材料(如,牙齿密封剂和延长接触清漆),其为耐久的并且为“半永久至永久的”;和b)临时涂层材料(如,清漆和凝胶),其可施用或干燥以提供弱的非耐久粘性涂层。此类涂层材料一般施用于牙齿组织后保持5-10分钟并且可从牙齿组织中冲洗掉。交联/固化材料为耐久的,但通常需要化学固化提供交联以针对延长耐久性和保持性提供交联。一些使用基于预防性活性物质的现有牙齿材料的方法需要具有初始有限释放活性剂的复杂工序。此外,基于预防性活性物质的一些现有牙齿材料的所释放活性物质浓度较低,并且牙齿结构和此类牙齿材料之间的接触时间较短。
疏水性涂层材料最近用于超敏反应降低和氟化物治疗。这些疏水性涂层材料一般来讲由树松香及其衍生物制成。树松香及其衍生物需要有机溶剂诸如己烷和乙醇的混合物来溶解。在施用到牙齿组织上之后,非水性溶剂诸如乙醇和己烷,缓慢蒸发以形成软而粘的疏水性涂层。所得疏水性涂层具有不期望的己烷气味,包含由于己烷蒸发引起的小气泡,并且表现出粗糙的口内表面感觉。当这些现有疏水性涂层材料用于递送活性剂时,这些疏水性涂层材料的活性剂的生物利用率和摄取量相对低并且无效,因为活性剂分散在有机溶剂和疏水性松香中,从而导致缓慢的离子传送和释放。此外,当软而粘的疏水性涂层接触热饮或食物时,涂层可很容易磨损,并且活性剂中的大部分在沉积于牙齿组织上之前被摄入人的胃中。
本公开整体涉及口腔组合物、递送口腔组合物的方法和牙齿结构。一般来讲,本公开的口腔组合物、方法和牙齿结构可提供增强的活性剂(药物)释放、更有效的生物活性和改善的施用便利性。本公开的口腔组合物可抵抗刷子磨蚀,但不需要网上化学固化。另外,本公开的口腔组合物与水接触或用压缩空气流干燥之后,该口腔组合物可在小于约30秒内形成膜。此外,本公开的口腔组合物和方法可提供涂层,该涂层密封开放的牙质小管和/或牙釉质裂缝,以使牙齿敏感性最小化。
本公开的一些方面提供一种口腔组合物。该口腔组合物可包含含有水和助溶剂的溶剂,该溶剂选自低级烷基醇、丙酮以及它们的组合;酸性共聚物,该酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;中性共聚物,该中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及任选的活性剂。口腔组合物可包含约6至约18重量%的水、约30至约80重量%的助溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和,并且每种组分的重量%基于组合物的总重量计。酸性共聚物和中性共聚物可溶解在口腔组合物中,并且口腔组合物在与水性溶液接触时可在表面上形成膜。
本公开的一些方面提供一种口腔组合物。该口腔组合物可包含溶剂,该溶剂选自低级烷基醇、THF、DMSO、离子液体、TEC、乙酸乙酯、丙酮以及它们的组合;酸性共聚物,该酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;中性共聚物,该中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及任选的活性剂。该口腔组合物可包含约30至约80重量%的溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和,并且每种组分的重量%是基于组合物的总重量计的。酸性共聚物和中性共聚物可溶解在口腔组合物中,并且口腔组合物在与水性溶液接触时能够在表面上形成膜。
本公开的一些方面提供一种口腔组合物。该口腔组合物可包含含有水和助溶剂的溶剂,该溶剂选自低级烷基醇、丙酮以及它们的组合;酸性共聚物,该酸性共聚物选自Eudragit S100、Eudragit L100、Eudragit L100-55、AC210以及它们的组合;中性共聚物,该中性共聚物选自Eudragit RS100和Eudragit RL 100;Eudragit E100;以及任选的氟化物盐。该口腔组合物可包含约8至约12重量%的水、约30至约80重量%的助溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和。酸性共聚物和中性共聚物可溶解在口腔组合物中,并且口腔组合物在与水性溶液接触时可在表面上形成膜。
本公开的一些方面提供了一种将口腔组合物递送至牙齿结构的方法。该方法可包括提供口腔组合物;将口腔组合物施用于牙齿结构;以及使口腔组合物与水性溶液接触,从而在牙齿结构上形成聚合物膜。
本公开的一些方面提供一种牙齿结构。该牙齿结构可包括牙齿制品、和牙齿制品的表面上的膜。可通过使口腔组合物与水性溶液接触或通过使口腔组合物在牙齿制品上干燥来形成膜。口腔组合物可包含酸性共聚物,该酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;中性共聚物,该中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及任选的活性剂。
参考详细说明和附图,本发明的其他特征和方面将变得显而易见。
附图说明
图1为根据本发明实施例的牙齿结构的示意性侧视图。
图2为经涂布和未涂布的牛牙质的SEM图像。
具体实施方式
在详细解释本公开的任何实施例之前,应当了解,本发明在其应用中不仅限于下文说明中所提及或下文附图中所示出的部件的使用、构造和布置方式的细节。本发明能够具有其他实施例并且能够以各种方式实施或执行,本领域的普通技术人员在阅读本公开时这将变得显而易见。另外,应当了解,本文使用的措词和术语是用于说明目的而不应被视为限制性的。本文使用“包括”、“包含”或“具有”及它们的变型形式意在涵盖其后所列出的项目及它们的等同形式以及额外项目。应当理解,可采用其他的实施例,并且可在不脱离本发明范围的情况下作出结构变化或逻辑变化。
本公开整体涉及递送口腔组合物的方法和将活性剂递送至牙齿结构的方法。具体地讲,例如,本公开的方法可提供活性剂的更有效使用、对牙齿结构的更佳粘附力、更耐用的涂层、更快的离子传送和释放、和牙齿结构上的非粘性平滑感觉。
如本文所用,牙齿结构包括但不限于牙齿组织和牙齿制品。
如本文所用,牙齿组织包括但不限于牙齿硬组织和牙齿软组织。口腔硬组织和口腔软组织包括但不限于牙齿、牙弓、以及周围的组织和支撑结构,包括齿龈和硬腭。
如本文所用,牙齿制品包括但不限于可附接(如,粘结)至牙齿组织(如,牙齿结构)的制品。牙齿制品的示例包括但不限于替换体、镶嵌物、高嵌体、镶面、全牙冠和部分牙冠、牙桥、植入物、植入物支座、牙内冠、义齿、柱状体、牙桥框架和其他牙桥结构、支座、牙齿矫正器械和装置,包括但不限于弓丝、颊面管、托架和带环、以及假体(如,局部或全口义齿)。
在一些实施例中,本公开的口腔组合物可包含溶剂、酸性共聚物、中性共聚物和任选的活性剂。
溶剂
在特定实施例中,溶剂可包含水和助溶剂。在此类特定实施例中,本公开的口腔组合物为水性口腔组合物。在这些特定实施例的一些中,口腔组合物包含约6至约18重量%的水。在这些特定实施例的一些中,口腔组合物包含约8至约12重量%的水。助溶剂可选自低级烷基醇和丙酮。本文中所指的低级烷基醇可包含低碳数(如,C1-C5)醇类。本文所用的低级烷基醇的示例包括但不限于乙醇、异丙醇、丙二醇、甘油以及基于低分子量聚乙二醇和乙二醇的酯醇类。在这些特定实施例的一些中,助溶剂可为乙醇。在一些其他实施例中,口腔组合物包含约30至约80重量%的助溶剂。在这些特定实施例的一些中,口腔组合物包含约45至约60重量%的助溶剂。
在其他实施例中,溶剂可选自低级烷基醇、四氢呋喃(THF)、二甲基亚砜(DMSO)、离子液体(如,三(2-羟乙基)-甲基铵甲硫酸盐)、柠檬酸三乙酯(TEC)、乙酸乙酯、丙酮、以及它们的组合。在此类其他实施例中,本公开的口腔组合物为非水性口腔组合物。在这些其他实施例的一些中,溶剂可为乙醇。在这些其他实施例的一些中,口腔组合物包含约30至约80重量%的溶剂。在这些特定实施例的一些中,口腔组合物包含约45至约60重量%的溶剂。
在上述实施例的任一者中,溶剂还可包含选自异丙醇、丙二醇、甘油、基于低分子量聚乙二醇、乙二醇的酯醇类、以及它们的组合的至少一种附加组分。
酸性共聚物
酸性共聚物可例如降低口腔组合物的pH。因此,酸性共聚物可用作成膜剂。当形成膜时,其可例如向牙齿结构提供锚固结构并且促进此类组织增强摄取活性剂。
在一些实施例中,酸性共聚物可包括但不限于选自丙烯酸、甲基丙烯酸以及它们的组合的单体单元的酸性丙烯酸共聚物。
在一些实施例中,酸性共聚物可包含甲基丙烯酸和甲基丙烯酸甲酯的共聚物。在一些其他实施例中,酸性共聚物可包含 S100(由德国达姆施塔特的赢创工业集团(Evonic Industries AG,Damstadt,Germany)销售)、 L100(由德国达姆施塔特的赢创工业集团(Evonic Industries AG,Damstadt,Germany)销售)、 L100-55(由德国达姆施塔特的赢创工业集团(Evonic Industries AG,Damstadt,Germany)销售)、AC210(由美国俄亥俄州威克里夫的路博润公司(The Lubrizol Corporation,Wickliffe,Ohio,USA)销售)、或它们的组合。
在一些实施例中,酸性共聚物的分子量可为约5,000至约500,000。在其他实施例中,中性共聚物的分子量可为约10,000至约100,000。
中性共聚物
在一些实施例中,中性丙烯酸酯单体单元可包括但不限于丙烯酸异丁酯、丙烯酸叔丁酯、丙烯酸2-乙基己酯、丙烯酸月桂酯、丙烯酸月桂酯/十三烷基酯、丙烯酸十六烷基酯、丙烯酸硬脂酯、丙烯酸环己酯、丙烯酸苄酯、丙烯酸异冰片酯、丙烯酸2-甲氧基乙酯、丙烯酸2-乙氧基乙酯、丙烯酸2-乙氧基乙氧基乙酯、丙烯酸2-苯氧基乙酯、丙烯酸四氢糠酯、丙烯酸2-羟乙酯、丙烯酸2-羟丙酯、丙烯酸4-羟丁酯、丙烯酸1,4-丁二醇脂、以及它们的组合。在一些其他实施例中,二丙烯酸酯可包括以下项的二丙烯酸酯:1,4-丁二醇、1,6-己二醇、四乙二醇、三丙二醇、和乙氧基化的双酚-A。在其他实施例中,三丙烯酸酯单体包含三羟甲基丙烷三丙烯酸酯单体、乙氧基化三丙烯酸酯单体、丙氧基甘油三丙烯酸酯单体、和季戊四醇三丙烯酸酯单体。
在一些实施例中,中性甲基丙烯酸酯单体单元可包括但不限于甲基丙烯酸甲酯、甲基丙烯酸乙酯、甲基丙烯酸正丁酯、甲基丙烯酸异丁酯、甲基丙烯酸叔丁酯、甲基丙烯酸2-乙基己酯、甲基丙烯酸月桂酯、甲基丙烯酸烷基酯、甲基丙烯酸十三烷基酯、甲基丙烯酸硬脂酯、甲基丙烯酸环己酯、甲基丙烯酸苄酯、甲基丙烯酸异冰片酯、甲基丙烯酸2-羟乙酯、甲基丙烯酸2-羟丙酯、甲基丙烯酸二甲氨基乙酯、甲基丙烯酸二乙氨基乙酯、甲基丙烯酸缩水甘油酯、甲基丙烯酸四氢糠酯、甲基丙烯酸烯丙酯、甲基丙烯酸乙二醇酯、甲基丙烯酸三乙二醇酯、甲基丙烯酸四乙二醇酯、甲基丙烯酸1,3-丁二醇酯、甲基丙烯酸1,6-己二醇酯、甲基丙烯酸三羟甲基丙烷酯、甲基丙烯酸乙氧基乙酯和甲基丙烯酸三氟乙酯、以及它们的组合。
在一些实施例中,中性共聚物可包含具有季铵基团的丙烯酸乙酯、甲基丙烯酸甲酯和甲基丙烯酸酯的共聚物。
在一些实施例中,中性共聚物可包含Eudragit RS100(由德国达姆施塔特的赢创工业集团(Evonic Industries AG,Damstadt,Germany)销售)、Eudragit RL 100(由德国达姆施塔特的赢创工业集团(Evonic Industries AG,Damstadt,Germany)销售)、以及它们的组合。
中性共聚物可用作具有柔性特性和低强度的成膜剂,该成膜剂在刮擦或刷牙期间保持粘附力。然而,中性共聚物在基于水和/或醇的涂层体系中具有较差溶解度。酸性共聚物可例如有助于使中性共聚物溶解于溶剂体系中,并且柔性的中性共聚物可有助于形成更坚韧的膜,并因此对牙齿结构提供良好粘附力。在一些实施例中,本公开的口腔组合物的稠度可为约45至约110。口腔组合物的粘度以稠度进行表征。组合物的稠度越高表示当施用压力时组合物越易铺展,这意味着粘度越低。口腔组合物具有要在口腔中施用的特定稠度范围。当口腔组合物的稠度过高时,口腔组合物过于易流动,并产生滴注问题。当口腔组合物的稠度过低时,口腔组合物过粘并难以铺展。
在一些实施例中,中性共聚物的分子量可为约10,000至约100,000。
在一些实施例中,口腔组合物可包含约15至约50重量%的酸性共聚物和中性共聚物的总和。本公开的每种组分的重量%是基于组合物的总重量计的。在一些其他实施例中,口腔组合物可包含约20至约48重量%的酸性共聚物和中性共聚物的总和。在其他实施例中,口腔组合物可包含约22至约37重量%的酸性共聚物和中性共聚物的总和。
碱性共聚物
在一些实施例中,本公开的方法中所用的口腔组合物还可包含碱性共聚物,该碱性共聚物具有碱性丙烯酸酯单体单元、碱性甲基丙烯酸酯单体单元、或它们的组合。碱性共聚物例如可用于通过离子交互作用使酸性聚合物交联,以改善本公开的口腔组合物的机械特性。
在一些实施例中,碱性共聚物可包含含有甲基丙烯酸二甲氨基乙酯的共聚物。在一些其他实施例中,碱性共聚物可包含基于甲基丙烯酸二甲氨基乙酯、甲基丙烯酸丁酯和甲基丙烯酸甲酯的共聚物。在其他实施例中,碱性共聚物可选自Eudragit E100和其他共聚物,该其他共聚物包含甲基丙烯酸二甲氨基乙酯以用于离子交联。
在一些实施例中,碱性共聚物的分子量可为约10,000至约100,000。在一些其他实施例中,口腔组合物包含约0至约1.0重量%的碱性共聚物。在其他实施例中,口腔组合物包含约0.1至约0.4重量%的碱性共聚物。
在一些实施例中,碱性共聚物与酸性聚合物的重量比可为约0至约1∶10。在其他实施例中,碱性共聚物与酸性聚合物的重量比可为约11100至约1∶15。此类重量比例如可提供良好的离子交联。当碱性共聚物与酸性聚合物的重量比过高时,碱性共聚物与酸性聚合物之间的交互作用过强。因此,所述两种共聚物形成非常高粘度的凝胶,该凝胶无法溶解于口腔组合物体系中并且非常难以处理和混合。具有过多碱性共聚物的此类口腔组合物失去了它作为涂层组合物的功能。
口腔组合物的特性和用途
在一些实施例中,口腔组合物在与水性溶液接触时可在表面上形成膜。在其他实施例中,本公开的口腔组合物与水接触或用压缩空气流干燥之后,该口腔组合物可在小于约30秒内形成膜。
当本公开的口腔组合物接触水时,水混溶性溶剂可扩散到水中并且水还可扩散到口腔组合物中。因此,共聚物链之间的分子交互作用可显著增加并然后形成耐用、抗牙刷磨损和光滑的膜。另选地,膜可通过空气干燥形成。例如,吹气可使水和溶剂蒸发以形成耐用、抗刷子磨损和光滑的膜。
本公开的口腔组合物可提供长效涂层/膜。在一些实施例中,在刷洗表面至少5个行程之后,膜保留在表面的至少90%上。在一些其他实施例中,在刷洗表面至少10个行程之后,膜保留在表面的至少90%上。在其他实施例中,在刷洗表面至少20个行程之后,膜保留在表面的至少90%上。在另一些其他实施例中,在刷洗表面至少30个行程之后,膜保留在表面的至少90%上。在一些情况下,在刷洗表面至少60个行程之后,膜保留在表面的至少90%上。在其他情况下,在刷洗表面至少90个行程之后,膜保留在表面的至少90%上。在另一些其他情况下,在刷洗表面至少120个行程之后,膜保留在表面的至少90%上。
在一些实施例中,在刷洗表面5至120个行程之后,膜保留在表面的至少90%上。在一些其他实施例中,在刷洗表面10至90个行程之后,膜保留在表面的至少90%上。在其他实施例中,在刷洗表面20至60个行程之后,膜保留在表面的至少90%上。在另一些其他实施例中,在刷洗表面5至120个行程之后,膜保留在表面的至少90%上。
可采用各种方法将口腔组合物施用在牙齿结构上。在一些实施例中,口腔组合物可从组合物的容器或分配器诸如瓶子、注射器或管施用。在一些实施例中,使用牙刷、微纤维、泡沫或海绵施用装置或棉花Q尖端擦刷牙齿结构表面并在表面上留下一薄层涂层。在一些其他实施例中,可使用填充有口腔组合物的托盘施用装置、牙托、或牙条。口腔组合物可覆盖牙齿结构的表面并在表面上留下一层涂层。在其他实施例中,可用喷涂装置或气溶胶施用装置将口腔组合物喷涂(如,气刷)到牙齿结构的表面上。在其他实施例中,可用附接到注射器的刷子尖端将口腔组合物直接涂到牙齿结构的表面上。在另外一些其他实施例中,可施用口腔组合物作为漱口液。口腔组合物可在30秒内通过水、唾液或通过吹气干燥而定形到牙齿结构及其附接件上的涂层中。
活性剂
在一些实施例中,本公开的口腔组合物可包含活性剂。在其他实施例中,活性剂可包括但不限于增白剂、防龋剂、氟化物递送剂、抗齿龈炎剂、牙垢控制剂、抗牙菌斑剂、牙周活性物质、口气清新剂、恶臭控制剂、牙齿脱敏剂、唾液刺激剂、调味剂、生物膜破坏剂、抗微生物剂、麻醉剂、镇痛剂、去污剂、着色剂、矿质补充剂、结石软化剂、以及它们的组合。
在各种实施例中,本公开的口腔组合物可包含增白剂。如下文进一步所述,“增白剂”为一种材料,该材料能够有效地实现施用有该材料的牙齿表面的增白。在各种实施例中,本公开的口腔组合物可包含过氧化物增白剂,该增白剂包含过氧化物化合物。本文中所指的“过氧化物化合物”为包含二价氧-氧基团的氧化化合物。过氧化物化合物可包括但不限于过氧化物和氢过氧化物,诸如过氧化氢、碱金属和碱土金属的过氧化物、有机过氧化物化合物、过氧化酸、它们的可药用盐、以及它们的混合物。碱金属和碱土金属的过氧化物可包括但不限于过氧化锂、过氧化钾、过氧化钠、过氧化镁、过氧化钙、过氧化钡、以及它们的混合物。有机过氧化物化合物可包括但不限于过氧化脲(也称为尿素过氧化氢)、甘油基过氧化氢、烷基过氧化氢、二烷基过氧化物、烷基过氧酸、过氧化酯、二酰基过氧化物、过氧化苯甲酰和单过氧邻苯二甲酸镁,以及它们的混合物。过氧酸和它们的盐可包括但不限于有机过氧酸诸如烷基过氧酸、和单过氧邻苯二甲酸镁、以及它们的混合物,以及无机过氧酸盐,诸如碱金属和碱土金属诸如锂、钾、钠、镁、钙和钡的过硫酸盐、过二硫酸盐、过碳酸盐、过磷酸盐、过硼酸盐和过硅酸盐,以及它们的混合物。在各种实施例中,过氧化物化合物可包括但不限于过氧化氢、过氧化脲、过碳酸钠以及它们的混合物。在一个实施例中,过氧化物化合物可包含过氧化氢。在一个实施例中,过氧化物化合物可基本上由过氧化氢组成。
本公开的口腔组合物可包含非过氧化物增白剂。本文可用的那些中的增白剂可包含非过氧化物化合物,诸如二氧化氯、亚氯酸盐和次氯酸盐。亚氯酸盐和次氯酸盐可包括但不限于碱金属和碱土金属诸如锂、钾、钠、镁、钙和钡的那些亚氯酸盐和次氯酸盐。非过氧化物增白剂还可包括但不限于着色剂,诸如二氧化钛和羟基磷灰石。
本公开的口腔组合物可包含牙垢控制(抗牙结石)剂。本文可用的那些牙垢控制剂中的牙垢控制剂可包括但不限于这些试剂中的任何一者的磷酸盐和多磷酸盐(例如焦磷酸盐)、聚氨基丙烷磺酸(AMPS)、聚烯烃磺酸盐、聚烯烃磷酸盐、二膦酸盐诸如氮杂环烷烃-2,2-二膦酸盐(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、膦酰基烷烃羧酸和盐,例如其碱金属和铵盐。可用的无机磷酸盐和多磷酸盐可包括但不限于一元、二元和三元磷酸钠、三聚磷酸钠、四聚磷酸盐、焦磷酸一钠、二钠、三钠和四钠、三偏磷酸钠、六偏磷酸纳以及它们的混合物,其中钠可任选地由钾或铵取代。其他可用抗牙结石剂可包括但不限于聚羧酸酯聚合物和聚乙烯基甲基醚/马来酸酐(PVME/MA)共聚物,诸如可以得自新泽西州韦恩的ISP公司(ISP,Wayne,N.J)的那些。
本公开的口腔组合物可包含亚锡离子源,该离子源可例如用作牙周活性物、牙垢控制剂、防龋剂或牙齿脱敏剂。可使用口服可接受的任何亚锡离子源,包括但不限于氟化亚锡;其他卤化亚锡,诸如氯化亚锡二水合物;有机亚锡羧酸盐,诸如甲酸亚锡、醋酸亚锡、葡萄糖酸亚锡、乳酸亚锡、酒石酸亚锡、草酸亚锡、丙二酸亚锡和柠檬酸亚锡;乙二醇亚锡等。
本公开的口腔组合物可包含抗微生物(如,抗菌)剂。可使用口服可接受的任何抗微生物剂,包括但不限于三氯生(5-氯-2-(2,4-二氯苯氧)苯酚);8-羟基喹啉及其盐;锌离子源和亚锡离子源,诸如柠檬酸锌、硫酸锌、甘氨酸锌、柠檬酸钠锌和焦磷酸亚锡;铜(II)化合物,诸如氯化铜(II)、氟化铜(II)、硫酸铜(II)和氢氧化铜(II);邻苯二甲酸及其盐,诸如邻苯二甲酸镁一钾;血根碱;季铵化合物,诸如氯化烷基吡啶(如,氯化十六烷基吡啶(CPC)、CPC与锌和/或酶的组合、氯化十四烷基吡啶、和N-十四烷基-4-氯化乙基吡啶);双胍,诸如氯己定二葡糖酸盐、海克替啶、奥替尼啶、阿来西定;氯代双酚化合物,诸如2,2′亚甲基双-(4-氯-6-溴苯酚);苯扎氯铵;水杨酰苯胺、杜灭芬;碘;磺酰胺;二双胍;酚醛树脂;哌啶衍生物,诸如地莫匹醇和辛哌醇;厚朴提取物;葡萄籽提取物;百里酚;丁子香酚;薄荷醇;香叶醇;香芹酚;柠檬醛;桉树脑;儿茶酚;4-烯丙基儿茶酚;己基间苯二酚;水杨酸甲酯;抗生素,诸如奥格门汀、阿莫西林、四环素、强力霉素、米诺环素、甲硝唑、新霉素、卡那霉素和克林霉素;以及它们的混合物。可用抗菌剂的进一步例示性列表在美国专利No.5,776,435中有所描述,该专利以引用方式并入本文中。
本公开的口腔组合物可包含抗氧化剂。可使用口服可接受的任何抗氧化剂,包括但不限于丁基化羟基苯甲醚(BHA)、丁基化羟基甲苯(BHT)、维生素A、类胡萝卜素、维生素E、类黄酮、多酚、抗坏血酸、植物抗氧化剂、叶绿素、褪黑激素、以及它们的混合物。
本公开的口腔组合物可包含唾液刺激剂,其可用于例如改善口干。可使用口服可接受的任何唾液刺激剂,包括但不限于食物酸,诸如柠檬酸、乳酸、苹果酸、琥珀酸、抗坏血酸、己二酸、富马酸和酒石酸、以及它们的混合物。
本公开的口腔组合物可包含口气清新剂。可使用口服可接受的任何口气清新剂,包括但不限于锌盐,诸如葡萄糖酸锌、柠檬酸锌和亚氯酸锌、α-紫罗兰酮、以及它们的混合物。
本公开的口腔组合物可包含抗牙菌斑(如,牙斑破坏)剂。可使用口服可接受的任何抗牙菌斑剂,包括但不限于亚锡盐、铜盐、镁盐和锶盐、聚二甲基硅氧烷共聚多元醇诸如鲸蜡基聚二甲基硅氧烷共聚多元醇、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、以及它们的混合物。
在一些实施例中,抗牙菌斑剂可包含通式I的化合物或其可药用盐:
其中R1和R2独立地选自氢原子、烷基基团、C(O)R3和SO2R4;R3和R4独立地选自烷基基团、芳基基团、和芳烷基基团;并且n为2至5的整数。在一些实施例中,可药用盐不含未取代的或取代的环庚三烯酚酮。在一些实施例中,R1和R2各自包含氢原子,或独立地选自氢原子和烷基基团。在某些实施例中,R1或R2独立地包含约一个至约四个碳原子的烷基基团。在其他实施例中,R1包含氢原子并且R2包含C(O)R3或SO2R4。通常,R3包含具有约一个至约二十六个碳原子、更典型地约六个至约十六个碳原子的烷基基团。可用抗牙菌斑剂的进一步例示性列表在美国申请和公布No.US2013/0052146中有详细描述,该申请和公布以引用方式并入本文中。
本公开的口腔组合物可包含抗炎剂。可使用口服可接受的任何抗炎剂,包括但不限于类固醇剂,诸如氟轻松和氢化可的松;和非类固醇剂(NSAID),诸如酮咯酸、氟比洛芬、布洛芬、萘普生、吲哚美辛、双氯芬酸、依托度酸、吲哚美辛、舒林酸、托美丁、酮洛芬、非诺洛芬、吡罗昔康、萘丁美酮、阿司匹林、二氟尼柳、甲氯芬那酸、羟基保泰松、保泰松;以及它们的混合物。
本公开的口腔组合物可包含H2拮抗剂。本文可用的H2拮抗剂包括但不限于西咪替丁、丙炔替丁、雷尼替丁、ICIA-5165、硫替丁、ORF-17578、卢皮替丁、冬尼替丁、法莫替丁、罗沙替丁、哌法替丁、兰替丁、BL-6548、BMY-25271、唑替丁、尼扎替丁、咪芬替丁、BMY-52368、SKF-94482、BL-6341A、ICI-162846、雷索替丁、Wy-45727、SR-58042、BMY-25405、拉伏替丁、DA-4634、比芬替丁、舒福替丁、乙溴替丁、HE-30-256、D-16637、FRG-8813、FRG-8701、英普咪定、L-643728、HB-408.4、以及它们的混合物。
本公开的口腔组合物可包含脱敏剂。本文可用的脱敏剂包括但不限于柠檬酸钾、氯化钾、酒石酸钾、碳酸氢钾、草酸钾、硝酸钾、锶盐、精氨酸、以及它们的混合物。另选地或除此之外,可使用局部或全身镇痛剂,诸如阿司匹林、可待因、对乙酰氨基酚、水杨酸钠或水杨酸三乙醇胺。
本公开的口腔组合物可包含营养物质。合适的营养物质可包括但不限于维生素、矿物质、氨基酸、以及它们的混合物。维生素包括但不限于维生素C和D、硫胺素、核黄素、泛酸钙、烟酸、叶酸、烟酰胺、吡哆素、氰钴胺、对氨基苯甲酸、生物类黄酮、以及它们的混合物。营养补充剂包括但不限于氨基酸(诸如L-色氨酸、L-赖氨酸、甲硫氨酸、苏氨酸、左卡尼汀和L-肉毒碱)、抗脂肪肝剂(诸如胆碱、肌醇、甜菜碱和亚油酸)、鱼肝油(包含它们的组分,诸如ω-3(N-3)多不饱和脂肪酸、二十碳五烯酸和二十二碳六烯酸)、辅酶Q10、以及它们的混合物。
本公开的口腔组合物可包含蛋白质。合适的蛋白质可包括但不限于牛奶蛋白和酶诸如过氧化物产生酶、淀粉酶、和牙斑破坏剂诸如木瓜蛋白酶、葡糖淀粉酶、葡萄糖氧化酶。
本公开的口腔组合物可包含可例如用作防龋剂的无机或有机氟化物离子源。可使用口服可接受的任何氟化物离子源,包括但不限于氟化钾、氟化钠和氟化铵和一氟磷酸、氟化亚锡、氟化铟以及它们的混合物。有机氟化物源可包括氟化四烷基铵或四烷基铵四氟硼酸盐等。在各种实施例中,使用水溶性氟化物离子源。在一些其他实施例中,活性剂可包含至少两种不同的氟化物盐。在其他实施例中,活性剂可包括但不限于氟化钠、氟化锶、氟化钙、氟化锌、氯化钙、硝酸钙、磷酸钙、磷酸氢钙、磷酸二氢钙、以及它们的组合。在一些实施例中,活性剂可提供至少24小时的氟化物持续释放。因此,本公开的口腔组合物可例如提供氟化物持续释放。
递送水性口腔组合物的方法
在一些实施例中,提供了一种将本公开的口腔组合物递送至牙齿结构的方法。该方法可包括提供口腔组合物;将口腔组合物施用于牙齿结构;以及使口腔组合物与水性溶液接触,从而在牙齿结构上形成聚合物膜。
具有由口腔组合物形成的膜的牙齿结构
如图1所示,在一些实施例中,提供了牙齿结构10。牙齿结构10可包括牙齿制品30、和牙齿制品的表面上的膜20。在这些实施例中,可通过使本公开的口腔组合物与水性溶液接触或通过使口腔组合物在牙齿制品上干燥来形成膜。口腔组合物可包含酸性共聚物、中性共聚物和任选的活性剂。酸性共聚物可具有酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合。中性共聚物可具有中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合。
下述实施例旨在说明本公开而非进行限制。
实施例
实施例1为一种口腔组合物,包含:
含有水和助溶剂的溶剂,所述溶剂选自低级烷基醇、丙酮以及它们的组合;
酸性共聚物,该酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;
中性共聚物,该中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及
任选的活性剂;
其中所述口腔组合物包含约6至约18重量%的水、约30至约80重量%的助溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和,并且每种组分的重量%是基于所述组合物的总重量计的;
其中酸性共聚物和中性共聚物溶解于口腔组合物中;并且
其中口腔组合物在与水性溶液接触时能够在表面上形成膜。
实施例2为实施例1所述的口腔组合物,其中所述助溶剂为乙醇。
实施例3为前述实施例中任一项所述的口腔组合物,其中所述口腔组合物包含约8至约12重量%的水。
实施例4为前述实施例中任一项所述的口腔组合物,其中所述口腔组合物包含约45至约60重量%的助溶剂。
实施例5为一种口腔组合物,包含:
溶剂,所述溶剂选自低级烷基醇、THF、DMSO、离子液体、TEC、乙酸乙酯、丙酮、以及它们的组合;
酸性共聚物,所述酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;
中性共聚物,所述中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及
任选的活性剂;
其中所述口腔组合物包含约30至约80重量%的溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和,并且每种组分的重量%是基于所述组合物的总重量计的;
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中;并且
其中所述口腔组合物在与水性溶液接触时能够在表面上形成膜。
实施例6为实施例5所述的口腔组合物,其中所述助溶剂为乙醇。
实施例7为前述实施例中任一项所述的口腔组合物,其中所述口腔组合物在与水接触之后,所述口腔组合物能够在小于约30秒内形成膜。
实施例8为前述实施例中任一项所述的口腔组合物,其中所述口腔组合物的稠度为约45至约110。
实施例9为前述实施例中任一项所述的口腔组合物,其中所述溶剂还包含选自异丙醇、丙二醇、甘油、基于低分子量聚乙二醇、乙二醇的酯醇类、以及它们的组合的至少一种附加组分。
实施例10为前述实施例中任一项所述的口腔组合物,其中所述酸性共聚物的分子量为约5,000至约500,000。
实施例11为前述实施例中任一项所述的口腔组合物,其中所述中性共聚物的分子量为约10,000至约100,000。
实施例12为前述实施例中任一项的口腔组合物,其中所述口腔组合物包含约20至约48重量%的酸性共聚物和中性共聚物的总和。
实施例13为前述实施例中任一项所述的口腔组合物,其中所述口腔组合物包含约22至约37重量%的酸性共聚物和中性共聚物的总和。
实施例14为前述实施例中任一项所述的口腔组合物,其中所述酸性共聚物选自Eudragit S100、Eudragit L100、Eudragit L100-55、AC210以及它们的组合。
实施例15为前述实施例中任一项所述的口腔组合物,其中所述中性共聚物选自Eudragit RS100和Eudragit RL 100。
实施例16为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面至少5个行程之后,膜保留在所述表面的至少90%上。
实施例17为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面至少10个行程之后,膜保留在所述表面的至少90%上。
实施例18为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面至少20个行程之后,膜保留在所述表面的至少90%上。
实施例19为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面至少30个行程之后,膜保留在所述表面的至少90%上。
实施例20为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面至少60个行程之后,膜保留在所述表面的至少90%上。
实施例21为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面至少90个行程之后,膜保留在所述表面的至少90%上。
实施例22为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面至少120个行程之后,膜保留在所述表面的至少90%上。
实施例23为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面5至120个行程之后,膜保留在所述表面的至少90%上。
实施例24为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面10至90个行程之后,膜保留在所述表面的至少90%上。
实施例25为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面20至60个行程之后,膜保留在所述表面的至少90%上。
实施例26为前述实施例中任一项所述的口腔组合物,其中在刷洗所述表面5至120个行程之后,膜保留在所述表面的至少90%上。
实施例27为前述实施例中任一项所述的口腔组合物,其中所述口腔组合物还包含碱性共聚物,所述碱性共聚物包含碱性丙烯酸酯单体单元、碱性甲基丙烯酸酯单体单元、或它们的组合。
实施例28为实施例27所述的口腔组合物,其中所述口腔组合物包含约0至约1.0重量%的碱性共聚物。
实施例29为实施例27-28所述的口腔组合物,其中所述口腔组合物包含约0.1至约0.4重量%的碱性共聚物。
实施例30为实施例27-29所述的口腔组合物,其中所述碱性共聚物与酸性共聚物的重量比为约0至约1∶10。
实施例31为实施例27-30所述的口腔组合物,其中所述碱性共聚物与酸性共聚物的重量比为约1∶100至约1∶15。
实施例32为实施例27-31所述的口腔组合物,其中所述碱性共聚物选自EudragitE100和其他共聚物,所述其他共聚物包含甲基丙烯酸二甲氨基乙酯以用于离子交联。
实施例33为实施例27-32所述的口腔组合物,其中所述碱性共聚物的分子量为约10,000至约100,000。
实施例34为前述实施例中任一项所述的口腔组合物,其中所述活性剂选自增白剂、防龋剂、氟化物递送剂、抗齿龈炎剂、牙垢控制剂、抗牙菌斑剂、牙周活性物、口气清新剂、恶臭控制剂、牙齿脱敏剂、唾液刺激剂、调味剂、生物膜破坏剂、抗微生物剂、麻醉剂、镇痛剂、去污剂、着色剂、矿质补充剂、结石软化剂、以及它们的组合。
实施例35为前述实施例中任一项所述的口腔组合物,其中所述活性剂为氟化物组合物。
实施例36为前述实施例中任一项所述的口腔组合物,其中所述活性剂提供至少24小时的氟化物持续释放。
实施例37为前述实施例中任一项所述的口腔组合物,其中所述活性剂包含至少两种不同的氟化物盐。
实施例38为前述实施例中任一项所述的口腔组合物,其中所述活性剂选自氟化钠、氟化锶、氟化钙、氟化锌、氯化钙、硝酸钙、磷酸钙、磷酸氢钙、磷酸二氢钙、以及它们的组合。
实施例39为一种口腔组合物,包含:
含有水和助溶剂的溶剂,所述溶剂选自低级烷基醇、丙酮以及它们的组合;
酸性共聚物,所述酸性共聚物选自Eudragit S100、Eudragit L100、EudragitL100-55、AC210以及它们的组合;
中性共聚物,所述中性共聚物选自Eudragit RS100和Eudragit RL 100;
Eudragit E100;以及
任选的氟化物盐;
其中所述口腔组合物包含约8至约12重量%的水、约30至约80重量%的助溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和;
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中;并且
其中口腔组合物在与水性溶液接触时能够在表面上形成膜。
实施例40为一种将口腔组合物递送至牙齿结构的方法,所述方法包括:
提供口腔组合物;
将所述口腔组合物施用于所述牙齿结构;以及
使所述口腔组合物与水性溶液接触,从而在所述牙齿结构上形成聚合物膜。
实施例41为实施例40所述的方法,其中所述口腔组合物包含
含有水和助溶剂的溶剂,所述溶剂选自低级烷基醇和丙酮;
酸性共聚物,所述酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;
中性共聚物,所述中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及
任选的活性剂;
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中。
实施例42为实施例40所述的方法,其中所述口腔组合物包含
溶剂,所述溶剂选自低级烷基醇、THF、DMSO、离子液体、TEC、乙酸乙酯、丙酮、以及它们的组合;
酸性共聚物,所述酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;
中性共聚物,所述中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及
任选的活性剂;
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中。
实施例43为一种牙齿结构,包括:
牙齿制品,和
所述牙齿制品的表面上的膜,
其中通过使口腔组合物与水性溶液接触或通过使所述口腔组合物在所述牙齿制品上干燥来形成膜;
其中所述口腔组合物包含:
酸性共聚物,所述酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;
中性共聚物,所述中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及
任选的活性剂。
实施例44为实施例43所述的牙齿结构,其中所述口腔组合物还包含含有水和助溶剂的溶剂,所述溶剂选自低级烷基醇和丙酮,
其中所述口腔组合物包含约6至约18重量%的水、约30至约80重量%的助溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和,并且每种组分的重量%是基于组合物的总重量计的;并且
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中。
实施例45为实施例43所述的牙齿结构,其中口腔组合物还包含选自低级烷基醇、THF、DMSO、离子液体、TEC、乙酸乙酯、丙酮、以及它们的组合的溶剂;
其中所述口腔组合物包含约30至约80重量%的溶剂、约15至约50重量%的酸性共聚物和中性共聚物的总和,并且每种组分的重量%是基于组合物的总重量计的;并且
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中。
下述工作实例旨在说明本公开而非进行限制。
实例
下面的实例对本发明的目的和有益效果作出更进一步的解释,但这些实例中列举的具体材料和用量以及其它条件和细节不应解释为是对本发明不当的限制。
下面概述了用于制备本发明的实例(Ex)以及比较例(CE)的材料。
材料
口服(涂层)组合物的制备
通过首先将指定量的溶剂称重到具有顶盖的250ml或30ml玻璃广口瓶中来制备聚合物溶液。然后将指定量的聚合物材料加入广口瓶中。将广口瓶密封并随后置于Wheaton培养辊中持续2-3天(~30rpm),直至聚合物完全溶解于溶剂中。在设定为3000rpm的高速混合器(SpeedMixer DAC150.1FVZ,可得自南卡罗来纳州兰德勒姆的FlakTek公司(FlacTek,Inc.,Landrum,SC))中使用两个2分钟循环,将附加成分诸如NaF、其他盐、粘度调节剂、调味剂等加入聚合物溶液中。每种涂层组合物中所用的材料以及量(以克计)示于下面的实例和表中。
人造唾液的制备
用下面的过程制备人造唾液:将3.52g胃粘蛋白、0.610g NaCl、0.341gCaCl2.2H2O、1.183g KH2PO4和1.179g KCL称重到2000ml烧瓶中。使用磁力搅拌棒将1600ml去离子(DI)水缓慢加入混合溶液中,直至所有固体均溶解。用50%NaOH溶液将pH调节至7.0。
测试方法
涂层评估-手感测试、定形测试、粘附力测试和耐磨性测试
使用棉拭子或小刷子将本公开的组合物和比较组合物涂布到玻璃(或塑料,如果注明)玻片(可得宾夕法尼亚州拉德诺的VWR公司(VWR,Radnor PA))或牛牙上。然后将经涂布基材浸入自来水容器中并在室温(~25℃)下保持30秒。随后对涂层进行定性评估以确定膜是否已形成(“定形”)以及膜的手感如何(“硬”、“软”或“粘”)。另外,评估定形膜对基材的粘附力。当无法通过指压将定形膜推离时,粘附力被视为“良好”,并且当可通过指压推离定形膜时,粘附力被视为“无”。通过用牙刷刷洗定形涂层并计算移除涂层所需的刷洗行程数来评估耐磨性。
氟化物释放测试
将大约40-50mg的涂层组合物均匀涂到1英寸×1英寸(2.54cm×2.54cm)的塑料玻片(RINZYL塑料微型玻片,可得自宾夕法尼亚州拉德诺的VWR公司(VWR,Radnor PA))上。将经涂布玻片浸入塑料测试管中的25ml去离子水中保持1小时。1小时之后,将玻片移除、冲洗并随后浸入另一个测试管中的第二25ml等分试样的水中。另外3小时(总共4小时)之后,重复该过程并且将玻片浸入第三25ml等分试样的水中。另外2小时(总共6小时)之后,再次重复该过程并且将玻片置于第四25ml等分试样的水中,该玻片在其中保留另外18小时(总共24小时),然后再被移除。然后对25ml等分试样去离子水中的每一者进行氟化物浓度评估。将上述制备的10ml样品溶液与10ml的TISAB II混合以使溶液用于氟化物浓度测量。使用配备有氟化物组合电极的科尔帕默(Cole Parmer)氟离子计测量氟化物浓度,其中已使用通过TISAB II缓冲的标准氟化物浓度将电极标准化。运行五个重复样品以获得平均值。以ppm计测量氟化物浓度并使用公式将氟化物释放报告为μgF/cm2涂层。
牛牙釉质上的氟化物摄取量测试
将牛牙封装在聚(甲基)丙烯酸甲酯树脂中并然后用320粗砂纸进行抛光以使牙釉质表面暴露在外。随后用约15mg的聚合物组合物涂布暴露表面的一半。用指甲油作为遮罩涂布所暴露牙釉质的另一半。然后将带涂层的牙齿置于37℃下的50m1人造唾液中保持30分钟或24小时。在所规定的时间之后,将牙齿从人造唾液中移除并用水冲洗。然后用乙醇/丙酮溶液冲洗带涂层的牙齿以移除涂层,并随后最终用水冲洗以获得清洁表面。使用HitachiTM3000桌面扫描电子显微镜确定牙齿表面上的氟化物原子%。针对每个涂层收集三个数据点并取平均值。
液体稠度
液体稠度为涂层组合物的粘度的测量值。通过将0.15g涂层液体置于4×4英寸(10.2×10.2cm)的第一玻璃板的中心来确定稠度。然后将相同的第二玻璃板置于第一玻璃板的顶部,从而将涂层液体夹在两个板之间。将2磅(0.91kg)压缩砝码置于第二板的顶部上保持2分钟。然后移除砝码并且围绕由压缩样品形成的圆以120°间隔进行压缩液体的三次直径测量。测量精确至1/32英寸(0.79mm)。所有测量均通过顶板进行,在进行测量时注意不要对板施用任何压力。报告三次测量的平均值(以1/32英寸计)。45-110(35-87mm)的稠度测量值被视为可接受的。
耐磨性牙刷测试
将牛牙封装在聚(甲基)丙烯酸甲酯(PMMA)树脂中并然后用320粗砂纸进行抛光以使牙釉质表面暴露在外。用纸巾擦拭所暴露牙釉质以移除过量的水,然后用约10mg材料涂布以在牙釉质上形成薄层,并然后存储在37℃的人造唾液中保持变化的时间量。使用牙刷机(可得自威斯康星州绿湾的福斯生产溶液公司(Foth Production Solution,LLC,Greenbay WI))测试牙釉质上的涂层磨损耐久性。用得自亨利施恩公司(Henry Schein)的品牌名为Acclean的牙齿护理装置从牙刷中切割牙刷头,并且将牙刷头插入牙刷机上的夹具中。插入封装的牛牙并将其固定在填充有刷子介质的塑料口中。将牙刷头静置于涂层表面上。牙刷机可控制牙刷头紧贴牙釉质上的涂层前后移动。刷洗行程被定义为前后刷洗表面一次。将5ml的1∶1水和牙膏(佳洁士口腔保护牙膏)混合物用作刷子介质。在特定的刷洗行程之后,检查涂层表面并估计磨损量。
牙质表面的SEM的样品制备
将牛牙封装在PMMA树脂中并然后用320粗砂纸进行抛光以使牙质暴露在外。使用SCOTCHBOND蚀刻剂(可得自明尼苏达州圣保罗的3M公司(3M Company,St.Paul,MN))对牙齿表面蚀刻10秒,并然后用水冲洗,以移除涂层并使牙质小管暴露在外。然后将所暴露牙质的一半涂布约15mg的涂层溶液,并且将所暴露牙质的另一半保留未涂布。然后将牙齿放入37℃下的20m1人造唾液中保持30分钟,并然后用水冲洗。使用Hitachi TM3000桌面显微镜拍摄牙质表面的扫描电子显微图(SEM)图像
比较例1-10:各种聚合物涂层组合物
如上所述使用下表1中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的定形、手感和粘附力进行评估。
实例1-3和比较例11-15:具有水和乙醇的组合物
如上所述使用下表2中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的定形、手感和粘附力进行评估。
实例4和比较例16-18:具有碱性聚合物的组合物
如上所述使用下表3中概述的材料和量(以克计)制备和涂布涂层组合物。
实例5-11和比较例19-20:具有水/乙醇/PPG溶剂的组合物
如上所述使用下表4中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的定形、手感和粘附力进行评估。
实例12-19和比较例21-23:具有水/乙醇/甘油溶剂的组合物
如上所述使用下表5中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的定形、手感和粘附力进行评估。
实例20-22和比较例24-25:具有水/乙醇/甘油/DEGEE作为溶剂的组合物
如上所述使用下表6中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的定形、手感和粘附力进行评估。
实例23-26:具有水/乙醇/PPG作为溶剂的组合物
如上所述使用下表7中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的定形、手感、粘附力和耐磨性进行评估。
实例27-28和比较例26:牛牙釉上的耐磨性和氟化物摄取量
如上所述使用下表8中概述的材料和量(以克计)制备涂层组合物。如上所述将涂层组合物施用至牛牙,并随后浸入人造唾液中保持30分钟或24小时。如上所述通过计算移除定形膜所需的刷洗行程数来测定耐磨性。随后如上所述测量牛牙釉质上的氟化物摄取量。
实例29-33:具有添加剂的组合物
如上所述使用下表9中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的定形、手感和粘附力进行评估。
实例34-52:氟化物释放
如上所述使用下表10中概述的材料和量(以克计)制备和涂布包含氟化物的涂层组合物。然后对形成于1英寸×1英寸(2.54cm×2.54cm)塑料玻片上的膜进行氟化物释放评估,如上所述。
如上所述使用下表11中概述的材料和量(以克计)制备和涂布包含氟化物盐的各种组合的涂层组合物。这些涂层示出氟化物持续释放。然后对形成于1英寸×1英寸(2.54cm×2.54cm)塑料玻片上的膜进行氟化物释放评估,如上所述。
如上所述使用下表12中概述的材料和量(以克计)制备和涂布包含氟化物盐的各种组合的涂层组合物。这些涂层示出氟化物持续释放。然后对形成于1英寸×1英寸(2.54cm×2.54cm)塑料玻片上的膜进行氟化物释放(FR)评估,如上所述。
如上所述使用下表14中概述的材料和量(以克计)制备和涂布包含氟化钠和氯化金属盐的各种组合的涂层组合物。然后对形成于1英寸×1英寸(2.54cm×2.54cm)塑料玻片上的膜进行氟化物释放(FR)评估,如上所述。
实例51-55;彩色涂层
如上所述使用下表14中概述的材料和量(以克计)制备和涂布包含各种颜料的涂层组合物。然后如上所述对形成于1英寸×1英寸(2.54cm×2.54cm)塑料玻片上的膜的定形、手感和粘附力以及外观(颜色)进行评估。
实例56-59和比较例23-25:具有各种助溶剂的水性涂层组合物
如上所述使用下表15中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的溶解、定形和粘附力进行评估。
实例60-70:涂层组合物稠度
如上所述使用下表16中概述的材料和量(以克计)制备和涂布涂层组合物。用上文列出上文所述的方法测量稠度数值并报告为1/32英寸(0.79mm)。
实例48:耐磨性
如上所述测定实例48的涂层组合物在牛牙上的耐磨性。将带涂层的牙齿的三个重复样品浸渍在37℃人造唾液中保持3小时或24小时,并然后使其经受刷洗。在特定刷洗行程数之后移除的涂层量报告于下表17中。
实例71:用于敏感性降低的涂层组合物
如上所述使用下表18中概述的材料和量(以克计)制备适用于降低牙齿敏感性的涂层组合物。
将敏感性降低涂层涂在不同牙齿器械、修复材料和它们与牙齿结构的组合上。通过使这些涂层暴露于水或人造唾液,将涂层定形到这些基材上的硬而光滑的膜中。修复基底为固化盘(15mm直径×1mm厚),该固化盘通过以下过程制备:将所指示修复牙齿材料置于不锈钢模具中,用压机将材料展平并随后用3M ESPE S10LED固化灯(可得自明尼苏达州圣保罗的3M公司(3M Company,St Paul,MN))进行光固化。除了牛牙以外,该测试中所用的所有材料和制品均可得自明尼苏达州圣保罗的3M公司(3M Company,St Paul,MN)。对涂层进行关于是否在基材上形成涂层以及该涂层通过手指触摸的手感如何的评估。对这些带涂层的基材的观察示于下表19中。
使如上所述制备和涂布的牛牙的SEM图像展示表18中概述的涂层组合物形成物理屏障以阻挡牙质小管降低牙齿敏感性。牛牙的SEM图像(图1)示出由左侧涂层阻挡的牙质小管,以及右侧的未经涂布开放牙质小管。
实例72-80:具有多种溶剂的非水性涂层组合物
如上所述使用下表20中概述的材料和量(以克计)制备和涂布涂层组合物。如上所述对带涂层的膜的溶解、定形和粘附力进行评估。
Claims (25)
1.一种口腔组合物,所述口腔组合物包含:
含有水和助溶剂的溶剂,所述溶剂选自C1-C5烷基醇、丙酮以及它们的组合;
酸性共聚物,所述酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;
中性共聚物,所述中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及
任选的活性剂;
其中所述口腔组合物包含6至18重量%的水、30至80重量%的助溶剂、15至50重量%的所述酸性共聚物和所述中性共聚物的总和,并且每种组分的重量%是基于所述组合物的总重量计的;
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中;并且
其中所述口腔组合物在与水性溶液接触时能够在表面上形成膜,
其中上述组分的总和小于或等于100%。
2.根据权利要求1所述的口腔组合物,其中所述口腔组合物包含8至12重量%的水,并且其中所述口腔组合物包含45至60重量%的所述助溶剂。
3.一种口腔组合物,所述口腔组合物包含:
溶剂,所述溶剂选自C1-C5烷基醇、THF、DMSO、离子液体、TEC、乙酸乙酯、丙酮、以及它们的组合;
酸性共聚物,所述酸性共聚物包含酸性丙烯酸酯单体单元、酸性甲基丙烯酸酯单体单元、或它们的组合;
中性共聚物,所述中性共聚物包含中性丙烯酸酯单体单元、中性甲基丙烯酸酯单体单元、或它们的组合;以及
任选的活性剂;
其中所述口腔组合物包含30至80重量%的溶剂、15至50重量%的所述酸性共聚物和所述中性共聚物的总和,并且每种组分的重量%是基于所述组合物的总重量计的;
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中;并且
其中所述口腔组合物在与水性溶液接触时能够在表面上形成膜。
4.根据权利要求3所述的口腔组合物,其中所述口腔组合物在与水接触之后,所述口腔组合物能够在小于30秒内形成所述膜。
5.根据权利要求3所述的口腔组合物,其中所述口腔组合物的稠度为45至110。
6.根据权利要求3所述的口腔组合物,其中所述溶剂还包含至少一种附加组分,所述至少一种附加组分选自异丙醇、丙二醇、甘油、基于低分子量聚乙二醇、乙二醇的酯醇类、以及它们的组合。
7.根据权利要求3所述的口腔组合物,其中所述酸性共聚物的分子量为5,000至500,000,并且其中所述中性共聚物的分子量为10,000至100,000。
8.根据权利要求4所述的口腔组合物,其中所述口腔组合物包含20至48重量%的所述酸性共聚物和所述中性共聚物的总和。
9.根据权利要求3所述的口腔组合物,其中在刷洗所述表面至少5个行程之后,所述膜保留在所述表面上的至少90%。
10.根据权利要求3所述的口腔组合物,其中所述口腔组合物还包含碱性共聚物,所述碱性共聚物包含碱性丙烯酸酯单体单元、碱性甲基丙烯酸酯单体单元、或它们的组合,并且其中所述口腔组合物包含0至1.0重量%的所述碱性共聚物。
11.根据权利要求10所述的口腔组合物,其中所述碱性共聚物与所述酸性共聚物的重量比为0至1:10。
12.根据权利要求10所述的口腔组合物,其中所述碱性共聚物选自Eudragit E100和其他共聚物,所述其他共聚物包含甲基丙烯酸二甲氨基乙酯以用于离子交联。
13.根据权利要求10所述的口腔组合物,其中所述碱性共聚物的分子量为10,000至100,000。
14.根据权利要求3所述的口腔组合物,其中所述活性剂选自防龋剂、抗齿龈炎剂、牙垢控制剂、牙周活性物、恶臭控制剂、牙齿脱敏剂、唾液刺激剂、调味剂、抗微生物剂、麻醉剂、镇痛剂、去污剂、着色剂、矿质补充剂、结石软化剂、以及它们的组合。
15.根据权利要求3所述的口腔组合物,其中所述活性剂提供至少24小时的氟化物持续释放。
16.根据权利要求3所述的口腔组合物,其中所述活性剂包含至少两种不同的氟化物盐。
17.根据权利要求3所述的口腔组合物,其中所述活性剂选自氟化钠、氟化锶、氟化钙、氟化锌、氯化钙、硝酸钙、磷酸钙、磷酸氢钙、磷酸二氢钙、以及它们的组合。
18.根据权利要求11所述的口腔组合物,其中所述碱性共聚物与所述酸性共聚物的重量比为1:100至1:15。
19.根据权利要求14所述的口腔组合物,其中所述防龋剂是氟化物递送剂。
20.根据权利要求14所述的口腔组合物,其中所述防龋剂是氟化物组合物。
21.根据权利要求14所述的口腔组合物,其中所述恶臭控制剂是口气清新剂。
22.根据权利要求14所述的口腔组合物,其中所述抗微生物剂是抗牙菌斑剂或生物膜破坏剂。
23.根据权利要求14所述的口腔组合物,其中所述去污剂是增白剂。
24.一种口腔组合物,包含:
含有水和助溶剂的溶剂,所述溶剂选自C1-C5烷基醇、丙酮以及它们的组合;
酸性共聚物,所述酸性共聚物选自Eudragit S100、Eudragit L100、Eudragit L100-55、AC210以及它们的组合;
中性共聚物,所述中性共聚物选自Eudragit RS100和Eudragit RL 100;
Eudragit E100;以及
任选的氟化物盐;
其中所述口腔组合物包含8至12重量%的水、30至80重量%的助溶剂、15至50重量%的所述酸性共聚物和所述中性共聚物的总和;
其中所述酸性共聚物和中性共聚物溶解于所述口腔组合物中;并且
其中所述口腔组合物在与水性溶液接触时能够在表面上形成膜,
其中上述组分的总和小于或等于100%。
25.根据权利要求1所述的口腔组合物,其中所述口腔组合物提供涂层,该涂层密封开放的牙质小管。
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US20170020800A1 (en) | 2014-04-14 | 2017-01-26 | 3M Innovative Properties Company | Oral compositions |
-
2014
- 2014-09-10 US US14/917,431 patent/US10064802B2/en active Active
- 2014-09-10 JP JP2016542055A patent/JP6625985B2/ja active Active
- 2014-09-10 CN CN201480049754.4A patent/CN105530999B/zh active Active
- 2014-09-10 EP EP14781718.3A patent/EP3043870B1/en active Active
- 2014-09-10 RU RU2016110107A patent/RU2662305C2/ru not_active IP Right Cessation
- 2014-09-10 WO PCT/US2014/054901 patent/WO2015038580A1/en active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US4134935A (en) * | 1971-08-12 | 1979-01-16 | Bayer Aktiengesellschaft | Dental varnishes |
US5330746A (en) * | 1988-05-03 | 1994-07-19 | Yissum Research Development Company Of The Hebrew University Of Jerusalem | Dental varnish composition, and method of use |
CN1713882A (zh) * | 2002-11-21 | 2005-12-28 | Lg生活健康株式会社 | 对牙龈安全的干型贴片 |
CN1816312A (zh) * | 2003-05-19 | 2006-08-09 | 考里安国际公司 | 与水性介质接触时显示相分离的水凝胶组合物 |
Also Published As
Publication number | Publication date |
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EP3043870A1 (en) | 2016-07-20 |
JP2016530312A (ja) | 2016-09-29 |
US20160220473A1 (en) | 2016-08-04 |
US10064802B2 (en) | 2018-09-04 |
JP6625985B2 (ja) | 2019-12-25 |
RU2662305C2 (ru) | 2018-07-25 |
WO2015038580A1 (en) | 2015-03-19 |
CN105530999A (zh) | 2016-04-27 |
RU2016110107A (ru) | 2017-10-16 |
EP3043870B1 (en) | 2020-03-04 |
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