CN111163841A - 口腔护理氟化物水性治疗组合物和方法 - Google Patents
口腔护理氟化物水性治疗组合物和方法 Download PDFInfo
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- CN111163841A CN111163841A CN201880063074.6A CN201880063074A CN111163841A CN 111163841 A CN111163841 A CN 111163841A CN 201880063074 A CN201880063074 A CN 201880063074A CN 111163841 A CN111163841 A CN 111163841A
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- therapeutic composition
- fluoride
- multivalent cation
- composition
- weight
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- 238000011282 treatment Methods 0.000 title claims abstract description 41
- 238000000034 method Methods 0.000 title claims abstract description 33
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Abstract
本发明公开了一种口腔护理氟化物水性治疗组合物、向患者的牙齿表面提供氟化物的方法和减少龋病的发病率的方法,其中该组合物包含:0.1重量%至3.0重量%的具有羧酸侧基的交联多元酸;药学上可接受的缓冲剂;1.0重量%至2.5重量%的氟化钠;0.025重量%至1.75重量%的多价阳离子盐;以及至少60重量%的水;其中重量百分比基于水性组合物的总重量。
Description
背景技术
氟化物治疗涉及向牙齿表面施用氟化物,同时形成氟磷灰石和氟化钙。
目前存在两种在使用中的主要诊所氟化物治疗方法。一种治疗方法在牙托中使用氟化物凝胶/泡沫。该方法需要将几克氟化物凝胶储存在牙托中,然后将该牙托放置到患者的口中的牙齿上。将该牙托放在口中,同时使凝胶/泡沫与牙齿接触1分钟至4分钟。凝胶/泡沫制剂为包含2%氟化钠的水性体系。该材料需要使用吸力将额外的凝胶从口中吸出,以避免摄入不必要的大量氟化物。
另一种治疗方法是牙科氟化物涂膜。市场上的大多数氟化物涂膜是具有疏水性质的基于松香/乙醇的制剂。将涂膜涂抹在牙齿上并保持就位达数小时,以允许氟化物从组合物中释放出来。通常,牙医使用氟化物涂膜进行诊所氟化物治疗。大多数牙科氟化物涂膜包含5%的氟化钠。涂膜的剂量为约0.5克。与氟化物凝胶/泡沫相比,牙科涂膜将少得多的量的氟化物放置到患者的口中。因此,在氟化物涂膜的情况下氟化物摄入较少。另外,氟化物涂膜更易于施用,因为它们只是涂抹在患者的牙齿上;然而,氟化物涂膜治疗比凝胶治疗更费力,并且氟化物涂膜治疗给患者留下令人不悦的“脏牙”感觉。
期望的是,像涂膜一样简单地施用到牙齿并能在像凝胶/泡沫制剂一样短的时间段内发挥作用的组合物。
发明内容
本公开提供了口腔护理氟化物水性治疗组合物和治疗方法(例如,向患者的牙齿表面提供氟化物的方法)。
此类组合物可以用作诊所氟化物治疗组合物。如果需要,可以将它们配制成可以被涂抹在牙齿表面上的组合物。它们可以在凝胶/泡沫制剂的较短时间段内提供类似于涂膜的氟化物功效的氟化物功效。
在一个实施方案中,本公开提供了一种口腔护理氟化物水性治疗组合物,该口腔护理氟化物水性治疗组合物包含:0.1重量%至3.0重量%的具有羧酸侧基的交联多元酸;药学上可接受的缓冲剂;1.0重量%至2.5重量%的氟化钠;0.025重量%至1.75重量%的多价阳离子盐;以及至少60重量%的水;其中重量百分比基于水性组合物的总重量。
在另一个实施方案中,本公开提供了一种向患者的牙齿表面提供氟化物的方法。该方法涉及将如本文所公开的口腔护理氟化物水性治疗组合物施用到患者的牙齿表面。
在另一个实施方案中,本公开提供了一种减少龋病的发病率的方法。该方法涉及将如本文所公开的口腔护理氟化物水性治疗组合物施用到患者的牙齿表面。
如本文所用,“烷基”是指作为烷烃基团的一价基团,并且包括直的链(即直链)、支链、环状和二环烷基基团以及它们的组合物,包括未取代的烷基基团和取代的烷基基团两者。除非另外指明,否则烷基基团通常含有1至100个碳原子。在一些实施方案中,烷基基团含有1至60个碳原子、1至30个碳原子、1至10个碳原子、1至6个碳原子、1至4个碳原子或1至3个碳原子。烷基基团的示例包括但不限于甲基、乙基、正丙基、正丁基、正戊基、异丁基、叔丁基、异丙基、正辛基、正庚基、乙基己基、环戊基、环己基、环庚基、金刚烷基、降冰片基等等。
术语“聚合物”和“聚合物材料”包括但不限于有机均聚物,共聚物诸如例如嵌段、接枝、无规和共聚物,三聚物等,以及它们的共混物和改性物。此外,除非另外明确限制,否则术语“聚合物”应包括材料的所有可能的几何构型。这些构型包括但不限于全同立构、间同立构和无规立构对称。
术语“包括”及其变型形式在说明书和权利要求书中出现这些术语的地方不具有限制的含义。此类术语将理解为暗示包括所陈述的步骤或要素或者步骤或要素的组,但不排除任何其他步骤或要素或者步骤或要素的组。所谓“由……组成”是指包括并且限于短语“由……组成”随后的内容。因此,短语“由……组成”指示列出的要素为所需的或强制性的,并且不可存在其他要素。所谓“基本上由……组成”是指包括在该短语之后所列出的任何要素,并且限于不妨碍或有助于本公开中对所列要素规定的活性或作用的其它要素。因此,短语“基本上由……组成”指示所列要素为所需的或强制性的,但其他要素为任选的并且可存在或可不存在,取决于它们是否实质上影响所列要素的活性或作用。
词语“优选的”和“优选地”是指在某些情况下可提供某些有益效果的本公开的实施方案。然而,在相同的情况或其它情况下,其它实施方案也可以是优选的。此外,对一个或多个优选的实施方案的表述并不暗示其他实施方案是不可用的,并且并不旨在将其他实施方案排除在本公开的范围之外。
在本申请中,术语诸如“一个”、“一种”、“该”和“所述”并非仅旨在指单一实体,而是包括一般类别,其具体示例可用于举例说明。术语“一个”、“一种”、“该”和“所述”可与短语“至少一个(种)”和“一个(种)或多个(种)”互换使用。后接列表的短语“……中的至少一个(种)”和“包含……中的至少一个(种)”是指列表中项目中的任一项以及列表中两项或更多项的任何组合。
除非内容另外清楚指出,否则术语“或”一般以包括“和/或”的普通意义使用。
术语“和/或”意指所列要素中的一个或全部,或者所列要素中的任何两个或更多个的组合。
另外在本文中,所有数值假定通过术语“约”修饰,并且在某些实施方案中优选地通过术语“精确地”修饰。如本文所用,关于所测量的量,术语“约”是指所测量的量方面的偏差,这个偏差为如一定程度地小心进行测量的技术人员应当能预期的那种与测量的目标和所用测量设备的精确度相称的偏差。在本文中,“至多”某数字(例如,至多50)包括该数字(例如,50)。
另外在本文中,通过端点表述的数值范围包括该范围内包含的所有数字以及端值(例如,1至5包括1、1.5、2、2.75、3、3.80、4、5等)。
术语“室温”是指20℃至25℃或22℃至25℃的温度。
贯穿本说明书的对“一个实施方案”、“实施方案”、“某些实施方案”或“一些实施方案”等的引用,意指结合实施方案描述的具体特征、构型、组合物或特性包括在本公开的至少一个实施方案中。因此,贯穿本说明书在各处出现的此类短语不一定是指本公开中的相同实施方案。此外,具体特征、构型、组合物或特性可在一个或多个实施方案中以任何合适的方式进行组合。
本公开的上述概述并非旨在描述本公开的每个公开实施方案或每种实现方式。以下描述更为具体地举例说明了例示性实施方案。在本申请通篇的若干处,通过示例列表提供了指导,这些示例可以各种组合使用。在每种情况下,所引用的列表都只用作代表性的组,并且不应被理解为排他性列表。
具体实施方式
本公开提供了口腔护理氟化物水性治疗组合物。本公开还提供了向患者的牙齿表面提供氟化物的方法,以及减少龋病的发病率的方法。此类方法涉及将如本文所述的口腔护理氟化物水性治疗组合物施用到患者的牙齿表面。
在某些实施方案中,施用口腔护理氟化物水性治疗组合物包括将治疗组合物涂抹在患者的牙齿表面上。
在某些实施方案中,施用口腔护理氟化物水性治疗组合物包括将治疗组合物分散到牙科牙托中,以及将其中具有治疗组合物的牙托附接到患者的牙齿表面。在某些实施方案中,牙科牙托包括正畸矫正器治疗牙托。
本公开的口腔护理氟化物水性治疗组合物包含基于水性组合物的总重量计至少60重量%、至少70重量%或至少80重量%的水。在某些实施方案中,治疗组合物包含基于水性组合物的总重量计至多96重量%或至多90重量%的水。
本公开的治疗组合物为水性组合物。尽管所述组合物可以包含少量的有机溶剂(例如(C1-C4)醇,诸如乙醇),但优选地它们不含用作液体载体的有机溶剂(与用作香料或甜味剂的载体/溶剂的有机溶剂相反)。例如,某些添加剂可以作为液体载体的有机溶剂的形式被提供为溶液或分散体。如果在本公开的口腔护理氟化物水性治疗组合物中存在任何有机溶剂(其用作液体载体),则该有机溶剂以基于水性组合物的总重量计小于5重量%的量存在。
本公开的口腔护理氟化物水性治疗组合物包含药学上可接受的缓冲剂。此类缓冲剂的类型和量被选择成提供pH为至少6或至少6.5的治疗组合物。在某些实施方案中,此类缓冲剂的类型和量被选择成提供pH为至多8、至多7.5或至多7的治疗组合物。在某些实施方案中,根据名称为“用于减少龋病的发病率的局部氟化物制剂”,联邦公报,第39卷,第94号,1974年5月14日(“Topical Fluoride Preparations for Reducing Incidence of DentalCaries”,Federal Register,Vol.39,No.94,May 14,1974)的专题著作,此类缓冲剂的类型和量被选择成提供pH为6.5至7.5或pH为7.0的治疗组合物,特别是用于减少龋病的发病率的方法。
多元酸
本公开的口腔护理氟化物水性治疗组合物包含交联多元酸。交联多元酸可以是一种或多种单体的均聚物或共聚物,该一种或多种单体具有一个或多个羧酸基团。
具有一个或多个羧酸基团的单体的示例包括丙烯酸、马来酸、马来酸酐、衣康酸、乙烯基醚、丙烯酸烷基酯和糖类。如果需要,可以使用此类单体的各种组合物。在某些实施方案中,交联多元酸包括丙烯酸、马来酸、衣康酸、丙烯酸(C10-C30)烷基酯以及它们的组合物的均聚物或共聚物。在某些实施方案中,交联多元酸包括交联聚丙烯酸均聚物。
交联剂的示例包括烯丙基蔗糖、烯丙基季戊四醇、甘油、双甘油、聚甘油、聚烯基醇或二乙烯基乙二醇。如果需要,可以使用交联剂的各种组合物。在某些实施方案中,聚丙烯酸与烯丙基蔗糖或烯丙基季戊四醇交联。
本公开的合适的多元酸有助于提供可用于开发具有宽范围流动和流变特性的半固体和液体制剂的组合物。多元酸还可以提供以下功能中的一种或多种功能:高效增稠剂;悬浮剂;消除沉降问题的稳定剂,即使以低水平(例如,0.1重量%至3.0重量%)使用时;流动改性剂;以及生物粘附剂。优选的多元酸在水合和中和时溶胀,从而形成胶态分散体。悬浮液中的不溶性成分随后被截留在水凝胶颗粒之间的间隙中,从而形成稳定的分散体。
多元酸可以具有多种粘度。在某些实施方案中,在0.5重量%的pH 7.5缓冲剂中,交联多元酸具有4,000厘泊至100,000厘泊(cP)的粘度。
示例性多元酸包括线性聚丙烯酸、丙烯酸共聚物、马来酸/马来酸酐共聚物、衣康酸共聚物、乙烯基醚和马来酸酐共聚物(诸如以商品名GANTREZ(来自亚什兰公司(Ashland))购得的产品)、高分子量交联聚丙烯酸均聚物和共聚物(诸如以商品名CARBOPOL(来自路博润生命科学公司(Lubrizol Life Sciences))购得的产品)以及羧酸改性纤维素(CMC)(诸如以商品名KLUCEL(来自亚什兰公司(Ashland))购得的产品)。这些均聚物和共聚物具有相同类型的羧酸侧基,该羧酸侧基可以用一些碱性化学物质中和以形成水性缓冲体系。这些聚合物是水溶性的或可分散的,或者能够与水溶液形成水凝胶。
优选的多元酸是丙烯酸的高分子量聚合物,用聚烯基醇或二乙烯基乙二醇化学交联,以商品名CARBOPOL购得。每个初级颗粒可以被看作通过交联互连的聚合物链的网络结构,从而使得聚合物的分子量为至多30亿道尔顿至40亿道尔顿。在没有交联的情况下,初级颗粒将是线性聚合物链的集合,物理上相互缠绕,但化学上不键合。这些聚合物在水中溶胀至其原始体积的至多1,000倍(和其原始直径的至多十倍),以当暴露于高于它们的6±0.5的pKa的pH环境时形成凝胶。聚合物主链上的羧酸基团离子化,从而导致负颗粒之间相互排斥,这增加了聚合物的溶胀。凝胶含有大量溶胀的微凝胶颗粒,其中间隙中可截留(悬浮)不溶性颗粒。
CARBOPOL聚合物微凝胶容易被剪切移动,但是一旦剪切停止,大凝胶结构立即再次形成。这使得高粘性悬浮液能够容易地搅拌或泵送,一旦搅拌或泵送停止,可以立即回收。CARBOPOL聚合物在水合和中和时溶胀,从而形成胶态分散体并捕获不溶性成分。
合适的CARBOPOL聚合物包括以商品名CARBOPOL 974P NF、CARBOPOL 971P NF和CARBOPOL 71G NF聚合物购得的那些。在这些中,CARBOPOL 974P NF聚合物是特别优选的。该聚合物是高度交联的,并且产生类似于蛋黄酱的高粘性凝胶。CARBOPOL 974P NF聚合物在pH 7下的粘度为10,000mPa*s(浓度为0.2%)、30,000mPa*s(浓度为0.5%)、60,000mPa*s(浓度为1.0%)、85,000mPa*s(浓度为2.0%),该粘度用布鲁克菲尔德粘度(20转/分钟(rpm))测量。CARBOPOL 974P NF聚合物在pH 6和pH 7下的粘度非常接近。
另一种合适的交联多元酸是以商品名NOVEON AA-1聚卡波非(一种用二乙烯基乙二醇交联的高分子量丙烯酸聚合物)购自路博润高级材料公司(Lubrizol AdvancedMaterials)的产品。
本公开的组合物包含基于水性组合物的总重量计至少0.1重量%或至少0.5重量%的具有羧酸侧基的交联多元酸。本公开的组合物包含基于水性组合物的总重量计至多3.0重量%或至多1.5重量%的具有羧酸侧基的交联多元酸。
多价阳离子盐
用于本公开组合物中的合适的多价阳离子盐包含+2多价阳离子、+3多价阳离子或它们的组合物。在某些实施方案中,多价阳离子盐包含+3多价阳离子。如果需要,可以使用此类盐的各种组合物。
盐中合适的多价阳离子的示例包括选自Ca、Mg、Ba、Mn、Fe、Zn、Al、Cu以及它们的组合物的那些。在某些实施方案中,多价阳离子选自Ca、Zn、Al以及它们的组合物。在某些实施方案中,多价阳离子包括Al和Ca。
多价阳离子盐中合适的抗衡离子的示例包括选自氯化物、硝酸盐、葡萄糖酸盐、乳酸盐、乙酸盐和硫酸盐的那些。如果需要,可以使用抗衡离子的各种组合物。另外,盐也可以包括其水合物。
在某些实施方案中,包含钙的多价阳离子盐(即钙盐)选自氯化钙、硝酸钙、葡萄糖酸钙、乳酸葡萄糖酸钙、乙酸钙、它们的水合物以及它们的组合物。在某些实施方案中,包含钙的多价阳离子盐选自氯化钙、硝酸钙、它们的水合物以及它们的组合物。
在某些实施方案中,包含铝的多价阳离子盐(即铝盐)选自氯化铝、硫酸铝、硝酸铝、硫酸铝钾、它们的水合物以及它们的组合物。在某些实施方案中,包含铝的多价阳离子盐选自氯化铝、硝酸铝、氯化铝以及它们的组合物。
本公开的组合物包含基于水性组合物的总重量计至少0.025重量%、至少0.05重量%或至少0.1重量%的多价阳离子盐。本公开的组合物包含基于水性组合物的总重量计至多1.75重量%、至多1.5重量%或至多1.0重量%的多价阳离子盐。
活性剂—氟化钠
本公开的口腔护理氟化物水性治疗组合物包含氟化钠作为活性剂。在某些实施方案中,治疗组合物包含基于水性组合物的总重量计至少1.0重量%。在某些实施方案中,治疗组合物包含基于水性组合物的总重量计至多2.5重量%。
在使用中,可以将氟化物释放组合物施用到口腔。在一个实施方案中,通常将氟化物释放组合物直接施用到一颗或多颗牙齿。氟化物释放组合物通常与牙齿保持接触足够的时间以释放治疗有效量的氟化物。氟化物从氟化物释放组合物中的释放可以例如通过在本公开的实施例部分中描述的方法来测量。
在某些实施方案中,本公开的治疗组合物在5分钟或更短时间内释放至少30%(或至少40%、或至少50%)的氟化钠。在某些实施方案中,本公开的治疗组合物在10分钟或更短时间内释放至少50%(或至少60%、或至少70%)的氟化钠。在某些实施方案中,本公开的治疗组合物在20分钟或更短时间内释放至少80%(或至少90%、或至少95%)的氟化钠。
在某些实施方案中,本公开的治疗组合物在1分钟或更短时间内释放至多93%(或至多90%、或至多88%)的氟化钠。在某些实施方案中,本公开的治疗组合物在3分钟或更短时间内释放至多97%(或至多95%、或至多94%)的氟化钠。在某些实施方案中,本公开的治疗组合物在5分钟或更短时间内释放至多99%(或至多98%、或至多96%)的氟化钠。
在某些实施方案中,本公开的治疗组合物在10分钟或更短时间内释放100%(或不小于98%、或不小于90%)的氟化钠。在某些实施方案中,本公开的治疗组合物在15分钟或更短时间内释放100%(或不小于99%、或不小于95%)的氟化钠。在某些实施方案中,本公开的治疗组合物在20分钟或更短时间内释放100%(或不小于99%、或不小于98%)的氟化钠。
附加的任选活性剂
本公开的口腔护理氟化物水性治疗组合物还可以含有除了氟化钠之外的一种或多种活性剂。当包含时,一种或多种附加活性剂通常但不总是包含一种或多种活性剂,这些活性剂在口腔中对牙齿、牙龈、脸颊、舌头、上腭等的障碍、疾病或病症是有效的。
可以采用的附加活性剂的示例包括一种或多种其他含氟化合物,诸如单氟磷酸钠、氟化亚锡、氟化钙、氟化锶、氟化锌、氟化锌钾、氟化铵、钾、氟化镁以及它们的组合物。
可以采用的附加活性剂的示例包括一种或多种增白剂、抗牙结石剂、再矿化剂、亚锡源、抗微生物剂、抗氧化剂、唾液刺激剂、口气清新剂、抗牙斑剂、抗炎剂、H2拮抗剂、脱敏剂、营养物质和蛋白质。如果需要,可以使用此类附加活性剂的各种组合物。当采用时,一种或多种附加活性剂将通常以足以达到其预期效果的量被使用。
当采用时,增白剂可以是多种合适的增白剂。增白剂可以包括例如过氧化物增白剂、非过氧化物增白剂、或两者。过氧化物增白剂包括过氧化氢、碱金属或碱土金属的过氧化物,诸如过氧化钠、过氧化钾、过氧化锂、过氧化镁、过氧化钙、过氧化钡等,过氧化甘油基氢、过氧化烷基氢、过氧化二烷基、过氧酸或过氧酸盐、过氧化苯甲酰、过氧化脲等。过氧化氢最为常见。非过氧化物增白剂包括二氧化氯、亚氯酸盐和次氯酸盐。亚氯酸盐和高氯酸盐通常为碱金属或碱土金属盐的形式,诸如锂、钾、钠、镁、钙或钡的盐。也可使用着色剂、二氧化钛和羟基磷灰石。
当采用时,抗牙结石剂可以是多种合适的抗牙结石剂。抗牙结石剂可以包括例如磷酸酯、多磷酸酯诸如焦磷酸酯、聚烯烃磺酸酯、聚烯烃磷酸酯、二膦酸酯、膦酰基烷烃羧酸、以及它们的盐,通常是碱金属盐或铵盐。
当采用时,再矿化剂可以是多种合适的再矿化剂。再矿化剂可以包括例如释放钙离子、含磷离子、或两者的材料,诸如磷酸钙(例如,磷酸一钙、磷酸二钙和/或磷酸三钙)、羟基磷灰石、碳酸钙等。
释放钙离子的材料的示例是水溶性的钙盐,诸如选自氯化钙、硝酸钙、葡萄糖酸钙、乳酸葡萄糖酸钙、乙酸钙、它们的水合物以及它们的组合物的那些。在某些实施方案中,钙盐选自氯化钙、硝酸钙、它们的水合物以及它们的组合物。
钙盐也可用于调节氟化物释放曲线。
当采用时,亚锡源可以是多种合适的亚锡离子源。亚锡离子源可以包括例如卤化亚锡、有机羧酸亚锡盐,诸如甲酸亚锡、乙酸亚锡、葡萄糖酸亚锡、乳酸亚锡、酒石酸亚锡和柠檬酸亚锡。当氟离子源是氟化亚锡时,它也可用作亚锡源。
当采用时,抗微生物剂可以包括多种口腔可接受的抗微生物剂。示例包括三氯生、8-羟基喹啉、锌离子、亚锡离子、铜化合物、邻苯二甲酸及其盐、季铵化合物、血根碱、水杨苯胺、水杨酸、百里酚、丁子香酚、新霉素、卡那霉素、克林霉素、阿莫西林、四环素、强力霉素、二甲胺四环素、甲硝哒唑、氯己定等。
当采用时,抗氧化剂可以是多种口腔可接受的抗氧化剂。示例包括丁基化羟基苯甲醚、丁基化羟基甲苯、维生素A、类胡萝卜素、维生素E、类黄酮、多酚、抗坏血酸或其盐、叶绿素、褪黑激素等。
当采用时,唾液刺激剂可以是多种口腔可接受的唾液刺激剂。示例包括柠檬酸、乳酸、琥珀酸、抗坏血酸、己二酸、富马酸和酒石酸。
当采用时,口气清新剂可以是多种口腔可接受的口气清新剂。示例包括锌盐,诸如葡萄糖酸盐、柠檬酸盐和亚氯酸盐、紫罗兰酮等的锌盐。
当采用时,抗牙斑剂可以是多种口腔可接受的抗牙斑剂。示例包括亚锡盐,铜、镁或锶的盐,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、葡萄糖淀粉酶、葡萄糖氧化酶、脲、乳酸钙、甘油磷酸钙、聚丙烯酸锶等。抗牙斑剂的另外的示例包括生物膜抑制剂,尤其是美国专利8,968,709(Yang等人)中描述的那些。
当采用时,抗炎剂可以是多种口腔可接受的抗炎剂。示例包括类固醇诸如氟轻松(flucinolone)和氢化可的松,非类固醇抗炎药诸如酮咯酸、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、痛灭定、酮洛芬、非诺洛芬、吡罗昔康、纳布美通、阿司匹林、水杨酸、二氟尼柳、甲氯芬那酸、甲灭酸、羟布宗、保泰松等。
当采用时,H2拮抗剂可以是多种口腔可接受的H2拮抗剂。示例包括西米替丁、丙炔替丁、雷尼替丁、硫替丁、卢皮替丁、多奈替丁(denetidine)、法莫替丁、罗沙替丁、哌芳酯丁、郎替定、唑替丁、尼扎替丁、芬替丁、雷索替丁、拉伏替丁、比芬替丁、苏福替丁、乙溴替丁、因普米丁等。
当采用时,脱敏剂可以是多种口腔可接受的脱敏剂。示例包括柠檬酸钾、氯化钾、酒石酸钾、碳酸氢钾、草酸钾、硝酸钾、锶盐、精氨酸、乙酰水杨酸或其盐、水杨酸或其盐、可待因、对乙酰氨基酚等。
当采用时,营养物质可以是多种口腔可接受的营养物质。示例包括维生素,诸如维生素C、D,硫胺素,核黄素,叶酸,烟酰胺,烟酸,吡哆素,生物类黄酮等;补充剂,诸如氨基酸、抗脂肪肝剂、鱼油、多不饱和脂肪酸、二十碳五烯酸、二十二碳六烯酸、辅酶Q10、泛醌;矿物质,诸如钾等。
当采用时,蛋白质可以包括多种口腔可接受的蛋白质。示例包括乳蛋白质、产生酶的过氧化物、淀粉酶、木瓜蛋白酶、葡糖淀粉酶、葡萄糖氧化酶等。
缓冲剂
本公开的口腔护理氟化物水性治疗组合物包含药学上可接受的缓冲剂。此类缓冲剂的类型和量被选择成提供pH为至少6或至少6.5的治疗组合物。在某些实施方案中,此类缓冲剂的类型和量被选择成提供pH为至多8、至多7.5或至多7的治疗组合物。在某些实施方案中,此类缓冲剂的类型和量被选择成提供pH为6.5至7.5或pH为7.0的治疗组合物。可以包括多种合适的药学上可接受的缓冲剂。示例包括乙酸盐(例如,乙酸钠)、碳酸钠、柠檬酸盐(例如,柠檬酸钠)、酒石酸盐、双甘氨肽、组氨酸、甘氨酸、赖氨酸、精氨酸、磷酸二氢钠、磷酸氢二钠、磷酸钠、三(羟甲基)-氨基甲烷或它们的混合物。
增稠剂
在某些实施方案中,本公开的口腔护理氟化物水性治疗组合物包含增稠剂,以提供具有合适粘度的组合物,以允许期望的施用方法。例如,可以使用足够量的合适的增稠剂来获得溶液粘度,该粘度足以将组合物保持在倒置的口承牙托施用器中达至多约四分钟(专业施用氟化物治疗的典型时间),并且仍然足够流体化以具有牙科操作者可接受的处理特性(例如,当分散到牙科牙托施用器中时)。或者,可以使用足够量的合适的增稠剂以获得足以在牙齿表面上进行涂抹的溶液粘度。
在某些实施方案中,增稠剂的类型和量被选择成提供在1.0/秒的剪切速率下粘度为至少0.5帕斯卡秒的治疗组合物。在某些实施方案中,增稠剂的类型和量被选择成提供在1.0/秒的剪切速率下粘度为至多500帕斯卡秒的治疗组合物。
在某些实施方案中,增稠剂以基于水性组合物的总重量计小于2.5重量%的量存在于治疗组合物中。在某些实施方案中,增稠剂以基于水性组合物的总重量计至少0.5重量%的量存在。
合适的增稠剂通常是通常对人体摄入安全(美国食品和药物管理局(FDA)批准用于内部使用)、不结合氟离子并且不显著影响氟离子的生物利用率的那些增稠剂。
在某些实施方案中,增稠剂选自天然树胶、非酸性纤维素衍生物(例如,羟乙基纤维素)、无机填料(例如,胶态二氧化硅、煅制二氧化硅、氧化铝、二氧化钛和氧化锌)、环氧烷聚合物(例如,聚乙二醇、聚丙二醇、以及聚乙二醇和聚丙二醇的共聚物)、非酸改性淀粉以及它们的组合物。
任选的添加剂
在某些实施方案中,本公开的口腔护理氟化物水性治疗组合物包含一种或多种任选的添加剂,该添加剂包括调味剂(即香料)和甜味剂。如果需要,可以使用此类添加剂的各种组合物。
在某些实施方案中,本公开的口腔护理氟化物水性治疗组合物包含甜味剂。可以使用多种口腔可接受的甜味剂。常见的甜味剂包括木糖醇、山梨醇、三氯蔗糖、天冬甜素、糖精(通常为糖精钠)等。当存在时,甜味剂可以任何合适的量被使用,最常见的是以足以向组合物赋予令人愉悦的甜味的量使用。合适的量通常为基于水性组合物的总重量计0.5重量%至15重量%。
在某些实施方案中,本公开的口腔护理氟化物水性治疗组合物包含调味剂。可以使用多种口腔可接受的调味剂。常见的调味剂包括薄荷油、留兰香油、樱桃香精、柠檬酸、橙子香精、香草、草莓香精、椰子香精和泡泡糖香精。当存在时,调味剂可以任何合适的量使用,最常见的是以足以向组合物赋予期望的风味的量使用。合适的量通常为基于水性组合物的总重量计1重量%至4重量%。
示例性实施方案
实施方案1是一种口腔护理氟化物水性治疗组合物,所述口腔护理氟化物水性治疗组合物包含:0.1重量%至3.0重量%的具有羧酸侧基的交联多元酸;药学上可接受的缓冲剂;1.0重量%至2.5重量%的氟化钠;0.025重量%至1.75重量%的多价阳离子盐;以及至少60重量%的水;其中重量百分比基于所述水性组合物的总重量。
实施方案2是根据实施方案1所述的治疗组合物,其中所述交联多元酸以0.5重量%至1.5重量%的量存在。
实施方案3是根据实施方案1或2所述的治疗组合物,其中所述交联多元酸包括一种或多种单体的均聚物或共聚物,所述一种或多种单体具有一个或多个羧酸基团。
实施方案4是根据实施方案3所述的治疗组合物,其中所述交联多元酸包括丙烯酸、马来酸、马来酸酐、衣康酸、乙烯基醚、丙烯酸烷基酯、糖类以及它们的组合物的均聚物或共聚物。
实施方案5是根据实施方案4所述的治疗组合物,其中所述交联多元酸包括丙烯酸、马来酸、衣康酸、丙烯酸(C10-C30)烷基酯以及它们的组合物的均聚物或共聚物。
实施方案6是根据实施方案5所述的治疗组合物,其中所述交联多元酸包括交联聚丙烯酸均聚物。
实施方案7是根据前述实施方案中任一项所述的治疗组合物,其中所述交联多元酸包括选自烯丙基蔗糖、烯丙基季戊四醇、甘油、双甘油、聚甘油、聚烯基醇、二乙烯基乙二醇以及它们的组合物的交联剂。
实施方案8是根据实施方案7所述的治疗组合物,其中所述聚丙烯酸与烯丙基蔗糖或烯丙基季戊四醇交联。
实施方案9是根据前述实施方案中任一项所述的治疗组合物,其中0.5重量%的pH7.5缓冲剂中的所述交联多元酸具有4,000cP至100,000cP的粘度。
实施方案10是根据前述实施方案中任一项所述的治疗组合物,其中所述多价阳离子盐包含+2多价阳离子、+3多价阳离子或它们的组合物。
实施方案11是根据前述实施方案中任一项所述的治疗组合物,其中所述多价阳离子盐包含选自Ca、Mg、Ba、Mn、Fe、Zn、Al、Cu以及它们的组合物的多价阳离子。
实施方案12是根据实施方案11所述的治疗组合物,其中所述多价阳离子盐包含选自Ca、Zn、Al以及它们的组合物的多价阳离子。
实施方案13是根据实施方案12所述的治疗组合物,其中所述多价阳离子盐包含Al和Ca。
实施方案14是根据前述实施方案中任一项所述的治疗组合物,其中所述多价阳离子盐包括氯化物盐、硝酸盐、葡萄糖酸盐、乳酸盐、乙酸盐、硫酸盐、它们的水合物以及它们的组合物。
实施方案15是根据实施方案11至14中任一项所述的治疗组合物,其中包含钙的所述多价阳离子盐选自氯化钙、硝酸钙、葡萄糖酸钙、乳酸葡萄糖酸钙、乙酸钙、它们的水合物以及它们的组合物。
实施方案16是根据实施方案15所述的治疗组合物,其中包含钙的所述多价阳离子盐选自氯化钙、硝酸钙、它们的水合物以及它们的组合物。
实施方案16是根据实施方案11至16中任一项所述的治疗组合物,其中包含铝的所述多价阳离子盐选自氯化铝、硫酸铝、硝酸铝、硫酸铝钾、它们的水合物以及它们的组合物。
实施方案17是根据前述实施方案中任一项所述的治疗组合物,其中所述多价阳离子盐以0.05重量%至1.5重量%、或0.1重量%至1.0重量%的总量存在。
实施方案18是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物还包含增稠剂。
实施方案19是根据实施方案18所述的治疗组合物,其中所述增稠剂以足以提供在1.0/秒的剪切速率下粘度为0.5帕斯卡秒至500帕斯卡秒的组合物的量存在。
实施方案20是根据实施方案18或19所述的治疗组合物,其中所述增稠剂以至少0.5重量%且小于2.5重量%的量存在。
实施方案21是根据实施方案18至20中任一项所述的治疗组合物,其中所述增稠剂选自天然树胶、非酸纤维素衍生物、无机填料、环氧烷聚合物、非酸改性淀粉以及它们的组合物。
实施方案22是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物具有6至8的pH,或6.5至7.5的pH。
实施方案23是根据实施方案22所述的治疗组合物,所述治疗组合物具有6至7的pH,或7.0的pH。
实施方案24是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物包含小于5重量%的用作载体液体的有机溶剂(例如,乙醇)。
实施方案25是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在5分钟或更短时间内释放至少30%(或至少40%、或至少50%)的所述氟化钠。
实施方案26是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在10分钟或更短时间内释放至少50%(或至少60%、或至少70%)的所述氟化钠。
实施方案27是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在20分钟或更短时间内释放至少80%(或至少90%、或至少95%)的所述氟化钠。
实施方案28是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在1分钟或更短时间内释放至多93%(或至多90%、或至多88%)的所述氟化钠。
实施方案29是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在3分钟或更短时间内释放至多97%(或至多95%、或至多94%)的所述氟化钠。
实施方案30是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在5分钟或更短时间内释放至多99%(或至多98%、或至多96%)的所述氟化钠。
实施方案31是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在10分钟或更短时间内释放100%(或不小于98%、或不小于90%)的所述氟化钠。
实施方案32是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在15分钟或更短时间内释放100%(或不小于99%、或不小于95%)的所述氟化钠。
实施方案33是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物在20分钟或更短时间内释放100%(或不小于99%、或不小于98%)的所述氟化钠。
实施方案34是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物包含至少70重量%(或至少80重量%)的水。
实施方案35是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物包含至多96重量%(或至多90重量%)的水。
实施方案36是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物包含除了氟化钠之外的一种或多种活性剂。
实施方案37是根据实施方案36所述的治疗组合物,其中所述一种或多种活性剂包括增白剂、抗牙结石剂、再矿化剂、亚锡源、抗微生物剂、抗氧化剂、唾液刺激剂、口气清新剂、抗牙斑剂、抗炎剂、H2拮抗剂、脱敏剂、营养物质、蛋白质或它们的组合物。
实施方案38是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物还包含调味剂。
实施方案39是根据前述实施方案中任一项所述的治疗组合物,所述治疗组合物还包含甜味剂。
实施方案40是一种向患者的牙齿表面提供氟化物的方法,所述方法包括将根据前述实施方案中任一项所述的口腔护理氟化物水性治疗组合物施用到所述患者的牙齿表面。
实施方案41是根据实施方案40所述的方法,其中施用包括将所述治疗组合物涂抹在所述患者的牙齿表面上。
实施方案42是根据实施方案40所述的方法,其中施用包括将所述治疗组合物分散到牙科牙托中,以及将其中具有所述治疗组合物的所述牙托附接到所述患者的牙齿表面。
实施方案43是根据实施方案42所述的方法,其中所述牙科牙托包括正畸矫正器治疗牙托。
实施方案44是一种减少患者的龋病的发病率的方法,所述患者需要减少龋病的发病率,所述方法包括将根据实施方案1至39中任一项所述的口腔护理氟化物水性治疗组合物施用到所述患者的牙齿表面。
实施方案45是根据实施方案44所述的方法,其中施用包括将所述治疗组合物涂抹在所述患者的牙齿表面上。
实施方案46是根据实施方案44所述的方法,其中施用包括将所述治疗组合物分散到牙科牙托中,以及将其中具有所述治疗组合物的所述牙托附接到所述患者的牙齿表面。
实施方案47是根据实施方案46所述的方法,其中所述牙科牙托包括正畸矫正器治疗牙托。
实施例
以下实施例进一步说明了本发明的目的和优点,但这些实施例中列举的具体材料及其量以及其它条件和细节不应被解释为是对本发明的不当限制。这些实施例仅为了进行示意性的说明,并非意在限制所附权利要求书的范围。
实施例
表1:材料
pH测试
在校准之后,在标准pH计上进行pH测试。pH计是来自飞世尔科技公司(FisherScientific)的ACCUMET 15型pH计。通过将pH探针插入溶液中,等待2分钟,并且记录pH值进行测量。pH值列于实施例表中。
氟化物释放测试
在Mettler Toledo T70滴定仪上测量氟化物释放。Cole Parmer氟化物电极在每天测量样品的氟化物释放之前,首先用TISAB III用百万分率(ppm)氟化物标准进行校准(总离子强度调节缓冲剂(TISAB)III浓缩溶液与西格玛奥德里奇公司(Sigma Aldrich)的氟化物离子选择电极一起使用)。将每种实施例组合物以薄层涂覆在RINZL塑料显微镜载玻片上,其中载玻片两侧的面积为2.54平方厘米。涂层的总重量为约0.045克。氟化物计量滴定仪杯填充有50毫升由45mL MilliQ DI水和5mL TISAB III浓缩物组成的混合物。将氟离子选择性电极放置在稀释的TISAB III溶液的滴定仪杯中,并且允许其在分析每个样品之前使计量仪平衡30秒。在30秒之后,将夹持的样品降低到50毫升的稀释的TISAB III溶液中。在用Mettler Toledo T70滴定仪进行30分钟滴定期间,在不同时间点处测量氟化物释放量(mV)。根据氟化物标准校准曲线计算氟化物释放量。报告每个实施例的两次滴定的平均值。
缓冲CARBOPOL多元酸溶液的制备:
碱性化学物质,诸如磷酸氢二钠、三乙醇胺,首先溶解在玻璃罐中的去离子(DI)水中,以形成透明溶液。然后向玻璃罐中加入CARBOPOL 974P NF,将该玻璃罐辊式混合以形成略粘稠且略混浊的溶液。用标准pH计测量pH。用表2所示的以下制剂制备了四种不同的缓冲CARBOPOL溶液(BCS)。
表2:缓冲CARBOPOL溶液
组分 | BCS-1 | BCS-2 | BCS-3 | BCS-4 |
DI水 | 773 | 770 | 774 | 776 |
CARBOPOL 974PNF | 8 | 8 | 8 | 8 |
三乙醇胺 | 0 | 0 | 8 | 8 |
Na<sub>2</sub>HPO<sub>4</sub> | 19 | 22 | 10 | 8 |
总计(份) | 800 | 800 | 800 | 800 |
pH | 6.45 | 6.52 | 6.75 | 6.63 |
实施例制备程序:
将适量的缓冲CARBOPOL多元酸溶液加入塑料瓶中;然后将计算量的氟化钠、木糖醇、香精/甜味剂加入塑料瓶中,并且磁力搅拌30分钟,以将所有这些化学物质溶解到水性实施例溶液中。首先将多价阳离子盐溶解在单独的玻璃罐中的DI水中,然后将这些盐溶液缓慢加入塑料瓶中的CARBOPOL溶液中。混合物在磁力搅拌下混合1小时。然后将羟乙基纤维素(HEC)加入实施例溶液中,在磁力搅拌下再混合30分钟。最后,实施例组合物在辊式混合器上再混合1至2天,以形成粘性水性涂覆液。每个实施例的总量示于表3A至表3E中,其中量以克为单位。
表3A:实施例Ex.1至Ex.5和比较例CE.1
组分 | Ex.1 | Ex.2 | Ex.3 | Ex.4 | Ex.5 | CE.1 |
CARBOPOL 974P NF | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
用于溶解CARBOPOL的水 | 77.3 | 77.3 | 77.3 | 77.3 | 77.3 | 77.3 |
Na<sub>2</sub>HPO<sub>4</sub> | 1.9 | 1.9 | 1.9 | 1.9 | 1.9 | 1.9 |
三乙醇胺 | 0 | 0 | 0 | 0 | 0 | 0 |
NaF | 2 | 2 | 2 | 2 | 2 | 2 |
香精 | 0 | 0 | 2 | 2 | 2 | 2 |
木糖醇 | 5 | 5 | 5 | 5 | 5 | 5 |
三氯蔗糖 | 0 | 0 | 0.4 | 0 | 0 | 0.4 |
HEC | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 |
用于溶解盐的水 | 11.4 | 11.4 | 8.6 | 9.1 | 9.4 | 9.4 |
SrCl<sub>2</sub>·6H<sub>2</sub>O | 0.2 | 0 | 0 | 0 | 0 | 0 |
ZnCl<sub>2</sub>·H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
FeCl<sub>3</sub>·6H<sub>2</sub>O | 0 | 0.2 | 0 | 0 | 0 | 0 |
AlCl<sub>3</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0.4 | 0.4 | 0 |
CaCl<sub>2</sub>·2H<sub>2</sub>O | 0.2 | 0.2 | 0.8 | 0.3 | 0 | 0 |
总水 | 88.7 | 88.7 | 85.9 | 86.4 | 86.7 | 86.7 |
总计 | 100 | 100 | 100 | 100 | 100 | 100 |
pH | 6.15 | 6.05 | 6.11 | 6.16 | 6.19 | 6.22 |
表3B:实施例Ex-6至Ex-10和比较例CE-2
组分 | Ex.6 | Ex.7 | Ex.8 | Ex.9 | Ex.10 | CE.2 |
CARBOPOL 974P NF | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
用于溶解CARBOPOL的水 | 77 | 77 | 77 | 77 | 77 | 77 |
Na<sub>2</sub>HPO<sub>4</sub> | 2.2 | 2.2 | 2.2 | 2.2 | 2.2 | 2.2 |
三乙醇胺 | 0 | 0 | 0 | 0 | 0 | 0 |
NaF | 2 | 2 | 2 | 2 | 2 | 2 |
香精 | 2 | 2 | 2 | 2 | 2 | 2 |
木糖醇 | 5 | 5 | 5 | 5 | 5 | 5 |
三氯蔗糖 | 0 | 0 | 0 | 0 | 0 | 0 |
HEC | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 |
用于溶解盐的水 | 9.2 | 9.1 | 9.3 | 9.1 | 9.2 | 9.8 |
SrCl<sub>2</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
ZnCl<sub>2</sub>·H<sub>2</sub>O | 0.2 | 0.2 | 0 | 0.15 | 0.1 | 0 |
FeCl<sub>3</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
AlCl<sub>3</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0.15 | 0.1 | 0 |
CaCl<sub>2</sub>·2H<sub>2</sub>O | 0.4 | 0.5 | 0.5 | 0.4 | 0.4 | 0 |
总水 | 86.2 | 86.1 | 86.3 | 86.1 | 86.2 | 86.8 |
总计 | 100 | 100 | 100 | 100 | 100 | 100 |
pH | 6.08 | 6.05 | 6.29 | 6.18 | 6.27 | 6.38 |
表3C:实施例Ex-11至Ex-17
组分 | Ex.11 | Ex.12 | Ex.13 | Ex.14 | Ex.15 | Ex.16 | Ex.17 |
CARBOPOL 974P NF | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
用于溶解CARBOPOL的水 | 77.4 | 77.4 | 77.4 | 77.6 | 77.6 | 77.6 | 77.6 |
Na<sub>2</sub>HPO<sub>4</sub> | 1 | 1 | 1 | 0.8 | 0.8 | 0.8 | 0.8 |
三乙醇胺 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
NaF | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
香精 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
木糖醇 | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
三氯蔗糖 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
HEC | 1.2 | 1.2 | 1.2 | 1 | 1 | 1 | 1 |
用于溶解盐的水 | 9.2 | 9.1 | 9.4 | 9.4 | 9.5 | 9.55 | 9.45 |
SrCl<sub>2</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
ZnCl<sub>2</sub>·H<sub>2</sub>O | 0.1 | 0.15 | 0 | 0.1 | 0 | 0 | 0 |
FeCl<sub>3</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AlCl<sub>3</sub>·6H<sub>2</sub>O | 0.1 | 0.15 | 0 | 0.1 | 0.1 | 0.05 | 0.15 |
CaCl<sub>2</sub>·2H<sub>2</sub>O | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 |
总水 | 86.60 | 86.50 | 86.80 | 87.00 | 87.10 | 87.15 | 87.05 |
总计 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
pH | 6.27 | 6.12 | 6.39 | 6.08 | 6.21 | 6.23 | 6.23 |
表3D:实施例Ex.18至Ex.23
组分 | Ex.18 | Ex.19 | Ex.20 | Ex.21 | Ex.22 | Ex.23 |
CARBOPOL 974P NF | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
用于溶解CARBOPOL的水 | 77.6 | 77.6 | 77.6 | 77.6 | 77.6 | 77.6 |
Na<sub>2</sub>HPO<sub>4</sub> | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
三乙醇胺 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
NaF | 2 | 2 | 2 | 2 | 2 | 2 |
香精 | 2 | 2 | 2 | 2 | 2 | 2 |
木糖醇 | 5 | 5 | 5 | 5 | 5 | 5 |
三氯蔗糖 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 |
HEC | 1.1 | 1.1 | 1.1 | 1.1 | 1.1 | 1.1 |
用于溶解盐的水 | 8 | 9.4 | 9.2 | 8.9 | 9.2 | 9.1 |
SrCl<sub>2</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
ZnCl<sub>2</sub>·H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
FeCl<sub>3</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
AlCl<sub>3</sub>·6H<sub>2</sub>O | 1.5 | 0.1 | 0.3 | 0.6 | 0.2 | 0.3 |
CaCl<sub>2</sub>·2H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0.1 | 0.1 |
总水 | 85.6 | 87 | 86.8 | 86.5 | 86.8 | 86.7 |
总计 | 100 | 100 | 100 | 100 | 100 | 100 |
表3E:实施例Ex.24至Ex.29
组分 | Ex.24 | Ex.25 | Ex.26 | Ex.27 | Ex.28 | Ex.29 |
CARBOPOL 974P NF | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
用于溶解CARBOPOL的水 | 77.6 | 77.6 | 77.6 | 77.6 | 77.6 | 77.6 |
Na<sub>2</sub>HPO<sub>4</sub> | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
三乙醇胺 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 |
NaF | 2 | 2 | 2 | 2 | 2 | 2 |
香精 | 2 | 2 | 2 | 2 | 2 | 2 |
木糖醇 | 5 | 5 | 5 | 5 | 5 | 5 |
三氯蔗糖 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 |
HEC | 0.4 | 0.7 | 1.1 | 1.5 | 1.9 | 2.3 |
用于溶解盐的水 | 9.8 | 9.5 | 9.1 | 8.7 | 8.3 | 7.9 |
SrCl<sub>2</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
ZnCl<sub>2</sub>·H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
FeCl<sub>3</sub>·6H<sub>2</sub>O | 0 | 0 | 0 | 0 | 0 | 0 |
AlCl<sub>3</sub>·6H<sub>2</sub>O | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
CaCl<sub>2</sub>·2H<sub>2</sub>O | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
总水 | 87.4 | 87.1 | 86.7 | 86.3 | 85.9 | 85.5 |
总计 | 100 | 100 | 100 | 100 | 100 | 100 |
粘度(pa*s) | 8.7 | 24.2 | 65.4 | 117.6 | 214.4 | 282.1 |
表4A:实施例Ex.1至Ex.5、CE1的氟化物释放测试结果
释放时间 | Ex1 | Ex2 | Ex3 | Ex4 | EX5 | CE1 |
min | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% |
0.0 | 2.1 | 2.1 | 1.6 | 1.6 | 1.6 | 2.1 |
1.0 | 90 | 87 | 78 | 73 | 80 | 97 |
1.5 | 93 | 91 | 81 | 76 | 82 | 98 |
2.0 | 94 | 93 | 83 | 78 | 82 | 99 |
2.5 | 96 | 95 | 85 | 79 | 83 | 100 |
3.0 | 97 | 96 | 88 | 80 | 83 | 100 |
3.5 | 97 | 97 | 89 | 81 | 83 | 100 |
4.0 | 98 | 98 | 91 | 82 | 84 | 100 |
4.5 | 98 | 98 | 92 | 83 | 85 | 100 |
5.0 | 99 | 98 | 93 | 83 | 85 | 100 |
6.0 | 99 | 99 | 95 | 84 | 86 | 100 |
7.0 | 99 | 99 | 97 | 86 | 88 | 100 |
9.0 | 99 | 99 | 98 | 88 | 91 | 100 |
10.0 | 99 | 100 | 99 | 90 | 92 | 100 |
12.0 | 99 | 100 | 99 | 92 | 94 | 100 |
15.0 | 100 | 100 | 100 | 95 | 97 | 100 |
20.0 | 100 | 100 | 100 | 98 | 99 | 100 |
25.0 | 100 | 100 | 100 | 99 | 100 | 100 |
30.0 | 100 | 100 | 100 | 100 | 100 | 100 |
表4B:实施例Ex.6至Ex.10、CE2的氟化物释放测试结果
释放时间 | Ex6 | Ex7 | Ex8 | Ex9 | EX10 | CE2 |
min | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% |
0.0 | 1.2 | 1.1 | 1.1 | 1.2 | 1.4 | 1.1 |
1.0 | 84 | 85 | 85 | 82 | 81 | 94 |
1.5 | 88 | 88 | 88 | 84 | 85 | 97 |
2.0 | 90 | 90 | 90 | 86 | 86 | 98 |
2.5 | 92 | 92 | 91 | 88 | 88 | 99 |
3.0 | 92 | 93 | 93 | 89 | 89 | 99 |
3.5 | 94 | 94 | 94 | 90 | 90 | 100 |
4.0 | 94 | 95 | 95 | 91 | 91 | 100 |
4.5 | 95 | 96 | 96 | 92 | 92 | 100 |
5.0 | 96 | 96 | 96 | 92 | 93 | 100 |
5.5 | 96 | 97 | 97 | 93 | 93 | 100 |
6.0 | 97 | 97 | 97 | 93 | 94 | 100 |
7.0 | 97 | 98 | 98 | 94 | 95 | 100 |
9.0 | 98 | 99 | 99 | 96 | 96 | 100 |
10.0 | 98 | 99 | 99 | 96 | 97 | 100 |
12.0 | 99 | 99 | 100 | 97 | 98 | 100 |
15.0 | 100 | 100 | 100 | 98 | 98 | 100 |
20.0 | 100 | 100 | 100 | 99 | 99 | 100 |
25.0 | 100 | 100 | 100 | 100 | 100 | 100 |
30.0 | 100 | 100 | 100 | 100 | 100 | 100 |
表4C:实施例Ex.11至Ex.17的氟化物释放测试结果
释放时间 | EX11 | Ex12 | EX13 | EX14 | Ex15 | EX16 | Ex17 |
min | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% |
0.0 | 1.0 | 1.4 | 1.1 | 1.0 | 1.0 | 1.1 | 1.1 |
1.0 | 81 | 82 | 86 | 81 | 82 | 84 | 81 |
1.5 | 85 | 85 | 89 | 85 | 84 | 87 | 83 |
2.0 | 87 | 87 | 91 | 88 | 87 | 88 | 85 |
2.5 | 89 | 88 | 92 | 90 | 88 | 90 | 86 |
3.0 | 90 | 90 | 94 | 91 | 89 | 91 | 88 |
3.5 | 91 | 90 | 95 | 92 | 91 | 92 | 89 |
4.0 | 92 | 91 | 96 | 93 | 92 | 93 | 90 |
4.5 | 93 | 92 | 96 | 93 | 93 | 94 | 91 |
5.0 | 94 | 92 | 97 | 94 | 93 | 95 | 92 |
6.0 | 94 | 93 | 98 | 95 | 95 | 96 | 93 |
7.0 | 95 | 94 | 98 | 95 | 95 | 97 | 94 |
9.0 | 96 | 95 | 99 | 96 | 97 | 98 | 96 |
10.0 | 97 | 96 | 100 | 97 | 97 | 98 | 96 |
12.0 | 97 | 96 | 100 | 98 | 98 | 99 | 97 |
15.0 | 98 | 98 | 100 | 99 | 99 | 99 | 98 |
20.0 | 99 | 99 | 100 | 100 | 99 | 100 | 100 |
25.0 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
30.0 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
表4D:实施例Ex.18至Ex.23的氟化物释放测试结果
释放时间 | EX18 | Ex19 | Ex20 | Ex21 | Ex22 | Ex23 |
min | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% | 氟化物% |
0.0 | 1.8 | 1.3 | 1.1 | 1.2 | 1.1 | 1.1 |
1.0 | 32 | 93 | 83 | 71 | 86 | 80 |
1.5 | 33 | 94 | 85 | 74 | 88 | 83 |
2.0 | 34 | 95 | 86 | 75 | 89 | 84 |
2.5 | 35 | 95 | 86 | 75 | 89 | 85 |
3.0 | 35 | 95 | 87 | 75 | 90 | 86 |
3.5 | 36 | 95 | 87 | 76 | 90 | 86 |
4.0 | 37 | 95 | 87 | 76 | 91 | 86 |
4.5 | 37 | 95 | 88 | 77 | 91 | 87 |
5.0 | 38 | 96 | 88 | 77 | 91 | 87 |
6.0 | 40 | 96 | 89 | 78 | 92 | 88 |
7.0 | 43 | 96 | 89 | 79 | 92 | 89 |
9.0 | 49 | 97 | 91 | 81 | 94 | 90 |
10.0 | 52 | 97 | 92 | 83 | 94 | 91 |
12.0 | 59 | 98 | 93 | 85 | 95 | 92 |
15.0 | 69 | 99 | 96 | 89 | 97 | 94 |
20.0 | 83 | 99 | 98 | 94 | 98 | 97 |
25.0 | 93 | 100 | 99 | 98 | 99 | 99 |
30.0 | 100 | 100 | 100 | 100 | 100 | 100 |
本文引用的专利、专利文献和公布的全部公开内容均全文以引用方式并入,如同每个文件都单独引用一样。在不脱离本公开的范围和实质的情况下,对本公开进行的各种变型和更改对于本领域的技术人员而言将变得显而易见。应当理解,本公开并不旨在受本文中示出的例示性实施方案和实施例的不当限制,并且此类实施例和实施方案仅以举例的方式呈现,本公开的范围旨在仅受本文中如下示出的权利要求书的限制。
Claims (20)
1.一种口腔护理氟化物水性治疗组合物,所述口腔护理氟化物水性治疗组合物包含:
0.1重量%至3.0重量%的具有羧酸侧基的交联多元酸;
药学上可接受的缓冲剂;
1.0重量%至2.5重量%的氟化钠;以及
0.025重量%至1.75重量%的多价阳离子盐;以及
至少60重量%的水;
其中重量百分比是基于所述水性组合物的总重量。
2.根据权利要求1所述的治疗组合物,其中所述交联多元酸以0.5重量%至1.5重量%的量存在。
3.根据权利要求1或2所述的治疗组合物,其中所述交联多元酸包括一种或多种单体的均聚物或共聚物,所述一种或多种单体具有一个或多个羧酸基团。
4.根据权利要求3所述的治疗组合物,其中所述交联多元酸包括丙烯酸、马来酸、马来酸酐、衣康酸、乙烯基醚、丙烯酸烷基酯、糖类以及它们的组合物的均聚物或共聚物。
5.根据权利要求4所述的治疗组合物,其中所述交联多元酸包括丙烯酸、马来酸、衣康酸、丙烯酸(C10-C30)烷基酯以及它们的组合物的均聚物或共聚物。
6.根据前述权利要求中的任一项所述的治疗组合物,其中所述多价阳离子盐包含+2多价阳离子、+3多价阳离子或它们的组合物。
7.根据权利要求6所述的治疗组合物,其中所述多价阳离子盐包含+3多价阳离子。
8.根据前述权利要求中的任一项所述的治疗组合物,其中所述多价阳离子盐包含选自Ca、Mg、Ba、Mn、Fe、Zn、Al、Cu以及它们的组合物的多价阳离子。
9.根据权利要求8所述的治疗组合物,其中所述多价阳离子盐包含选自Ca、Zn、Al以及它们的组合物的多价阳离子。
10.根据权利要求9所述的治疗组合物,其中所述多价阳离子盐包含Al和Ca。
11.根据前述权利要求中的任一项所述的治疗组合物,其中所述多价阳离子盐以0.05重量%至1.5重量%的总量存在。
12.根据前述权利要求中的任一项所述的治疗组合物,所述治疗组合物还包含增稠剂。
13.根据权利要求12所述的治疗组合物,其中所述增稠剂以小于2.5重量%的量存在。
14.根据前述权利要求中的任一项所述的治疗组合物,所述治疗组合物具有6至8的pH。
15.根据前述权利要求中的任一项所述的治疗组合物,所述治疗组合物包含小于5重量%的有机溶剂。
16.根据前述权利要求中的任一项所述的治疗组合物,所述治疗组合物包含至多96重量%的水。
17.一种向患者的牙齿表面提供氟化物的方法,所述方法包括将根据前述权利要求中的任一项所述的口腔护理氟化物水性治疗组合物施用到所述患者的牙齿表面。
18.根据权利要求17所述的方法,其中施用包括将所述治疗组合物涂抹在所述患者的牙齿表面上。
19.根据权利要求17所述的方法,其中施用包括将所述治疗组合物分散到牙科牙托中,以及将其中具有所述治疗组合物的所述牙托附接到所述患者的牙齿表面。
20.一种减少患者的龋病的发病率的方法,所述患者需要减少龋病的发病率,所述方法包括将根据实施方案1至16中的任一项所述的口腔护理氟化物水性治疗组合物施用到所述患者的牙齿表面。
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US10682300B2 (en) | 2020-06-16 |
EP3892336A1 (en) | 2021-10-13 |
ES2877656T3 (es) | 2021-11-17 |
CN111163841B (zh) | 2024-03-12 |
EP3484589A1 (en) | 2019-05-22 |
JP2023099112A (ja) | 2023-07-11 |
JP2020535166A (ja) | 2020-12-03 |
WO2019064091A1 (en) | 2019-04-04 |
EP3484589B1 (en) | 2021-04-28 |
AU2018343159B2 (en) | 2021-10-28 |
JP7273805B2 (ja) | 2023-05-15 |
BR112020006262B1 (pt) | 2023-03-21 |
US20200268625A1 (en) | 2020-08-27 |
AU2018343159A1 (en) | 2020-04-16 |
BR112020006262A2 (pt) | 2020-10-06 |
US20190099338A1 (en) | 2019-04-04 |
US11337902B2 (en) | 2022-05-24 |
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