CN109152936B - 治疗牙膏及相关方法及试剂盒 - Google Patents
治疗牙膏及相关方法及试剂盒 Download PDFInfo
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- CN109152936B CN109152936B CN201780032378.1A CN201780032378A CN109152936B CN 109152936 B CN109152936 B CN 109152936B CN 201780032378 A CN201780032378 A CN 201780032378A CN 109152936 B CN109152936 B CN 109152936B
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- toothpaste
- fluoride
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Abstract
本发明提供了牙膏,所述牙膏包含:(i)式(I)化合物:(ii)式(II)化合物或其药学上可接受的盐:以及(iii)牙科磨料。
Description
技术领域
本公开总体上涉及治疗牙膏,并且更具体地说,涉及抑制生物膜的形成在受试者的口腔中的牙膏及相关联方法和试剂盒。
背景技术
牙斑,其可包括细菌如变异链球菌(streptococcus mutans),其包含形成在口腔中的表面上的生物膜。牙斑至少部分地导致龋齿、齿龈炎和牙周病。牙斑中的细菌代谢口中的碳水化合物(例如简单糖)并产生可蚀刻牙釉质的酸。因此暴露的牙质可随后被细菌定殖。牙斑可用作用于沉积牙垢或结石的基底。结石的生成可导致齿龈炎,并最终导致牙周病。用于从牙齿上去除牙斑的当前可用方法是用例如牙线或牙刷机械去除。牙刷可有助于从牙齿的暴露表面去除牙斑,并且牙线可有助于从例如近侧和龈下表面去除牙斑。牙线和牙刷的适当和常规使用可机械去除或减少牙斑,并且可降低牙齿龋齿、齿龈炎和牙周病的发生率。定期探访牙医或卫生员以接受专业的预防疗法也有助于减少此类口腔疾病。可获得某些抗微生物制剂(例如,以漱口水、漂洗水和洁齿剂的形式)以帮助控制和治疗牙斑、龋齿、牙龈炎和牙周病。抑制生物膜形成的治疗性牙科组合物和相关方法已在美国专利号8,968,709(Yang等人)中描述。
发明内容
如上所述,牙线和牙刷的适当和常规使用以及常规的专业牙齿清洁可减少牙斑和龋齿的发生率。然而,牙线和牙刷不总是正确且常规地使用。因此,需要用于控制或预防牙斑而不是去除牙斑的替代方法。因此,需要组合物、方法和试剂盒来抑制生物膜的形成,特别是在口腔中。
在一个方面,本公开提供一种牙膏。牙膏包含:(i)式I化合物:
其中R1为氢原子或烷基,R2为C(O)R3,其中R3为C7–C9烷基,以及n为约2至约5的整数;(ii)式II化合物或其药学上可接受的盐:
其中R4为氢原子或烷基,m为约2至约5的整数;以及(iii)牙科磨料。
在另一方面,提供了治疗受试者口腔中的表面的方法。该方法可以包括:(a)提供牙膏;以及(b)将所述牙膏施用到受试者口腔中的表面。
在另一方面,提供用于治疗受试者口腔中的表面的试剂盒。该试剂盒可以包括:(a)牙膏;和(b)施用装置。
在另一方面,提供了在受试者口腔中的表面上抑制生物膜形成的方法。该方法可以包括:(a)提供牙膏;以及(b)将所述牙膏施用到受试者口腔中的表面。
通过考虑详细描述,本公开的其它特征和方面将变得显而易见。
具体实施方式
定义
通过端点表述的任何数值范围包括该范围内所包含的所有数值(例如,1至5包括1、1.5、2、2.75、3、3.80、4、5等)。
术语“一个”、“一种”和“该”、“所述”可互换使用,其中“至少一个(种)”意指一个(种)或多个(种)所述要素。
术语“和/或”是指任一者或两者。例如,“A和/或B”是指仅A、仅B、或A和B两者。
术语“包括”、“包含”或“具有”及其变型意在涵盖其后所列出的项目和它们的等同形式以及附加项目。
“膏”是指在施加足够大的载荷或应力之前表现为固体的物质,此在施加应力时它像液体一样流动。膏可以包括固体在背景流体或载体中的悬浮液。膏可通过其粘度或其稠度进行分类。
术语“牙膏”是指在受试者的口腔中使用的膏。
术语“洁齿剂”是指一种类型的牙膏,其用作常规个人护理的清洁剂,例如通过每日刷牙。牙膏可用作预防龋齿、齿龈炎或牙周炎的措施。
术语“预防性膏”(或更简单地,“预防膏”)是指牙科专业人员(诸如牙医或牙科保健员)使用的一种牙膏,以去除粘附的沉积物,诸如污渍、牙斑或牙垢,它可以粘在受试者口腔中的坚硬表面上。在常规刷牙过程中可能无法完全去除这种粘附沉积物。可以在称为“预防性杯”(或更简单地,“预防杯”)的旋转预防膏保持器上使用预防膏。还可用刷子(诸如旋转刷子)施加预防膏。与可商购获得的洁齿剂相比,可商购获得的预防膏可具有不同的粘度。
术语“治疗”是指预防、改良、治疗、改善或治愈疾病或病症。
术语“生物膜”是指包括细菌的基质。与细菌一起,受试者口腔中的生物膜另外可包括上皮细胞、白细胞、巨噬细胞和其它口腔渗出物。
术语“生物膜抑制”是指限制生物膜的生长或形成。
术语“硬表面”是指在受试者的口腔中的表面,包括硬质材料,诸如骨、牙釉质、牙本质和牙科修复物。
术语“牙科修复物”是指填充物、嵌体、高嵌体、贴面、临时和永久性牙冠或牙桥,植入体,或正畸装置和器具,诸如托槽或弓丝。
术语“烷基”是指为烷烃的基团的一价基团,该烷烃为饱和烃。烷基可以是直链的、支链的、环状的或它们的组合,并且可具有1至20个碳原子。在一些实施方案中,烷基包含1至18个、1至12个、1至10个、1至8个、1至6个或1至4个碳原子。烷基基团的示例包括但不限于甲基、乙基、正丙基、异丙基、正丁基、异丁基、叔丁基、正戊基、正已基、环己基、正庚基、正辛基和乙基己基。
术语“室温”和“环境温度”互换使用,意指20℃至25℃范围内的温度。
根据一个方面,本公开提供牙膏。牙膏包含:(i)式I的化合物:
其中R1为氢原子或烷基,R2为C(O)R3,其中R3为C7-C9烷基,以及n为约2至约5的整数;(ii)式II化合物或其药学上可接受的盐:
其中R4为氢原子或烷基,m为约2至约5的整数;以及(iii)牙科磨料。
本公开的牙膏包含式I化合物。在式I化合物中,基团R1为氢原子或烷基。当R1为烷基时,该烷基可以包含约一个碳原子(即C1)、约两个碳原子(即C2)、约三个碳原子(即C3)、约四个碳原子(即C4)、约五个碳原子(即C5)、约六个碳原子(即C6)、约八个碳原子(即C8)、约十个碳原子(即C10)、约十二个碳原子(即C12)、超过约十二个碳原子,或这些值中的任何两个之间的范围。例如,当R1为烷基时,R1可以是C1–C12烷基、C1–C10烷基、C1–C6烷基或C2–C7烷基。在特定实施方案中,R1为氢原子或C1-C2烷基。当R1为烷基时,烷基可包括直链烷基、支链烷基或环状烷基。烷基的非限制性示例包括甲基、乙基、1-丙基、异丙基、丁基、异丁基、仲丁基、叔-丁基、戊基、异戊基、新戊基、己基、庚基、2-乙基己基、辛基、异辛基、壬基、癸基、十一烷基、十二烷基、十四烷基、十五烷基、十八烷基、环己基、4-甲基环己基、环己基甲基、环戊基和环辛基。
在式I化合物中,基团R3为C7-C9烷基,例如,烷基包括约七个碳原子(即C7)、约八个碳原子(即C8)或约九个碳原子(即C9)。此类烷基可包括直链烷基、支链烷基或环状烷基。R3的C7-C9烷基的非限制性示例包括为R1列出的那些(例如,庚基、2-乙基己基、辛基、异辛基和壬基)。在特定实施方案中,R3为C8烷基(例如辛基)。应理解在R1为烷基基团(而不是氢原子)的情况下,此烷基可以是与R3的C7-C9烷基相同或不同的烷基。
在式I的化合物中,n是约2至约5的整数。在一些实施方案中,n是整数,其值为约2、约3、约4或约5。在特定实施方案中,n是整数,其值为约4。应理解本公开的牙膏可以包含一种以上的式I化合物,并且该化合物可以由式I表示,具有不同的n的整数值。在这些实施方案中,化合物的n的平均值可以是非整数。在特定实施方案中,本公开的牙膏可仅包含一种式I化合物,并且n为具有2、3、4或5的值的整数。
本公开的牙膏还包含式II化合物或其药学上可接受的盐。在式II化合物或其药学上可接受的盐中,R4为氢原子或烷基。当R4为烷基时,该烷基可以包含约一个碳原子(即C1)、约两个碳原子(即C2)、约三个碳原子(即C3)、约四个碳原子(即C4)、约五个碳原子(即C5)、约六个碳原子(即C6)、约八个碳原子(即C8)、约十个碳原子(即C10)、约十二个碳原子(即C12)、超过十二个碳原子,或这些值中的任何两个之间的范围。例如,当R4为烷基时,R4可为C1-C12烷基、C1-C10烷基、C1-C8烷基、C1-C6烷基或C2-C7烷基。在具体实施方案中,R4为氢原子、C1-C12烷基、C1-C10烷基或C1-C8烷基。当R1为烷基时,烷基可包括直链烷基,支链烷基或环状烷基。烷基的非限制性示例包括甲基、乙基、1-丙基、异丙基、丁基、异丁基、仲丁基、叔-丁基、戊基、异戊基、新戊基、己基、庚基、2-乙基己基、辛基、异辛基、壬基、癸基、十一烷基、十二烷基、十四烷基、十五烷基、十八烷基、环己基、4-甲基环己基、环己基甲基、环戊基和环辛基。
在式II化合物或其药学上可接受的盐中,m为约2至约5的整数。在一些实施方案中,n为整数,其值为约2、约3、约4或约5。在特定实施方案中,n为整数,其值为约4。应理解本公开的牙膏可以包含一种以上的式II化合物或其药学上可接受的盐,并且该化合物可以由具有不同的m的整数值的式II(或其药学上可接受的盐)表示。在这些实施方案中,m的平均值可以是非整数。在特定实施方案中,本公开的牙膏仅包含一种式II化合物或其药学上可接受的盐,并且m为具有约2、约3、约4或约5的值的整数。
式II化合物可为药学上可接受的盐的形式。药学上可接受的盐包括铵盐。因此,在一些实施方案中,本公开的牙膏可包含铵盐。铵盐可表示为酸与胺的反应产物,或表示为胺与烷基化试剂诸如例如碘甲烷、溴乙烷或苄基溴的反应产物。铵盐包括质子化胺化合物,例如式II化合物,其中基团NHR4的氮原子已被无机酸、有机酸或无机酸和有机酸的组合质子化。铵盐也包括烷基化胺化合物,例如式II化合物,其中基团NHR4的氮原子已被烷基化试剂烷基化。
铵盐包含至少一种抗衡离子,所述抗衡离子可以为无机阴离子、有机阴离子或阴离子的组合。阴离子的组合包括一种以上的无机阴离子的组合、一种以上的有机阴离子的组合,或无机离子和有机阴离子的组合。无机离子包括例如卤化物(氟化物、氯化物、溴化物和碘化物)、硝酸根、硫酸根、磷酸根(包括磷酸根、磷酸氢根和磷酸二氢根无机离子中的一种或多种)、四氟硼酸根和四(芳基)硼酸根。四(芳基)硼酸根包括具有式Z4B–的化合物,其中Z为芳族基团,例如取代或未取代的苯基。四(芳基)硼酸根的示例包括但不限于四苯基硼酸根、四(4-甲基苯基)硼酸根、四(2-甲基苯基)硼酸根、四(1,3,5-三甲基苯基)硼酸根、四(4-氟苯基)硼酸根、四(五氟苯基)硼酸根和四(4-三氟甲基苯基)硼酸根。有机阴离子包括例如链烷酸根(诸如例如乙酸根、丙酸根和丁酸根),苯甲酸根、延胡索酸根、马来酸根、酒石酸根、抗坏血酸根、苯磺酸根、甲苯磺酸根和柠檬酸根。
在某些具体实施中,铵盐可通过将式II化合物与无机酸、有机酸或无机酸和有机酸的组合质子化而形成。在另一个实施方案中,铵盐可通过式II化合物与烷基化试剂的烷基化反应形成。在另一个实施方案中,铵盐可通过与先前形成的铵盐的离子交换或复分解反应形成。
在一些实施方案中,所述通式II化合物的形式是药学上可接受的盐,例如卤化物铵盐,磷酸铵盐的盐(包括一个或更多个磷酸铵盐,磷酸氢铵盐,或磷酸二氢铵盐),或柠檬酸铵盐。
认识到式I和II的化合物包含手性碳原子。为简单起见,在式I和II中,没有规定关于手性碳原子中的每个的立体化学构形。其用意在于,在本说明书和权利要求中所用的式I和II代表具有任何可能的立体化学构形的化合物中的每种。在一些实施方案中,式I和II的化合物为氨基糖醇及具有通用名称D-葡糖胺、N-甲基-D-葡糖胺、N-乙基-D-葡糖胺、N-辛基-D-葡糖胺和N-甲基-N-辛酰基-D-葡糖胺、N-甲基-N-壬酰基-D-葡糖胺、N-甲基-N-癸酰基-D-葡糖胺的衍生物。
令人惊讶的是,发现与单独的式I化合物相比,式I化合物和式II化合物或其药学上可接受的盐的组合在抑制表面上的生物膜形成方面表现出改善的效力。该协同效应可用于开发改善的口腔护理组合物,诸如本发明公开的牙膏。具体地讲,已发现在高于某些阈值的浓度下,式I化合物可引起口腔组织(例如,软组织,诸如粘膜)的脱落。因此,本公开提供了口腔护理组合物,包括牙膏,其具有降低浓度的式I化合物,同时仍然保持可接受的抑制生物膜形成的活性。类似地,将式II化合物或其药学上可接受的盐加入口腔护理组合物诸如牙膏(包含式I化合物)中可以提供增强的生物膜抑制活性。
本公开的牙膏包含足以抑制生物膜形成的量的式I化合物。在一些实施方案中,牙膏可包含足以抑制受试者口腔中形成生物膜的量的式I化合物。在一些实施方案中,牙膏可包含足以抑制在受试者口腔中的硬质表面上形成生物膜的量的式I化合物。在此类实施方案中,硬质表面可包括牙齿。在其他实施方案中,牙膏可包含足以抑制在牙科修复物上形成生物膜的量的式I化合物。牙膏可以包含基于牙膏总重量(即,式I化合物、式II化合物、牙科磨料和可任选地包含在牙膏中的任何其他组分的组合重量)计约40重量%(重量百分比)、约30重量%、约20重量%、约16重量%、约12重量%、约10重量%、约6重量%、约4重量%、约3.75重量%、约3.5重量%、约3.25重量%、约3重量%、约2.75重量%、约2.5重量%、约2.25重量%、约2重量%、约1.75重量%、约1.5重量%、约1.25重量%、约1重量%、约0.75重量%、约0.5重量%、约0.25重量%,或在这些值的任何两个之间并且包括这些值的任何两个的范围内的式I化合物。在某些实施方案中,牙膏包含基于牙膏总重量计约0.25重量%至约40重量%、约0.25重量%至约20重量%、约0.25重量%至约10重量%、约0.25重量%至约5重量%、约0.25重量%至约4重量%、约0.5重量%至约3.5重量%、约1重量%至约3重量%、约1.5重量%至约2.5重量%,或约2重量%的式I化合物。在其他实施方案中,基于牙膏总重量计,牙膏中式I化合物的量为至少约0.25重量%。
在一些实施方案中,牙膏可以在介质诸如例如水、培养液或唾液中提供一定浓度的式I化合物,直至约化合物的溶解度极限。在某些实施方案中,牙膏可以在介质诸如例如水,培养液或唾液中提供低于化合物溶解度极限的式I化合物的浓度。认识到溶解度极限可以在不同介质中不同。如本文所用,术语“提供式I化合物的浓度”是指牙膏释放或转移至介质(诸如,例如水、培养液或唾液)的在介质中产生化合物浓度的化合物的量的性质。在一些实施方案中,牙膏可在介质中提供式I化合物的浓度为至多约0.5摩尔,至多约0.3摩尔,至多约0.15摩尔,至多约0.1摩尔,至多约0.05摩尔,至多约0.03摩尔,至多约0.02摩尔,至多约0.01摩尔,至多约0.005摩尔,至多约0.002摩尔,或至多约0.001摩尔。在某些实施方案中,牙膏可在介质中提供式I化合物的浓度为至多约化合物的溶解度极限。
如上所述,本公开的牙膏包含式II化合物或其药学上可接受的盐。牙膏可以包含基于牙膏总重量计约40重量%、约30重量%、约20重量%、约16重量%、约12重量%、约10重量%、约6重量%、约4重量%、约3.75重量%、约3.5重量%、约3.25重量%、约3重量%、约2.75重量%、约2.5重量%、约2.25重量%、约2重量%、约1.75重量%、约1.5重量%、约1.25重量%、约1重量%、约0.75重量%、约0.5重量%、约0.25重量%,或在这些值的任何两个之间并且包括这些值的任何两个的范围内的式II化合物或其药学上可接受的盐。在某些实施方案中,牙膏包含基于牙膏总重量计约0.25重量%至约40重量%、约0.25重量%至约20重量%、约0.25重量%至约10重量%、约0.25重量%至约5重量%、约0.25重量%至约4重量%、约0.5重量%至约3.5重量%、约1重量%至约3重量%、约1.5重量%至约2.5重量%,或约2重量%的式II化合物或其药学上可接受的盐。在其他实施方案中,基于牙膏总重量计,牙膏中式II化合物或其药学上可接受的盐的量为至少约0.25重量%。
应当理解,式I化合物和式II化合物或其药学上可接受的盐在牙膏中的量能够并且可以不同。例如,基于牙膏总重量计,牙膏可包含约2重量%的式I化合物和约1重量%、约2.5重量%或3重量%的式II化合物或其药学上可接受的盐。在某些实施方案中,基于牙膏总重量计,式I化合物和式II化合物或其药学上可接受的盐的量各自独立地为约10重量%、约6重量%、约4重量%、约3.75重量%、约3.5重量%、约3.25重量%、约3重量%、约2.75重量%、约2.5重量%、约2.25重量%、约2重量%、约1.75重量%、约1.5重量%、约1.25重量%、约1重量%、约0.75重量%、约0.5重量%、约0.25重量%,或在这些值的任何两个之间并且包括这些值的任何两个的范围内。在特定实施方案中,基于牙膏总重量计,式I化合物和式II化合物的量各自为约2重量%。
本公开的牙膏还包含牙科磨料。一般来说,牙科磨料应适合用于口腔环境中。可选择牙科磨料类型和特性(例如,粒度、硬度等),以及牙膏中牙科磨料的量,使得牙釉质和牙本质在牙膏的正常使用过程中,诸如在刷牙期间或在预防过程期间不会过度磨损。牙科磨料可起到一种或多种功能,包括但不限于研磨和/或以其他方式清洁牙齿表面的碎屑和/或牙斑,从牙齿表面去除污渍,抛光牙齿表面,和/或提供牙齿美白效果。
合适的牙科磨料的示例可包括但不限二氧化硅、硅胶、水合二氧化硅、沉淀二氧化硅、熔融二氧化硅、氧化铝、煅烧氧化铝、不溶性磷酸盐、碳酸钙、磨砂玻璃、碳化硅、钛铁矿、碳酸氢钠、膨润土、云母、氧化锆、氧化锆硅酸盐、黄玉、二氧化钛、沉淀石灰、白垩、浮石(例如浮石粉)、沸石、滑石、高岭土、硅藻土、硅酸盐、甘氨酸、树脂磨料诸如脲醛缩合产物等等。可用作牙科磨料的磷酸盐为正磷酸盐、聚偏磷酸盐和焦磷酸盐,以及它们的盐;例示性示例是二水合正磷酸二钙、磷酸二钙、焦磷酸钙、磷酸三钙、聚偏磷酸钙、羟基磷灰石、正磷酸镁和不溶性聚偏磷酸钠。
珍珠岩也可用作本公开的牙科磨料,例如,如在美国专利号5,266,304(Baffelli等人)和6,576,225(Kilcher等人)中所述,其各自以引用方式全文并入本文。
在一些实施方案中,可以使用水溶性牙科磨料(单独地或与其它牙科磨料组合,其中的每个可以是水溶性或水不溶性的),如在美国专利号8,858,921(Schmid等人)中所述,其全文以引用方式并入本文。在此类实施方案中,牙膏可基本上不含水(例如,基于牙膏的总重量,小于约5重量%的水或小于约1重量%的水),并且任选地包括水可混溶性或水溶性液体。
牙科磨料的平均粒度通常为约0.1微米、约1微米、约5微米、约10微米、约15微米、约20微米、约25微米、约30微米、约35微米、约40微米、约50微米、约75微米、约90微米、约100微米、约150微米、约200微米、约250微米、约300微米,或这些值中的任何两个之间并且包括这些值的任何两个的范围。例如,在一些实施方案中,牙科磨料的平均粒度为约0.1微米至约300微米、约20微米至约300微米、约90微米至约300微米、约0.1微米至约50微米、约1微米至约40微米,或约5微米至约30微米。应理解,本公开的牙膏可包含一种以上的牙科磨料。在此类情况下,平均粒度旨在表示牙膏中包含的每种牙科磨料的平均粒度。例如,牙膏可包含作为第一牙科磨料的平均粒度为约1微米至约40微米的二氧化硅,以及作为第二牙科磨料的平均粒度为约30微米至约75微米的碳酸钙。
在本公开的牙膏的某些具体实施中,掺入各种类型的含二氧化硅的牙科磨料,因为它们提供优异的牙齿清洁和抛光性能而不会过度研磨牙釉质或牙本质。本文所述的含二氧化硅的牙科磨料材料以及其他牙科磨料通常具有约0.1微米至约30微米或约5微米至约15微米的平均粒度。含二氧化硅的牙科磨料可以是沉淀二氧化硅或二氧化硅凝胶诸如以下专利中描述的二氧化硅干凝胶:美国专利号3,538,230(Pader等人)和3,862,307(DiGuilio),其各自以引用方式全文并入本文。可用于本公开的牙膏中的其他类型的含二氧化硅的牙齿磨料描述于美国专利号4,340,583(Wason)、5,589,160(Rice)、5,603,920(Rice)、5,651,958(Rice)、5,658,553(Rice)和5,716,601(Rice)中,其各自以引用方式全文并入本文。用于包含在本文所述牙膏中的合适的含二氧化硅的牙科磨料可从以下获得:胡贝尔工程材料公司(Huber Engineered Materials),以商品名ZEODENT;格雷斯公司(Grace),以商品名SYLOID和SYLODENT;以及赢创公司(Evonik),以商品名SIDENT。
存在一种或多种牙科磨料,其总量基于牙膏的总重量计为约4重量%、约5重量%、约6重量%、约8重量%、约10重量%、约15重量%、约20重量%、约30重量%、约40重量%、约50重量%、约60重量%、约70重量%、约80重量%,或在这些值中的任何两个之间并包括这些值中的任何两个的范围。在一些实施方案中,基于牙膏的总重量计,所述牙膏包含约4重量%至约80重量%的牙科磨料。在其它实施方案中,基于牙膏的总重量计,牙膏包含约8重量%至约50重量%、约10重量%至约50重量%、约10重量%至约30重量%,或约5重量%至约25重量%的牙科磨料。
其他牙膏组分
在各种实现方式中,本公开的牙膏可任选地包含一种或多种其他组分,包括但不限于载体、添加剂、佐剂、试剂和/或改性剂。此类组分的示例包括但不限于防龋剂(例如氟化物源)、脱敏剂、抗龈炎剂、抗斑剂、流变改性剂、缓冲剂、稀释剂、溶剂、表面活性剂、填充剂、乳化剂、发泡剂、pH调节剂、保湿剂、抗微生物剂(例如抗菌剂)、口感剂、质地改良剂、油,口腔干燥症缓解剂(例如唾液刺激剂)、抗口臭剂、口气清新剂、甜味剂、药剂、治疗剂、抗炎剂、调味剂、着色剂(例如颜料或染料)、防腐剂、稳定剂、牙垢控制剂、炭黑、再矿化剂、抗腐蚀剂、装饰剂、营养素、酶(例如溶菌酶、氧化酶等)、蛋白质(例如,釉质基质蛋白,富含脯氨酸的蛋白质)、蜡、其他合适的材料,以及它们的组合和混合物,包括例如下面列出的类别中所指示的那些。可用于本公开的牙膏中的各种牙膏组分也可包含美国专利号5,624,906(Vermeer)中公开的那些,该专利以引用方式全文并入本文。
本公开的牙膏的任何单独组分可以在牙膏中溶解、分散、悬浮或乳化。应当理解,虽然各类组分的一般属性可不同;可以存在一些常见属性,并且任何给定组分可以在此类组分中的两种或更多种内服务于多个目的。例如,如果将山梨醇包含在牙膏中,则山梨醇可充当甜味剂和湿润剂。另外应理解,牙膏的组分应适合在口腔环境中使用(例如,药学上可接受的和/或食品级的)。
载体
在各种实施方案中,本公开的牙膏可包含载体。载体(如果存在的话)可包括液体、固体或两者。在一些实施方案中,载体在约室温下可为液体。在其他实施方案中,载体在约室温下可为固体。在一些实施方案中,载体在约人的口腔的温度(即,在约37℃下)可为液体。在其他实施方案中,载体在约人的口腔的温度下可为固体。应当理解,可使用多个载体。液体载体的示例包括但不限于水、甘油、丙二醇、聚亚烷基二醇(例如聚乙二醇,聚丙二醇等)以及它们的组合。
合适的载体的另外示例包括美国专利号6,669,929(Boyd等人)、6,379,654(Gebreselassie等人)和4,894,220(Nabi等人)中所述的那些,这些专利中的每个以引用方式全文并入本文。在一些实施方案中,载体(或载体的组合)基本上不含水(例如,基于一种或多种载体的总重量计,小于约5重量%,或小于约1重量%的水)。在其中载体或载体的组合基本上不含水的一些实施方案中,此类载体或载体的组合是水可混溶的(例如,水溶性的)。在包括基本上不含水的载体(或载体的组合)的另外的实施方案中,牙膏也基本上不含水(例如,基于牙膏的总重量计,小于约5重量%的水,或小于约1重量%的水)。在其它实施方案中,牙膏包含水,并且基于牙膏的总重量计,水以至少约10重量%、至少约20重量%、至少约30重量%、至少约40重量%,或至少约50重量%的量存在。
牙膏的每种非载体组分,包括但不限于式I化合物、式II化合物或其药学上可接受的盐和牙科磨料可独立地溶解、分散、悬浮或乳化在载体中。在一些实施方案中,将牙膏的至少一种组分溶解在载体中。在一些实施方案中,将牙膏的至少一种组分分散在载体中。在一些实施方案中,将牙膏的至少一种组分悬浮在载体中。在一些实施方案中,将牙膏的至少一种组分乳化在载体中。在一些实施方案中,式I化合物和式II化合物或其药学上可接受的盐各自溶解在载体中。
氟化物源(防龋剂)
在一些实施方案中,本公开的牙膏可包含一种或多种防龋剂,诸如例如一种或多种氟化物源。此类氟化物源释放或以其他方式提供口腔中的氟离子。氟化物源可以是无机氟化物源、有机氟化物源或它们的组合。
无机氟化物源的实例可包括但不限于碱金属、碱土金属和氟化铵盐,诸如例如氟化钾、氟化钠、二氟化铵、氟化钙、铜氟化合物(例如氟化亚铜、氟化铜)、氟化钡、氟硅酸钠、氟硅酸铵、氟锆酸钠、单氟磷酸钠、单-和二-氟磷酸铝、氟焦磷酸钙钠、氟化亚锡、氟化锌、氟化锂、氟化铯、氟化铝、氟化铟、氟锆酸亚锡、氟化铁、氟化镍、氟化钯、氟化银、氟化锆、银二胺氟化物,以及它们的组合。另一类氟化物源是含氟化物玻璃,诸如氟铝硅酸盐玻璃。合适的氟铝硅酸盐玻璃描述于美国专利号5,063,257(Akahane等人)、4,209,434(Wilson等人)和4,043,327(Potter等人)中,这些专利中的每个以引用方式全文并入本文。在一些实施方案中,牙膏包含无机氟化物源例如氟化钠、氟化亚锡、单氟磷酸钠、银二胺氟化物、氟化锶、氟化钙、氟铝硅酸盐玻璃或其组合。
有机氟化物来源可包括但不限于N,N,N'-三(2-羟乙基)-N'-十八烷基-1,3-二氨基丙烷二氢氟化物、氢氟酸己胺、氢氟酸月胺、氢氟酸肉豆蔻胺、氢氟酸癸醇胺,氢氟酸十八烯胺、氢氟酸肉豆蔻氧胺(myristoxyamine hydrofluoride)、氢氟酸二乙基氨乙基辛基酰胺、氢氟酸二乙醇胺乙基酰胺、二乙醇胺丙基-N'-十八烯基胺二氢氟化物、1-乙醇-2-十六烷基咪唑啉二氢氟化物、辛基乙醇胺氟氟化物、辛基三甲基氟化铵,十二烷基乙基二甲基氟化铵、四乙基氟化铵、二月桂基二甲基氟化铵、δ-8-9-十八碳烯基苄基二甲基氟化铵、二辛基二乙基氟化铵,环己基鲸蜡基二甲基氟化铵,呋喃基月桂基二甲基氟化铵,苯氧基乙基鲸蜡基二甲基氟化铵、N,N'-四甲基-N,N'-二月桂基亚乙基二氟化二铵、N-鲸蜡基吡啶鎓氟化物、N,N-二月桂基氟化吗啉鎓、N-肉豆蔻基-N-乙基氟化吗啉鎓、N-(辛基氨基羰基乙基)-N-苄基二甲基氟化铵、N-(B-羟基十二烷基)三甲基氟化铵,N-苯基-N-十六烷基二乙基氟化铵、N-环己基-N-十八烷基二甲基氟化铵、N-(2-甲氧甲酰基乙基)-N-苄基二甲基氟化铵、N-(2-碳环己氧基乙基)-N-肉豆蔻基二甲基氟化铵、N-(2-苄氧羰基乙基)-N-十二烷基二甲基氟化铵、N-[2-(N,N'-二甲基氨基羰基)-乙基]-N-十二烷基二乙基氟化铵、N-羧甲基-N-二十烷基二甲基氟化铵、奥拉氟(N'-十八烷基三亚甲基二胺-N,N,N'-三(2-乙醇)二氢氟化物)、甜菜碱氢氟酸、肌氨酸氟化亚锡、丙氨酸氟化亚锡、氟化甘氨酸钾、氟化肌氨酸钾、甘氨酸氢氟酸盐、四氟硼酸四丙基铵、四氟硼酸四丁基铵、四氟硼酸苄基三乙基铵、赖氨酸氢氟酸盐、丙氨酸氢氟酸盐、甜菜碱氟化锆及它们的混合物。在一些实施方案中,有机氟化物源可包括四丙基四氟硼酸铵,四丁基四氟硼酸铵,苄基三乙基四氟硼酸铵,或它们的组合。
氟化物源(如果存在的话)可存在于牙膏中,其量足以释放约200ppm至6,000ppm的氟离子,在一些实施方案中,释放约800ppm至约1,500ppm的氟离子或约2,500ppm至约5,000ppm的氟离子。在一些用于办公室程序的牙膏中,氟化物源的存在量足以释放约10,000ppm至23,000ppm之间的氟离子。基于牙膏的总重量,氟化物源可以以约0.001重量%至约5重量%存在于牙膏中。应理解,可以使用氟化物源的组合。氟化物源可溶解、分散、悬浮或乳化在牙膏中。在其中牙膏包含载体的一些实施方案中,氟化物源可以在载体中溶解、分散、悬浮或乳化。
抗菌剂
在一些实施方案中,本公开的牙膏可包含一种或多种抗菌剂。合适的抗菌剂的示例可包括但不限于醛(戊二醛、邻苯二醛)、酚类或酸的盐、氯己定或其衍生物(包括酸加合物,诸如乙酸盐、葡糖酸盐、氯化物、硝酸盐、硫酸盐或碳酸盐),及其组合。
抗菌剂的非限制性示例包括:锌盐、氧化锌、锡盐、氧化锡、苯扎氯铵、己啶、长链烷基铵或吡啶盐(例如氯化十六烷基吡啶、氯化十四烷基吡啶)、精油(例如百里香酚)、呋喃酮、氯己定及其盐形式(如葡萄糖酸氯己定)、血根碱、三氯生、氯化亚锡、氟化亚锡、奥替尼啶、非离子或离子表面活性剂(例如季铵化合物)、醇类(单体、聚合物、单醇、多元醇)、芳香醇(例如苯酚)、抗微生物肽(例如,组氨酸蛋白)、杀菌素(例如乳链菌肽)、抗生素(例如四环素)、醛(例如戊二醛)无机和有机酸(例如,苯甲酸、水杨酸、脂肪酸等)或其盐,此些酸的衍生物诸如酯(例如对羟基苯甲酸酯或其他对羟基苯甲酸酯、脂肪酸的甘油酯诸如十二烷酸二羟丙基酯)、氟化物、EDTA、银化合物、银纳米颗粒、过氧化物(例如过氧化氢)以及它们的组合。抗菌剂可溶解、分散、悬浮或乳化在牙膏中。在其中所述牙膏包含载体的一些实施方案中,所述抗菌剂可溶解、分散、悬浮或乳化在载体中。在其他实施方案中,牙膏不含抗菌剂。
表面活性剂和发泡剂
本公开的牙膏的一些实施方案可包含一种或多种表面活性剂。所述表面活性剂可为阴离子表面活性剂、阳离子表面活性剂、两性离子表面活性剂、非离子表面活性剂,或它们的组合。在一些情况下,表面活性剂也可用作发泡剂。合适的表面活性剂和发泡剂的示例可包括但不限于月桂基硫酸钠,以及美国专利号6,174,515(Suhonen)和4,301,141(Stier等人)中所述的那些,这些专利中的每个以引用方式全文并入本文。
增稠剂
本公开的牙膏可包含一种或多种无机或天然或合成的增稠剂或胶凝剂。任选地,基于牙膏的总重量,一种或多种增稠剂的总含量为约0.01重量%至约15重量%,在一些实施方案中为约0.1重量%至约10重量%,在一些实施方案中为约0.10重量%至约5重量%,在一些实施方案中为约0.2重量%至约5重量%,并且在一些实施方案中为约0.2重量%至约1重量%。在一些实施方案中,牙膏中增稠剂的比例足以形成可挤出的形状保持产品,其可以从管挤压到牙刷上并且不会落在刷子的刷毛之间,而是在上面基本上保持其形状。在一些实施方案中,如果例如在抛光或清洁过程期间使用旋转抛光装置(例如,洁牙杯),则增稠剂足以使牙膏的飞溅最小化。在一些实施方案中,本公开的牙膏的可以包含至少一种增稠剂,例如用于赋予牙膏所需的稠度和/或口感。
可使用任何口服可接受的增稠剂。适用于本公开的牙膏的增稠剂或胶凝剂包括无定形二氧化硅(例如,可从胡贝尔公司(Huber Corporation)以商品名ZEODENT 165获得)、热解法二氧化硅、沉淀二氧化硅、胶体二氧化硅、天然和合成树胶和胶体、泊洛沙姆、卡波姆(也称为羧乙烯基聚合物)、角叉菜胶、爱尔兰苔藓、ι-角叉菜胶、纤维素聚合物诸如羟乙基纤维素、羧甲基纤维素(carboxymethylcellulose)(羧甲基纤维素(carmellose)、纤维素胶)及其盐例如羧甲基纤维素钠、天然树胶诸如刺梧桐、黄原胶、阿拉伯树胶、黄蓍胶、聚乙烯吡咯烷酮、琼脂、胶体硅酸镁铝,及其组合。基于牙膏的总重量,一种或多种增稠剂任选以约0.01重量%至约15重量%,例如约0.1重量%至约10重量%或约0.2重量%至约5重量%的总量存在。可将增稠剂或胶凝剂溶解、分散、悬浮或乳化在牙膏中。在一些实施方案中,其中所述牙膏包含载体,所述增稠剂或胶凝剂可溶解、分散、悬浮或乳化在载体中。
湿润剂
在一些实施方案中,本公开的牙膏可包含湿润剂或多种湿润剂。湿润剂的示例包括但不限于多元醇,诸如甘油、山梨醇、木糖醇、亚烷基二醇(例如聚乙二醇、丙二醇),以及它们的组合。在各种实施方案中,湿润剂能够操作以防止牙膏在暴露于空气时硬化。在各种实施方案中,湿润剂也可用作甜味剂。任选存在一种或多种润湿剂,总量为约1重量%、约2重量%、约5重量%、约10重量%、约15重量%、约20重量%、约25重量%、约30重量%、约40重量%、约50重量%、约60重量%、约70重量%、约80重量%、大于约80重量%,或在这些值中的任何两个之间并且包括该任何两个值的范围内。例如,基于牙膏的总重量,牙膏可包含约1重量%至约80重量%,约2重量%至约25重量%,或约5重量%至约15重量%。在一些实施方案中,牙膏包含湿润剂,基于牙膏的总重量,其量为至少约10重量%、至少约15重量%,或至少约20重量%。在一些此类实施方案中,湿润剂包括山梨醇。润湿剂可以溶解、分散、悬浮、或乳化在牙膏中。在其中牙膏包含载体的一些实施方案中,湿润剂可溶解、分散、悬浮或乳化在载体中。
缓冲剂
在一些实施方案中,本公开的牙膏可包含缓冲剂或缓冲系统,或多种缓冲剂或系统。合适的缓冲剂的示例包括磷酸盐缓冲剂,如美国专利号9,149,661(Pilch等人)中进一步描述的,其全部内容通过引用并入本文。该缓冲剂或缓冲系统可以溶解、分散、悬浮或乳化在牙膏中。在其中牙膏包含载体的一些实施方案中,缓冲剂或缓冲体系可溶解、分散、悬浮或乳化在载体中。
染色剂
在一些实施方案中,本公开的牙膏可包含一种着色剂或多种着色剂。着色剂可以是任何染料或颜料。该着色剂可以溶解、分散、悬浮或乳化在牙膏中。在其中牙膏包含载体的一些实施方案中,着色剂可溶解、分散、悬浮或乳化在载体中。
调味剂
在一些实施方案中,本公开的牙膏可包含一种调味剂或多种调味剂。在一些实施方案中,调味剂包括给牙膏赋予风味例如薄荷风味的试剂。合适的调味剂的示例包括但不限于冬青油、胡椒薄荷油、绿薄荷油、丁香芽油、薄荷醇、茴香脑、水杨酸甲酯、桉叶油素、肉桂、醋酸1-薄荷酯、鼠尾草、丁子香酚、欧芹油、覆盆子酮(oxanone)、α-紫罗兰酮、马郁兰、柠檬、橙、丙烯基檀香醇、肉桂粉(cinnamon)、香草醛、乙基香兰素、天芥菜精、4-顺式-庚烯醛、二乙酰基、对-叔丁基苯基乙酸甲酯,及其混合物。在一些实施方案中,牙膏包含给牙膏赋予触感(例如,凉爽感)的试剂。提供清凉感的试剂的示例包括但不限于对位甲烷羧酰胺试剂,例如N-乙基-对-薄荷烷-3-甲酰胺(商业上称为“WS-3”)。调味剂和/或赋予触感的试剂可各自独立地溶解、分散、悬浮或乳化在牙膏中。在一些实施方案中,其中牙膏包含载体,调味剂或赋予触感的试剂可各自独立地溶解、分散、悬浮或乳化在载体中。基于牙膏的总重量,牙膏可包含约0.001重量%至约5重量%的调味剂(或赋予触感的试剂)。
甜味剂
在一些实施方案中,本公开的牙膏可包含一种甜味剂或多种甜味剂。合适的甜味剂的非限制性示例包括单糖、二糖和多糖,诸如木糖、核糖、葡萄糖(右旋糖)、甘露糖、半乳糖、麦芽糖;糖醇,包括赤藓糖醇、苏糖醇、阿拉伯糖醇、木糖醇、核糖醇、甘露糖醇、山梨醇等;人造甜味剂诸如可溶性糖精盐,即,钠或钙糖精盐、环己基氨基磺酸盐、基于二肽的甜味剂、诸如L-天冬氨酸衍生的甜味剂、诸如L-天冬氨酰-L-苯丙氨酸甲酯(天冬甜素)、三氯蔗糖、乙酰磺胺酸钾、AdvantameTM,NeotameTM;天然甜味剂诸如甜叶菊、索马甜、莫内林、布拉齐因、潘塔亭;以及它们的组合。甜味剂可以溶解、分散、悬浮、或乳化在牙膏中。在其中牙膏包含载体的一些实施方案中,甜味剂可溶解、分散、悬浮或乳化在载体中。
再矿化剂
在一些实施方案中,本公开的牙膏可包含一种再矿化剂或多种再矿化剂。再矿化剂可以提供钙(例如钙离子)和/或磷(例如磷酸根离子)释放到口腔环境中以增强再矿化,诸如例如牙釉质和/或牙本质的再矿化。已知钙和磷离子释放到口腔环境中增强牙齿结构的天然再矿化能力。合适的再矿化剂包括但不限于:表面处理的磷酸钙颗粒,其在美国专利号8,556,553(Karlinsey)、9,023,373(Karlinsey)、8,790,707(Rusin等人)和9,220,673(Rusin等人)中描述;具有含磷表面处理的颗粒,其在美国专利号8,710,114(Rusin等人)中描述;和β磷酸三钙,如美国专利号9,205,036(Karlinsey)中所述,这些专利中的每个以引用方式全文并入本文。还可用的是美国专利号5,037,639(Tung)、5,993,784(Hill)、5,711,936(Hill)和5,651,959(Hill等人)中描述的化合物和方法,这些专利中的每个以引用方式全文并入本文。还可用的是各种形式的磷酸钙颗粒或纳米颗粒,包括偏磷酸钙、磷酸一钙、(无水、一水合物或二水合物)、连二磷酸钙、磷酸二钙(无水、一水合物或二水合物)、单氟磷酸钙、焦磷酸钙、磷酸八钙、无定形磷酸钙、磷酸三钙(α或β)、羟基磷灰石、氟磷灰石、磷酸四钙及其组合。还有用的是具有钙和磷的分子,包括甘油磷酸钙、植酸钙镁、酪蛋白及其衍生物等,如美国专利申请公布号2009/0208909(Rusin等人)和美国专利号8,278,368(Rusin等人)、5,015,628(Reynolds)、6,780,844(Reynolds)、8,609,071(Reynolds)和9,241,883(Reynolds)中所述,这些专利中的每个通过引用全文并入本文。还有用的是钙磷玻璃,如美国专利申请公布号2015/0125823(Rusin等人)和美国专利号6,709,744(Day等人)以及5,735,942(Litowski等人)中所述。用于包含在本公开的牙膏中的合适的生物活性玻璃也可以商品名VITRYXX从肖特公司(Schott)获得。牙齿再矿化剂可以溶解、分散、悬浮、或乳化在牙膏中。在一些实施方案中牙膏包含载体,牙齿再矿化剂可以溶解、分散、悬浮、或乳化在载体中。
脱敏试剂
在一些实施方案中,本公开的牙膏可包含一种脱敏剂或多种脱敏剂。脱敏剂可用于对抗牙本质过敏症。脱敏剂的示例包括但不限于小管阻断剂、神经脱敏剂,以及它们的组合。脱敏剂的示例还包括但不限于不限于锶盐(例如,氯化锶、乙酸锶和/或硝酸锶)、钾盐(例如,柠檬酸钾、氯化钾、碳酸氢钾、葡萄糖酸钾和/或或硝酸钾)、氟化亚锡;
游离形式或盐形式的碱性氨基酸(例如精氨酸、赖氨酸、瓜氨酸、鸟氨酸、肌酸、组氨酸、二氨基丁酸和/或二氨基丙酸及其盐),及其组合。脱敏剂可溶解、分散、悬浮或乳化在牙膏中。在其中牙膏包含载体的一些实施方案中,脱敏剂可溶解、分散、悬浮或乳化在载体中。
治疗剂
在一些实施方案中,本公开的牙膏可包含一种治疗剂或多种治疗剂。此类治疗剂可为具有治疗性质的添加剂。治疗性质可包括例如抗牙斑活性、防龋活性或抗微生物(例如抗菌)活性。在一些实施方案中,治疗剂可具有生物膜抑制或生物膜破坏活性。治疗剂可溶解、分散、悬浮或乳化于牙膏中。在其中牙膏包含载体的一些实施方案中,所述治疗剂可溶解、分散、悬浮或乳化在载体中。
粘结剂
在一些实施方案中,本公开的牙膏可包含一种粘合剂或多种粘结剂。该粘结剂可以在受试者的口腔中提供式I化合物的储库。式I化合物可从粘结剂中释放。粘结剂可以将式I化合物保持在受试者口腔表面上或附近,使得例如表面可以暴露于化合物。所述表面可为硬质表面,例如,其包括牙齿。所述表面可为牙科修复物。美国专利号8,968,709(Kennedy等人)中公开了合适的粘结剂的示例,该专利全文以引用方式并入本文。
所述牙膏可具有包括溶液、分散体、悬浮液、乳液、固体、糊剂、泡沫或凝胶的形式。在一些实施方案中,牙膏为洁齿剂。在一些实施方案中,牙膏为预防膏。牙膏的任何组分可以溶解、分散、悬浮、或乳化在牙膏的任何其它组分中。在一些实施方案中,组分中的一种或多种是相互可溶的(即,彼此混溶)。
在一些实施方案中,牙膏在单个部分或相内提供。在其它实施方案中,牙膏包含第一部分和第二部分,所述第一部分和第二部分分别保持直至它们在使用时混合。分开保持第一部分和第二部分仅需要以这样的方式保持部分,即基本上防止牙膏的一部分与牙膏的另一部分相互作用。可以使用双重部分牙膏,其中牙膏中包含一种或多种不相容的成分(组分)。例如如果牙膏包含两种不相容的活性成分,则将它们分开保持可能是有利的。
牙膏可以通过将式I化合物、式II化合物或其药学上可接受的盐与研磨剂,任选地与牙膏的另一种组分(例如载体诸如液体载体)或多种组分组合来配制。在牙膏包含液体载体的情况下,式I化合物和/或式II化合物或其药学上可接受的盐可与液体载体组合。该化合物可以各自独立地被溶解、分散、悬浮或乳化在该液体载体中。在一些实施方案中,牙膏的所有组分在大约相同的时间组合。
方法和套件
在另一方面,本公开提供了在受试者的口腔中处理表面的方法,包括以下步骤:(a)提供本文所公开的牙膏中的任一种,和(b)将所述牙膏施用到受试者口腔中的表面。受试者口腔中的表面包括例如颊面,齿龈表面,牙齿,牙科修复体和骨。在一些实施方案中,表面是硬质表面,例如牙齿的表面(包括诸如釉质和/或牙质的重要表面),但也是非重要的表面,诸如牙齿修复的表面)。该牙膏可通过例如,刷洗(例如,刷牙),抛光,擦拭,或其组合施加至受试者的口腔。牙科用糊剂施用到口腔中的表面还可包括抛光表面,例如抛光牙齿的表面。虽然抛光表面可在刷洗过程中发生(例如,在家中常规刷牙),抛光可在牙科预防过程中执行,诸如在临床环境中由牙科专业人员(如牙科保健学家)执行的。受试者可以是人,或者受试者可以是非人类动物。非人类动物包括哺乳动物如犬类和猫科动物。本公开的牙膏可用于抑制生物膜形成,例如抑制受试者口腔中表面上的生物膜形成。因此,在另一方面,本公开还提供了在受试者的口腔中处理表面的方法,所述方法包括以下步骤:(a)提供本文所公开的任何一种牙膏,和(b)将所述牙膏施用到受试者口腔中的表面。受试者口腔中的表面和施用牙膏的方式可为之前描述的那些中的任一种。
在又一个方面,本公开提供了一种试剂盒,包括(a)本文所公开的牙膏中的任一种,和(b)施用装置。施用装置可以是刷子、拭子、预防装置以及它们的组合。预防装置的示例包括但不限于预防杯(即,“洁牙杯”)和预防角形(“洁牙角形”)。施用装置可为适于在给定应用中使用的任何尺寸。试剂盒可包括多于一个施用装置或不止一种施用装置(例如刷子和拭子)。该试剂盒还可包括用于使用试剂盒的说明。
牙膏可以与口腔表面接触足够的时间以抑制口腔中的生物膜形成。时间可为至多约一秒、至多约五秒、至多约十秒、至多约三十秒、至多约一分钟、至多约两分钟、至多约五分钟、至多约十分钟、至多约十五分钟,至多约三十分钟,或至多约六十分钟。时间可为少于约一个月、少于约两周、少于约一周、少于约二十四小时、少于约二十小时、少于约十六小时、少于约十二小时、小于约十小时、少于约八小时、少于约六小时、少于约四小时,或少于约两小时。
牙膏可包含一定量的式I化合物,其足以抑制生物膜的形成,该生物膜包含在受试者口腔中发现的细菌中的至少一种。在一些实施方案中,受试者为人类。在其他实施方案中,受试者为非人类动物。细菌包括例如变异链球菌(streptococcus mutans)和血练球菌(S.sanguis)。
以下实施方案旨在举例说明本公开而非进行限制。
实施方案
实施方案1是一种牙膏包括:
(i)式(I)化合物:
其中:
R1为氢原子或烷基;并且
R2为C(O)R3,其中R3为C7–C9烷基,并且
n为约2至约5的整数。
(ii)式II化合物或其药学上可接受的盐:
其中:
R4为氢原子或烷基;并且
R为约2至约5的整数;和
(iii)牙科磨料。
实施方案2为根据实施方案1所述的牙膏,其中R1为氢原子或C1-C2烷基。
实施方案3为根据实施方案1或实施方案2所述的牙膏,其中R3为C8烷基。
实施方案4为根据实施方案1至3中任一项所述的牙膏,其中n为4。
实施方案5为根据实施方案1至4中任一项所述的牙膏,其中R4为氢原子或C1-C12烷基。
实施方案6为根据实施方案1至5中任一项所述的牙膏,其中m为4。
实施方案7为根据实施方案1至6中任一项所述的牙膏,其中R1为C1烷基;R3为C8烷基;n为4;R4为氢原子或C1-C8烷基;以及m为4。
实施方案8为根据实施方案1至7中任一项所述的牙膏,其中所述牙科磨料包含二氧化硅、氧化铝、珍珠岩、浮石、碳酸钙、焦磷酸钙、磷酸二钙、磷酸三钙、碳酸氢钠、甘氨酸及其组合中的至少一种。
实施方案9为根据实施方案1至8中任一项所述的牙膏,另外包含液体载体。
实施方案10为根据实施方案9所述的牙膏,其中所述液体载体包含水、甘油、丙二醇、聚乙二醇及其组合中的至少一种。
实施方案11为根据实施方案1至10中任一项所述的牙膏,另外包含氟化物源、抗菌剂、表面活性剂、增稠剂、保湿剂、缓冲剂、着色剂、颜料、调味剂、甜味剂、再矿化剂、脱敏剂、发泡剂、治疗剂、抗龈炎剂及其组合。
实施方案12为根据实施方案1至11中任一项所述的牙膏,另外包含基于牙膏总重量的浓度为至少10重量%的山梨糖醇。
实施方案13为根据实施方案1至12中任一项所述的牙膏,其中所述牙膏为洁齿剂。
实施方案14为根据实施方案1至13中任一项所述的牙膏,其中所述牙膏为预防膏。
实施方案15为一种治疗受试者口腔表面的方法,所述方法包括:
(a)提供根据实施方案1至14中任一项所述的牙膏;和
(b)将所述牙膏施用到所述受试者口腔中的表面。
实施方案16为根据实施方案15所述的方法,其中所述表面为硬质表面。
实施方案17为根据实施方案15或实施方案16所述的方法,其中所述表面为牙齿的表面。
实施方案18是根据实施方案15至17中任一项所述的方法,其中施用所述牙膏包括刷洗、擦拭,或其组合。
实施方案19为一种用于治疗受试者口腔表面的试剂盒,所述试剂盒包括:
(a)根据实施方案1至14中的任一项所述的牙膏;和
(b)施用装置。
实施方案20为根据实施方案19所述的试剂盒,其中所述施用器选自刷子、拭子和其组合。
实施方案21是一种抑制受试者口腔中的表面上生物膜形成的方法,所述方法包括:
(a)提供根据实施方案1至14中的任一项所述的牙膏;以及
(b)将所述牙膏施用到所述受试者口腔中的表面。
应当理解,本发明并不将其应用局限于以上描述所提及的具体构造和部件布置方式。本发明能够具有其它的实施方案,并且能够以多种方式进行实践或实施。而且,应当理解,本文使用的措辞和术语是用于说明目的而不应视为限制性的。另外应当理解,可利用其它实施方案,并且可在不脱离本公开范围的情况下作出结构改变或逻辑改变。
下面实例旨在示出本发明而非进行限制。
实施例
如本文所用,除非另外指明,所有份数和百分比均按重量计,所有水为去离子水(“DI水”),并且所有分子量为平均分子量。除非另外指明,否则材料可获自威斯康星州密尔沃基的西格玛奥德里奇公司(Sigma-Aldrich,Milwaukee,WI)。
材料
D-葡糖胺得自俄勒冈州波特兰的TCI美国公司(TCI America,Portland,OR);N-甲基-D-葡糖胺和N-乙基-D-葡糖胺可从俄亥俄州梭伦的生物医药公司(MP Biomedicals(Solon,OH))商购获得。N-甲基-N-壬酰基-D-葡糖胺(“MEGA 9”)可从加利福尼亚州圣迭戈的EMD化学公司(EMD Chemicals,Inc.(San Diego,CA))商购获得。N-辛基-D-葡糖胺可从加利福尼亚州圣迭戈的卡博森斯公司(Carbosynth,Inc.((San Diego,CA))商购获得。
山梨醇(70重量%水溶液)可从新泽西州新不伦瑞克的光谱公司(Spectrum Inc.(New Brunswick,NJ))商购获得。甘油可从威斯康星州密尔沃基的西格玛奥德里奇公司(Sigma-Aldrich(Milwaukee,WI))商购获得。二氧化钛(型号MT-500B)可得自新泽西州帕特森的Diacolor-Pope公司(Diacolor-Pope Inc.(Paterson,NJ))。纤维素胶(食品级羧甲基纤维素,对于1重量%溶液显示出约3,000cps的粘度)、二氧化硅增稠剂(平均粒径为12微米,吸油值为220cc/100g)和二氧化硅磨料(通过激光衍射测定的平均粒径为9微米,吸油值为120g/100g,表面积为45m2/g)可从各种商业供应商处获得。
补充有约5重量%蔗糖(MCM)的含粘蛋白的培养基的制备
如下制备补充有约5重量%蔗糖的含粘蛋白的培养基的1L储备溶液。将Lab-lemco牛肉提取物粉末(1.0g,购自马萨诸塞州沃尔瑟姆的Thermo Fisher科学公司(ThermoFisher Scientific,Waltham,MA))、酵母提取物粉末(2.0g,购自新泽西州富兰克林湖的Becton、Dickinson and Company公司(Becton,Dickinson and Company,Franklin Lakes,NJ))、蛋白胨(proteose peptone,5g,购自新泽西州富兰克林湖的Becton、Dickinsonand Company公司(Becton,Dickinson and Company,Franklin Lakes,NJ))、来自猪胃的粘蛋白III型(2.5g,购自密苏里州圣路易斯的西格玛-奥德里奇公司(Sigma-Aldrich,St.Louis,MO)),氯化钠(0.35g)、氯化钙二水合物(0.2g)和氯化钾(0.2g)溶解在去离子水(800mL)中。用校准的pH电极测量pH(pH=6.9)。加入另外的DI水(100mL)并将溶液在121℃下高压灭菌15分钟。冷却至室温后,加入40%(w/v)尿素水溶液(1.25mL,过滤除菌),然后加入50%(w/v)蔗糖水溶液(98.75mL,高压灭菌)。MCM溶液的成分总结在表1中。
表1
生物膜微观测试方法
使用由市售的并用1000粒度的抛光剂抛光至最终厚度2.0mm的牙科磨坯空白(Paradigm MZ100,购自明尼苏达州圣保罗的3M口腔护理公司(3M Oral Care,St.Paul,MN))形成的复合盘(10mm直径×2.1mm厚)作为生物膜生长的底物。在使用之前,将这些盘在75%(v/v)乙醇中消毒45至60分钟。通过在1%氢氧化钠水溶液中摇动盘以除去生物膜生长,用水冲洗并储存在50%乙醇水溶液中来清洁盘以重复使用。
将一个灭菌的复合盘放置在无菌24孔板中的每个孔中。将来自单个健康供体的1:4人唾液的混合物:MCM(1.8mL)加入到每个含有盘的孔中。将24孔板置于37℃下的培养箱中,同时振荡(60rpm)4小时。从培养箱中取出板,除去生长培养基,向各孔加入新鲜的MCM(1.8mL,无唾液),并将板在37℃振荡培养4小时。此后,只有没有唾液的MCM用于另外的培养基更换。
然后如下对盘进行五个处理/生长循环。通过移液管将来自孔的液体去除。向每个孔中加入处理溶液(1.8mL),然后在盘暴露1分钟后从每个孔中取出。然后用去离子水漂洗每个盘2分钟,向每个孔中加入MCM(1.8mL),并将板在37℃下培养4小时。在冷冻下过夜储存,去除MCM并用磷酸盐缓冲盐水替换(PBS;也称为“Dulbecco A”,在Dulbecco&Vogt 1954,J.ExpMed.99,167-182中描述)。在测试方法结束前两小时进行最后一次培养基更换。
在第四天的最后一次处理/生长循环之后,用干燥的滤纸收集生物膜以确定每个盘的无水生物膜质量。具体地讲,将具有生长的生物膜的盘小心地转移到填充有DI水(每孔1.0mL)的新24孔板中。每个盘用去离子水(1.0mL)洗涤三次,持续1分钟,同时适度摇动(约400rpm)。洗涤后,将盘在滤纸上小心吸干,以除去过量的液体。然后通过用滤纸擦拭每个盘的表面从盘上除去生物膜,滤纸在70℃的微量离心管中干燥过夜并称重以确定干燥纸和微量离心管的总重量。然后将具有湿生物膜的每个滤纸放回到相同的微量离心管中,在70℃下干燥过夜,并通过称重干燥的生物膜、纸和微量离心管并减去管和纸的初始质量来确定生物膜质量。生物膜微观测试方法的步骤总结在表2中。
表2
牙膏制剂
根据表3中所示的组分和量制备牙膏制剂,混合直至各组分均匀分散。
为了制备用于生物膜微观测试方法的测试(处理)溶液,将表3中的牙膏制剂中的每种与去离子水(牙膏:去离子水=1:3,按重量计)混合,将所得混合物离心,并且除去离心混合物的上清液水层并用作测试溶液。以相同的方式,通过与去离子水(牙膏:去离子水=1:3,按重量计)混合、离心混合物、回收上清液来从市售牙膏(Colgate Total Clean Mint,防龋齿氟化物及抗龈炎牙膏(Anticavity Fluoride and Antigingivitis toothpaste),包含0.30%三氯生,“高露洁(Colgate)”)制备测试溶液用于测试。
研究1
生物膜微观测试方法用于评估牙膏制剂CE-1、CE-2、CE-3、EX-1和市售高露洁(Colgate)(阳性对照)的测试溶液。生物膜微观测试方法重复三次,每次测试中六个重复。用于研究1的测试方法的人唾液由单个健康志愿者(供体A)提供。生物量数据示于表4中。
表4
表4中的数据显示仅包含MEGA-9(CE-2)或仅包含N-甲基-D-葡糖胺(CE-3)的牙膏对生物膜生长几乎没有抑制作用,导致与阴性对照(去离子水)和CE-1类似的生物量。相反,包含MEGA-9和N-甲基-D-葡糖胺(EX-1)的牙膏提供了对生物膜生长的显著抑制,类似于市售的含抗菌牙膏高露洁(Colgate)。
研究2
使用生物膜微观测试方法评估牙膏配方CE-2,CE-4,EX-2和市售高露洁(Colgate)的测试溶液作为阳性对照。生物膜微观测试方法进行一次,每次测试中六个重复。用于研究2的测试方法的人唾液由单个健康志愿者(供体B)提供。生物量数据示于表5中。
表5
表5中的数据显示仅包含MEGA-9(CE-2)或仅包含N-乙基-D-葡糖胺(CE-4)的牙膏对生物膜生长几乎没有抑制作用,导致与阴性对照(去离子水)相似的生物量。相反,包含MEGA-9和N-乙基-D-葡糖胺(EX-2)的牙膏提供了对生物膜生长的显著抑制,类似于市售的含抗菌牙膏高露洁(Colgate)。
研究3
使用生物膜微观测试方法评估牙膏制剂CE-2、CE-5、CE-6、EX-3、EX-4和市售高露洁(Colgate)(阳性对照)的测试溶液。生物膜微观测试方法进行一次,每次测试中六个重复。用于研究3的测试方法的人唾液由单个健康志愿者(供体C)提供。生物量数据示于表6中。
表6
表7中的数据显示,仅包含MEGA-9(CE-2)或仅包含D-葡糖胺(CE-5)或仅包含N-辛基-D-葡糖胺(CE-6)的牙膏对生物膜生长几乎没有抑制作用,导致类似于阴性对照(去离子水)的生物量。相比之下,包含MEGA-9和D-葡糖胺(EX-3),或包含MEGA-9和N-辛基-D-葡糖胺(EX-4)的牙膏都能显著抑制生物膜生长,类似于商业上可获得的含抗菌牙膏高露洁(Colgate)。
上述实施方案仅以举例的方式给出,并且无意于限制本公开的概念和原则。因此,本领域的普通技术人员应当理解,在不脱离本公开实质和范围的情况下可对元件及其构造和布置方式作出各种改变。
本文中引用的所有参考文献和出版物明确地以全文引用方式并入本公开。
以下权利要求书陈述了本公开的各种特征和方面。
Claims (13)
2.根据权利要求1所述的牙膏,其中R3为C8烷基。
3.根据权利要求1中所述的牙膏,其中R1为C1烷基;R3为C8烷基;以及R4为氢原子或C1-C8烷基。
4.根据权利要求1至3中任一项所述的牙膏,其中所述牙科磨料包含二氧化硅、氧化铝、珍珠岩、浮石、碳酸钙、焦磷酸钙、磷酸二钙、磷酸三钙、碳酸氢钠、甘氨酸及其组合中的至少一种。
5.根据权利要求1至3中任一项所述的牙膏,另外包含液体载体。
6.根据权利要求5所述的牙膏,其中所述液体载体包含水、甘油、丙二醇、聚乙二醇及其组合中的至少一种。
7.根据权利要求1至3中任一项所述的牙膏,另外包含氟化物源、表面活性剂、增稠剂、保湿剂、缓冲剂、着色剂、调味剂、再矿化剂、治疗剂、及其组合。
8.根据权利要求1至3中任一项所述的牙膏,另外包含基于牙膏总重量的浓度为至少10重量%的山梨糖醇。
9.根据权利要求1至3中任一项所述的牙膏,其中所述牙膏为洁齿剂。
10.根据权利要求1至3中任一项所述的牙膏,其中所述牙膏为预防膏。
11.根据权利要求1至3中任一项所述的牙膏,另外包含抗菌剂、颜料、甜味剂、脱敏剂、发泡剂、抗龈炎剂及其组合。
12.一种用于治疗受试者口腔中的表面的试剂盒,所述试剂盒包括:
(a) 根据权利要求1至11中任一项所述的牙膏;和
(b) 施用装置。
13.根据权利要求12所述的试剂盒,其中所述施用装置选自刷子、拭子和其组合。
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