CN112423724A - 用于牙齿增白和抗微生物效果的固体组合物 - Google Patents
用于牙齿增白和抗微生物效果的固体组合物 Download PDFInfo
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Abstract
本文公开了一种用于口腔护理的固体组合物,所述固体组合物包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种碳酸盐碱和任选地至少一种泡腾酸。本文还公开了一种包括固体组合物和水性液体组合物的套件,以及增白牙齿和/或在口腔中产生抗菌效果的方法,所述方法包括混合固体组合物与水性液体组合物直至固体组合物崩解以产生包含次氯酸盐的漱口水;以及使牙齿与包含次氯酸盐的漱口水接触。
Description
背景技术
许多消费者期望具有抗微生物效果如减少菌斑的效果的口腔护理产品。牙菌斑是在牙齿上形成并由细菌和细菌副产物的积聚组成的软沉积物。除了不美观外,牙菌斑还牵涉牙龈炎和其他形式的牙周病的发生。已提出在口腔护理组合物中使用阳离子抗菌剂(例如,基于精氨酸的酯、Sn(II)化合物和十六烷基氯化吡啶鎓),特别是来对抗菌斑形成和与菌斑形成相关联的口腔感染。然而,这些试剂常常与漱口水配方中存在的其他成分不相容,从而降低它们在这样的配方中的抗微生物活性。
许多消费者还期望更白的牙齿,这可通过使用牙齿增白产品实现。可通过改变或去除污渍和/或改变对牙齿颜色的视觉感知来化学地产生增白效果。
过氧化物化合物(例如,过氧化氢(H2O2)可在漱口水配方中提供增白益处。然而,这些配方因过氧化物化合物在水溶液中相对不稳定而可能随时间丧失其增白功效。此外,过氧化物化合物与许多活性口腔护理剂不相容,包括抗微生物化合物。例如,SnF2(Sn II)在不存在过氧化物化合物的情况下具有抗菌活性;然而,SnF2在过氧化物的存在下不稳定并发生向Sn(IV)的氧化。其他阳离子抗菌剂如十六烷基氯化吡啶鎓可能污染牙齿并因此降低过氧化物化合物的增白功效。
由于配方中过氧化氢的货架稳定性要求,大多数牙齿增白产品在约4.5至约5.5的低pH下配制。这也可能导致不良的增白功效,因为货架稳定的过氧化氢也具有较低的氧化电位。包含过氧化氢的产品的另一个问题在于对口腔护理产品中过氧化氢的政府规定。例如,在欧洲,对于非处方产品,过氧化氢浓度必须保持低于0.1%。
虽然其他漂白和/或抗微生物剂是已知的,但它们在水溶液中或在较低的pH下可能不稳定,并因此不被用在口腔护理组合物如漱口水中。例如,已知次氯酸盐既是有效的漂白剂又是有效的抗微生物剂。因此,包含次氯酸盐的组合物可用于口腔护理以提供牙齿增白益处以及抗微生物益处。然而,次氯酸盐在水性环境中在低于约13的pH下不稳定;因此,不能将它直接添加到许多口腔护理组合物如漱口水。为了避免在液体组合物中直接使用基于次氯酸盐的化学品的稳定性问题,已使用前体分子如二氯异氰脲酸钠(NaDCC)通过在与水接触时触发NaDCC向次氯酸盐的转化而在使用过程中产生次氯酸盐。这样的材料已被用于饮用水处理中,这给予了机会将它们用作口腔护理产品中的成分而无需担心安全性。根据世界卫生组织的规定,成人的NaDCC每日摄入量限制为例如2.2mg/天/kg体重。
因此,期望提供既具有增白活性又具有抗微生物活性的稳定、安全且有效的口腔护理组合物。
发明内容
本文公开了一种用于口腔护理如用于提供牙齿增白和/或抗菌效果的固体组合物,其包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种碳酸盐碱和任选地至少一种泡腾酸。在某些实施方案中,所述至少一种碳酸盐碱以相对于固体组合物的总重量在约45重量%至约95重量%、如约65重量%至约80重量%的范围内的量存在于固体组合物中,并且在某些实施方案中,所述至少一种泡腾酸以相对于组合物的总重量在约0.01重量%至约20重量%、如约1重量%至约5重量%的范围内的量存在于固体组合物中。在某些实施方案中,本文提供了一种用于牙齿增白的固体组合物,其包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂和至少一种以约45%至约95%的范围内的量存在于固体组合物中的碳酸盐碱,其中所述固体组合物不含泡腾酸。
根据本公开的各种实施方案,所述至少一种增白剂为氯化异氰脲酸盐,如二氯异氰脲酸钠,并且在某些实施方案中,氯化异氰脲酸盐以相对于固体组合物的总重量在约0.5重量%至约50重量%、如约10重量%至约30重量%的范围内、或约20重量%的量存在于固体组合物中。根据本公开的各种实施方案,所述至少一种碳酸盐碱为碳酸氢钠,并且在某些实施方案中,所述至少一种泡腾酸为酸式焦磷酸钠。
在本公开的某些实施方案中,固体组合物为片剂,并且在某些实施方案中,固体组合物是无水的。另外,在某些示例性实施方案中,所述至少一种固体组合物不含微晶纤维素、不含硬脂酸镁和/或不含聚合物如水溶性聚合物。在某些其他实施方案中,固体组合物包含至少一种水溶性聚合物,如至少一种选自聚乙烯基吡咯烷酮和聚乙烯基吡咯烷酮乙酸乙烯酯的水溶性聚合物。
根据本文公开的某些实施方案,约50mg固体组合物能够在约20mL水性液体组合物如漱口水中在不到约180秒、如不到约90秒内或在约15秒或更短时间内崩解。
本文还公开了一种套件,其包括(1)用于口腔护理的固体组合物,其包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种以相对于固体组合物的总重量在约45重量%至约95重量%的范围内的量存在于固体组合物中的碳酸盐碱和至少一种以相对于固体组合物的总重量在约0.01重量%至约20重量%的范围内的量存在的泡腾酸;和(2)包含水性漱口水组合物的容器。在某些实施方案中,套件还包括适于容纳特定量如约20mL或约15mL的水性漱口水组合物和单位剂量的固体组合物的杯子,并且在某些实施方案中,套件中固体组合物中的所述至少一种增白剂为二氯异氰脲酸钠。在某些实施方案中,提供了一种套件,其包括(1)用于口腔护理的固体组合物,其包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂和至少一种以相对于固体组合物的总重量在约45重量%至约95重量%的范围内的量存在于固体组合物中的碳酸盐碱;和(2)包含水性漱口水组合物的容器,所述水性漱口水组合物包含至少一种泡腾酸。在本文公开的套件的某些实施方案中,当将固体组合物与单位剂量的水性漱口水组合物合并时,所述至少一种泡腾酸可以相对于固体组合物的重量在约0.01重量%至约20重量%的范围内的量存在于所述单位剂量的水性漱口水组合物中。
本文还公开了一种增白牙齿的方法,其包括(1)混合用于口腔护理的固体组合物与水性液体组合物直至固体组合物崩解以产生包含次氯酸盐的漱口水,其中所述固体组合物包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种以在约45%至约95%的范围内的量存在于固体组合物中的碳酸盐碱和至少一种以在约0.01%至约20%的范围内的量存在的泡腾酸;(2)使牙齿与包含次氯酸盐的漱口水接触;和(3)任选地吐出包含次氯酸盐的漱口水。在本公开的其他实施方案中,提供了一种增白牙齿的方法,其包括(1)混合用于口腔护理的固体组合物与包含至少一种泡腾酸的水性液体组合物直至固体组合物崩解以产生包含次氯酸盐的漱口水,其中所述固体组合物包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂和至少一种以在约45%至约95%的范围内的量存在于固体组合物中的碳酸盐碱;(2)使牙齿与包含次氯酸盐的漱口水接触;和(3)任选地吐出包含次氯酸盐的漱口水。在本文公开的方法的某些实施方案中,约50mg固体组合物在约20mL水性液体组合物中在不到约180秒、如不到约90秒、不到约60秒内、在约15秒或更短、或在约10秒或更短时间内崩解。
本公开的其他适用领域将因下文中所提供的详细描述而变得显而易见。应理解,虽然详细描述和具体实施例指示了本公开的某些优选实施方案,但意在仅出于说明的目的而非意在限制本公开的范围。
具体实施方式
以下对优选实施方案的描述在本质上仅是示例性的,并且决不意图限制本发明、本发明的应用或用途。
通篇使用的范围用作描述范围内的每个值的简略表达方式。范围内的任何值都可以被选为范围的终点。此外,本文引用的所有参考文献特此以全文引用的方式并入。在本公开中的定义与所引用的参考文献的定义冲突的情况下,以本公开为准。
如本文所用,关于条目列表(诸如例如A和B)的术语“……中的一者或多者”意指单独的A、单独的B或A和B。术语“……中的至少一者”用于意指可以选择所列条目中的一者或多者。
除非另外指明,否则本文和在本说明书中其他地方表述的所有百分数和量均应理解为是指重量百分数。给定的量基于材料的有效重量。
本文公开了一种固体组合物如片剂或粉末,其包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种碳酸盐碱和任选地至少一种泡腾酸。所述固体组合物可以是快速崩解的,使得可将其添加到液体水性组合物如水、唾液或漱口水以供消费者使用来提供牙齿增白和/或抗菌益处。
本文公开的固体组合物包含至少一种至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂。合适的氯化异氰脲酸盐的非限制性实例包括无水二氯异氰脲酸钠(NaDCC)、二氯异氰脲酸钠二水合物(NaDCC2H2O)、二氯异氰脲酸钾(KDCC)、三氯异氰脲酸(TCCA)和二氯异氰脲酸钙以及其他二氯异氰脲酸盐、水合物及其组合。在某些实施方案中,氯化异氰脲酸盐包括NaDCC。NaDCC通常具有化学式C3Cl2N3NaO3,CAS编号2893-78-9,并也可称为二氯-s-三嗪-三酮钠、3,5-二氯-2,4,6-三氧代-1,3,5-三嗪烷-1-化钠、sodium troclosene、sodic troclosene、troclosenum natricum、二氯异氰脲酸或二氯异氰脲酸的钠盐。NaDCC在下文以式I示出:
在某些实施方案中,所述至少一种增白剂选自次氯酸金属盐。合适的次氯酸金属盐的非限制性实例包括次氯酸锂、次氯酸钾、次氯酸钠、次氯酸镁、次氯酸钙、次氯酸钡及其混合物。
本文公开的所述至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂可以任何有效于牙齿增白和/或抗菌益处的量存在于固体组合物中。例如,在本文公开的固体组合物中至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂的量可在用于漱口水中时与无所述增白剂的对照漱口水相比有效地导致改善的牙齿增白。另外,在本文公开的固体组合物中至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂的量可在使用者的口腔中有效地导致抗菌活性。在某些实施方案中,所述至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂的量可相对于固体组合物的总重量在约0.5重量%至约50重量%、如约5重量%至约40重量%、约7.5重量%至约37重量%、约10重量%至约25重量%的范围内、或为约20重量%。在某些实施方案中,氯化异氰脲酸盐为NaDCC,其以相对于固体组合物的总重量在约1重量%至约25重量%的范围内、如为约20重量%的量存在。在某些实施方案中,固体组合物中存在的NaDCC的量使得单位剂量的固体组合物不超过2.2mg NaDCC每天每kg使用者体重。
氯化异氰脲酸盐如NaDCC和次氯酸金属盐如次氯酸钠在水的存在下可能不稳定。相反,当与水接触时,NaDCC将转化为次氯酸盐。下面的化学反应示意了NaDCC向次氯酸盐的转化:
如上文所讨论,同其他形式的氯化物一样,次氯酸盐是已知的漂白剂和消毒剂。本文公开了一种在用于牙齿增白和/或抗菌效果的口腔组合物中使用氯化异氰脲酸盐和次氯酸金属盐中的至少一种的方法,其包括通过将本文公开的固体组合物混合到水性液体组合物如水、唾液或漱口水中来原位生成次氯酸盐。固体组合物中的氯化异氰脲酸盐或次氯酸金属盐在暴露于水后将释放次氯酸盐。通过使用固体组合物(如片剂)加水性液体组合物如漱口水的方法,可在保持漱口水制剂货架稳定性的同时改善增白和/或抗菌功效,因为在使用时当固体组合物与漱口水混合时将生成活性成分次氯酸盐。
本文公开的固体组合物还包含至少一种碳酸盐碱。合适的碳酸盐碱的实例包含碳酸氢钠、碳酸钠、倍半碳酸钠、碳酸钾、碳酸氢钾、碳酸钙、碳酸镁、氧化镁、甘氨酸碳酸钠、L-赖氨酸碳酸盐、精氨酸碳酸盐、碳酸锌、氧化锌及其混合物。所述至少一种碳酸盐碱可以任何有效量存在于本文公开的组合物中。在某些实施方案中,所述至少一种碳酸盐碱以相对于固体组合物的总重量在约45重量%至约95重量%、如约65重量%至约80重量%、或约72重量%至约78重量%的范围内的量存在于固体组合物中。
本文公开的固体组合物可还包含至少一种泡腾酸。本发明的固体组合物任选地是泡腾组合物。如本文所用,术语“泡腾组合物”意指当与水接触时将产生气泡如二氧化碳气泡的组合物。当本文公开的固体组合物是泡腾组合物时,其可包含泡腾剂。泡腾剂可以是包含酸和碱的泡腾剂对(effervescent couple)。当与水接触时,如当将固体组合物置于水性液体组合物如水或漱口水的容器中时,泡腾剂对将被活化。水释放泡腾酸和碱,允许所述酸和碱彼此反应产生二氧化碳气体,这使得水性液体组合物碳酸化。可提及的泡腾酸的实例包括酸及其酸酐和盐,如柠檬酸、抗坏血酸、苹果酸、己二酸、酒石酸、富马酸、琥珀酸、酸式焦磷酸钠、乳酸、环己磺酸、柠康酸酐、葡萄糖酸-D-内酯、琥珀酸酐、酒石酸氢钾、酸式柠檬酸盐、磷酸二氢钠、磷酸二氢二钠、酸式亚硫酸钠及其组合。所述至少一种泡腾酸可以相对于固体组合物的总重量在约0重量%至约50重量%、如约0.01重量%至约20重量%、约0.1重量%至约10重量%、约1.5重量%至约8重量%、或约2重量%至约7.5重量%的范围内的量存在于固体组合物中。在某些实施方案中,所述至少一种泡腾酸为焦磷酸钠。在本公开的某些实施方案中,所述至少一种碳酸盐和所述至少一种泡腾酸以大于约1∶1、如大于约2∶1、大于约10∶1、大于约15∶1、或大于约30∶1的比率存在。
在本公开的某些其他实施方案中,固体组合物可不含泡腾酸,如不含己二酸。当固体组合物不含泡腾酸时,在某些实施方案中,可将固体组合物与包含至少一种泡腾酸的水性组合物如包含至少一种泡腾酸的水性漱口水组合物合并。当将不含泡腾酸的固体组合物与包含至少一种泡腾酸的水性组合物合并时,所述至少一种泡腾酸和所述至少一种碳酸盐碱可化合而允许固体组合物在水性组合物中崩解。
本文公开的固体组合物可以是无水的,这意味着组合物不含水或基本上不含水。如本文所用,术语“不含或基本上不含”某物质指的是组合物不包含有效量的该物质,如不包含有效量的水。在固体组合物的各种实施方案中,基于组合物的总重量计,水的量为小于1重量%的量,如小于0.5重量%、约0.001重量%至约4重量%、约0.0001重量%至约0.5重量%、或约0重量%至约0.1重量%。
本文公开的固体组合物可任选地含有至少一种崩解剂,例如当组合物为片剂如泡腾片剂时。崩解剂可包括天然淀粉如玉米淀粉、马铃薯淀粉等;直接可压缩淀粉如淀粉1500;改性淀粉如可以知获得的羧甲基淀粉和羟基乙酸淀粉钠;和淀粉衍生物如直链淀粉。其他实例可包括交联的聚乙烯基吡咯烷酮,如可例如以XL和XL获得的交聚维酮;改性纤维素,如可例如以 XLT、和ZSX获得的交联的羧甲基纤维素钠;海藻酸和海藻酸钠;微晶纤维素,如和可例如以IRP-88获得的甲基丙烯酸-二乙烯基苯共聚物盐。崩解剂的其他实例可包括轻质硅酸酐、硅酸钙、偏硅酸铝酸镁和羧甲基纤维素。所述至少一种崩解剂的量可相对于组合物的总重量在约0重量%至约20重量%、如约1重量%至约5重量%、或约1重量%至约3重量%的范围内。在某些实施方案中,所述至少一种崩解剂为微晶纤维素。在某些实施方案中,固体组合物不含崩解剂,并且在某些实施方案中,固体组合物不含微晶纤维素。
本文公开的固体组合物可任选地包含至少一种润滑剂。各种润滑剂均适合用于所述组合物中,包含水分散性、水溶性、水不溶性润滑剂及其组合。可用的水溶性润滑剂的实例可包括苯甲酸钠、聚乙二醇、L-亮氨酸、己二酸及其组合。所述组合物还可包含水不溶性润滑剂,包括例如硬脂酸盐如硬脂酸镁、硬脂酸钙和硬脂酸锌;油如矿物油、氢化和部分氢化的植物油及棉籽油;动物脂肪;聚氧乙烯单硬脂酸酯;滑石;及其组合。当固体组合物呈片剂形式时,组合物可包含足够量的润滑剂以使得组合物能够形成为片剂并以片剂形式从高速压片机释放。在某些实施方案中,组合物中润滑剂的量可相对于固体组合物的总重量在约0重量%至约15重量%、如约0.5重量%至约10重量%、约1重量%至约5重量%、或约1.5重量%至约2.5重量%的范围内。在一个实施方案中,固体组合物不含润滑剂,并且在一个实施方案中,固体组合物不含硬脂酸镁。在某些其他实施方案中,固体组合物包含至少约0.5%、至少约1%、或至少约1.5%的硬脂酸镁。
根据本公开的各种实施方案,本文公开的固体组合物可还包含至少一种水溶性聚合物。可提及的示例性水溶性聚合物包括纤维素醚、甲基丙烯酸酯、聚乙烯基吡咯烷酮及其混合物。在某些实施方案中,水溶性聚合物可以是纤维素醚,包括选自以下的那些:羟烷基纤维素聚合物如羟丙基甲基纤维素(HPMC)、羟丙基纤维素、羟乙基纤维素、甲基纤维素、羧甲基纤维素及其混合物。可用于本文中的其他聚合物包括聚乙烯基吡咯烷酮(PVP)、交联的聚乙烯基吡咯烷酮、聚乙烯基吡咯烷酮-乙酸乙烯酯(PVP-VA)共聚物、聚乙烯醇、聚丙烯酸、聚丙烯酸酯聚合物、交联的聚丙烯酸酯聚合物、交联的聚丙烯酸(如)、聚氧化乙烯、聚乙二醇、聚乙烯基烷基醚-马来酸共聚物(如)和羧基乙烯基聚合物;天然胶,如海藻酸钠、角叉菜胶、黄原胶、阿拉伯树胶、阿拉伯胶、瓜尔胶、支链淀粉、琼脂、甲壳质、壳聚糖、果胶、刺梧桐胶、玉米醇溶蛋白、大麦醇溶蛋白、麦醇溶蛋白、刺槐豆胶、西黄蓍胶和其他多糖;淀粉,如麦芽糊精、直链淀粉、高直链淀粉、玉米淀粉、马铃薯淀粉、大米淀粉、木薯淀粉、豌豆淀粉、甘薯淀粉、大麦淀粉、小麦淀粉、糯玉米淀粉、改性淀粉(如羟丙基化高直链淀粉)、糊精、果聚糖、elsinan和谷蛋白;以及蛋白质如胶原蛋白、乳清分离蛋白、酪蛋白、牛奶蛋白、大豆蛋白和明胶。在某些实施方案中,本文公开的固体组合物可不含水溶性聚合物,如不含PVP和PVP-VA。
本文公开的固体组合物可任选地包含至少一种除氯化异氰脲酸盐和次氯酸金属盐外的增白剂。在各种实施方案中,本文公开的组合物可任选地包含过氧化物增白剂,其包含过氧化物化合物。过氧化物化合物为包含二价氧-氧基团的氧化化合物。过氧化物化合物包括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、有机过氧化合物、过氧酸、其药学上可接受的盐及其混合物。碱金属和碱土金属的过氧化物包括过氧化锂、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。有机过氧化合物包括过氧化脲(也称为脲过氧化氢)、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、过氧酯、二酰基过氧化物、过氧化苯甲酰、和单过氧邻苯二甲酸盐及其混合物。过氧酸及其盐包括有机过氧酸如烷基过氧酸、单过氧邻苯二甲酸盐、过氧单硫酸盐及其混合物,以及无机过氧酸盐如碱金属和碱土金属如锂、钾、钠、镁、钙和钡的过硫酸盐、二过硫酸盐(dipersulfate)、过碳酸盐、过磷酸盐、过硼酸盐和过硅酸盐,及其混合物。在各种实施方案中,过氧化物化合物包括过氧化氢、过氧化脲、过碳酸钠及其混合物。在一些实施方案中,过氧化物化合物包括过氧化氢。在一些实施方案中,过氧化物化合物基本上由过氧化氢组成。在一些实施方案中,可提供非过氧化物增白剂。非过氧化物增白剂可包括例如着色剂如二氧化钛和羟基磷灰石。一种或多种另外的增白剂任选地以有效增白牙齿的总量存在。在一些实施方案中,本文公开的固体组合物另外包含至少一种活化剂,如四乙酰乙二胺。
本文公开的固体组合物可任选地包含本领域已知的任何其他成分,包括例如填充剂;表面活性剂;调味剂;防腐剂,如苯甲酸钠和山梨酸钾;着色剂;和甜味剂。
填充剂的实例包括结晶纤维素、乙基纤维素、糊精、各种环糊精(-环糊精、β-环糊精和-环糊精)、支链淀粉和硫酸钠以及其衍生物。
可使用的表面活性剂的实例是月桂基硫酸钠、失水山梨醇脂肪酸酯、聚氧乙烯(20)失水山梨醇单油酸酯(Polysorbate 80或80)、聚乙二醇脂肪酸酯、聚氧乙烯失水山梨醇脂肪酸酯、聚氧乙烷烷基醚、聚氧乙烯聚氧丙烯烷基醚、聚氧乙烯聚氧丙烯嵌段共聚物、聚氧乙烯烷基苯基醚、聚氧乙烯蓖麻油、聚氧乙烯氢化蓖麻油、聚氧乙烯山梨醇脂肪酸脂和聚氧乙烯甘油脂肪酸酯。在其中在本文公开的固体组合物中包含至少一种表面活性剂的实施方案中,所述一种或多种表面活性剂可以相对于固体组合物的总重量在约0.5重量%至约3重量%、如约0.75重量%至约2重量%、或约1重量%至约1.5重量%的范围内的量存在。
可提及的示例性调味剂包括天然和合成的调味源,包括挥发性油、合成调味油、调味芳香剂、油、液体、油树脂及来源于植物、叶、花、水果、茎及其组合的提取物。调味剂可包括例如柠檬油,如柠檬、橙、葡萄、酸橙和葡萄柚;水果香精,如苹果、梨、桃、葡萄、草莓、覆盆子、樱桃、李子、菠萝、杏;及其他水果调味剂。其他可用的调味剂包括例如醛和酯(如苯甲醛(樱桃、杏仁))、柠檬醛即α-柠檬醛(柠檬、酸橙)、橙花醛即β-柠檬醛(柠檬、酸橙)、癸醛(橙、柠檬)、醛C-8(柑桔属水果)、醛C-9(柑桔属水果)、醛C-12(柑桔属水果)、甲苯基醛(樱桃、杏仁)、2,6-二甲基辛醛(未熟果实)、2-十二碳烯醛(柑橘、橘子)及其混合物。
示例性着色剂可包括食品、药品和化妆品(FD&C)色料,包括例如染料、色淀、颜料以及某些天然和衍生的着色剂。色淀包括吸收在氢氧化铝和其他合适的载体上的染料。
合适的甜味剂可包括甜叶菊;糖如蔗糖、葡萄糖、转化糖、果糖、核糖、塔格酮糖、三氯蔗糖、麦芽糖醇、赤藓糖醇、木糖醇及其混合物;糖精及其各种盐(例如,糖精的钠盐和钙盐);环己氨磺酸及其各种盐;二肽甜味剂(例如,阿斯巴甜);乙酰磺胺酸钾;二氢查耳酮;甘草素;和糖醇,包括例如山梨醇、山梨醇糖浆、甘露醇和木糖醇,及其组合。
本发明的固体组合物可呈多种形式,包括例如粉末(例如,自由流动造粒)、片剂、囊片、颗粒剂、丸剂、圆片、膜和珠粒。
本文公开的固体组合物如片剂可被形成为具有任何期望的重量和尺寸。例如,片剂的重量可为约0.05克至约5克,如约20mg至约1000mg、约40mg至约500mg、或约50mg至约100mg。片剂也可例如形成为具有至少约1mm、如约1mm至约100mm或约5mm至约50mm的直径和至少约0.5mm、如约1mm至约20mm或5mm至约15mm的厚度。在一些实施方案中,固体组合物如片剂或珠粒的表面积可例如为约0.55cm2至约9.5cm2,如约0.9cm2至约5cm2。
因为本文公开的固体组合物如片剂在水的存在下不稳定,故可将所述组合物包装在无湿气的环境中。在某些实施方案中,固体组合物可以单位剂量单独包装和密封。如本文所用,术语“单位剂量”指示预期一次使用的固体组合物的量。可将固体组合物保存在气密的防潮包装中,包括例如密封的金属箔袋、泡罩包装和管如盖中含干燥剂的管。
根据某些实施方案,一定量如至少约20mg、至少约30mg、至少约40mg、至少约50mg、至少约75mg或至少约100mg本文公开的固体组合物可在20mL水性液体组合物如水或漱口水中在室温下在约500秒或更短、如不到约400秒、不到约360秒、不到约180秒、不到约120秒、不到约60秒、不到约45秒、不到约30秒、约15秒或更短、或约10秒或更短时间内完全崩解。在某些实施方案中,本文公开的固体组合物可在口腔中存在的唾液中在体温下在约500秒或更短时间、如不到约400秒、不到约360秒、不到约180秒、不到约120秒、不到约60秒、不到约45秒、不到约30秒、约15秒或更短、或约10秒或更短时间内完全崩解。如本文所用,表述“完全崩解”指的是固体组合物完全解体成微粒物质,如细粉末。在某些实施方案中,可使用搅动来崩解固体组合物。如本文所用,“搅动”指的是消费者在合适的容器如杯子中用手或使用工具摇动或旋转或搅拌混合物。
本文公开的固体组合物可经由本领域已知的技术制造。在某些实施方案中,可将所述成分与有机溶剂一起捏合、填充在模具中并进行压缩模制。所述有机溶剂可以是醇如甲醇、乙醇、丙醇、异丙醇等。通过添加用于制备制剂的此类助剂并通过添加此类溶剂进行的捏合和造粒操作可使用任何常规使用的设备来进行。例如,可使用流化床造粒机、翻滚造粒机、挤出造粒机或喷雾干燥干燥器。固体组合物也可经由冷冻干燥来制备。可通过将成分和任选地碳酸钙以及必要时更多的口服可接受的添加剂混配并以常规方式混合来制备粉末。可通过用于制备颗粒剂的已知方法中的任何一种如干法造粒、分层造粒、浸渍造粒等来制备颗粒剂。
片剂可通过任一以下方式制造:对以与上述相同的方式制备的混合物按原样进行压缩模制,或对所述混合物进行如上文所提及的造粒并然后在添加例如任何期望的崩解剂、润滑剂等之后进行压缩模制。如果混配了碳酸盐,则其可在添加任何任选的崩解剂和/或润滑剂的同时添加。压缩模制可使用常规制片机如旋转制片机、单冲制片机、双重制片机等来进行,压缩压力通常为约50至4,000kg/cm2。
本文还公开了包括如本文所公开的固体组合物的套件。在某些实施方案中,套件包括(1)固体组合物,所述固体组合物包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种碳酸盐碱和至少一种泡腾酸;和(2)水性液体组合物,如漱口水。在某些其他实施方案中,本文公开了一种套件,其包括(1)固体组合物,所述固体组合物包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂和至少一种碳酸盐碱;和(2)包含至少一种泡腾酸的水性液体组合物,如漱口水。根据各种实施方案,本文公开的套件可包括多个单位剂量的固体组合物,其一个一个单独地包装在无湿气的包装中或与多个单位剂量一起包装在单个气密的可重复密封的容器中。在某些实施方案中,套件还包括能够容纳单个单位剂量的水性液体组合物如能够容纳约15mL或约20mL的水性液体组合物以及单个单位剂量的固体组合物的杯子。
术语“漱口水”或“漱口液”通常表示用来冲洗口腔的表面并提供使用者口腔清洁和清新感觉的液体配方。漱口水是一种口腔用组合物,其非意在出于全身施用治疗剂的目的而吞服,而是施加到口腔、用来处理口腔并然后任选地吐出。
水性漱口水组合物可包含液体载体如水;湿润剂,如甘油、山梨醇和丙二醇;表面活性剂,如和月桂基硫酸钠;甜味剂,如糖精钠和木糖醇;调味剂;着色剂;防腐剂,如山梨酸钾和苯甲酸钠;缓冲剂,如磷酸钠;防龋剂,如氟化钠;和抗菌剂,如十六烷基氯化吡啶鎓。在某些实施方案中,本文公开的水性漱口水组合物可具有在约4至约7的范围内的pH,如约4.5的pH。在某些实施方案中,水性漱口水组合物可包含如上所述的至少一种泡腾酸。
本文还公开了一种增白牙齿的方法,其包括将单位剂量的包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂的固体组合物混合到水性液体组合物如水或漱口水中直至固体组合物在液体中崩解形成包含次氯酸盐的漱口水溶液,然后使牙齿与包含次氯酸盐的漱口水溶液接触。在某些实施方案中,所述方法包括由使用者将包含次氯酸盐的漱口水溶液置于口腔中并在任选地吐出漱口水之前绕口腔旋转或甩动漱口水达一段时间来接触牙齿。在某些实施方案中,漱口水可在口腔中接触牙齿至少约10秒的时间,如至少约20秒、至少约30秒、至少约45秒、至少约1分钟、或至少约2分钟。为了获得最大增白功效,本文公开的方法可还包括将所述增白牙齿的方法重复多次。在某些实施方案中,所述方法可一天至少一次、如一天两次地重复一段时间如5天、10天、2周或1个月。在某些实施方案中,可根据需要重复所述增白牙齿的方法。
在本文公开的增白牙齿的方法中,可例如使用由国际照明委员会(CIE)开发的CIEL*a*b*(CIELAB)尺度来度量组合物的增白功效。CIELAB为基于以下事实的对立色彩系统:视网膜颜色刺激被转化为量与暗、红与绿以及蓝与黄之间的区别。CIELAB以三条轴线指示这些值:L*、a*和b*。L值指示颜色的亮度,其中L=0为黑色并且L=100为白色。L=L处理后-L初始。因此,较大的正L值指示较白的牙齿。a值的范围在+a=品红与-a=绿色之间。b值的范围在+b=黄色与-b=蓝色之间。W值结合了L、a和b值来描述所测量的颜色接近于真白色的程度,其中W*=(a2+b2+(L*-100)2)1/2。较大的负W值对应于较大的增白。
本文还公开了一种产生抗菌效果的方法,其包括将单位剂量的包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂的固体组合物混合到水性液体组合物如水或漱口水中直至固体组合物在液体中崩解形成包含次氯酸盐的抗菌溶液,然后使口腔与包含次氯酸盐的抗菌溶液接触。在某些实施方案中,所述方法包括由使用者将抗菌溶液置于口腔中并在任选地吐出抗菌溶液之前绕口腔旋转或甩动抗菌溶液达一段时间来接触牙齿。在某些实施方案中,抗菌溶液可在口腔中至少约10秒的时间,如至少约20秒、至少约30秒、至少约45秒、至少约1分钟、或至少约2分钟。为了获得最大抗菌功效,本文公开的方法可还包括将所述产生抗菌效果的方法重复多次。在某些实施方案中,所述方法可一天至少一次、如一天两次地重复;在某些实施方案中,所述方法可重复一段时间如5天、10天、2周、1个月、每天、每周、每月、或根据需要。作为非限制性实例,抗菌效果可包括减少或抑制龋齿形成、牙龈炎、呼吸时的不良气味、口腔中微生物生物膜形成及菌斑积聚中的至少之一。
实施例
实施例1-牙齿增白评价
如下表1中所示制备最终pH为4.33的漱口水制剂,并如下表2中所示制备包含NaDCC的四种无水片剂(片剂A、B、C和D)。所有片剂均含40mg碳酸氢钠,并且片剂A、B、C和D分别含有20%的NaDCC、11.1%的NaDCC、4.8%的NaDCC和0%的NaDCC。
表1-漱口水配方
表2-片剂配方
使用自制压机和直径为5mm的模具制备片剂。最终压制力为600磅,并且对于片剂A、B、C和D,片剂的最终重量分别为50mg、45mg、42mg和40mg/片剂。
安装在树脂中的人工染色牛中切牙购自Dental Product Testing TherametricTechnologies,Inc.。本研究选择L*值在58至63之间的牙齿。将如上制备的片剂A、B、C和D中的每一种分别在20mL如上所述制备的漱口水溶液中崩解,使得所得的四种溶液分别以500ppm、250ppm、100ppm和0ppm的量含NaDCC。为了崩解片剂,将片剂和漱口水混合并摇动90秒以确保片剂在漱口水中完全崩解。然后将液体汇集到托盘中并用来浸泡染色的牙齿。将每个托盘浸泡1分钟,然后用流动的自来水冲洗约20秒。在每次处理后,使用Medical HighTechnology(MHT)制造的Spectroshade Micro仪器测量L*、a*和b*值。以处理后与基线值相比绝对W*值的变化报告增白性能。ΔW值越高,则与基线测量相比,牙齿越白。使用下式计算白度和白度变化:
W*=(a*2+b*2+(L*-100)2)1/2
ΔW=W*处理后-W*基线
由于每个片剂中碳酸钠的量相同(40mg),故对于四种溶液中的每一种,片剂/漱口水溶液的最终pH是相似的,为约5.0。据发现,如下表3中所示,漱口水溶液加NaDCC与含约4%SAPP的单独的漱口水溶液相比增强了增白功效。特别地,具有500ppm NaDCC的增白溶液(包含片剂A的溶液)给出快得多的增白速率。例如,在10次处理后,漱口水与500ppm NaDCC的组合显示出高的增白功效(ΔW500ppm=-8.260)。此增白功效大于在相同条件下用碳酸氢钠处理的单独的漱口水的增白功效(ΔWMW=-3.732)并大于在漱口水溶液中含较少NaDCC的组合物的增白功效(即,ΔW250ppm=-6.541;ΔW100ppm=-5.777)。在20次处理后发现类似的增白趋势。参见下表3。由于片剂/漱口水溶液具有相似的pH,故据信含NaDCC的制剂增强的增白功效归因于使用时次氯酸盐的形成。
表3-对染色的牛牙进行体外处理的增白功效(ΔW*)
实施例3-NaDCC溶液的抗菌研究
为了筛选初步的抗菌功效,对NaDCC溶液进行ATP-细菌活力测试。该方法基于对所存在的三磷酸腺苷(ATP)的量化来确定培养物中活细菌细胞的数量。ATP是葡萄糖分解代谢(糖酵解)和有氧呼吸的产物。这种必不可少的三磷酸核苷几乎发挥所有细胞功能并在细胞分裂、核酸和蛋白质的合成、大分子的运输、细胞信号传导及细菌运动过程中为细菌所使用。鉴于其重要性,ATP是存在代谢活性细胞的信号,并因此可用来定量细胞活力。该方法使用萤光素酶报告基因来量度存在的细胞ATP的量,因此组合物具有越有效的抗菌性,则发现的ATP将越少。
在反应中,荧光素酶在ATP和氧的存在下将荧光素转化为氧化荧光素(oxiluciferin)。反应的光输出与代谢活性细胞的数量之间存在直接关系,这使得该方法可理想地在口腔护理制剂的开发过程中快速筛选抗微生物剂以确立其潜在抗菌功效。使用唾液ATP测定来评价含NaDCC的片剂对受刺激的唾液样品的细菌活力的抗菌功效。
在该测定中,使用含0.075%十六烷基氯化吡啶鎓(CPC)这种已知抗菌剂的漱口水溶液作为阳性对照。将仅含NaDCC且重20mg的NaDCC片剂在两种磷酸盐缓冲盐水(PBS)溶液中崩解以得到500ppm的NaDCC溶液和1000ppm的NaDCC溶液二者。结果显示,在一分钟处理后,NaDCC溶液(500ppm和1000ppm两者)与0.075%的CPC溶液相比在抗菌性的递送方面表现出统计学上显著的改善,如下表4中所示。对两种溶液和对照溶液中的每一种进行两次处理实验,并对结果取平均。较低的活力对应于较高的抗菌性。下表4中的数据是使用Tukey方法计算的,平均值的置信区间为95%。
表4-活力的Log10区间对处理
溶液 | 平均值 |
0.075%的CPC溶液 | 5.061±0.032 |
500ppm的NaDCC/PBS | 4.139±0.001 |
1000ppm的NaDCC/PBS | 3.530±0.048 |
实施例4-NaDCC溶液的pH依赖性漂白能力
制备两种不同的溶液:溶液A和溶液B。溶液A含2%的SAPP、0.1%的丽丝胺绿B染料和97.9%的水。溶液B含2%的焦磷酸四钠(TSPP)、0.1%的丽丝胺绿B染料和97.9%的水。接下来,通过以不同的体积比(即,1∶0、1∶5、1∶1、5∶1和0∶1)混合两种不同的溶液A和B来获得具有各种pH的溶液。将20mL所得溶液加到10mg NaDCC中,并记录漂白掉所有丽丝胺绿B颜色所需的时间。
如下表5中所示,随着溶液的pH增加,漂白掉丽丝胺绿B所需的时间增加,表明NaDCC向次氯酸盐的转化或次氯酸盐的氧化或两者随pH增加而变得更有限。为了获得增白功效而不损害牙釉质,可在弱酸性条件下在口腔护理产品中使用NaDCC。
表5-NaDCC在不同pH溶液中的漂白功效
混合溶液 | V<sub>A</sub>:V<sub>B</sub> | pH | 漂白的时间 |
1 | 1∶0 | 4.6 | 瞬时 |
2 | 1∶5 | 5.8 | 15秒 |
3 | 1∶1 | 7.4 | 8分钟 |
4 | 5∶1 | 8.8 | 35分钟 |
5 | 0∶1 | 10.5 | 80分钟 |
实施例5-崩解速率
将含20重量%NaDCC的片剂在pH为4.33的漱口水中崩解并测量崩解速率,如下表6中所示。使用压机和直径为5mm的模具制备片剂。最终压制力为600磅,并且每个片剂的最终重量为50mg。漱口水配方在上面表1的实施例1中提供。崩解基于的是片剂在20mL漱口水中完全崩解所需的时间。
表6-NaDCC片剂在漱口水中的崩解速率
将50mg含有NaDCC的市售水溶性消毒片剂也在上面表1中提供的漱口水配方中崩解。对于试验#1、#2和#3,在20mL漱口水中的崩解时间分别为538秒、607秒和591秒,平均崩解时间为579秒。因此,在相似的崩解条件下,全部片剂E、F、G、H、I、K、L和M均具有比快的崩解速率。
接下来,将含20重量%NaDCC的片剂在pH为4.5的漱口水中崩解并测量崩解速率,如下表7中所示。与上文讨论的崩解实验一样,使用压机和直径为5mm的模具制备片剂。最终压制力为600磅,并且每个片剂的最终重量为50mg。崩解基于的是片剂在20mL漱口水中完全崩解所需的时间。
表7-NaDCC片剂在漱口水中的崩解速率
结果指示不含硬脂酸镁的组合物的崩解时间可能缩短(即,崩解速率提高)。还显示,通过比较片剂I与片剂2,移除微晶纤维素提高了崩解速率,这是基于微晶纤维素已知的有助于片剂崩解的能力而预期的。然而,微晶纤维素本身不是可溶性的,因此可能在漱口水或其他水性组合物中留下消费者可能不可接受的残留物。相应地,可能有利的是使组合物像片剂5-8一样不含微晶纤维素。最后,结果显示可从组合物移除水溶性聚合物如PVP-VA和PVP和/或泡腾酸如酸式焦磷酸钠而仍然获得崩解时间缩短的片剂,如片剂7和8所示。
Claims (20)
1.一种用于口腔护理的固体组合物,所述固体组合物包含:
至少一种增白剂,所述至少一种增白剂选自氯化异氰脲酸盐和次氯酸金属盐;
至少一种碳酸盐碱,所述至少一种碳酸盐碱以相对于所述固体组合物的总重量在约45重量%至约95重量%的范围内的量存在于所述固体组合物中;和
至少一种泡腾酸,所述至少一种泡腾酸以相对于所述固体组合物的总重量在约0.01重量%至约20重量%的范围内的量存在于所述固体组合物中。
2.根据权利要求1所述的用于口腔护理的固体组合物,其中所述至少一种增白剂为二氯异氰脲酸钠。
3.根据权利要求1或2所述的用于口腔护理的固体组合物,其中所述至少一种增白剂以相对于所述固体组合物的总重量在约0.5重量%至约50重量%的范围内的量存在于所述固体组合物中。
4.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中所述至少一种碳酸盐碱为碳酸氢钠。
5.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中所述至少一种碳酸盐碱以相对于所述固体组合物的总重量在约65重量%至约80重量%的范围内的量存在于所述固体组合物中。
6.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中所述至少一种泡腾酸为酸式焦磷酸钠。
7.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中所述固体组合物为片剂。
8.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中所述固体组合物不含微晶纤维素。
9.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中所述固体组合物不含硬脂酸镁。
10.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中所述固体组合物不含水溶性聚合物。
11.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中50mg所述固体组合物能够在20mL水性液体组合物中在不到约180秒内崩解。
12.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中50mg所述固体组合物能够在20mL水性液体组合物中在不到约90秒内崩解。
13.根据前述权利要求中任一项所述的用于口腔护理的固体组合物,其中50mg所述固体组合物能够在20mL水性液体组合物中在约15秒或更短时间内崩解。
14.一种套件,所述套件包括:
用于口腔护理的固体组合物,所述固体组合物包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种以在约45%至约95%的范围内的量存在于所述固体组合物中的碳酸盐碱和至少一种以在约0.01%至约20%的范围内的量存在于所述固体组合物中的泡腾酸;
容器;和
所述容器内的水性漱口水组合物。
15.根据权利要求14所述的套件,所述套件还包括适于容纳特定量的所述水性漱口水组合物和适合于所述特定量的单位剂量的所述固体组合物的杯子。
16.根据权利要求14或15所述的套件,其中所述至少一种增白剂为二氯异氰脲酸钠。
17.一种增白牙齿的方法,所述方法包括:
混合用于口腔护理的固体组合物与水性液体组合物直至所述固体组合物崩解以产生包含次氯酸盐的漱口水,所述用于口腔护理的固体组合物包含至少一种选自氯化异氰脲酸盐和次氯酸金属盐的增白剂、至少一种以在约45%至约95%的范围内的量存在于所述固体组合物中的碳酸盐碱和至少一种以在约0.01%至约20%的范围内的量存在于所述固体组合物中的泡腾酸;
使所述牙齿与所述包含次氯酸盐的漱口水接触;以及
任选地吐出所述包含次氯酸盐的漱口水。
18.根据权利要求17所述的方法,其中50mg所述固体组合物在约20mL所述水性液体组合物中在不到约90秒内崩解。
19.根据权利要求17或18所述的方法,其中50mg所述固体组合物在约20mL所述水性液体组合物中在约15秒或更短时间内崩解。
20.一种用于口腔护理的固体组合物,所述固体组合物包含:
至少一种增白剂,所述至少一种增白剂选自氯化异氰脲酸盐和次氯酸金属盐;和
至少一种碳酸盐碱,所述至少一种碳酸盐碱以相对于所述固体组合物的总重量在约45重量%至约95重量%的范围内的量存在于所述固体组合物中,
其中所述固体组合物不含至少一种泡腾酸。
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US5114647A (en) * | 1991-02-01 | 1992-05-19 | Olin Corporation | Effervescent tablets having increased disintegration rates |
US6099861A (en) * | 1995-10-06 | 2000-08-08 | Chemlink Laboratories, Llc | Disinfectant effervescent tablet formulation |
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2019
- 2019-08-09 MX MX2021001487A patent/MX2021001487A/es unknown
- 2019-08-09 CN CN201980047455.XA patent/CN112423724A/zh active Pending
- 2019-08-09 BR BR112021001964-2A patent/BR112021001964A2/pt not_active Application Discontinuation
- 2019-08-09 AU AU2019319961A patent/AU2019319961B2/en active Active
- 2019-08-09 US US16/536,474 patent/US20200046620A1/en not_active Abandoned
- 2019-08-09 WO PCT/US2019/045843 patent/WO2020033793A1/en unknown
- 2019-08-09 CA CA3106107A patent/CA3106107A1/en active Pending
- 2019-08-09 EP EP19755786.1A patent/EP3817707A1/en not_active Withdrawn
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US3936385A (en) * | 1973-08-09 | 1976-02-03 | Colgate-Palmolive Company | Denture cleanser |
US4552679A (en) * | 1984-03-16 | 1985-11-12 | Warner-Lambert Company | Method for deodorizing hypochlorite denture cleansing solutions and product containing a delayed release hypochlorite deactivator |
EP0323049A2 (en) * | 1987-12-03 | 1989-07-05 | The Procter & Gamble Company | Denture cleansing tablet |
US5741520A (en) * | 1995-10-06 | 1998-04-21 | Southland, Ltd. | Disinfectant effervescent tablet formulation |
US20110059882A1 (en) * | 2008-12-09 | 2011-03-10 | The Clorox Company | Solid-layered bleach compositions and methods of use |
CN105120961A (zh) * | 2013-04-18 | 2015-12-02 | 宝洁公司 | 芳香剂材料 |
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AU2019319961B2 (en) | 2022-06-30 |
BR112021001964A2 (pt) | 2021-04-27 |
MX2021001487A (es) | 2021-04-28 |
CA3106107A1 (en) | 2020-02-13 |
US20200046620A1 (en) | 2020-02-13 |
WO2020033793A1 (en) | 2020-02-13 |
EP3817707A1 (en) | 2021-05-12 |
AU2019319961A1 (en) | 2021-01-28 |
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