CN100548265C - 口腔护理套件和组合物 - Google Patents
口腔护理套件和组合物 Download PDFInfo
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- CN100548265C CN100548265C CNB02806545XA CN02806545A CN100548265C CN 100548265 C CN100548265 C CN 100548265C CN B02806545X A CNB02806545X A CN B02806545XA CN 02806545 A CN02806545 A CN 02806545A CN 100548265 C CN100548265 C CN 100548265C
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- China
- Prior art keywords
- oral care
- polybutene
- composition
- agent
- compositions
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000000203 mixture Substances 0.000 title claims abstract description 238
- 229920001083 polybutene Polymers 0.000 claims abstract description 85
- 210000000214 mouth Anatomy 0.000 claims description 97
- 239000003795 chemical substances by application Substances 0.000 claims description 70
- 239000000463 material Substances 0.000 claims description 35
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- 239000000796 flavoring agent Substances 0.000 claims description 19
- 235000019634 flavors Nutrition 0.000 claims description 17
- PUZPDOWCWNUUKD-UHFFFAOYSA-M sodium fluoride Chemical compound [F-].[Na+] PUZPDOWCWNUUKD-UHFFFAOYSA-M 0.000 claims description 16
- 239000004094 surface-active agent Substances 0.000 claims description 16
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- 239000000551 dentifrice Substances 0.000 claims description 14
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- 229940122957 Histamine H2 receptor antagonist Drugs 0.000 claims description 11
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- 239000003485 histamine H2 receptor antagonist Substances 0.000 claims description 11
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- ANOBYBYXJXCGBS-UHFFFAOYSA-L stannous fluoride Chemical compound F[Sn]F ANOBYBYXJXCGBS-UHFFFAOYSA-L 0.000 claims description 11
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Abstract
口腔护理组合物包括分子量为约300至约3000的聚丁烯和口腔护理活性物质。口腔护理组合物还包括口腔护理载体。本发明也公开了包括聚丁烯、容器和使用说明书或将组合物直接涂敷到牙齿表面的涂药器的套件。所述套件的聚丁烯组分还可包括口腔护理活性物质或口腔护理载体。
Description
相关申请的交叉参考
本申请要求提交于2001年3月19日的美国临时申请60/276,979和同样提交于2001年3月19日的美国临时申请60/276,978的优先权。
发明领域
本发明涉及口腔护理组合物和口腔护理套件,该口腔护理组合物和套件给口腔提供长时间释放的治疗、预防性和美容性活性物质,并抑制牙斑和其它碎屑在牙齿上的形成。
发明背景
口腔护理产品是先前已知的,通过该口腔护理产品可以将各种各样的口腔护理活性物质递送到牙齿的硬表面。该类型的口腔护理产品实施例包括:刷洗助剂,例如递送抗龋齿活性物质例如氟化物的洁齿剂产品;和包含口气清新剂或抗菌活性物质的漱剂。众所周知,口腔护理产品可以给消费者提供治疗和美容有益效果。然而,该类型的常规口腔护理产品在口腔中典型地不能保持足够长时间的活性,以最佳地提高或延长由活性物质提供的治疗、预防性和/或美容性有益效果。
聚丁烯被认为是牙齿粘合剂的一种组分和一种口香糖基质。美国专利5,880,172(Rajaiah等人,公布于1999年3月3日)公开了一种可剥落从而易于去除的自支承的牙齿粘合剂,其掺入了聚丁烯作为任选成分。美国专利5,496,541(Cutler,公布于1996年3月5日)涉及一种洁齿剂口香糖,并讲授了聚丁烯作为任选的口香糖基质的应用。为了获得期望的效果,该类型的已知应用通常使用较高分子量的聚丁烯。
在本发明中,将较低分子量的聚丁烯掺入口腔护理套件和组合物中,以在牙齿上提供一层保护涂层。因为较低分子量的聚丁烯是一种易流动的液体,所以可获得优良、均匀的牙齿涂层。在口腔护理套件和组合物的包含聚丁烯的组分中使用较低分子量的聚丁烯提供了充分的直接性,提供了口腔护理活性物质的持续释放,而不会在口腔粘膜上引起不必要的涂敷或堆积。
本发明提供了口腔护理套件和组合物,其有效地涂敷和保护牙齿,以免牙斑和其它碎屑的堆积,从而抑制或预防牙齿的齿龈炎、龋齿和色斑。该涂层也给口腔的硬表面提供了光滑、柔和的感觉,消费者视其为清洁牙齿的标志。通过将所述活性物质掺入包含聚丁烯的组分中,也可将本发明用于将口腔护理活性物质递送到牙齿和口腔。
发明概述
本发明涉及口腔护理组合物,其包含分子量为约300至约3000的聚丁烯和口腔护理活性物质。也公开了一种口腔护理组合物,其包含分子量为约300至约3000的聚丁烯和口腔护理载体。在一种实施方案中,组合物用于将治疗和美容性有益效果直接递送到牙齿和口腔,其中该组合物包括分子量为约300至约3000的聚丁烯、口腔护理载体和口腔护理活性物质。本发明也涉及一种口腔护理套件,其包括分子量为约300至约3000的聚丁烯、容器和套件的使用说明书。本发明的另一种口腔护理套件包括分子量为约300至约3000的聚丁烯和将组合物涂敷到牙齿的涂药器,其中涂药器不是带状部件。
掺入到组合物中的和可任选包括到口腔护理套件内的口腔护理活性物质可选自防牙结石剂或防牙垢剂、氟离子源、二价锡离子源、增白剂、抗微生物剂和抗牙斑剂、抗炎剂、营养物、抗氧化剂、抗病毒剂、杀真菌剂、止痛剂和麻醉剂、H-2拮抗剂、香料和可感觉物质、给予牙齿清洁感的非聚丁烯的组分、颜料和着色剂,及其混合物。适用于本发明的口腔护理载体包括但不限于磨料抛光材料、碱金属碳酸氢盐、酸性化合物、缓冲剂、聚氧乙烯、增稠剂、湿润剂、水、表面活性剂、遮光剂、食用香料、甜味剂和木糖醇。当需要时,本发明可任选地掺入粘度改性剂。组合物不是自承的。
发明详述
定义
本发明所用术语“牙齿”是指真牙和任何其它的硬表面,例如齿冠、齿冠遮盖物、补牙的填充料、假牙上的齿桥、植入的牙齿等等,它们永久地固定在口腔中并可就地在口腔中清洁。
口腔护理组合物可以是一种单相的口腔护理组合物,也可以是在许多相中递送的至少两种口腔组合物的组合物。口腔组合物是这样一种产品,在平常的使用过程中,其不是为了特殊治疗剂的全身给药来有目的地吞咽,而是为了口腔活性而在口腔中停留足够长的时间,以使其充分地接触所有的牙齿表面和/或口腔组织。
本发明所用术语“容器”是指广口瓶、杯、罐、管、气溶胶罐、盆、唧筒、瓶或任何其它的盛装液体或配送液体的部件。
除非另有说明,本发明所用术语“洁齿剂”是指用于清洁牙齿的糊剂、凝胶剂或液体制剂。洁齿剂组合物可以是任何所需的形式,例如深带的、面带的、多层的、凝胶环绕糊状物的,或其任意组合。可以将洁齿剂组合物装在分配器的物理分开的隔室中,并将其并行地分配。
本发明所用术语“口腔护理载体”是指用于本发明组合物中的任何安全有效的物质。该类型的物质包括聚氧乙烯、酸性化和物、缓冲剂、磨料抛光材料、碱金属碳酸氢盐、增稠剂、湿润剂、水、表面活性剂、遮光剂如二氧化钛、食用香料、甜味剂、木糖醇、着色剂,及其混合物。
本发明所用“安全有效量”是指在合理的医疗/牙齿的判断范围内,活性剂(例如,防牙结石剂)量足够高足以有效地改善要治疗的病症,但其也足够低以避免严重的副作用(合理的效/险比)。活性剂(例如防牙结石剂)的安全有效量可以随以下因素而变化:被治疗的特定病症、被治疗患者的年龄和身体状况、病症的严重性、治疗的持续时间、并发治疗的特性、所用源的特定形式和活性剂由其而应用的特定赋形剂。
本发明所用术语“粘膜粘合剂”或“生物粘合剂”是指将天然或合成的物质应用到湿粘膜上皮,通常生成一个新的界面而粘附于粘膜层的现象。(CRC Critical Review in TherDrug Carrier,第5卷,第1期,第21页(1988))。通常,可以通过物理或化学的方法或二者而获得粘膜粘附。这个机理描述于Journal of Controlled Release第2卷,第257页(1982)和Journal of Controlled Release第18卷(1992)第249页。上述参考文献均全文引入本文以供参考。
术语“非自承的”用于描述缺乏整体性和强度的组合物。在本发明的情形中,这意味着即使将组合物用于口腔几个小时后,其也不能作为一个固体片从牙齿上脱离下来。组合物不能被切削和形成维持它们初始大小的确定形状,例如薄片或锥形体。
“牙结石”和“牙垢”是指矿物化的牙斑生物膜,可互换使用。
术语“单位剂型”指物理分离的适于人类和其它哺乳动物单位剂量的单位,每个包含预先确定的计算出的活性物质的量,以产生期望的治疗效果。
本发明所用术语“粘度”是指运动学粘度,可用透明和不透明液体的运动学粘度(运动学粘度计算),ASTM D-445的标准测试方法进行测量。如本文所给出的那样,除非另有指明,粘度是在99℃(210°F)下测量的。将样品放置进U形“Cannon-Fenske”粘度计(对于透明的液体)管中,并将其浸没在恒温浴中。记录管上两个标记之间的流动时间,根据时间和管制造商提供的标准系数,通过简单的计算测定出粘度。
本发明所称之为“分子量”是用凝胶渗透色谱法测定的一个平均数给出的。数均分子量或算术平均数是聚合物给定质量中的分子数目的一个函数。它可用下式表示:
除非另有指明,本文中的百分数和比例均以总组合物的重量计。
聚丁烯
聚丁烯是异丁烯和丁烯单体的粘稠共聚物。本发明所用术语“聚丁烯”是指氢化(CAS #68937-10-0)和未氢化(CAS #9003-29-6)形式的聚合物。聚丁烯是一种粘稠、无色、非干燥的液体聚合物。聚丁烯可在从易流动的液体到接近半固态的范围内变化。聚丁烯是透明的、无嗅的、化学稳定的、对光和热抗氧化的、无毒性的和无危险的。
本发明的口腔护理组合物和套件包含较低分子量的聚丁烯,其分子量为约300至约3000,在另一个实施方案中为约500至约2200,并且在另一个实施方案中还为约750至约1500。本发明公开的聚丁烯的粘度范围为在38℃测量的约30cSt至在99℃测量的约4,500cSt,在另一个实施方案中为在38℃测量的约200cSt至在99℃测量的约3,500cSt,并且在另一个实施方案中为在99℃测量的约75cSt至在99℃测量的约700cSt。聚丁烯占包含聚丁烯的组分重量的约0.01%至约100%,在另一个实施方案中占包含聚丁烯的组分重量的约1%至约100%,在另一个实施方案中还占包含聚丁烯的组分重量的约50%至约100%。
本发明较低分子量的聚丁烯不表现出弹性特性。弹性体是具有能伸展出和弹回它们原样的能力的非晶性聚合物。该类型的弹性聚合物必须具有适度的交联量,以防止聚合链相互滑越,并且链必须具有不规则的形状,以防止在聚合物链中形成结晶区域。人工合成的弹性体更详细地描述于Kirk-Othmer,Encyclopedia of Chemical Technology第4版,第8卷,Wiley-Interscience出版社(1996),第934至955页,包括引入到Kirk-Othmer中的参考文献在内的所有参考文献均全文引入本文以供参考。用于本发明的聚丁烯是不交联的,并且不表现出弹力或弹性行为。当遭受到张力或弯曲力时,本发明的聚丁烯在解除该力后不能恢复它的原样。
较低分子量的聚丁烯(分子量=300至3000)是一种因为它的粘合性而知名的可流动液体,它实际上是非粘膜粘合剂。即,当聚丁烯在口腔的硬表面上显示出卓越的粘合性时,其将不会有效地粘附到粘膜或口腔的湿软组织上。事实上,当将聚丁烯涂敷到牙齿上时,其是非常牢固的,使其适于每天一次的涂敷和治疗。甚至当发生彻底的刷洗时,也可获得聚丁烯的高保留性。因此,一旦将聚丁烯涂敷到牙齿的表面,其就是长期持久的,并且抗漂洗,这就允许一些任选的口腔护理活性物质的持续释放。重要的是,在将本发明的组合物涂敷到牙齿上之前、期间或之后,其是非自承的。一旦将聚丁烯涂敷到牙齿上,其就具有非常柔和、光滑的结构,消费者感受到期望、清洁的感觉。聚丁烯起润滑剂的作用,并且减轻了当舌头滑过牙齿时通常产生的摩擦。
用于本发明的适宜的聚丁烯包括但不限于:吲杜L-14(Indopol L-14),分子量(“MW”)=370;吲杜L-50,MW=455;吲杜L-65,MW=435;吲杜L-100,MW=510;H-15,MW=600;H-25,MW=670;H-35,MW=725;H-40,MW=750;H-50,MW=815;H-100,MW=940;H-300,MW=1330;H-1500,MW=2145;H-1900,MW=2270;哌呢雷L-14E(PanalaneL-14E),MW=370;哌呢雷H-300E,MW=1330;BP Amoco Chemicals(Chicago,IL)的所有商品名。其它适宜等级的聚丁烯包括Parapol450,MW=420;哌偌700(Parapol 700),MW=700;哌偌950,MW=950;哌偌1300,MW=1300和哌偌2500,MW=2700;ExxonMobil Corporation的所有商品名。
口腔护理活性物质
本发明的口腔护理套件和组合物可以包含一种或多种单位剂量形式的口腔护理活性物质,其中在指导使用下,在没有损害口腔护理活性物质涂敷的口腔表面的情况下,可增进使用者要求的有益效果。这些活性物质针对的口腔病症的实施例包括但不限于牙齿的外观和结构变化,牙斑、牙垢、空洞、齿龈发炎和/或流血、齿龈炎、真菌感染如假丝酵母感染、粘膜创伤、损伤、溃疡、口疮性溃疡、唇疱疹、牙齿脓肿的治疗和预防,以及上述病症和其它原因如微生物增殖导致的口臭消除。
适宜的口腔护理活性物质包括通常被认为安全用于口腔的和提供给口腔总外观和/或健康变化的任何物质。当存在口腔护理活性物质时,除非另外指明,本发明的口腔护理套件和组合物中的口腔护理活性物质的含量通常占组合物重量的约0.001%至约90%,在一个实施方案中为约0.01%至约50%,在另一个实施方案中为约0.1%至约30%。当口腔护理活性物质是颗粒形式时,适用于本发明的粒径为约0.01微米至约1000微米,在一个实施方案中为约0.1微米至约500微米,在另一个实施方案中为约1微米至约100微米。本发明的口腔护理套件和组合物可以包括许多先前在本领域中公开的口腔护理活性物质。下列是可用于本发明的口腔护理活性物质的一个非限制性列表。
本发明的组合物可以包括至少一种防牙结石(即防牙垢)剂,其以占组合物重量的约0.001%至约50%的含量存在,在另一个实施方案中为约0.01%至约25%,在另一个实施方案中还为约0.1%至约15%。防牙结石剂基本上应该与本发明的其它组合物相容。防牙结石剂可以选自多磷酸酯(包括焦磷酸酯)及其盐、聚氨基丙烷磺酸(AMPS)及其盐、聚磺酸烯烃酯及其盐、聚磷酸乙烯酯及其盐、聚磷酸烯烃酯及其盐、二膦酸酯及其盐、膦酰基烷羧酸及其盐、聚膦酸酯及其盐、聚膦酸乙烯酯及其盐、聚膦酸烯烃酯及其盐、多肽,及其混合物。在一个实施方案中,盐是碱金属盐。多磷酸盐通常用作它们全部或部分被中和的水溶性的碱金属盐如钾盐、钠盐、铵盐,及其混合物。无机多磷酸盐包括碱金属(例如,钠)三聚磷酸盐、四聚磷酸盐、二烷基金属(例如,二钠)二元酸、三烷基金属(例如,三钠)一元酸、磷酸氢钾、磷酸氢钠和碱金属(例如,钠)六偏磷酸盐,及其混合物。多磷酸盐比四聚磷酸盐更多地以非晶形玻璃状物质出现。在一个实施方案中,多磷酸盐是FMC公司制造的那些,它们商业上被称为寿达缶斯(Sodaphos)(n≈6),海克缶斯(Hexaphos)(n≈13),和格拉斯H(Glass H)(n≈21,六偏磷酸钠),及其混合物。用于本发明的焦磷酸盐包括碱金属焦磷酸盐、焦磷酸二、三和一钾或钠、二碱金属焦磷酸盐、四碱金属焦磷酸盐,及其混合物。在一个实施方案中,焦磷酸盐选自焦磷酸三钠、焦磷酸二氢二钠((Na2H2P2O7)、焦磷酸二钾、焦磷酸四钠(Na4P2O7)、焦磷酸四钾(K4P2O7),及其混合物。聚磺酸烯烃酯包括其中烯烃基团包含2个或多个碳原子的那些,及其盐。聚膦酸烯烃酯包括其中烯烃基团包含2个或多个碳原子的那些。聚膦酸乙烯酯包括聚乙烯膦酸。二膦酸酯及其盐包括偶氮环烷-2,2-二膦酸及其盐、偶氮环烷-2,2-二膦酸及其盐的离子、氮杂环己烷-2,2-二膦酸、氮杂环戊烷-2,2-二膦酸、N-甲基-氮杂环戊烷-2,3-二膦酸、EHDP(乙烷-1-羟基-1,1,-二膦酸)、AHP(氮杂环庚烷-2,2-二膦酸)、乙烷-1-氨基-1,1-二膦酸盐、二氯甲烷-二膦酸盐等等。膦酰基烷羧酸或它们的碱金属盐包括PPTA(膦酰基丙烷三羧酸)、PBTA(膦酰基丁烷-1,2,4-三羧酸),分别为酸或碱金属盐。聚磷酸烯烃酯包括其中烯烃基团包含2个或多个碳原子的那些。多肽包括聚天冬氨酸和聚谷氨酸。
氟离子源因用于口腔护理组合物中作为牙齿抗龋齿剂而著名,其可任选地掺入本发明中。将氟离子应用到真牙的牙釉质上可保护牙齿不受腐蚀。品类繁多的产生氟离子的物质可用作本发明组合物中的可溶性的氟化物源。适宜的产生氟离子物质的实施例,参见Briner等人的美国专利3,535,421和Widder等人的美国专利3,678,154中。用于本发明的优选的氟离子源包括氟化钠、氟化钾、氟化亚锡、一氟磷酸盐(MFP)和氟化铵。在一个实施方案中,氟化钠是氟离子源。本发明提供的氟离子在总组合物中为约5ppm至约10,000ppm,在一个实施方案中为约100ppm至3000ppm。
本发明的组合物可以包括亚锡离子源。可以从氟化亚锡和/或其它的亚锡盐中提供亚锡离子。已经发现氟化亚锡有助于减轻齿龈炎、牙斑、敏感性,并且有助于改善呼吸的有益效果。口腔护理组合物中提供的亚锡离子通过用该组合物而给受治疗者提供功效。虽然功效能包括不同于减轻齿龈炎的有益效果,但是其被定义为就地牙斑代谢的明显减少量。提供该功效的制剂典型地包括由氟化亚锡和/或其它的亚锡盐提供的亚锡含量,亚锡离子在总组合物中的含量范围为约3000ppm至约15,000ppm。如果亚锡的含量低于约3,000ppm,则亚锡的功效不足。亚锡离子以约4,000ppm至约12,000ppm、在另一个实施方案中为约5,000ppm至约10,000ppm的含量存在。其它的亚锡盐包括有机亚锡羧酸盐,例如乙酸亚锡、葡萄糖酸亚锡、草酸亚锡、丙二酸亚锡、柠檬酸亚锡、乙烯糖氧化亚锡、甲酸亚锡、硫酸亚锡、乳酸亚锡、酒石酸亚锡等等。其它的亚锡离子源包括亚锡卤化物,例如氯化亚锡、溴化亚锡、碘化亚锡和氯化亚锡二氢化物。在一个实施方案中,亚锡离子源是氟化亚锡,在另一个实施方案中是氯化亚锡二氢化物。组合的亚锡盐可以占组合物重量的约0.01%至约11%的含量存在。亚锡盐可典型地以占组合物重量的约0.1%至约7%、在一个实施方案中为约1%至约5%、并且在另一个实施方案中还以约1.5%至约3%的含量存在。
抗微生物剂也可存在于本发明的组合物中。该类型的物质可以包括但不限于:5-氯-2-(2,4-二氯苯氧基)-苯酚,通常称为三氯生,并且描述于The Merck Index,第11版(1989)1529页(编目流水号,9573),描述于美国专利3,506,720,以及描述于Beecham Group,PLC的欧洲专利申请0,251,591;8-羟喹啉及其盐;铜II化合物,包括但不限于氯化铜(II)、硫酸铜(II)、乙酸铜(II)、氟化铜(II)和氢氧化铜(II);邻苯二甲酸及其盐,包括但不限于描述于美国专利4,994,262中的那些,优选的是邻苯二甲酸一钾镁、氯己定、阿来西定、海克替啶、血根碱、烷基苄基二甲基铵氯化铵、水杨酰苯胺、度米芬、氯化十六烷基吡啶鎓(CPC)、氯化十四烷基吡啶鎓(TPC)、氯化N-十四烷基-4-乙基吡啶鎓(TDEPC)、奥替尼啶、碘、磺酰胺类药物、双双胍类药物、酚类药物、地莫匹醇、辛哌醇和其它的哌啶子基衍生物、烟酸制剂(nicinpreparations)、锌/亚锡离子剂、制霉菌素、柚子香精、苹果香精、百里香油、百里酚、抗生素,例如奥格门汀、阿莫西林、四环素、强力霉素、二甲胺四环素、甲硝唑、新霉素、卡那徽素和克林霉素,类似物及上述盐;香精油,其包括百里酚、香叶醇、香芹酚、柠檬醛、日扁柏素、桉油精、儿茶酚(尤其是4-烯丙基儿荼酚),及其混合物;水杨酸甲酯;过氧化氢;亚氯酸盐的金属盐;及上述所有的混合物。
本发明的组合物可包括一种抗牙斑剂如亚锡盐、铜盐、锶盐、镁盐或聚二甲基硅氧烷共聚醇。聚二甲基硅氧烷共聚醇选自C12-C20的烷基聚二甲基硅氧烷共聚醇及其混合物。在一个实施方案中,聚二甲基硅氧烷共聚醇是以商品名Abil EM90市售的鲸蜡基聚二甲基硅氧烷共聚醇。聚二甲基硅氧烷共聚醇通常以占组合物重量约0.001%至约25%、在一个实施方案中为约0.01%至约5%、并且在另一个实施方案中为约0.1%至约1.5%的含量存在。
抗炎剂也可存在于本发明的口腔护理套件和组合物中。该类型的物质可以包括但不限于非甾族抗炎剂oxicams、水杨酸酯、丙酸、乙酸和灭酸类药物。该类型的NSAID包括但不限于酮咯酸、氟比洛芬、布洛芬、萘普生、消炎痛、双氯芬酸、依托度酸、消炎痛、舒林酸、托美丁、酮洛芬、非诺洛芬、吡罗昔康、萘丁美酮、阿斯匹林、二氟尼柳、甲氯芬那酸盐、扑湿痛、羟基保泰松、保泰松和醋氨酚。公布于1997年5月6日的美国专利5,626,838要求保护NSAID如酮咯酸的应用。其中公开了通过给口腔或口咽局部施用有效量的NSAID,以预防和/或治疗原发性和复发的口腔或口咽鳞状上皮细胞癌的方法。适宜的甾族抗炎剂包括皮质类固醇,例如fluccinolone和氢化可的松。
营养物可以改善口腔的状况,并且可以包括进本发明的组合物中。营养物包括矿物、维生素、口腔营养增补剂、肠内营养增补剂,及其混合物。有用的矿物包括钙、磷、锌、锰、钾,及其混合物。维生素可与矿物一起使用,或是单独使用。适宜的维生素包括维生素C和D、维生素B1、核黄素、泛酸钙、烟酸、叶酸、烟酰胺、吡哆素、氰钴维生素、对氨基苯甲酸、生物类黄酮,及其混合物。口腔营养增补剂包括氨基酸、抗脂肪肝剂、鱼油,及其混合物。氨基酸包括但不限于L-色氨酸、L-赖氨酸、甲硫氨酸、苏氨酸、左旋肉毒碱或L-肉毒碱,及其混合物。抗脂肪肝剂包括但不限于胆碱、肌醇、甜菜碱、亚油酸、亚麻酸,及其混合物。鱼油含有大量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。肠内营养增补剂包括但不限于蛋白质产品、葡萄糖、玉米油、红花油、中等链长的甘油三酯。矿物、维生素、口腔营养增补剂和肠内营养增补剂更详细地描述于Drug Facts and Comparisons(活页药物信息服务),Wolters Kluer Company,St.Louis,Mo.,1997,第3至17页和第54至57页中。
增白剂可包括进本发明的口腔护理活性物质中。该类型的物质选自过氧化物、金属亚氯酸盐、过硼酸盐、过碳酸盐、过氧酸、过硫酸盐,及其混合物。适宜的过氧化物包括过氧化氢、过氧化脲、过氧化钙、尿素过氧化物,及其混合物。在一个实施方案中,过氧化物是尿素过氧化物。适宜的金属亚氯酸盐包括亚氯酸钙、亚氯酸钡、亚氯酸镁、亚氯酸锂、亚氯酸钠和亚氯酸钾。另外的漂白物质可以是次氯酸盐和二氧化氯。在一个实施方案中,亚氯酸盐是亚氯酸钠。在另一个实施方案中,过碳酸盐是过碳酸钠。在一个实施方案中,过硫酸盐是过硫酸氢钾制剂。这些物质的含量取决于分别可得到的氧或氯,这些分子能够提供着色斑漂白作用。这些物质通常以组合物的约0.1%至约35%、在一个实施方案中为约1%至约25%、并且在另一个实施方案中为约5%至约10%的含量用在本发明的组合物中。
在口腔护理组合物中,抗氧化剂被公认为是有用的。抗氧化剂公开于教科书中,例如Cadenas和Packer的The Handbook of Antioxidants,1996,由Marcel Dekker,Inc出版。本发明可包括的抗氧化剂包括但不限于维生素E、抗坏血酸、尿酸、类胡罗卜素、维生素A、类黄酮和多酚、草本植物抗氧化剂、退黑激素、氨基吲哚、硫辛酸,及其混合物。
用于本发明的抗病毒活性物质包括任何已知的日常用于治疗病毒感染的活性物质。该类型的抗病毒活性物质包括但不限于:膦酰基甲酸、胞嘧啶衍生物、嘌呤类似物如腺嘌呤核苷、鸟嘌呤核苷和次黄嘌呤核苷类似物、嘧啶碱如citidine和胸腺嘧啶核苷、三环癸胺、金刚乙胺HCl、病毒唑、扎那米韦、奥塞米韦磷酸盐、曲氟尿苷、杂环染料、阿昔洛韦、泛昔洛韦、伐昔洛韦、西多福韦、更昔洛韦、levimisole、疱疹净、亲脂性β-酮和缩氨基硫脲。这些抗病毒活性物质描述于Drug Facts andComparisons(活页药物信息服务),Wolters Kluwer Company,St.Louis,Mo.,2001,第1400至1423(b)页,和Kirk-Othmer,Encyclopedia of Chemical Technology,第四版,第3卷,Wiley-Interscience出版社(1992),第576至607页中,二者均全文引入本文以供参考。具体的实施例包括Majeti的公开的美国专利5,747,070中的抗病毒活性物质,该专利全文引入本文以供参考。所述专利公开了亚锡盐在控制病毒中的应用。亚锡盐更详细地描述于上文。当氟化亚锡可用作抗病毒剂时,它典型地仅与卤化亚锡或一种或多种羧酸亚锡或其它的治疗剂联合使用。
本发明的口腔护理套件和组合物也可包括杀真菌剂。杀真菌剂是破坏或抑制真菌类生长的活性剂。用于本发明的杀真菌剂是那些适合于全身性霉菌病(mycoses)的药物或适合于粘膜与皮肤感染的药物。适宜的杀真菌剂包括但不限于制霉菌素、咪康唑、硝酸益康唑、克霉唑和氟胞嘧啶。在一个实施方案中,杀真菌剂是制霉菌素。
本发明的口腔护理套件和组合物也可包括镇痛剂或脱敏剂。止痛药是这样的活性剂,其在没有妨碍知觉或改变其它感觉形态的情况下,通过在中枢起作用以增加痛苦阈值而减轻痛苦。该类型的活性剂可以包括但不限于氯化锶、硝酸钾、氟化钠、硝酸钠、退热冰、非那西汀、醋托芬(acertophan)、thiorphan、螺朵林、阿斯匹林、可待因、蒂巴因、左啡诺、氢吗啡酮、羟吗啡酮、苯唑星、芬太奴、丁丙诺啡、butaphanol、纳布啡、镇痛新、天然药草如五倍子、细辛、荜澄茄素、高良姜、黄芩、两面针、Baizhi等等。也可存在麻醉剂或局麻剂,例如醋氨酚、水杨酸钠、水杨酸三乙醇胺、利多卡因和苯佐卡因。这些止痛的活性物质详细地描述于Kirk-Othmer,Encyclopedia of Chemical Technology,第四版,第2卷,Wiley-Interscience Publishers(1992),第729至737页中,全文引入本文以供参考。
组胺-2(H-2或H2)受体拮抗剂化合物(H-2拮抗剂)可用于本发明的组合物中。当用于本发明时,选择性H-2拮抗剂是这样的化合物,其阻断H-2受体,但是在阻断组胺-1(H-1或H1)受体方面,其不具有显著活性。选择性H-2拮抗剂刺激各器官例如肠和支气管的平滑肌收缩;这种作用可以通过低浓度的美吡拉明-一种典型的抗组胺药来抑制。用于本发明的H-2拮抗剂如下,其阻断被包括进对美吡拉明不敏感的非H-1(H-2)组胺反应中的受体,但不阻断被包括进对美吡拉明敏感的组胺反应中的受体。选择性H-2拮抗剂包括满足上述标准的化合物,其描述于授予Singer等人的、且转让给The Procter & Gamble Company的美国专利5,294,433和5,364,616中,其中选择性H-2拮抗剂选自甲腈咪胺、西咪替丁、依汀替丁、雷尼替丁、ICIA-5165、硫替丁、ORF-17578、鲁匹替丁、多奈替丁、法莫替丁、罗沙替丁、皮伐替丁、兰替丁、BL-6548、BMY-25271、唑替丁、尼扎替丁、咪芬替丁、BMY-25368(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、莫普咪定、L-643728和HB-408。相关适合的H-2拮抗剂包括布立马胺和甲硫米特。
本发明也可包括一种或多种提供香味和/或可感觉有益效果(加温或冷却剂)的组分。适宜的组分包括薄荷醇、乳酸薄荷酯、冬青油、薄荷油、留兰香油、叶醇、樟脑、丁香芽油、桉树油、对丙烯基茴香醚、水杨酸甲酯、桉油精、肉桂、1-8乙酸薄荷酯、丁子香酚、oxanone、α-紫罗兰酮、丙烯基乙氧愈创木酚、肉桂、百里酚、里哪醇、苯甲醛、称为CGA的肉桂醛甘油缩醛,及其混合物,和冷却剂。冷却剂可以是任何各种各样的物质。包括进本发明中的该类型的物质是酰胺化合物、薄荷醇、缩酮、二醇,及其混合物。本发明组合物中的优选的冷却剂是对酰胺试剂,例如商业上称为“WS-3”的N-乙基-对--3-酰胺、称为“WS-23”的N,2,3-三甲基-2-异丙基丁酰胺,及其混合物。另外优选的冷却剂选自薄荷醇、由Takasago生产的被称为TK-10的3-1-薄荷醇氧丙烷-1,2-二醇、由Haarmann和Reimer生产的被称为MGA的薄荷酮甘油缩醛和由Haarmann和Reimer生产的被称为的乳酸薄荷酯。用于本发明的术语薄荷醇和薄荷基包括这些化合物的右旋和左旋异构体,及其外消旋的混合物。TK-10描述于Amano等人的美国专利4,459,425中。WS-3和其它试剂描述于Watson等人的美国专利4,136,163中。两者的公开内容均全文引入本文以供参考。
可将颜料加到本发明的组合物中,以更准确地显示出组合物实际接触的位置。另外,这些物质可适于修饰牙齿的颜色以使消费者满意。这些物质包括这样的颗粒,当将其涂敷到牙齿的表面时,其可从吸收和/或光反射的方面修饰牙齿的表面。当将包含该类型颗粒的薄层涂敷到牙齿的表面时,该类型的颗粒提供外观有益效果。也可加入颜料、染料、着色剂和色淀以修饰本发明组合物的外观,致使产品对于消费者来说更合意。为了达到消费者期望的特殊效果而选择合适的颜料含量。例如,对于特别黑或有色斑的牙齿,将典型地用足量的颜料以使牙齿的颜色变浅。另一方面,当个别牙齿或牙齿上的斑点较别的牙齿颜色较浅时,可以使用使牙齿颜色变深的颜料。颜料和着色剂的含量占组合物总重量的约0.001%至约20%,在一个实施方案中为约0.01%至约15%,在另一个实施方案中为约0.1%至约10%。
颜料和着色剂包括无机白色颜料、无机有色颜料、珠光剂、填充粉等等,参见公布于1997年4月15日的日本出版的专利申请Kokai No.9[1997]-100215,引入本文以供参考。具体的实施例选自滑石、云母、碳酸镁、碳酸钙、硅酸镁、硅酸铝镁盐、二氧化硅、二氧化钛、氧化锌、红色氧化铁、褐色氧化铁、黄色氧化铁、黑色氧化铁、氰亚铁酸铁铵、锰紫、佛青、尼龙粉、聚乙烯粉、异丁烯酸盐粉、聚苯乙烯粉、丝粉、结晶纤维素、淀粉、钛酸云母、氧化铁钛酸云母、氯氧化铋,及其混合物。在一个实施方案中,颜料和着色剂选自二氧化钛、氯氧化铋、氧化锌、Opatint D&C Red 27、CI 16185:1 Acid 27 Lake E123、CI14720:1Carmosoisine Aluminum Lake E122、Red 7 Lake或Red 30 Lake,及其混合物。
适用于本发明的另外的活性物质可以包括但不限于胰岛素、甾体化合物、源自草本植物和其它植物的药物和抗肿瘤剂。另外,也可包括本领域中已知的抗齿龈炎剂或齿龈护理剂。可任选地包括给予牙齿清洁感的非聚丁烯的组分。这些组分可以包括例如碳酸氢钠或Glass-H。同样,据认为为了获得最佳的效果,将这些上述指定的活性剂以一定的治疗形式组合起来,也许是有用的。因此,例如可以将抗微生物剂和抗炎剂组合在单一的组合物中,以提供联合的效果。
口腔护理载体
将一种或多种口腔护理载体掺入本发明的口腔护理组合物中,该类型的物质选自本领域中公知的那些,并且本领域的技术人员基于对要制备的组合物所期望的物理和美学特性,可容易地选择该类型的物质。最终的口腔护理组合物可以是洁齿剂、口腔漂洗剂、口腔喷剂、局部口服凝胶剂、牙齿增白凝胶剂等等。可以以不妨碍或阻止表面调理的含量来包括这些口腔护理载体。口腔护理载体典型地占口腔组合物总重量的约10%至约99%,在一个实施方案中为约45%至约98%,在另一个实施方案中还为约75%至约95%。在一个实施方案中,也可包含活性物质的组合物的聚丁烯组分和口腔护理载体组分可被分别地制备,然后可将二者混合成一种单相的口腔护理产品,或者在直至给药时间之前是物理分开的而制得一种多相的口腔护理产品。
本发明口腔组合物中的口腔护理载体可包括磨料抛光材料。用于本发明的设想的磨料抛光材料可以是任何不过度磨损牙质的材料。磨料抛光材料应该在口腔组合物中配制,这样它就不会危害任何成分如氟化亚锡的稳定性。典型的磨料抛光材料包括硅胶和沉淀物、氧化铝、包括正磷酸盐的磷酸盐、聚偏磷酸盐和焦磷酸盐,及其混合物。具体的实施例包括二水合正磷酸二钙、焦磷酸钙、磷酸三钙、聚偏磷酸钙、不溶性的聚偏磷酸钠、氢氧化铝、β焦磷酸钙、碳酸钙和树脂磨料材料如尿素和甲醛的颗粒缩合产物,以及其它公开于Cooley等人的美国专利3,070,510中的材料,引入本文以供参考。可以选用各种类型的二氧化硅牙齿磨料,这是因为在不过度磨损牙釉或牙质的情况下,它们具有优越的牙齿清洁和抛光性能的独特有益效果。磨料可以是沉淀二氧化硅或硅胶如二氧化硅干凝胶,其描述于Pader等人的美国专利3,538,230和DiGiulio的美国专利3,862,307中,二者均引入本文以供参考。优选的是W.R.Grace & Company,Davison Chemical Division的以商品名“Syloid”出售的二氧化硅干凝胶,和沉淀二氧化硅材料如J.M.Huber Corporation的以商品名“Zeodent”尤其是带有名称“Zeodent 119”出售的那些。用于本发明牙膏中的该类型的二氧化硅牙齿磨料更详细地描述于Wason的美国专利4,340,583中,引入本文以供参考。本发明描述的牙膏组合物中的磨料通常以占组合物重量的约6%至约70%的含量存在。在一个实施方案中,牙膏包含占本发明口腔护理组合物的口腔护理组分重量的约10%至约50%的磨料。也可用磨料的混合物。本发明的磨料抛光材料通常具有的平均粒径在约0.1至约30微米之间,并且在一个实施方案中为约5至约15微米。
本发明可包括作为口腔护理载体的碱金属碳酸氢盐。碱金属碳酸氢盐是可溶于水的,并且如果其在含水体系中不稳定,则倾向于释放出二氧化碳。碳酸氢钠也称为小苏打,是优选的碱金属碳酸氢盐。碱金属碳酸氢盐也用作缓冲剂。本发明可包含占口腔护理组合物的口腔护理载体组分重量的约0.001%至约50%、在一个实施方案中为约0.01%至约30%、在另一个实施方案中为约0.1%至约20%、并且在另一个实施方案中为约1%至约18%的碱金属碳酸氢盐。
口腔护理组合物可包含缓冲剂。用于本发明的缓冲剂是指可用于将组合物的pH值调节至约pH3至约pH10范围的试剂。包含聚合表面活性剂的口腔护理组合物具有的浆料pH值典型地为约4至约10,在一个实施方案中为约4.5至约8,并且在另一个实施方案中为约5至约7。缓冲剂包括碱金属氢氧化物、碳酸盐、倍半碳酸盐、硼酸盐、硅酸盐、磷酸盐、咪唑,及其混合物。具体的缓冲剂包括磷酸一钠、磷酸三钠、氢氧化钠、氢氧化钾、碱金属碳酸盐、碳酸钠、碳酸盐、咪唑、焦磷酸盐、柠檬酸和柠檬酸钠。缓冲剂可以占口腔组合物的口腔护理载体组分重量的约0.01%至约30%、在一个实施方案中为约0.1%至约10%、并且在另一个实施方案中为约1%至约3%的含量使用。
在制备商业上适合的口腔组合物中使用的水应该优选为低离子量和不含有机杂质的水。水通常占本发明描述的口腔护理组合物的口腔护理载体组分重量的约5%至约70%、并且在另一个实施方案中为10%至约50%。聚合表面活性剂可能需要较低含量的水来保持稳定。通常,水的含量为占口腔护理组合物的口腔护理载体组分重量的最高达约20%,在一个实施方案中为约5%至约14%,并且在另一个实施方案中为约7%至约12%。水的总量包括加入的游离水和那些与其它的物质如山梨醇、二氧化硅、表面活性剂溶液和/或有色溶液掺入到一起的水。
本发明的口腔护理组合物也可包括表面活性剂,通常是指起泡剂。适宜的表面活性剂是那些相当稳定的、并且在整个宽的pH值范围内起泡沫的表面活性剂。表面活性剂以占口腔护理组合物的口腔护理载体组分重量的约0.001%至约12%、在一个实施方案中为约0.01%至约8%、并且在另一个实施方案中为约0.1%至约6%的含量存在。表面活性剂可以是阴离子的、非离子的、两性的、两性离子的、阳离子的,或其混合物。用于本发明的阴离子表面活性剂包括在烷基中具有8至20个碳原子的烷基硫酸的水溶性盐(例如烷基硫酸钠),还包括具有8至20个碳原子的脂肪酸的磺化甘油单酯的水溶性盐。这种类型的阴离子表面活性剂的实施例是月桂基硫酸钠和椰子油甘油单酯磺酸钠。其它适宜的阴离子表面活性剂是肌氨酸盐如月桂基肌氨酸钠、牛磺酸盐、月桂基磺基乙酸钠、月桂酰羟乙基磺酸钠、月桂基聚氧乙烯醚羧酸钠和十二烷基苯磺酸钠。也可使用阴离子表面活性剂的混合物。许多适宜的阴离子表面活性剂公开于Agricola等人的美国专利3,959,458中,该专利全文引入本文以供参考。用于本发明组合物中的非离子表面活性剂可广泛地定义为通过氧化烯基团(亲水性质的)与本身可以是脂族或烷基-芳族的有机疏水化合物的缩合而产生的化合物。适宜的非离子表面活性剂实施例包括泊洛沙姆(以商品名Pluronic售卖)、脱水山梨糖醇聚氧乙烯酯(以商品名Tween售卖)、脂肪醇乙氧基化物、烷基酚的聚环氧乙烷缩合物、衍生于环氧乙烷与氧化丙烯和1,2-乙二胺的反应产物的缩合的产品、脂族醇的环氧乙烷缩合物、长链叔胺氧化物、长链叔膦氧化物、长链二烷基亚砜,及该类型物质的混合物。用于本发明的两性表面活性剂可广泛地定义为脂族仲和叔胺的衍生物,其中脂族基团可以是直链或支链的,并且一个脂族取代基包含约8至约18个碳原子,且包含阴离子增水溶性的基团,例如羧酸盐、磺酸盐、硫酸盐、磷酸盐或膦酸盐。其它适宜的两性表面活性剂是甜菜碱,具体为椰油酰氨基丙基甜菜碱。也可用两性表面活性剂的混合物。许多这些适宜的非离子表面活性剂和两性表面活性剂公开于Gieske等人的美国专利4,051,234中,该专利全文引入本文以供参考。
本发明的口腔护理载体组分可掺入酸性化合物。酸性化合物可以是有机或无机的。酸性化合物可以是任何能起中合碳酸氢盐的质子给体作用的物质。适用的酸性化合物包括羧酸、磷酸、α-羟基酸、磺酸,及其混合物。具体的酸包括柠檬酸、苹果酸、藻酸、琥珀酸、乳酸、酒石酸、乙醇酸、己二酸、酒石酸氢钾、酸式柠檬酸钠、磷酸、硼酸和酸式磷酸焦磷酸盐,及其混合物。在一个实施方案中用柠檬酸,在另一个实施方案中用苹果酸。也可用上述酸的酸酐和酸式盐。适宜的盐包括柠檬酸的一或二钠盐、苹果酸的一钠盐,及其混合物。口腔护理组合物的口腔护理载体组分可包含占口腔护理组分总重量的约0.01%至约20%、在一个实施方案中为约0.1%至约15%、并且在另一个实施方案中为约1%至约12%的酸性化合物。
本发明可包括聚氧乙烯。聚氧乙烯将增加本发明的口腔护理载体组分产生的泡沫量和泡沫厚度。聚氧乙烯通常也称为聚乙二醇(“PEG”)或聚环氧乙烷。适于本发明的聚氧乙烯具有的分子量为约200,000至约7,000,000。在一个实施方案中分子量为约600,000至约2,000,000,并且在另一个实施方案中为约800,000至约1,000,000。“Polyox”是由Union Carbide生产的高分子量的聚氧乙烯商品名。聚氧乙烯可以占本发明口腔护理组合物的口腔护理载体组分重量的约0.1%至约8%、在一个实施方案中为约0.2%至约5%、并且在另一个实施方案中为约0.3%至约2%的含量存在。
本发明的组合物可包含一些增稠物质或粘合剂以提供期望的稠度。适宜的增稠剂包括但不限于羧乙烯基聚合物、角叉菜胶、羟乙基纤维素和纤维素酯的水溶性盐如羧甲基纤维素钠和羟乙基纤维素钠。也可用天然树胶如刺梧桐树胶、黄原胶、阿拉伯胶和黄蓍胶。胶态的硅酸铝镁或细分的二氧化硅可用作增稠剂的一部分以进一步改善结构。增稠剂可以以口腔护理载体组分重量的约0.01%至约15%的含量使用。
湿润剂是本发明描述的组合物的另一种任选组分。湿润剂适于保护牙膏组合物以避免当其暴露于空气中时发生硬化,并且某些润湿剂也可赋予牙膏组合物所期望的香甜味。用于本发明的适宜的湿润剂包括甘油、山梨醇、聚乙二醇和其它可食用的多元醇。湿润剂占口腔护理组合物的口腔护理载体组分重量的约0%至约70%,并且在一个实施方案中为约15%至约55%。
本发明也可包括木糖醇。木糖醇是一种用作甜味剂和湿润剂的糖醇。木糖醇可提供治疗效果,例如抗菌和抗龋齿效果。本发明的组合物可以包含占总口腔护理载体组分重量约0.01%至约25%、在一个实施方案中为约3%至约15%、并且在另一个实施方案中为约5%至约12%的木糖醇。可供选择地,如果将木糖醇用作甜味剂,它可以以较低的含量存在,例如占本发明口腔护理组合物的口腔护理组分重量的约0.005%至约5%。
可以将任何本领域中已知的其它相容的口腔护理载体掺入本发明口腔护理组合物的口腔护理载体组分中。例如,可将二氧化钛作为遮光剂掺入本发明。上述某些口腔护理活性物质如氟化亚锡和抗微生物剂,因为这些物质作为口腔护理载体也是众所周知的,所以可以将它们掺入口腔护理组合物的口腔护理载体组分中。
口腔护理套件和组合物还可包括粘度改性剂,该粘度改性剂以促进再分散和能调节流动性的方式抑制组分的沉淀和析出或控制沉淀。粘度改性剂尤其用于保持以颗粒的形式悬浮于本发明聚丁烯中的口腔护理活性物质。本发明适宜的粘度改性剂包括矿物油、有机改性粘土、凡士林、二氧化硅,及其混合物。在一个实施方案中,当掺入时,粘度改性剂二氧化硅以占组合物的约0.1%至约30%、在一个实施方案中为约0.5%至约10%、并且在另一个实施方案中为约1%至约3%的含量存在于本发明的聚丁烯组分中。
组合物还可任选地包含一种或多种食用香料。这些调味剂可以选自衍生于植物的叶、花、果实等及其混合物的合成食用液质香精和/或食用油质香精。代表性的食用液质香精包括:香草醛、鼠尾草、甘牛至草、欧芹油、留兰香油、肉桂油、冬青油(水杨酸甲酯)、薄荷油、丁香油、月桂油、茴香油和桉树油。同样有用的是人造的、天然的或合成的水果香料如包括柠檬、桔、香蕉、葡萄、酸橙、杏和柚子的柑橘类水果油和包括苹果、草莓、樱桃、桔、菠萝等的水果香精,豆和坚果如咖啡豆、可可豆、可乐果、花生果、杏仁等的衍生香料。另外,可包括吸附到亲水基质上的香料,例如“喷雾干燥的”香料。此外,可包括有胶囊包着的香料。所用的食用香料量通常取决于个人偏爱,其取决于例如期望的香味类型和香味强度因素。食用香料以占总组合物重量的最高达约4%、在一个实施方案中为约0.05%至约3.0%、并且在另一个实施方案中为约0.8%至约2.5%的含量存在。
本发明的组合物还可包含甜味剂。适宜的甜味剂包括天然和人造的、水溶性的、水不溶性的和强烈的甜味剂。甜味剂可以是右旋糖、蔗糖、麦芽糖、糊精、干燥的转化糖、甘露糖、木糖、核糖、葡萄糖、果糖、左旋糖、半乳糖、玉米糖浆、高果糖玉米糖浆、玉米糖浆固体物、部分水解的淀粉、天冬甜素、糖精、糖醇如山梨醇、甘露糖醇、木糖醇、麦芽糖醇、异麦芽和氢化的淀粉水解产物,或其混合物。天然或人造的强烈甜味剂如基于强烈甜味剂的二肽、莫内林、thaumaoccous danielli和L-天冬氨酰基L-苯基丙氨酸甲酯和溶解的糖精盐也可作为甜味剂包含在内。甜味剂的量随选择的甜味剂和期望的甜量而变化。甜味剂和调味剂以占组合物重量的约0.005%至约5%的含量典型地用于口腔护理组合物中。
制备方法
在上述套件和组合物中,聚丁烯组分如下适宜地制备:将聚丁烯与任何任选的口腔护理活性物质混合进混合容器中,并用本领域已知的任何工具如刮铲或混合器将其充分混合。在混合期间可对组合物加热。继续混合直至均匀。当口腔护理活性物质是固体颗粒时,加入粘度改性剂如二氧化硅可能适于保持分散和悬浮于组合物中的颗粒。如需要,可加入食用香料和甜味剂。
当口腔护理组合物包含口腔护理载体时,如上制备聚丁烯组分。然后将可能是洁齿剂、口腔漂洗剂、口腔喷剂或局部口服凝胶载体的口腔护理载体直接加到组合物中,以产生单相的口腔护理组合物。当期望提供在应用时混合的多相组合物时,将口腔护理载体和包含聚丁烯的组分物理分开直至使用。
如上所示制备本发明口腔护理套件中的聚丁烯组分。在一种口腔护理套件中,向容器如广口瓶、杯、罐、管、气溶胶罐、盆、唧筒、瓶或任何其它的盛装液体或配制液体的工具中填充聚丁烯组分。随附套件使用说明书的样品上写着:“将口腔护理组合物直接涂敷到牙齿上。通过手指、刷子、牙棒或棉签将足量的组合物直接涂敷到牙齿的表面。在涂敷前或涂敷后不必清洁或弄于牙齿。”在另一个口腔护理套件中,为了直接涂于敷牙齿,将聚丁烯组分放进任何适宜的涂药器如管或笔式涂药器中。可供选择地,聚丁烯组分可用于连接用作涂药器设备的浅盘或stint。当本发明的口腔护理套件包括涂药器时,样品用法说明书上写着:“将口腔护理组合物直接涂敷到牙齿上。通过使用封闭式涂药器将足量的组合物充分地涂敷到牙齿上。在涂敷前或涂敷后不必刷洗牙齿而过度地清洁牙齿或弄干牙齿。”在另一个实施例中,样品用法说明书上可写着:“把补给浅盘装上适量的口腔护理组合物。将浅盘放入口腔中,并直接涂敷到牙齿上。在涂敷前或涂敷后不必刷洗而过度地清洁牙齿或弄干牙齿。”
使用方法
本发明的口腔组合物是牙膏、洁齿剂、局部口服凝胶剂、牙齿增白凝胶剂、口腔漂洗剂或口腔喷剂等的形式。洁齿剂组合物可以是糊状物、凝胶或任何构型,或其组合。如果使用多相制剂,则物理分开的洁齿剂组合物是优选的。在多相制剂中,组分的形式可以不同。例如在一个实施方案中,糊状物形式的一种组分和凝胶形式的另一种组分组成了双相组合物。分配器可以是管、唧筒或适于配送的任何其它容器。适于此目的双和/或多隔室封包装描述于Shaeffe的美国专利4,528,180、4,687,663和4,849,213中,所有这些专利均全文引入本文。分配器通过开孔而递送近似等量的每一洁齿剂组合物。组合物一旦配送即可混合。可供选择地,可从包含至少两种分开的分配器的套件中递送口腔制剂,其中该口腔制剂被用于递送同时使用的至少两种洁齿剂组合物。
在使用本发明的口腔护理套件和组合物期间,使用者将本发明公开的口腔护理组合物直接涂敷到牙齿的表面。当套件中包括涂药器时,用本领域中已知的刷子、笔式涂药器、雌鹿脚涂药器、浅盘、stint或任何其它的补给涂敷设备涂敷组合物。当本发明的口腔护理套件或组合物不提供涂药器时,也可通过手指、棉签或牙棒等等涂敷组合物。当口腔护理组合物掺入到本发明中时,组合物是洁齿剂、牙膏、口腔漂洗剂、口腔喷剂、局部口服凝胶剂或增白凝胶剂的形式,可通过传统的方式使用组合物。例如,通过用牙刷刷洗而使用牙膏组合物;通过在口腔中快速摇动组合物和吐出而使用口腔漂洗剂。
在使用本发明的组合物之前不需要对口腔做准备。例如,在使用组合物之前,使用者可以选择或不选择刷洗牙齿或漂洗牙齿。在使用组合物之前,口腔的表面既不要求弄干也不必用唾液或水过度地弄湿。然而,据信当使用组合物时,如果表面是较干的,将会增进牙齿表面的粘附力。
应该理解,本发明不仅涉及用于人的口腔的牙齿和硬表面上的口腔护理组合物,而且还涉及用于动物如家常宠物或其它家畜或被驯养动物的口腔中的口腔护理组合物。
实施例
下列非限制性实施例进一步举例说明和描述了有关发明的实施方案,其中必需成分和任选成分都是组合的。应该理解,仅仅是说明性地举出实施例,而不是被认为限制本发明的范围,因为在不背离本发明精神和范围的条件下,可以对其进行许多种变化。
将聚丁烯与口腔护理活性物质(如果包括)混合到混合容器中,并用机械混合器将其充分混合。混合组合物直至均匀。当口腔护理活性物质是固体颗粒形式时,可将粘度改性剂如二氧化硅以同样的方式加入到混合物中,并继续混合直至均匀。下面给出的数值以本发明口腔护理套件和组合物的聚丁烯组分的重量百分比计。
实施例1-6
1I ndopol H-300,MW=1330,BP Amoco Chemicals(Chicago,IL)的商品名。
实施例7-12
2Indopol H-40,MW=750,BP Amoco Chemicals(Chicago,IL)的商品名.
实施例13-19
3Indopol H-100,MW=940,BP Amoco Chcmicals(Chicago,IL)的商品名.
实施例20-25
4Indopol H-1900,MW=2270,BP Amoco Chemicals(Chicago,IL)的商品名。
实施例26-33
5Indopol H-300,MW=1330,Amoco Chemicals(Chicago,IL)的商品名。
实施例34-37
6Indopol H-300,MW=1330,BP Amoco Chemicals(Chicago,IL)的商品名。
应该理解,上述包含聚丁烯的组合物可以以任意比率混合,并且可用于本发明的组合物和套件中。也应该理解,这些实施例是非限制性的。本发明举例说明的聚丁烯和口腔护理活性物质的含量可以变化多达80%,并且仍适用于本发明公开的组合物和套件中。
当口腔护理组和物可任选包含口腔护理载体时,通过常规的方法制备载体。通过常规方法制备口腔护理载体组分#1。在水中混合氟化钠和糖精。将黄原胶分散在山梨醇中,然后加到该混合物中。加入丙二醇。加入食用香料、二氧化钛和烷基硫酸钠。加入二氧化硅。继续混合直至均匀。如果偏爱美感,将最终的产品磨碎和/或脱气。
通过常规方法制备口腔护理载体组分#2。在混合容器的水中混合氟化钠和糖精。将增稠剂、羧甲基纤维素和黄原胶分散在甘油中,然后加到该混合物中。加入丙二醇。加入食用香料、二氧化钛和烷基硫酸钠。加入碳酸钠。加入二氧化硅,然后加入碳酸氢钠。缓慢地加入焦磷酸四钠,然后加入过氧化钙。继续混合直至均匀。如果偏爱美感,将最终的产品磨碎和/或脱气。
通过常规方法制备口腔护理载体组分#3。将氟化钠、糖精和水加入到混合容器中混合。将增稠剂、羧甲基纤维素分散在甘油和山梨醇中,然后加到该混合物中。加入丙二醇、食用香料、二氧化钛和烷基硫酸钠。然后加入碳酸钠、二氧化硅和碳酸氢钠。继续混合直至均匀。如果偏爱美感,将最终的产品磨碎和/或脱气。
可将两种组分物理分开,直至使用双室洁齿剂分配器将组分施加到口腔的牙齿和硬、固定的表面上。可供选择地,可将聚丁烯组分和口腔护理载体组分混合并包装为一种单相的口腔护理组合物。当期望单相组合物时,可能需要将聚丁烯组分与口腔护理组合物的口腔护理载体组分一起乳化。
应该理解,本发明所述的实施例和具体实施方案仅仅是说明性的,在不背离本发明范围的条件下,本领域专业人员可以对其进行各种改变或变化。
Claims (30)
1.口腔护理组合物,该组合物包括:
(a)分子量为300至3000的聚丁烯;和
(b)一种或多种口腔护理载体,该载体选自磨料抛光材料、缓冲剂、水、表面活性剂、颜料、着色剂、染料和色淀、甜味剂、食用香料、增稠剂、遮光剂、湿润剂、木糖醇,及其混合物;
其中所述组合物不是自承的,并且所述组合物不是口香糖。
2.如权利要求1所述的口腔护理组合物,其中所述聚丁烯具有的分子量为500至2200。
3.如权利要求2所述的口腔护理组合物,其中所述聚丁烯具有的分子量为750至1500。
4.如权利要求1所述的口腔护理组合物,其中所述组合物是单相或多相、牙膏、洁齿剂、局部口服凝胶剂、牙齿增白凝胶剂、口腔漂洗剂或口腔喷剂的形式。
5.口腔护理组合物,该组合物包括:
(a)分子量为300至3000的聚丁烯;和
(b)口腔护理活性物质,该口腔护理活性物质选自防牙结石剂、氟离子源、二价锡离子源、增白剂、抗微生物剂、抗牙斑剂、抗炎剂、营养物、抗氧化剂、抗病毒剂、杀真菌剂、止痛剂和麻醉剂、H-2拮抗剂、给予牙齿清洁感的非聚丁烯的组分、香料和可感觉物质、食用香料、甜味剂,及其混合物,
其中所述组合物不是自承的,并且所述组合物不是口香糖;
所述给予牙齿清洁感的非聚丁烯的组分是碳酸氢钠或Glass-H,所述可感觉物质是加温或冷却剂。
6.如权利要求5所述的口腔护理组合物,其中所述口腔护理活性物质选自三氯生、碳酸氢钠、氟化钠、硝酸钾、硝酸钠、制霉菌素、柚子种子提取物、氟化亚锡、焦磷酸四钠、一氟代磷酸盐、D&C Red 27、多磷酸盐和氯化十六烷基吡啶。
7.如权利要求6所述的口腔护理组合物,其中所述多磷酸盐是六偏磷酸钠。
8.如权利要求5所述的口腔护理组合物,其中所述口腔护理组合物还包括口腔护理载体。
9.如权利要求8所述的口腔护理组合物,其中所述口腔护理载体选自磨料抛光材料、缓冲剂、水、表面活性剂、甜味剂、食用香料、增稠剂、遮光剂、湿润剂、木糖醇,及其混合物。
10.如权利要求9所述的口腔护理组合物,其中所述组合物是单相或多相、牙膏、洁齿剂、局部口服凝胶剂、牙齿增白凝胶剂、口腔漂洗剂或口腔喷剂的形式。
11.如权利要求5所述的口腔护理组合物,其中所述口腔护理组合物还包括粘度改性剂。
12.如权利要求5所述的口腔护理组合物,其中所述聚丁烯具有的分子量为500至2200。
13.如权利要求12所述的口腔护理组合物,其中所述聚丁烯具有的分子量为750至1500。
14.口腔护理套件,该套件包括:
(a)组合物,该组合物包括分子量为300至3000的聚丁烯;
(b)容器;和
(c)使用说明书;
其中所述聚丁烯组合物不是自承的。
15.如权利要求14所述的口腔护理套件,其中所述聚丁烯具有的分子量为500至2200。
16.如权利要求15所述的口腔护理套件,其中所述聚丁烯具有的分子量为750至1500。
17.如权利要求14所述的口腔护理套件,其中所述组合物还包括至少一种口腔护理活性物质。
18.如权利要求17所述的口腔护理套件,其中所述口腔护理活性物质选自防牙结石剂、氟离子源、二价锡离子源、增白剂、抗微生物剂、抗牙斑剂、抗炎剂、营养物、抗氧化剂、抗病毒剂、杀真菌剂、止痛剂和麻醉剂、H-2拮抗剂、给予牙齿清洁感的非聚丁烯的组分、香料和可感觉物、食用香料、甜味剂,及其混合物;
所述给予牙齿清洁感的非聚丁烯的组分是碳酸氢钠或Glass-H,所述可感觉物是加温或冷却剂。
19.如权利要求18所述的口腔护理套件,其中所述口腔护理活性物质选自三氯生、碳酸氢钠、氟化钠、硝酸钾、硝酸钠、制霉菌素、柚子种子提取物、氟化亚锡、焦磷酸四钠、一氟代磷酸盐、D&C Red 27、多磷酸盐和氯化十六烷基吡啶。
20.如权利要求19所述的口腔护理套件,其中所述多磷酸盐是六偏磷酸钠。
21.如权利要求17所述的口腔护理套件;其中所述聚丁烯组合物还包括粘度改性剂。
22.口腔护理套件,该套件包括:
(a)组合物,该组合物包括分子量为300至3000的聚丁烯;
(b)涂药器,用于将聚丁烯涂敷到牙齿上,
其中所述涂药器不是牙带,并且其中所述聚丁烯不是自承的。
23.如权利要求22所述的口腔护理套件,其中所述聚丁烯具有的分子量为500至2200。
24.如权利要求23所述的口腔护理套件;其中所述聚丁烯具有的分子量为750至1500。
25.如权利要求22所述的口腔护理套件,其中所述组合物还包括至少一种口腔护理活性物质。
26.如权利要求25所述的口腔护理套件;其中所述口腔护理活性物质选自防牙结石剂、氟离子源、二价锡离子源、增白剂、抗微生物剂和抗牙斑剂、抗炎剂、营养物、抗氧化剂、抗病毒剂、杀真菌剂、止痛剂和麻醉剂、H-2拮抗剂、给予牙齿清洁感的非聚丁烯的组分、香料和可感觉物质、颜料和着色剂,及其混合物;
所述给予牙齿清洁感的非聚丁烯的组分是碳酸氢钠或Glass-H,所述可感觉物质是加温或冷却剂。
27.如权利要求26所述的口腔护理套件,其中所述口腔护理活性物质选自三氯生、碳酸氢钠、氟化钠、硝酸钾、硝酸钠、制霉菌素、柚子种子提取物、氟化亚锡、焦磷酸四钠、一氟代磷酸盐、D&C Red 27、多磷酸盐和氯化十六烷基吡啶。
28.如权利要求27所述的口腔护理套件,其中所述多磷酸盐是六偏磷酸钠。
29.如权利要求28所述的口腔护理套件,其中所述聚丁烯组合物还包括粘度改性剂。
30.一种口腔护理组合物在制备用于抑制和预防在口腔中形成齿龈炎、骨溃疡、色斑、真菌、细菌和牙斑的药物中的用途,其包括将包含聚丁烯的口腔护理组合物涂敷到牙齿上,其中所述聚丁烯具有的分子量为300至3000;
所述口腔护理组合物不是自承的。
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US27697901P | 2001-03-19 | 2001-03-19 | |
US27697801P | 2001-03-19 | 2001-03-19 | |
US60/276,978 | 2001-03-19 | ||
US60/276,979 | 2001-03-19 |
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- 2002-03-15 AU AU2002242342A patent/AU2002242342B2/en not_active Ceased
- 2002-03-15 EP EP02707983A patent/EP1370227B1/en not_active Expired - Lifetime
- 2002-03-15 AT AT02707983T patent/ATE361053T1/de not_active IP Right Cessation
- 2002-03-15 HU HU0303498A patent/HUP0303498A3/hu unknown
- 2002-03-15 DE DE60219893T patent/DE60219893T2/de not_active Expired - Lifetime
- 2002-03-15 CA CA2441865A patent/CA2441865C/en not_active Expired - Lifetime
- 2002-03-15 RU RU2003130736/15A patent/RU2003130736A/ru not_active Application Discontinuation
- 2002-03-15 PL PL368943A patent/PL205934B1/pl not_active IP Right Cessation
- 2002-03-15 ES ES02707983T patent/ES2283530T3/es not_active Expired - Lifetime
- 2002-03-15 WO PCT/US2002/008136 patent/WO2002074274A2/en active IP Right Grant
- 2002-03-15 MX MXPA03008497A patent/MXPA03008497A/es active IP Right Grant
- 2002-03-15 CN CNB02806545XA patent/CN100548265C/zh not_active Expired - Fee Related
- 2002-03-15 JP JP2002572982A patent/JP4030104B2/ja not_active Expired - Fee Related
- 2002-03-15 KR KR1020037012200A patent/KR100580352B1/ko not_active IP Right Cessation
- 2002-03-19 AR ARP020100967A patent/AR033870A1/es not_active Application Discontinuation
- 2002-09-12 US US10/242,012 patent/US6905673B2/en not_active Expired - Lifetime
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- 2005-12-29 HK HK05112145.4A patent/HK1079710A1/zh unknown
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Also Published As
Publication number | Publication date |
---|---|
US6509007B2 (en) | 2003-01-21 |
KR100580352B1 (ko) | 2006-05-16 |
DE60219893D1 (de) | 2007-06-14 |
MXPA03008497A (es) | 2003-12-08 |
HUP0303498A3 (en) | 2006-11-28 |
PL205934B1 (pl) | 2010-06-30 |
WO2002074274A3 (en) | 2003-09-25 |
US6905673B2 (en) | 2005-06-14 |
HK1079710A1 (zh) | 2006-04-13 |
EP1370227B1 (en) | 2007-05-02 |
KR20040025908A (ko) | 2004-03-26 |
AR033870A1 (es) | 2004-01-07 |
US20020187108A1 (en) | 2002-12-12 |
EP1370227A2 (en) | 2003-12-17 |
JP2004524334A (ja) | 2004-08-12 |
RU2003130736A (ru) | 2005-03-10 |
ES2283530T3 (es) | 2007-11-01 |
CA2441865C (en) | 2013-03-12 |
WO2002074274A2 (en) | 2002-09-26 |
AU2002242342B2 (en) | 2005-12-15 |
CA2441865A1 (en) | 2002-09-26 |
JP4030104B2 (ja) | 2008-01-09 |
US20030082113A1 (en) | 2003-05-01 |
ATE361053T1 (de) | 2007-05-15 |
CN1635866A (zh) | 2005-07-06 |
HUP0303498A2 (hu) | 2004-03-01 |
DE60219893T2 (de) | 2008-01-17 |
PL368943A1 (en) | 2005-04-04 |
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