CN1756524A - 口腔护理组合物和方法 - Google Patents
口腔护理组合物和方法 Download PDFInfo
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- CN1756524A CN1756524A CNA2003801100647A CN200380110064A CN1756524A CN 1756524 A CN1756524 A CN 1756524A CN A2003801100647 A CNA2003801100647 A CN A2003801100647A CN 200380110064 A CN200380110064 A CN 200380110064A CN 1756524 A CN1756524 A CN 1756524A
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- A61K2800/59—Mixtures
- A61K2800/594—Mixtures of polymers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/60—Particulates further characterized by their structure or composition
- A61K2800/61—Surface treated
- A61K2800/62—Coated
- A61K2800/621—Coated by inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/60—Particulates further characterized by their structure or composition
- A61K2800/65—Characterized by the composition of the particulate/core
- A61K2800/651—The particulate/core comprising inorganic material
Abstract
包含载体内携带的薄膜或多个薄膜碎片的组合物。该薄膜或多个薄膜碎片可含功能物质。该薄膜或多个薄膜碎片可构成重复的(repeated)形状。本发明还公开了包含载体内携带的多个可辨别的薄片状碎片的组合物。本发明还公开了一种将功能物质应用到需要其的人或动物受试者的方法,该方法包括将包含载体内携带的薄膜或多个薄膜碎片的组合物应用到受试者,其中薄膜含有功能物质。该组合物优选为含有成形的和/或有色的薄膜碎片的洁牙剂。
Description
引言
[0001]本申请涉及口腔和个人的护理组合物,更具体地说涉及包含在载体内携带的薄膜的组合物。这类组合物例如包括洁牙剂。
[0002]用于增强健康、卫生或外观的组合物如口腔护理组合物、皮肤护理组合物和毛发护理组合物,为数百万的人所使用。这些组合物用于各种各样的目的,包括用于增强个人的健康、卫生和外观,也用于预防或治疗人和动物体内的各种疾病及其它病症。
[0003]这类组合物的制剂提出了许多挑战。为了其预期的应用它们必须是在药学上和/或化妆品上可接受的。含治疗活性剂物质的组合物优选以有效含量输送活性剂,同时避免不当的化学降解。类似地,含化妆品功能物质的组合物在消费者通常使用它们的条件下必须以有效含量将该物质输送至例如口腔、皮肤或毛发。
[0004]此外,所有这类组合物的美学需求也是重要的,可能对消费者的接受和使用具有明显的影响。美学效应在消费者对许多产品的接受中起重要作用已经得到承认。尽管这类产品已经为消费者认可,但本领域还在寻求进一步改进这类产品的美学效应以及化妆品和治疗的益处。实际上,许多本领域已知的这类组合物在一种或多种特性上存在不足。因此,不断地需要新的口腔和个人的护理组合物,以及它们的使用方法。
发明概述
[0005]本发明以多个实施方案提供包含载体内携带的薄膜的口腔和个人的护理组合物,其中所述薄膜含有功能物质。在一实施方案中,薄膜包含多个薄膜碎片。在多个实施方案中,本发明提供包含载体内的多个薄片状碎片的组合物。
[0006]在一些实施方案中,薄膜可以含聚合物,如水溶性聚合物、可水分散的聚合物、水不溶性聚合物或其混合物。在多个实施方案中,该组合物可适于用作口腔护理组合物、毛发护理组合物或皮肤护理组合物。在多个实施方案中,薄膜含有功能物质。在多个实施方案中,这类功能物质包括治疗活性剂物质、香料(flavorants)、化妆品物质、香精(fragrances)、和制剂着色剂。
[0007]本发明还提供将功能物质应用到需要其的人或动物受试者的方法,所述方法包括将含有载体内携带的薄膜的组合物局部应用到所述受试者,其中所述薄膜含有所述的功能物质。在各种方法中,这类方法进一步包括在局部施用之后使薄膜破裂。在多个实施方案中,该组合物可包括含一种或多种功能物质的薄膜,其中功能物质以控释的方式如通过持续或延缓释放的方式在不同的时间或同时释放。
[0008]本发明的组合物和方法能提供优于本领域中已知的组合物和方法的益处。这些益处包括以下中的一种或多种:增加消费者的接受性、增强美学、改善活性物质或其它功能物质的稳定性、以及功能物质的控制输送。本发明的进一步的益处和实施方案从本文中所述的说明清晰可见。
说明
[0009]本发明提供用于施用到人或其它动物受试者、或人或其它动物受试者使用的组合物和方法。因此,用于本发明的具体物质和组合物优选地是药学上或化妆品上可接受的。本文中使用的这类″药学上可接受的″或″化妆品上可接受的″成分为适于人和/或动物使用的成分,以提供期望的治疗的、感觉的、装饰的或化妆品益处而没有不当的不良副作用(如毒性、刺激和过敏反应),即具有合理的益处/危险比。在阅读和理解本文中描述的本发明的说明时必须要考虑下列定义和非限制性准则。
[0010]本文中使用的标题(如″引言″和″发明概述″)和小标题(如″薄膜″和″载体″)只用于本发明公开内容中的主题的总体构造,而不是用于限制本发明的公开内容或其任何方面。尤其,″引言″中公开的主题可以包括本发明范围内技术的多个方面,以及也许不构成对先有技术的列举。″发明概述″中公开的主题不是本发明全部范围或其任何一个实施方案的详尽或完全的公开。
[0011]本文中参考文献的引用并不意味承认那些参考文献是先有技术或与本文中公开的发明的专利性有任何关联。本说明书的说明部分中引用的所有参考文献在此全文引入本文作为参考。
[0012]描述本发明的实施方案时,说明以及具体的实施例仅仅是为了说明而不旨在限制本发明的范围。具有所述特征的多个实施方案的列举并不旨在排除具有其它特征的其它实施方案、或包括所述特征不同的组合的其它实施方案。提供具体的实施例是为了举例说明如何制备、使用和实际应用本发明的组合物和方法,除非明确地叙述已经完成了的行为(即采用过去时态),否则并不表示所给的本发明的实施方案已经、或未曾完成。
[0013]本文中使用的词语″优选″和″优选地″在某种情况下是指提供某些益处的本发明的实施方案。不过,在相同的情况或其它情况下,也可以优选其它实施方案。此外,一个或多个优选的实施方案的列举并不意味其它实施方案不中用,而且并不旨在将其它实施方案排除在本发明的范围之外。本文中使用的词语″包括″,及其变化形式旨在非限制性的,以便叙述列出的对象不排除也可用于本发明的物质、组合物、装置以及方法中的其它类似的对象。
[0014]本发明提供口腔或个人的护理组合物,其包含载体内携带的薄膜,其中所述薄膜含有功能物质。如本文中所述,″口腔或个人的护理组合物″是适于施用或应用到人或动物受试者以增强受试者的健康、卫生或外观的任何组合物,包括预防或治疗任何生理的病症或机能障碍,提供感觉的、装饰的或化妆品益处及其组合。本文中所提供的组合物包括口腔护理组合物、皮肤护理组合物、毛发护理组合物、局部的药物组合物、以及眼用的组合物。本文中使用的″口腔护理组合物″是指预期的用途可包括口腔护理、口腔卫生、或口腔外观,或预期的使用方法可包括应用到口腔的组合物。本文中使用的″皮肤护理组合物″是指预期的用途可包括促进或改善皮肤的健康、清洁、气味、外观、或吸引力的组合物。
薄膜:
[0015]本发明的实施方案包含薄膜。如本文中所述,″薄膜″为具有基本上薄片状结构的物质。″薄片状的″结构具有或能够具有在一维或二维上的尺寸(例如,x维或y-维)显著大于所述结构在第三维(例如,z轴方向)上的厚度。用于本发明中的薄片状结构包括基本上平面的、层状的、或薄片形(lamelliform)的结构。在一实施方案中,薄片状结构基本上为平面,在x维和y维上的尺寸显著大于z轴方向的尺寸。在其它实施方案中,薄片状结构为非平面。在一实施方案中,本发明的薄膜包含可以基本上平面出现的基本上连续的表面,尽管在一些实施方案中薄膜有变形。在诸如此类的实施方案中,薄膜可以具有许多形状中的任何一种形状,包括具有平滑弯曲的表面。
[0016]用于本发明中的薄膜可以为刚性或塑性,含有多种物质中的任何一种物质,包括选自成膜物质、粘土、蜡及其混合物的物质。在一实施方案中,薄膜含有成膜聚合物。用于本发明中的成膜聚合物包括选自水溶性聚合物、可水分散的聚合物、水不溶性聚合物、及其混合物中的物质。
[0017]在一些实施方案中,薄膜含有至少一种成膜物质。在某些实施方案中,成膜物质为聚合物。用于本发明中的聚合物包括亲水性聚合物和疏水性聚合物。在某些实施方案中,所述聚合物为水溶性聚合物。在一些实施方案中,所述聚合物为水溶性、易破碎的(breakable)聚合物,其在使用过程中例如在牙刷过程中会溶解。溶解可以由于例如剪切力和/或暴露于含高浓度水的溶剂如唾液而发生。在一些实施方案中,所述聚合物是不溶的但由于是可分散的而在水中易破碎,即聚合物,例如,由于剪切力断裂为小的碎片。在一些实施方案中,聚合物是不溶的但可膨胀。其中在使用过程中聚合物不断裂的组合(configurations)中,该聚合物可能是防水的聚合物或水稳定的亲水性聚合物如某些类型的纤维素,例如纸。在一些实施方案中,薄膜碎片可含成膜物质的混合物。
[0018]用于本发明中的水溶性聚合物包括纤维素醚、甲基丙烯酸酯、聚乙烯吡咯烷酮及其混合物。在一实施方案中,所述聚合物为纤维素醚,包括选自羟烷基纤维素聚合物的纤维素醚,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。用于本发明中的其它聚合物包括聚乙烯吡咯烷酮、交联聚乙烯基吡咯烷酮、聚乙烯吡咯烷酮-醋酸乙烯酯共聚物、聚乙烯醇、聚丙烯酸、聚丙烯酸酯聚合物、交联聚丙烯酸酯聚合物、交联聚丙烯酸(例如,Carbopol)、聚环氧乙烷、聚乙二醇、聚乙烯基烷基醚-马来酸共聚物(如Gantrez)以及羧基乙烯基聚合物;天然的树胶如海藻酸钠、角叉菜胶、黄原胶(xantham gum)、微粉硅胶(gumacacia)、阿拉伯树胶(arabic gum)、瓜尔胶、芽霉菌糖、琼脂、壳多糖、壳聚糖、果胶、刺梧桐树胶、玉米蛋白、大麦醇溶蛋白、麸朊、刺槐豆胶、南欧黄蓍胶及其它多糖。淀粉如麦芽糊精、直链淀粉、高直链淀粉淀粉、玉米淀粉、马铃薯淀粉、米淀粉、木薯淀粉、豌豆淀粉、甘薯淀粉、大麦淀粉、小麦淀粉、蜡质玉米淀粉、改性淀粉(例如羟丙基化高直链淀粉淀粉)、糊精、果聚糖、爱生兰(elsinan)和面筋;以及蛋白质如胶原蛋白、乳清蛋白分离物、酪蛋白、乳蛋白、大豆蛋白和明胶。
[0019]可水分散和可膨胀的聚合物的非限制性例子包括改性淀粉、藻酸酯、藻酸盐二价或多价离子盐。水不溶性聚合物的非限制性例子包括在至少一种有机溶剂中可溶的聚合物,如醋酸纤维素、硝酸纤维素、乙烯-醋酸乙烯酯共聚物、醋酸乙烯酯均聚物、乙基纤维素、丁基纤维素、异丙基纤维素、虫胶、硅氧烷聚合物(例如二甲基硅氧烷)、PMMA(聚甲基丙烯酸甲酯)、醋酞纤维素以及天然的或合成橡胶;在有机溶剂中不溶的聚合物,如纤维素、聚乙烯、聚丙烯、聚酯、聚氨酯和尼龙。
[0020]在一些实施方案中,本发明的薄膜含无机物。这类物质包括选自云母、包被有二氧化钛的云母、粘土、珍珠母及其组合的物质。在一些实施方案中,成膜物质含有石墨。在一些实施方案中,成膜物质含有疏水性的有机非聚合物如蜡,例如黄蜡或石蜡。
[0021]在一实施方案中,薄膜含有羟烷基纤维素如羟丙基甲基纤维素、羟乙基丙基纤维素、羟丁基甲基纤维素、羟基丙基甲基纤维素和羧甲基纤维素。在这样一种实施方案中,优选地纤维素聚合物为低粘度的HPMC。当HPMC作为成膜剂使用时,优选HPMC的粘度在约1至约1000毫帕秒(mPa.s)的范围内,其中所述粘度是使用Ubbelohde管式粘度计在20℃下对HPMC的2%重量的水溶液测量的粘度。优选地HPMC的粘度在20℃下为约3至约500mPa.s。HPMC在市场上有售,例如,以商品名Methocel从Dow Chemical Company购得,Methocel包括例如Methocel E5LV、Methocel E50和Methocel K100。MethocelE5 LV为USP级的低粘度HPMC,含29.1%甲氧基和9%hydroxyproxyl的取代基团。它是一种白色或灰白色自由流动的干粉。当用Ubbelohde管式粘度计测量其2wt.%的水溶液时其粘度在20℃下为5.1mPa.s。在一实施方案中,将羟烷基甲基纤维素以约10-约80%重量优选以约30-约60%重量的量掺入薄膜基质中。
[0022]在多个实施方案中,本发明的组合物包含载体内携带的多个薄片状碎片。在一实施方案中,所述组合物包含薄膜,其中薄膜包含薄膜物质的薄片状碎片。在一实施方案中,所述组合物包含多个薄片状碎片分散于其中的载体,其中所述碎片含基质和功能物质。在这样一种实施方案中,基质包括薄膜。这样的碎片可以是各种形状或形式中的任何一种,包括半固体的或固体不连续的(discrete)的部分、碎片、粒子、薄片或其组合。在多个实施方案中,薄膜包括第一多个碎片和第二多个碎片,其中第一多个碎片在组成或外观上不同于第二多个碎片。这种在组成或外观上的差异可以是碎片的成分(例如,不同的薄膜组分、不同的功能物质、不同的制剂着色剂)、不同的外观(例如,形状、颜色、纹理、折光率、反射率)或其组合的任何方面。
[0023]在多个实施方案中,碎片显示出与载体可觉察的对比。所述可觉察的对比可以是感觉的对比,如视觉的对比(opticalcontrast)、触觉的对比、味觉对比、或嗅觉的对比。在一些组合(configurations)中,视觉的对比可以是色度对比、或在折光率或反射率上的差异。在一些组合(configurations)中,色度对比可以由一种或多种构成组合物的不同组分的着色剂赋予。在多个实施方案中,本发明提供包含载体内的多个薄膜碎片的组合物,其中所述碎片明显可辨别。本文中所述的″明显可辨别″指相对于其中携带碎片的载体,碎片的一种或多种特性引起碎片具有不同的物理外观,优选地凭肉眼观察到的物理外观。这类特征包括颜色、不透明度(opacity)、折光率、反射率、尺寸、形状、及其组合。
[0024]在多个实施方案中,所述碎片具有非随机形状。在一实施方案中,″非随机″(non-random)形状为由成形、切割的制造工序、或其它成形工序产生的形状,通过该工序赋予碎片具体的形状。在这样的实施方案中,非随机的形状不同于由物质的简单沉淀或粉碎而产生的形状。在一实施方案中,″非随机的″形状为″重复的(repeating)″,其中所述组合物包含多个具有基本上相同形状的碎片。这种重复的形状可为各种形状中的任何一种,且可以根据各种美学或功能标准选择。在某些实施方案中,薄膜碎片的形状可以为可认识的形状。在某些实施方案中,薄膜碎片可包括非随机的形状。此类的形状包括简单的几何形状,如多角形和椭圆形,如三角形、四边形(如正方形、矩形、菱形)、五边形、六边形、椭圆形、和圆形。在一实施方案中,重复的形状为正方形。在其它实施方案中,重复的形状包括表示图形或有生命或无生命的物体如星、心脏、宝石、花、树、三叶草、字母表中的字母、数字、动物、人以及脸面的形状。在多个实施方案中,所述组合物包括单一的重复的形状。在其它种实施方案中,本发明组合物包括具有多种重复的形状的多个碎片。在一实施方案中,本发明的组合物包括具有第一重复的形状的多个第一薄膜碎片和具有第二重复的形状的多个第二薄膜碎片,其中第一重复的形状不同于第二重复的形状。
[0025]在多个实施方案中,碎片的尺寸并不关键,可以按照各种标准中的任何一种标准测定,包括制备的方便,影响视觉外观、表面积,影响组合物的纹理,以及其组合。在一些实施方案中,薄膜碎片最长维度的长度可以最高至约1英寸(25.4mm)。如本文中所述,″长维度″为碎片长或宽(即当碎片为、或变形为平面形状时在x-维和y-维上)的维度,基本上垂直于碎片的″厚″或最短的维度(即,z-维度)。应理解在含多个碎片的各种实施方案中,碎片由于各种因素,包括尺寸的随机变动、制造公差、和与目的有关的尺寸定位或通过筛网或类似的方式碎片的混合,可能以一定范围的尺寸存在。如本文中所述,尺寸指的是碎片在给定的多个碎片的平均尺寸。
[0026]在多个实施方案中,碎片的长维度为约0.2mm-约15mm。在多个实施方案中,碎片的长维度为0.2mm-约10mm,约0.5mm-约10mm,约0.8mm-约8mm,约0.9mm-约5mm,约1.0mm-约5mm,或约1.5mm-约2.5mm。在一些实施方案中,碎片的长维度为至少约3mm,可为约6mm-约13mm。在某些实施方案中,多个薄膜碎片的最长维度大于约600微米。在某些实施方案中,多个薄膜碎片的最长维度大于约1毫米。
[0027]在一实施方案中,其中所述碎片含有珍珠母,碎片的最长维度大于约590微米。在一实施方案中,其中碎片含有一薄层二氧化钛包被的云母薄膜碎片,薄膜碎片的最长维度大于110微米。
[0028]在多个实施方案中,本发明的碎片的厚度为约1密尔(千分之一英寸,25.4微米)至约3密尔(76.2微米)。在多个实施方案中,所述碎片的厚度为约0.1密尔(2.54微米)至最高达约10密尔(254微米),约0.5密尔(12.7微米)至最高达约5密尔(127微米),或约1.4密尔(35.6微米)至约2.0密尔(50.8微米)。
[0029]在一些实施方案中,本发明的组合物包含纵横比为至少约5∶1的碎片。如本文中所述,碎片的″纵横比″为能包围该物体的最小虚球的直径与能完全在所述物体之内且与该物体表面相切的最大虚球的直径之比。例如,球体的纵横比为1∶1;在另一个例子中,长2英寸(50.8mm)且直径为1/4英寸(6.35mm)的圆柱体的纵横比略超过8∶1;在另一个例子中,本发明的薄膜碎片厚1密尔(25.4微米),长1英寸(25.4毫米),且宽1英寸(25.4毫米),纵横比为约1414∶1。
[0030]在一些实施方案中,本发明的组合物包含纵横比为至少约10∶1的碎片。在多个实施方案中,碎片的纵横比为约5∶1至约10,000∶1,约5∶1至约500∶1,约10∶1至约1,000∶1,约10∶1至约100∶1,约20∶1至约100∶1,或约25∶1至约35∶1。
[0031]在多个实施方案中,薄膜含制剂着色剂,它赋予薄膜、组合物或两者以颜色。在多个实施方案中,薄膜碎片与载体形成对比,为白色、黑色、或相对载体背景或与载体背景形成对比的明显的任何颜色。用于本发明中的制剂着色剂包括无毒的水溶性染料或颜料,例如金属氧化物″沉淀色料(lakes)。″在某些实施方案中,着色剂被管理机构批准用于掺入食品或药物,如被FDA批准可在美国使用的FD&C或D&C颜料和染料。用于本发明中的着色剂包括3号FD&C红(四碘荧光素钠盐)、Food Red 17、6-羟基-5-{(2-甲氧基-5-甲基-4-磺基苯基)偶氮}-2-萘磺酸二钠盐、Food Yellow 13、quinophtalone或2-(2-喹啉基)茚满二酮的单磺酸和二磺酸的混合物的钠盐、5号FD&C黄(4-对磺基苯基偶氮-1-对磺苯基-5-羟吡唑-3-羧酸的钠盐)、6号FD&C黄(对磺基苯基偶氮-B-萘酚-6-单磺酸的钠盐)、3号FD&C绿(4-{[4-(N-乙基-对磺基苄胺基)-苯基]-(4-羟基-2-锍苯基)亚甲基}-[1-(N-乙基-N-对磺苄基)-Δ-3,5-环己二烯亚胺]的二钠盐、1号FD&C蓝(二苄基二乙基-二氨基三苯基甲醇三磺酸无水石膏的二钠盐)、2号FD&C蓝(靛蓝的二磺酸钠盐)、以及它们各种比例的混合物。在一实施方案中,着色剂包括水不溶性的无机颜料,如二氧化钛、氧化铬绿、酞菁绿、群青、氧化铁、或水不溶性的染料沉淀色料。在一些实施方案中,染料沉淀色料包括FD&C染料的钙盐或铝盐如FD&C绿#1沉淀色料、FD&C蓝#2沉淀色料、D&C红#30沉淀色料或FD&C黄#15沉淀色料。在某些实施方案中,水不溶性的聚合物如聚乙烯例如见于聚乙烯珠(例如,Microblue Spectrabeads,由Micropowders,Inc.出售)中含有水溶性染料如FD&C蓝#1。在某些实施方案中,薄膜含有染料如D&C红#30。在某些实施方案中,使用白色着色剂,例如二氧化钛(TiO2)、涂布二氧化钛的云母(例如,Timiron)、矿物质、或粘土。在某些实施方案中,着色剂为非洇色(non-bleeding)的染料。在多个实施方案中,薄膜含有的着色剂的量为薄膜重量的约0.5%至约20%,或薄膜重量的约1%至约15%,或薄膜重量的约3%至约12%。在一实施方案中,本发明的组合物含有含第一色的第一多个薄膜碎片和含第二色的第二多个薄膜碎片。优选地,第二色不同于第一色。
[0032]在一些实施方案中,可分别测定组合物的相的色空间座标(color space coordinates),例如薄膜和载体(例如牙膏)。在某些实施方案中,产品薄膜/载体配对的座标可能离得很远(如下文实施例12中公开的),有助于组合物美学的作用,例如有助于组合物美学的作用的吸引人的特性。在某些替代的实施方案中,产品薄膜/载体配对的座标可能不是特别大,但仍然具有引人注意的美学效应。在某些实施方案中,由Commission Internationale d′Eclairage(CIE)建立的L a*b*系统可用于确定色值(color values)。(例如,参见:McClelland,D.,MacworldPhotoshop4 Bible,IDG BooksWorldwide,Inc.1997,第157-184页。)此外,ΔE*的量还可以指示显著的色差(color differences)。ΔE*可采用以下公式测定。
ΔE*={(ΔL*)2(Δa*)2+(Δb*)2}1/2
[0033]其中ΔL*为光差异,Δa*和Δb*为在色空间座标a*和b*上的差异。在某些组合(configurations)中,可使用比色计进行色值测量,并采用标准程序收集L*a*b*彩色座标模式的数据。
[0034]在多个实施方案中,本发明的薄膜在组合物的使用过程中破碎。在其它实施方案中,薄膜在组合物的使用过程中不破碎。在一些实施方案中,薄膜将物质如功能物质释放到载体中。如本文中所述,″破碎″指薄膜或碎片物质的物理破裂,以致产生比原始薄膜的尺寸减小的薄膜或薄膜碎片。这种破裂可通过机械的、化学的、或物理-化学方式进行。例如,这种破碎可由在使用过程中剪切、粉碎、或暴露于高温产生。在本发明的多个洁牙剂实施方案中,这种破碎由组合物在使用该组合物的受试者牙齿上刷洗引起。在一实施方案中,薄膜破碎以便释放功能物质(本文中将进一步描述)。在一些实施方案中,薄膜碎片可以破碎成不能在视觉上辨别的小块。在一些实施方案中,薄膜碎片破碎以共同形成胶体或凝胶。
[0035]在多个实施方案中,本发明的组合物通过了破碎试验。在优选的破碎试验中,将1克含薄膜碎片样品的组合物置于2英寸(50.8mm)磁性搅拌棒的顶端。将该搅拌棒放入透明的容器如装有300ml 30℃水的500ml烧杯中。然后将含该搅拌棒的水在750rpm下搅拌5分钟。然后对水进行分析以分析破碎的和未破碎的薄膜碎片的存在。该分析可以包括将水通过小于薄膜形状原始长维度一半的网孔粗滤。该试验将显示是否有任何碎片没有破碎。
[0036]在一实施方案中,本发明的薄膜具有可操作的溶出度值,它影响在所述组合物的使用过程中所述功能物质的释放。如本文中所述,溶出度值按以下试验测量:将1英寸的圆形薄膜置于含水的容器中,不搅拌,在约30℃下。然后随时间的推移测定溶出度值直到薄膜破碎以致不剩余在任何维度上尺寸大于0.25(0.63cm)英寸的薄膜碎片。在某些洁牙剂实施方案中,多个碎片在正常使用的条件下在约两分钟内破碎或溶出。在多个实施方案中,破碎值可以为约2秒至约200秒,约5秒至约120秒,或约50秒至约100秒。在多个实施方案中,溶出度值可以为至少约5秒,约10至约200秒,约30至约120秒,或约40至约100秒。
[0037]在一些实施方案中,薄膜含选自水不溶性聚合物、非高分子成膜物质且其混合物的物质,它们能形成稳定的薄膜碎片,即在正常的预期使用条件下薄膜碎片不破碎。在多个实施方案中,薄膜包括多个具有第一破碎值的第一薄膜碎片、和第二多个破碎值明显不同于所述第一破碎值的第二薄膜碎片。
[0038]本发明的薄膜任选地含有影响薄膜的物理或功能特征的物质。例如,这种附加的物质可以是乳化剂、增塑剂、填充剂或纹理改变剂。用于本发明中的填充剂包括惰性的淀粉微粒和纤维素。纹理改变剂包括可冷水膨胀的、物理改变和预胶化的淀粉,以增加聚合物薄膜如含羟烷基甲基纤维素的薄膜的挺度。在这类淀粉产品的制备中,优选地将颗粒状的淀粉在水和任选的有机溶剂存在的情况下在不高于比其胶凝温度高10℃的温度下蒸煮。然后将得到的淀粉干燥。
[0039]用于本发明中的预胶化玉米淀粉可在市场上购得。优选淀粉可以商品名Cerestar Polar Tex-Instant 12640从CerestarCompany购得。该Cerestar淀粉为预胶化的、稳定的和交联的糯质种玉米淀粉。它在冷水中易分散和可膨胀。在其干燥的形式时,它是一种白色的自由流动粉末,平均的薄片尺寸不大于180微米且85%的薄片小于75微米。其堆积密度为441bs/ft3。该Cerestar淀粉具有极好的冷藏性能和冻熔稳定性。它具有快速的水合率且不经蒸煮就能达到极高的粘度。它具有与煮过的淀粉相似的平滑和奶油状的(creamy)纹理。它还具有极好的糊剂澄明度和清淡的味道。在一实施方案中,该预胶化淀粉以约5-约50%重量优选以约10-约35%重量的量存在于薄膜基质中。羟烷基纤维素与淀粉之比(按重量计算)可在约1∶3至约5∶1之间且优选在约1∶1至约4∶1之间变化。
[0040]在一实施方案中,薄膜含一个以上的层。例如,薄膜可以包括含聚合物的第一层、提供包衣的一个或多个附加层。例如,包衣可以是虫胶包衣。包衣可包括在聚合物层的一侧或两侧上的层。这样,在一些实施方案中,制备多层薄膜的方法可包括形成第一薄膜层如聚合物层,然后用另一或后续的包衣材料(例如虫胶)层对第一层包衣。功能物质:
[0041]在多个实施方案中,本发明的薄膜含功能物质。如本文中所述,″功能物质″是口腔或个人的护理组合物中具有期望的用途的物质。在多个实施方案中,这类用途为治疗的、化妆用的、美学的、装饰的、感觉的用途或其组合。在一些实施方案中,由组合物构成的薄膜片可以含多种功能物质。这类功能物质可以掺入到薄膜内或在薄膜的表面上构成包衣。在一实施方案中,本发明的组合物包括多个具有第一功能物质的第一薄膜碎片和多个具有第二功能物质的第二薄膜碎片,其中第二功能物质不同于第一功能物质。
[0042]在多个实施方案中,功能物质为香料(flavorant)。在某些口腔护理实施方案中,当碎片在产品的使用过程中破碎时香料迅速释放,将呼吸新鲜调味剂或期望的口感或甜味传递到口腔中。用于本发明中的香料包括合成的调味油或调味芳香剂、由植物、叶、花、果实等获得的油树脂(oleo resins)和提取物、以及它们的组合。代表性的调味油包括留兰香油(spearmint oil)、肉桂油、椒样薄菏油(peppermint oil)、丁香油、月桂油、麝香草油、雪松叶油、肉豆蔻油、南欧丹参油、和苦杏仁油。香料可以单独或混合使用。通常使用的调味剂(flavors)包括薄荷如胡椒薄荷、人造香草精、肉桂衍生物、以及各种的果味调味剂。在某些实施方案中,薄膜含有调味剂或食品添加剂,如在National Academy of Sciences的出版物1274,Chemicals Used in Food Processing,第63-258页中描述的调味剂或食品添加剂。在多个实施方案中,薄膜含的香料的含量为薄膜重量的约1%至约30%,或薄膜重量的约8%至约25%。
[0043]在一些实施方案中,薄膜还含有甜味剂。用于本发明中的甜味剂包括天然的和合成的甜味剂。在一实施方案中,甜味剂为水溶性甜味剂如单糖、二糖或多糖。例如,水溶性甜味剂包括木糖、核糖、葡萄糖(右旋糖)、甘露糖、glatose、果糖(左旋糖)、蔗糖(糖)、麦芽糖、可溶性糖精钠盐即糖精钠盐或钙盐、环己烷氨基磺酸盐、基于二肽的甜味剂,例如L-天冬氨酸衍生的甜味剂如L-天冬氨酰-L-苯丙氨酸甲酯(阿司帕坦)。在多个实施方案中,薄膜含甜味剂的含量为薄膜重量的约0.01%至约10%。
[0044]在多个实施方案中,薄膜含有治疗活性剂。如本文中所述,治疗活性剂为用于预防或治疗生理机能障碍或病症的物质。诸如此类的机能障碍或病症包括口腔(包括牙齿和齿龈)、皮肤,毛发、和眼睛的机能障碍或病症。具体的治疗活性剂优选地根据组合物期望的用途确定。诸如此类活性剂包括下列:
A.抗微生物剂,如三氯生、氯化十六烷吡啶鎓、度米芬、季铵盐、锌化合物、血根碱、氟化物、阿立西定、octonidine、EDTA、必需的油如麝香草酚、水杨酸甲酯、桉树脑以及薄荷醇等,
B.非甾体抗炎药,如阿司匹林、对乙酰氨基酚、布洛芬、酮洛芬、二氟苯水杨酸、苯氧苯丙酸钙、萘普生、甲苯酰吡啶乙酸钠、消炎痛等,
C.镇咳药,如苯佐那酯、咳美芬乙二磺酸盐、薄荷醇、氢溴酸右甲吗喃、盐酸氯二苯二甲丙胺醇等,
D.解充血药,如盐酸伪麻黄碱、苯肾上腺素、苯丙醇胺、硫酸伪麻黄碱等,
E.抗组胺药,如马来酸溴苯吡胺、马来酸氯苯吡胺、马来酸氯苯吡醇胺、氯马斯汀富马酸盐、右氯苯那敏马来酸盐、盐酸苯海拉明、二苯拉林盐酸盐、阿扎他定马来酸盐、枸橼酸苯海拉明、琥珀酸多西拉敏、盐酸异丙嗪、马来酸美吡拉敏、曲吡那敏枸橼酸盐、盐酸丙吡咯啶、阿伐斯汀、氯雷他定、溴苯那敏、右溴苯那敏等,
F.祛痰药,如愈创木酚甘油醚、吐根、碘化钾、水合萜二醇等,
G.抗痢疾药,如洛哌丁胺等,
H.H2拮抗剂,如法莫替丁、雷尼替丁等;以及
I.质子泵抑制剂,如奥美拉唑、兰索拉唑等,
J.普通的非选择性CNS镇静剂,如脂族醇、巴比妥类药物等,
K.普通的非选择性CNS兴奋药如咖啡因、尼古丁、士的宁、印防己毒素、戊四氮等,
L.选择性地改变CNS功能的药物如phenyhydantoin、苯巴比妥、扑米酮、酰胺咪嗪、乙琥胺、甲琥胺、苯琥胺、三甲双酮、安定、苯并二氮杂类、苯乙酰脲、苯丁酰脲、乙酰唑胺、舒噻美(sulthiame)、溴化物等,
M.抗帕金森氏病药如左旋多巴、金刚烷胺等,
N.麻醉剂-镇痛药如吗啡、海洛因、氢化吗啡酮、美托酮、氧吗啡酮、左吗南、可待因、氢可酮、xycodone、烯丙吗啡、纳洛酮、纳曲酮等,
O.止痛-解热药如salycilates、苯基保泰松、消炎痛、非那西汀等,
P.精神类药物(psychopharmacological drugs)如氯丙嗪、甲氧异丁嗪、氟哌啶醇、氯氮平、利血平、丙咪嗪、反苯环丙胺、苯乙肼、锂等。
可用于薄膜中的药物的量,依赖于提供有效量的药物需要的剂量。可以以组合物构成的薄膜形式传递的具体药物的剂量的实例在实施例23中作了综述。
[0045]在多个实施方案中,这类用途为治疗的、化妆用的、美学的、装饰的、感觉的用途或其组合。在非限制性实施例中,用于本发明中的功能物质包括香料、香精、必需的油、乳化剂、增稠剂、着色剂、冷却剂、甜味剂、粘合剂、表面活性剂、硫沉淀剂、增塑剂、药物活性剂、唾液刺激剂、预防色斑活性剂(stain preventionactives)、抗微生物试剂、维生素、药草和药草浸液、氨基酸、酶或其它蛋白质、研磨剂、抗龋剂、增白剂、气味控制剂(odor controlagents)、呼吸新鲜试剂、牙石防治活性剂(tartar controlactives)、色斑控制剂、牙周活性剂、防汗活性剂、除臭活性剂、调节剂、增湿剂、毛发染色剂、以及它们的组合。
[0046]在多个实施方案中,用于本发明中的治疗剂包括抗龋剂、牙石控制剂、抗牙斑剂、牙周的活性剂、呼吸新鲜试剂、恶臭控制剂、增白剂、抗菌药物、甾类化合物、消炎药、维生素、蛋白质、调节剂、增湿剂、防汗活性剂、除臭活性剂、麻醉剂、以及它们的混合物。
[0047]在某些口腔护理实施方案中,薄膜含有口腔护理活性剂,用于预防或治疗口腔护理失调或病症。用于本发明中的口腔护理活性剂包括研磨剂、抗龋剂、牙石控制剂、抗牙斑剂、牙周活性剂、呼吸新鲜剂、恶臭控制剂、牙齿脱敏剂、唾液刺激剂、增白剂、以及它们的组合。用于本发明中的活性物质在Leung等的美国专利6,596,298中有描述。
[0048]用于本发明中的牙石控制剂包括焦磷酸二碱金属或四碱金属盐如Na4P2O7、K4P2O7、Na2K2P2O7、Na2H2P2O7和K2H2P2O7;长链多磷酸盐如六偏磷酸钠;以及环磷酸盐如三偏磷酸钠。在一些组合(configurations)中,多磷酸盐为β相焦磷酸钙,如White,Jr.的美国专利6,241,974中公开的多磷酸盐。在一些实施方案中,薄膜含有含量为薄膜重量的约15至20%的抗石剂。
[0049]用于本发明中的气味减弱剂(Odor reducing agents)包括硫沉淀剂。这类硫沉淀剂包括金属盐,如铜盐或锌盐。诸如此类的盐包括葡萄糖酸铜、枸橼酸锌和葡萄糖酸锌。在多个实施方案中,薄膜含有的硫沉淀剂的量为薄膜重量的约0.01至约30%,薄膜重量的约2%至约2.5%,或薄膜重量的约10%至约20%。
[0050]在某些实施方案中,功能物质包括唾液刺激剂(″succulent″),这类试剂包括Kleinberg等的美国专利4,820,506中公开的试剂。在一些组合(configurations)中,唾液刺激剂可包括食用酸如柠檬酸、乳酸、苹果酸、琥珀酸、抗坏血酸、己二酸、富马酸和酒石酸。在多个实施方案中,薄膜含有的唾液刺激剂的量为薄膜重量的约0.01至约12%,薄膜重量的约1%至约10%,或薄膜重量的约2.5%至约6%。在一些实施方案中,唾液刺激剂可用于改善口干燥。
[0051]在某些口腔护理实施方案中,薄膜含有其它活性物质,如抗菌剂如木兰提取物、三氯生、葡萄种子提取物、麝香草酚、水杨酸甲酯、桉树脑、薄荷醇、酒花酸、十六烷基吡啶鎓氯化物、(包括CPC/Zn和CPC+酶)和地衣酸;消炎药如呼吸新鲜试剂(例如葡萄糖酸锌、枸橼酸锌、亚氯酸锌和α紫罗酮);牙齿脱敏剂如硝酸钾、脱敏聚合物、和脱敏矿物质;消炎药如木兰提取物、熊果酸;芦荟和酸果蔓提取物;维生素如万神殿(pantheon)、棕榈酸视黄酯、叶酸、醋酸生育酚和维生素A;药草或药草提取物如迷迭香、皮萨草、chamomilla recutita、椒样薄荷、圆丹参、orcommiphora和没药;蛋白质,如乳蛋白和酶如过产氧化物酶、淀粉酶、色斑分裂剂(plaque-disrupting agents)如木瓜蛋白酶、葡糖淀粉酶、葡萄糖氧化酶、以及″下一代″酶;增白剂如过氧化氢、过氧化脲和磷酸盐;药物,如阿司匹林(乙酰水杨酸)、咖啡因、和苯佐卡因;益生素;研磨剂如硅土(包括高清洗硅土);抗龋剂如亚锡盐(例如,氟化亚锡)或氨基氟化物;氧化氮合酶抑制剂如胍乙基二硫化物;钙;抗粘附剂(antiattachmetn ingredients),如polyumylphosphonic acid;防腐剂如Solbrol(Bayer ChemicalsAG);硅酮;叶绿素化合物、抗粘膜白斑剂如β-胡萝卜素;抗氧化剂如维生素E;以及它们的组合。在一些实施方案中,薄膜含这类活性物质的浓度为薄膜重量的约0.01至约30%,薄膜重量的约2%至约25%,或薄膜重量的约10%至约20%。
[0052]某些皮肤护理实施方案中,功能物质含有选自表面活性剂、调节剂、增湿剂、酶及其它蛋白、维生素、及其混合物的物质。
[0053]某些毛发护理实施方案中,功能物质含有选自表面活性剂、着色剂、变性剂、成膜聚合物、调节剂、增湿剂、酶及其它蛋白、维生素、去头屑剂、及其混合物的物质。
[0054]某些防汗或除臭的实施方案中,功能物质含有选自香精、醇、抗胆碱能药、防汗的盐(如铝盐和锆盐)、增湿剂、及其混合物的物质。
[0055]在多个实施方案中,薄膜含有相容性增强的活性剂。如本文中所述,″相容性增强的活性剂″是相对于该物质在组合物中作为载体成分的功用,其在组合物中作为薄膜成分的功用增强的功能物质。这种增强的功用可起因于各种因素中的任何一种因素,包括该物质的输送增强或物理或化学降解降低。在一些实施方案中,这种相容性增强的物质与载体中一种组分或多种组分不相容。例如,与载体不相容的组分可以是与载体的组分起化学反应或形成沉淀的组分。
[0056]用于本发明中的相容性增强的活性剂包括阳离子抗微生物剂、钙盐、氟化物盐类、酶及其它蛋白、和其它与阴离子组分不相容的成分、以及它们的混合物。在一洁牙剂实施方案中,相容性增强的活性剂为阳离子抗微生物剂,如含四价(quaternary)基团的抗微生物剂。这类抗微生物剂的例子包括十六烷基吡啶鎓氯化物(CPC)、洗必泰、以及盐酸乙基月桂酰精氨酸。这类活性剂通常与含表面活性剂月桂基硫酸钠(SLS,一种洁牙剂的常用成分)或硅酸盐研磨剂的载体不相容。例如,在这类组合物中,CPC和SLS通常在混合时形成络合物。该络合物的形成致使两种化合物对于它们在洁牙剂中的预期目的无效。然而,在同时含薄膜和载体(其中含SLS)的本发明洁牙剂组合物的薄膜中掺入CPC将维持两种物质在洁牙剂中的有效状态。用于本发明的洁牙剂组合物中相容性增强的活性剂的其它例子包括抗龋剂氟化钠(NaF),它是一些洁牙剂中的成分,可能与一些洁牙剂也含有的钙不相容,因为氟化钙(CaF2)可形成沉淀。然而,如果这些组分之中的一种(例如,氟化钠)含在口腔护理组合物的薄膜碎片中,那么该组合物就可以提供钙和抗龋剂两者的有效量。
[0057]在某些实施方案中,薄膜含有防腐剂。防腐剂可以以薄膜的约0.001wt%至约5wt%,优选约0.01wt%至约1wt%的量加入。防腐剂的非限制性例子包括苯甲酸钠和山梨酸钾。
[0058]在多个实施方案中,本发明提供一种其中携带可水合的薄膜的薄片的洁牙剂,其中水合的薄膜包含水溶性羟烷基纤维素聚合物和任选的淀粉的均匀混合物,薄膜基质中携带选自治疗的、化妆用的、感觉的、以及装饰的试剂。在一实施方案中,提供一种整个薄膜薄片都分布的美学装饰的洁牙剂,其中在薄膜基质中携带装饰着色剂,洁牙剂赋形剂基本上是透明的以致用户可以观察到其美学装饰效应。在多个实施方案中,在薄膜片基质中携带有治疗剂如抗菌剂和氟化物抗龋盐。在多个实施方案中,薄膜片基质中携带有感觉试剂如呼吸新鲜试剂、口感试剂、以及甜味剂。在一个这样的实施方案中,当薄片在刷牙过程中破碎时香料迅速释放,将令人愉快的甜味或呼吸新鲜调味剂突然释放到口腔中。
[0059]在某些实施方案中,在悬浮在洁牙剂或其它组合物中的薄膜基质内携带治疗的、化妆用的、感觉的以及装饰的试剂,由于与存在于组合物中的活性成分相互作用而使这些试剂分离出来,以致在制备和贮存过程中这些试剂基本上保持与这些活性组合物成分分离,当该组合物使用时随后从薄膜基质中释放出来。
[0060]本发明的薄膜可以由多种方法制造,包括本领域已知的制备薄膜的方法。在多个实施方案中,将成膜浆液的组分如下面的例子中公开的组分混合形成成膜浆液组合物。将该浆液浇注在能释放的底物上并干燥形成一层成膜物质。在一实施方案中,基底材料的表面张力允许薄膜浆液基本上均匀地涂抹在基底的表面上,从而避免薄膜和基底之间形成破坏性粘合。合适基底的非限制性例子包括玻璃、不锈钢、TeflonTM和聚乙烯或硅酮浸渍纸。浇注之后,然后将薄膜干燥。该浆液的干燥可以在高温下借助于干燥箱、干燥终端设备(dryingterminal)、真空干燥器、或本领域已知的任何其它合适的干燥设备进行。在其它实施方案中,薄膜通过以下方式制备:挤压薄膜组合物通过压模,之后切割至期望的厚度,并干燥。在其它实施方案中,薄膜通过溶剂浇铸的方式制备。
[0061]在一些实施方案中,具有能重复的形状如几何的或具象(representational)的形状的薄膜碎片由浆液或干膜形成。在某些组合(configurations)中,形状的形成可以通过熟练技工已知的任何方法进行,例如将浆液加入到具有模型的基底上。在某些实施方案中,可将干膜切割或冲压成有形状的薄膜碎片。
[0062]薄膜碎片以较宽范围的浓度掺入到本发明的基质洁牙剂中。在多个洁牙剂实施方案中,载体含碎片的含量为组合物重量的约0.005%至约5%,或组合物重量的约0.05至约0.5%。载体:
[0063]本发明的组合物包含其中携带薄膜、或碎片的载体。如本文中所述,″载体″为其中可携带薄膜的任何物质或组合物并适合于给药或应用到人或动物受试者,对于这些受试者给药或施用该组合物。如本文中所述,″携带″指薄膜在载体中的包埋或悬浮。在各种包含多个碎片的实施方案中,这样的碎片可以通过碎片在载体中的包埋、悬浮、分散或其它分布而被携带。在多个实施方案中,碎片基本上均匀分布在整个载体中。在其它实施方案中,碎片不是均匀分布在载体中。在某些实施方案中,多个薄膜碎片的分布在载体内基本上是各向同性。
[0064]本发明的组合物可以描述为包括两相,其中一相包括载体而另一相包括薄膜或碎片。本文中使用的″相″是指物理和材料学领域理解的物理相,即其性质和组成均匀的一部分物质。不过,本文中使用的相可以是不连续的,即可含多种分离组分。例如,具有相同组成的多个聚合物薄膜碎片被认为是由单一相构成。在一些实施方案中,薄膜碎片可以完全包埋在构成第一相的物质内,或全部或部分暴露于第一相的表面上。例如,假如该组合物为包含凝胶和薄膜碎片两者的洁牙剂,则薄膜碎片可以被凝胶全部包围,或全部或部分暴露于凝胶的表面上。在某些实施方案中,组合物包括两相以上。这类多相组合物包括含两种载体的组合物,其中每种载体为该组合物提供一相,除本文中描述的薄膜碎片之外。其它多相组合物包括含单一载体和两种或更多的多个碎片的组合物,其中多个碎片含不同的组合物。
[0065]在某些实施方案中,包括至少两相的组合物可以含一种或多种组分,这些组分当不是组合物的结构或稳定性所必需的组分时能提供有益的或美学的效应。在一些组合(configurations)中,提供有益的或美学的效应的成分可以是与组合物中至少一相不相容的成分。这种成分可包含在该组合物的不同相中。
[0066]在多个实施方案中,载体为液体、半固体或固体。″液体″可以是低粘度或高粘度的液体。液体可以是在环境条件下觉察不到流动的液体。例如,肥皂如普通的洗手的肥皂块,可以被认为是本发明中的液体。液体可以为触变性液体。本文中使用的″半固体的″可以是凝胶、胶体、或胶。本文中使用的半固体和液体根据粘度区分:半固体的为高粘度流体,而液体具有较低的粘度。在两种类型流体之间没有明确的界限。在某些实施方案中,半固体的粘度高达数千mPa.s。用于本发明中的载体包括液体、糊剂、油膏、和凝胶,且可以是透明的、半透明的或不透明的。
[0067]在某些实施方案中,本发明的组合物为适于应用到口腔的口腔护理组合物。这类组合物包括洁牙剂、嗽口水、牙齿凝胶剂(dentalgels)、锭剂、珠粒(beads)、树胶、口腔条(oral strips)、薄荷糖、液体牙膏、喷雾剂、凝胶上的脂粉(paint-on gels)、唇香膏、增白带(whitening strips)、呼吸带(breath strips)、口腔咀嚼物、而它们的组合。例如,本发明公开的口腔护理组合物,用于孔穴的预防、增白、色斑的预防或减少、牙龈炎的预防或减少、牙石的控制、敏感的预防或降低、或呼吸恶臭的预防或降低、以及色斑的预防。
[0068]在某些实施方案中,包括至少两相的组合物可以是皮肤护理组合物,例如肥皂、洗剂、身体洗涤剂、洗浴凝胶、洗发香波、调节剂、除臭剂、防汗剂、香精、香水、化妆品或它们的组合、如防汗/除臭剂(ABDO)。在某些实施方案中,包括至少两相的组合物可以是毛发护理组合物,如洗发香波或调节剂、或其组合。
[0069]载体的具体组合物优选地依赖于该组合物期望的用途。在多个实施方案中,载体为水,包括约5%至约95%的水或约10%至约70%的水。在其它实施方案中,载体基本上是无水的。在洁牙剂载体中,含水量可以为约5%至约70%,约10%至约50%,或约20%至约40%。
[0070]载体可以含多种物质中的任何物质,包括乳化剂、增稠剂,填充剂、以及防腐剂。在一些实施方案中,载体含功能物质,如上面描述的物质。在一些实施方案中,载体含有与薄膜具有相同的功能物质。
[0071]在一实施方案中,载体适合于用作洁牙剂。在一些实施方案中,载体包括湿润剂,如甘油、山梨醇或烷撑二醇如聚乙二醇或丙二醇。在一些组合(configurations)中,载体含湿润剂的含量为组合物的约10%至约80%重量,或约20%至约60%重量。用于本发明中的载体组合物在Garlick,Jr等的美国专利5,695,746、和Mei-King Ng等的美国专利4,839,157中公开。
[0072]在多个洁牙剂实施方案中,载体含增稠剂、胶凝剂或其组合。用于本发明中的增稠剂或胶凝剂包括无机的、天然的或合成的增稠剂或胶凝剂。在一些组合(configurations)中,载体含增稠剂和胶凝剂的总含量为组合物的约0.10%至约15%重量,或约0.4%至约10%重量。用于本发明中的增稠剂和胶凝剂的例子包括无机增稠硅土如:无定形硅土,例如Zeodent165(Huber Corporation);爱尔兰藓(Irish moss);微小的角叉菜胶;黄蓍胶;或聚乙烯吡咯烷酮。在某些实施方案中,载体含磨光剂,如硅土、煅烧氧化铝、碳酸氢钠、碳酸钙、磷酸二钙或焦磷酸钙。在多个实施方案中,载体可以是视觉上透明的组合物。
[0073]在多个含视觉上透明的载体的洁牙剂实施方案中,组合物含至少一种磨光剂。用于本发明中的磨光剂包括collodial硅土,例如Zeodent115(Huber Corporation),以及铝硅酸碱金属盐络合物(即,含氧化铝的硅土)。在一些组合(configurations)中,磨光剂的折光率可以接近于结合有水和/或湿润剂的胶凝剂的折光率。在多个实施方案中,载体含磨光剂的含量为组合物的约5%至约70%重量。
[0074]在某些洁牙剂中,载体含有表面活性剂或表面活性剂的混合物。用于本发明中的表面活性剂包括至少一种高级脂肪酸甘油单酯单硫酸酯的水溶盐,如氢化椰子油脂肪酸的单硫酸化甘油单酯的钠盐;cocamidopropyl甜菜碱;高级烷基硫酸盐如月桂基硫酸钠;烷基芳基磺酸盐如十二烷基苯磺酸钠;高级烷基磺基醋酸盐;月桂基磺基醋酸酯钠;1,2-二羟基丙磺酸的高级脂肪酸酯;以及低级脂肪氨基羧酸的基本上饱和的高级脂肪酰基酰胺,如在脂肪酸、烷基或酰基上含12至16碳的这类物质;以及它们的混合物。例如,酰胺可以是N-月桂酰肌氨酸、以及N-月桂酰、N-豆蔻酰、或N-棕榈酰肌氨酸的钠盐、钾盐和乙醇胺盐。在多个实施方案中,载体含表面活性剂的含量为组合物的重量的约0.3%至约5%重量,或组合物的重量的约0.5%至约3%重量。
[0075]本发明还提供制备洁牙剂载体的方法。在一实施方案中,水和至少一种湿润剂在常规的混合机中分散直到形成第一均匀的胶体相。将磨光剂加入到第一均匀的胶体相中。混合第一均匀的胶体相和磨光剂直到形成另一均匀的胶体相。将增稠剂、香料和表面活性剂加入到第二均匀的胶体相中。将这些成分在约20至100mmHg的真空下高速混合。
[0076]在一些实施方案中,包括载体和多个薄膜碎片的组合物可适合于用作身体清洁制剂,如肥皂、或基于肥皂的凝胶制剂。在这些实施方案中,载体可包括清洁制剂如在非限制性例子中、聚乙二醇二异硬脂酸酯如Hall-Puzzio等的美国专利6,531,119中公开的。在某些实施方案中,包括载体和多个薄膜碎片的组合物,其中载体包括清洁制剂,可含平均乙氧基化程度为40-100的聚乙二醇二异硬脂酸酯。在某些组合(configurations)中,这种二异硬脂酸酯可以是基于肥皂的凝胶组合物的一种成分。在一些实施方案中,这种二异硬脂酸酯可以适合用于稳定的化妆品组合物中,尤其作为防汗剂和/或除臭剂,且二异硬脂酸酯与这类制剂相容。
[0077]在一些实施方案中,包括载体和多个薄膜碎片的组合物可适合于用作化妆品,如可用肥皂和水除去的染眉毛制剂。在这些实施方案中,载体可以是染眉毛制剂如在Alwattari等的美国专利6,503,495中公开的制剂。在某些组合(configurations)中,这些载体组合物可以含约3%至约60%水不溶性的聚合物材料、约2%至约50%水溶性的成膜聚合物、和约0.05%至约20.0%有机粘土。在某些实施方案中,这些组合物可以制成多种形式,如霜剂、糊剂和固体。在一些实施方案中,染眉毛载体组合物可以在水乳剂中含水不溶性的聚合物质。在某些实施方案中,水不溶性的聚合物质可以是含聚合物的聚合物质的水乳剂或分散体。在一些组合(configurations)中,聚合物可以含前体物单体、单体的混合物、天然的聚合物以及它们的混合物。在一些组合(configurations)中,聚合物质还可以包括水不溶性的聚合物质。在某些组合(configurations)中,水不溶性的聚合物可以占组合物重量的约3%至约60%;约4%至约40%,或约5%至约30%。在非限制性实施例中,水不溶性的聚合物质可以由选自芳族乙烯基化物、二烯烃、乙烯基氰、卤乙烯、亚乙烯基二卤化物、乙烯基酯、链烯烃及其异构体、乙烯基吡咯烷酮、不饱和羧酸、不饱和羧酸的烷基酯、不饱和羧酸烷基酯的羟基衍生物、不饱和羧酸的酰胺、不饱和羧酸的胺类衍生物、不饱和羧酸烷基酯的缩水甘油基衍生物、烯的二胺及其异构体、芳族二胺、对酞酰基(terephthaloyl)卤化物、烯的多元醇且其混合物的单体构成。
[0078]在一些实施方案中,包括载体和多个薄膜碎片的组合物可适合于用作防汗剂、除臭剂或防汗-除臭剂(ABDO),例如防汗剂。这些实施方案中的载体可以包括防汗剂组合物,例如,在Guskey的美国国专利6,524,562中公开的防汗剂组合物。在这些实施方案中,例如载体可以是含溶解的防汗活性剂、硅酮弹性体和挥发性硅酮的单相系统。在一些实施方案中,防汗剂载体还可以含结构剂(structurant。)
[0079]在一些实施方案中,包括载体和多个薄膜碎片的组合物可适合于用作洗发香波,例如去头屑洗发剂。这些实施方案中的载体可以包括去头屑组合物,例如,在Winkler的美国专利4,470,982中公开的去头屑组合物。在某些实施方案中,例如载体可以是含阴离子表面活性剂、悬浮剂和烷醇酰胺的去头屑洗发剂组合物。在一些实施方案中,表面活性剂可以是烷基硫酸盐、乙氧基化烷基硫酸盐或其混合物。在一些组合(configurations)中,烷基硫酸盐可以是烷基硫酸的钠盐、铵盐和三乙醇胺盐,其中烷基链含约8至约22个碳原子,或烷基链含约8至约18个碳原子,或含约8至约18个碳原子。在某些实施方案中,在非限制性实施例中悬浮剂可以含具有约16至约22个碳原子的脂肪酸的乙二醇酯,例如,硬脂酸乙二醇酯,单硬脂酸酯和二硬脂酸酯,或脂肪酸的烷醇酰胺,含约16至约22个碳原子、或约16至18个碳原子。烷醇酰胺可以是硬脂酸的单乙醇酰胺、硬脂酸的二乙醇酰胺、硬脂酸的单异丙醇酰胺以及硬脂酸的单乙醇酰胺硬脂酸酯。在某些实施方案中,酰胺可以是用于洗发香波中的任何脂肪酸的烷醇酰胺。在某些组合(configurations)中,这些酰胺通常可以是含约8至约14个碳原子的脂肪酸的单乙醇酰胺和二乙醇酰胺,如椰子单乙醇酰胺、月桂酸二乙醇酰胺及其混合物。在某些实施方案中,去头屑载体可以含粒子(particulate)去头屑剂。在一些组合(configurations)中,例如这些去头屑剂可以是硫、硫化硒、水杨酸、吡啶硫酮锌、其它1-羟基吡啶酮类,如Dittmar等的美国专利4,185,106中公开的物质,以及1978年2月22日的英国专利1,502,144中的唑类抑霉物质。
[0080]在一些实施方案中,包括载体和多个薄膜碎片的组合物可适合于用作洗剂,如Scholz等的美国专利6,352,701中公开的洗剂。在此全文引入作为参考。在一些组合(configurations)中,洗剂载体在单用和复合应用之后都有极好的感觉。在一些组合(configurations)中,含洗剂载体和多个薄膜碎片的组合物在复合应用之后可以维持或改善皮肤的状况,施涂后的洗手期间没有可察觉的发粘或异常的感觉。在一些方面,当用作手术前洗涤替代品时,含洗剂载体和多个薄膜碎片的组合物可以在较短的时间内达到等于或超过传统的肥皂和水洗涤杀死细菌、真菌、和病毒的效果,同时保持或改善皮肤对微生物和化学污染物的自然屏障。在某些实施方案中,含洗剂载体和多个薄膜碎片的组合物可以提供含高浓度低级醇的粘性组合物,而不需要聚合增稠剂来使组合物粘稠。此外,在某些方面,含洗剂载体和多个薄膜碎片的组合物可以具有化妆品优雅的感觉及可以作为洗剂或作为泡沫剂进行调配。
[0081]含洗剂载体和多个薄膜碎片的组合物可以含重量比为约35∶65至100∶0的低级醇和水、至少0.5%-8.0%重量由至少两种乳化剂组成的增稠剂系统,每种乳化剂存在的量为至少0.05%重量,其中乳化剂可以选择以使不含辅助增稠剂的该组合物在23℃下具有至少4,000厘泊的粘度,且其中每种乳化剂可以由至少一个疏水基和至少一个亲水基组成,其中:(i)疏水基可以含至少16个碳原子的烷基;至少16个碳原子的烯基;或至少20个碳原子的芳烷基或芳链烯基;且(ii)至少一种乳化剂的亲水基可以含:具有结构--NHC(O)R或--C(O)NHR的酰胺基,其中R可以是氢或任选地在可利用的位置上被N;O、和S原子取代的1-10个碳原子的烷基;短链醇或酸的酯基(例如,L=--C(O)OR′或--OC(O)R′,其中R′可以是C1-C4支链或直链烷基,其任选地在可利用的位置上被羟基取代);含1-10个葡萄糖单元的多聚葡糖苷基团;含1-5个甘油单元的聚甘油酯基团,仲胺基团;叔胺基团;季胺基团;阴离子团如硫酸根、磺酸酯基、磷酸基、膦酸酯基、羧酸酯基、或两性离子的基团。
[0082]在某些实施方案中,包含本发明的薄膜和载体以使该组合物的美学可接受性最大化。如本文中所述,″美学可接受性″指组合物对于该组合物期望的用户与一种或多种无功能的特征相应的可接受性,如外观(包括颜色和纹理)、气味、香味、和口感。薄膜碎片或含薄膜碎片的组合物可以通过使用快乐试验(hedonic testing)进行美学作用的试验,包括使用本领域已知的方法。例如,感官审评的标准试验方法可以包括给一系列试验者提供样品,试验者采用所述的9-点嗜好等级(9-point hedonic scale)对样品进行评价。
评分/评价
标准的嗜好等级
9 极喜欢
8 非常喜欢
7 中等喜欢
6 有一点喜欢
5 既不喜欢也不厌恶
4 有一点不喜欢
3 中等不喜欢
2 非常不喜欢
1 极不喜欢
[0083]按照9-点嗜好等级,对于形状、颜色、气味、口感和纹理中至少一个、更优选两个和最优选所有的感官特征评分在中性之上,即5.0或更高的薄膜或组合物,可以被认为该测量的特性是可接受的。这样,例如,将含特定形状的薄膜碎片或含特定形状的薄膜碎片(例如,包含正方形薄膜碎片的洁牙剂)的多相组合物提供给包括至少十名的一系列试验者,他们可以对薄膜碎片或组合物的特性如形状、颜色、气味、强度、泡沫、余味、感觉净度、装紧(impact)、口感、纹理和总体喜欢程度按照上述等级进行评价。在某些实施方案中,薄膜碎片的形状影响用户对特性如颜色、气味、强度、泡沫、余味、感觉净度、装紧、口感、纹理和总体喜欢程度的反应。在某些实施方案中,对试验者指明进行试验的产品的特性、或产品的用途,会影响试验者的快乐反应。
[0084]本发明的组合物优选地在正常贮存条件下是稳定的。如本文中所述,″稳定的″指对组合物的一个特性、优选组合物的所有特性如外观、气味、流变学、以及化学成分没有明显的不利影响。优选地,本发明组合物的稳定性包括组合物中薄膜(包括碎片,如果有的话)的组成和物理稳定性。在多个实施方案中含薄膜的组合物在环境温度下贮存至少约两年是稳定的。不过,应理解,在一些实施方案中其他方面稳定的薄膜可能在使用过程中破碎(正如以上的讨论),例如在使用洁牙剂组合物刷牙的过程中破碎。
[0085]在某些实施方案中,除本文中描述的薄膜碎片之外,组合物可包含两种或多种载体,其中每种载体为该组合物提供一相。这种组合物可能对于洇色(color bleeding)是稳定的。例如,组合物可包括薄膜碎片和条纹(striped)洁牙剂如Wong等的美国专利6,315,986中公开的组合物。在某些实施方案中,薄膜碎片可比条纹具有不同的颜色以增强美学的作用。
制备方法:
[0086]本发明提供制备含有在载体中携带薄膜的组合物的方法。在多个实施方案中,多个碎片与载体结合。在一些组合(configurations)中,可将载体和多个薄膜碎片混合。在一些组合(configurations)中,这种混合可以包括慢速搅拌。在一实施方案中,本发明提供方法制备包含其中分布多个薄片状碎片的载体的组合物的方法,其中所述方法包括:
(a)提供所述载体;
(b)将所述薄片状的碎片加入到所述载体中形成混合物;和
(c)匀化所述混合物。
[0087]如本文中所述,″匀化″指混合碎片和载体以便获得碎片在载体中的基本上均匀分布。不过,应当指出所得的组合物还保持双相的组合物。匀化可以使用各种常规的匀化机中的任何一种来完成。
[0088]在另一方法中,将薄膜加入到载体的一种组分中(例如,加入到洁牙剂的湿润剂中)。然后制备载体的其余部分,然后将薄膜混合物加入到载体中。
使用方法:
[0089]本发明提供将功能物质应用到人或动物受试者的方法。如本文中所述,″应用″指将组合物涂于受试者或给受试者应用的任何方法。在多个实施方案中,应用为局部的应用,其中将组合物应用到受试者的外表面,如应用到口腔的表面(例如牙齿、齿龈、和舌)、皮肤、眼睛、以及毛发。当然,具体的应用途径和方法将依赖于该组合物期望的用途。
[0090]在多个实施方案中,本发明提供将功能物质应用到需要它的人或动物受试者的方法,该方法包括将包含在载体内携带的薄膜的组合物局部应用到所述受试者,其中所述薄膜含有该功能物质。在一实施方案中,该方法另外包括在局部应用薄膜之后使薄膜破裂。这种破裂可以通过任何的各种方法包括化学法和/或机械法完成。化学方法包括通过与存在于应用部位的水或物质(例如,口腔护理应用中的唾液)接触而使薄膜降解。物质方法包括在应用过程中通过将物理能应用到组合物产生的搅动、粉碎、和剪切力(例如,在洁牙剂应用过程中刷)。
[0091]在多个实施方案中,本发明提供治疗口腔护理病症的方法。如本文中所述,″口腔护理病症″为可通过将组合物应用到口腔来预防或治疗的任何机能障碍或病症,包括牙齿、口腔粘膜、齿龈和舌的机能障碍或病症。这类病症包括龋齿、牙龈炎、牙周炎、以及美容病症(cosmetic conditions)如变黄和恶臭。
[0092]在一实施方案中,本发明提供通过将本发明的组合物应用到口腔来增强全身健康的方法。本文中使用的″全身健康″是指整个系统的健康,特征为:系统疾病发展的危险降低,如主要系统的疾病如心血管疾病、中风、糖尿病、严重的呼吸道感染,早熟和出生体重低的婴儿(包括相关的分娩后神经/发育功能障碍)、以及相关的死亡危险的增加。在多个实施方案中,组合物的一相或多相含功能物质。在多个实施方案中,薄膜含功能物质;在其它实施方案中,载体含功能物质;在其它实施方案中,载体和薄膜都含这类功能物质。在一实施方案中,功能物质为口腔护理活性剂。在一实施方案中,功能物质可提供不仅仅限于口腔健康的健康益处,例如功能物质可能有助于疾病,功能障碍、或其它异常的改善、危险降低、治疗或预防。用于本发明中的这类物质包括PCT出版物Doyle等的WO 02/02128 A2中描述的物质。
[0093]疾病、功能障碍或异常可能影响身体的一个或多个部分。组合物可以通过促进口腔健康而促进全身健康。例如,组合物可以降低心血管疾病、中风、动脉粥样硬化、糖尿病、呼吸道感染、早产、出生体重过轻、分娩后神经和发育功能障碍发展的危险、以及相关的死亡危险。例如,通过口腔的治疗而促进全身的健康可以通过下列健康标志证明:
1)减少心脏病发作、中风、糖尿病、严重的呼吸道感染、婴儿出生体重过轻、和分娩后神经/发育功能障碍发展的危险以及相关的增加的死亡危险。
2)减少脂肪性动脉条斑(fatty arterial streaks)、动脉粥样硬化斑点、斑点发展的进展、动脉粥样硬化斑点的纤维覆盖的变薄、动脉粥样硬化斑点的破裂、以及随后的血液凝固现象的发展;
3)减少颈动脉(内膜的)管壁厚度(例如,这可通过超声技术评价);
4)减少血液循环和体循环与口腔病原体和/或其毒性组分的接触,尤其导致口腔细菌、脂多糖(LPS)在血液中含量的降低和/或见于动脉斑点、动脉结构、和/或远离的器官(例如,心脏、肝、胰、肾)中的口腔病原体和/或其组分引起的发病率降低;
5)减少下呼吸道与细菌性病原体吸入的接触以及随后的肺炎的发展和/或慢性阻塞性肺部疾患的恶化;
6)减少循环血细胞比容、血红蛋白、白血球计数和/或血小板计数的变化;
7)减少炎症介质/细胞因子如TNF-α、IL-6、CD-14和IL-1的血液/血清水平失调(disregulation)的发生率;
8)减少急性期反应物包括C反应蛋白、纤维蛋白原、和结合珠蛋白的血液/血清水平失调的发生率;
9)减少代谢失调的血液/血清标记物包括同型半胱氨酸、糖基化的血红蛋白、8-异-PGF-2α、和尿酸失调的发生率;
10)减少葡萄糖代谢失调的发生率,葡萄糖代谢失调通常由受损的葡萄糖耐量试验、增加的空腹血糖水平、以及异常的空腹胰岛素水平进行评价;和
11)减少血脂水平失调,其中血脂具体包括血液或血清胆固醇、甘油三酯、LDL、HDL、VLDL、载脂蛋白B、和/或载脂蛋白A-1。
[0094]通过参考以下非限制性实施例可以更进一步理解本发明。
实施例1
[0095]该实施例以表1举例说明可用于制备薄荷醇调味的白色薄膜的浆液制剂。
表1
成分 | %浆液组合物 | %组合物(干) |
水 | 80.65% | 5.00% |
甲基纤维素E15 | 3.90% | 19.15% |
甲基纤维素E50 | 3.90% | 19.15% |
薄荷醇 | 4.40% | 21.60% |
芸苔油 | 2.60% | 12.76% |
二氧化钛 | 2.00% | 9.82% |
Solka-floc 300 | 1.60% | 7.86% |
吐温80 | 0.25% | 1.23% |
甘油 | 0.25% | 1.23% |
甘油醋酸酯 | 0.25% | 1.23% |
玉米淀粉 | 0.20% | 0.98% |
%固体 | 19.35% | |
总计 | 100.00% |
实施例2
[0096]该实施例举例说明含二氧化钛(TiO2)的浆液制剂。在该实施例中,实施例1或实施例2的处方可以这样变化:用云母包被的二氧化钛(如Timiron,Merck&Co.Inc.)替代二氧化钛。
实施例3
[0097]该实施例以表2举例说明可以提供银色薄膜的薄膜浆液组合物的制剂、以及制造该薄膜浆液的方法。
表2
成分 | %浆液组合物 |
甲基纤维素E15* | 3.92% |
甲基纤维素E50* | 3.92% |
Cerestar玉米淀粉12640 | 0.392% |
Solka-floc 300 | 1.57% |
吐温80 | 0.474% |
芸苔油 | 0.949% |
Timeron | 2.00% |
加水至 | 100% |
*甲基纤维素E15和甲基纤维素E50为羟丙基甲基纤维素食品级的聚合物(MethocelTM;Dow Chemical Co.)。
实施例4
[0098]该实施例以表3举例说明提供黄色薄膜的薄膜浆液组合物的制剂。
表3
成分 | %浆液组合物 |
甲基纤维素E15* | 3.92% |
甲基纤维素E 50* | 3.92% |
Cerestar玉米淀粉12640 | 0.392% |
Solka-floc 300 | 1.57% |
吐温80 | 0.474% |
芸苔油 | 0.949% |
Blue Poly 100 | 1.00% |
Timeron | 1.00% |
加水至 | 100% |
*甲基纤维素E15和甲基纤维素E50为羟丙基甲基纤维素食品级的聚合物(MethocelTM;Dow Chemical Co.)。
实施例5
[0100]该实施例以表4举例说明洁牙剂载体,其中薄膜碎片如实施例1的薄膜碎片不稳定。在该实施例中,这种不稳定性可以通过形状的散开和变形显现,比原始尺寸大10%,典型地比原始尺寸大大约50%。这种散开和变形在室温下通常在一周之内发生。一旦该形状散开和变形,则该形状在包装或使用期间(例如,在洁牙剂的情况下刷牙时)不再清楚地观察到。包含该薄膜碎片的多相组合物(如洁牙剂)受到轻微的力,例如通过挤压管或振摇含该组合物的瓶,会使薄膜碎片破裂。
表4
成分 | Wt% |
羧甲基纤维素钠 | 0.65 |
聚乙二醇600(PEG-12) | 3.0 |
山梨醇(70%的水溶液) | 57.69 |
糖精钠 | 0.3 |
氟化钠 | 0.24 |
焦磷酸四钠 | 0.5 |
FD&C蓝#1染料(1.25%在水中) | 0.4 |
硅土研磨剂(Sylodent XWA 650) | 20 |
硅土增稠剂(Zeodent 165) | 4.25 |
调味油 | 1.15 |
月桂基硫酸钠(29%在水中) | 5.172 |
白色,加调味剂的薄膜 | 0.3 |
水 | 适量 |
实施例6
[0101]该实施例以表5举例说明一种其中携带薄膜碎片且保持稳定的洁牙剂载体。在含该处方的成形的薄膜碎片的组合物中,形状可以经得起挤压、振摇等,但不失去它们清晰的大小与形状。
表5
成分 | Wt% |
羧甲基纤维素钠 | 0.65 |
聚乙二醇600(PEG-12) | 3.0 |
山梨醇 | 57.69 |
糖精钠 | 0.3 |
氟化钠 | 0.24 |
焦磷酸四钠 | 0.5 |
FD&C蓝#1染料(1.25%在水中) | 0.4 |
硅土研磨剂(Sylodent XWA 650) | 20 |
硅土增稠剂(Zeodent 165) | 4.25 |
调味油 | 1.15 |
月桂基硫酸钠(29%在水中) | 5.172 |
Cocamidopropyl甜菜碱(35%在水中) | 1.25 |
白色,加有调味剂的薄膜 | 0.3 |
水 | 适量 |
实施例7
该实施例以下表举例说明可用于形成稳定的洁牙剂混合料的洁牙剂制剂。在含该处方的成形的薄膜碎片的组合物中,形状可以经得起挤压、振摇等但不丧失它们的清晰的尺寸和形状。
成分 | Wt% |
黄原胶 | 0.45 |
聚乙二醇600 OPEG-12) | 3.0 |
山梨醇 | 66.638 |
糖精钠 | 0.3 |
氟化钠 | 0.24 |
焦磷酸四钠 | 0.5 |
FD&C蓝#1染料(1.25%在水中) | 0.4 |
硅土研磨剂(Sylodent XWA 650) | 10.0 |
硅土增稠剂(Zeodent 165) | 2.50 |
调味油 | 1.15 |
月桂基硫酸钠(29%在水中) | 5.172 |
Cocamidopropyl甜菜碱 | 1.25 |
白色,加有调味剂的薄膜 | 0.2 |
水 | 适量 |
实施例8
[0102]该实施例以表6举例说明可用于制备薄荷醇调味的白色薄膜的浆液制剂。
表6
成分 | %浆液组合物 |
水 | 72.5 |
甲基纤维素E5 | 10 |
甲基纤维素E50 | 3 |
薄荷醇 | 4.375 |
玉米淀粉 | 4 |
芸苔油 | 2.625 |
二氧化钛 | 1 |
吐温80 | 0.5 |
丙二醇 | 2 |
%固体 | 27.5 |
总计 | 100.00 |
实施例9
[0103]该实施例以表7举例说明可用于制备薄荷醇调味的绿色薄膜的浆液制剂。
表7
成分 | %浆液组合物 |
水 | 73.95 |
甲基纤维素E5 | 9.55 |
薄荷醇 | 6.875 |
玉米淀粉 | 4 |
芸苔油 | 4.125 |
Pigment Green 7(50%) | 1 |
吐温80 | 0.5 |
TP-206鹿角菜胶 | 0.10% |
%固体 | |
总计 | 100.00 |
实施例10
[0104]该实施例举例说明制备薄膜洁牙剂组合物如实施例6中的薄膜洁牙剂组合物的方法。在该方法中,羧甲基纤维素(CMC)分散于聚乙二醇600(PEG 600)中。NaF和糖精溶解于单独容器的水中。将山梨醇混入CMC/PEG部分,之后混入水/盐溶液中。加入焦磷酸四钠(TSPP),然后加入蓝色染料如FD&C蓝#1。然后加入硅土,并在真空下混合。加入甜菜碱、SLS和调味剂并在真空下混合,最后加入白色加有调味剂的薄膜。
实施例11
[0105]该实施例举例说明制备本文所公开的组合物如实施例6中的组合物的方法。
第I部分-处方组分:净化水,氟化钠
称取或量取净化水到浆液罐中。在加入处方量的氟化钠时装上搅拌器。混合至少10分钟。
第II部分-处方组分:PEG,CMC,TSPP,糖精
称取或量取PEG到分散罐中。加入处方量的CMC、TSPP和糖精。混合至少15分钟。
第III部分-处方组分:山梨醇、第II部分、第I部分
称取或量取处方量的山梨醇到主混合机上。提高真空并开始搅动。将第II部分转移到该混合机中。将第I部分的混合物转移到该混合机中。在完全真空下混合至少15分钟。
第IV部分-处方组分:染色溶液,ZEODENT 165,XWA 650,调味剂
停止搅拌并释放真空。加入染色溶液。提高真空并开始搅动。加入处方量的ZEODENT 165、和XWA 650时保持混合机高速运转(和均化器)。在添加粉末的过程中加入调味剂(如果温度<110F)。提高真空直到至少达到28″。在完全真空下混合15分钟。
第V部分-处方组分:液体SLS,甜菜碱,薄膜碎片
在非真空和混合机的速度为25%时加入处方量的甜菜碱。应用完全真空。在完全真空、50%的搅拌速度和没有均化器的情况下加入处方量的液体SLS。将搅拌速度提高到100%并在完全真空下混合至少10分钟。关闭混合机并释放真空。将薄膜碎片加入到混合机中。以25%的速度开始搅拌并混合两分钟。将真空提高到至少28″。将搅拌速度提高到100%并混合至少10分钟。关闭混合机并释放真空。检查产品并取样品。通过均化器将该批产品泵出(泵转速100%,均化器速度50%)至手提储存罐中。
实施例12
[0106]该实施例举例说明通过测定色空间座标进行色度对比的测定。可以分别测定薄膜和牙膏的色空间座标。如上文所述,La*b*值表示由Commission Internatioanle d′Eclairage(CIE)建立的系统定义的在色空间中的色值(color values)。下面的表8显示白色薄膜和相应的蓝色牙膏的La*b*值。该分析显示了在两种光L*、以及颜色参数a*和b*方面存在大的差异。如对白色薄膜所期望的,该薄膜的a*和b*接近0。
表8.
L*a*b*颜色和色差,ΔE*
样品 | L* | a* | b* | ΔE*a |
含薄荷醇的白色薄膜 | 89.74 | -0.49 | 1.97 | --- |
蓝色增白牙膏 | 36.82 | 19.10 | 42.47 | 69.46 |
a色差,ΔE*,是相对于白色薄膜而言的。
[0107]为了完成这些测量,使用Minolta CR-321比色计,并收集L*a*b*彩色座标模式的数据。将各样品置于相配的白色背景下。将一层薄膜或1″的牙膏置于检测器上并插入白色背景旁的顶部。
实施例13
[0108]该实施例举例说明银色、星形的薄膜碎片及其生产方法。用于制备薄膜碎片的成膜浆液的组分列于下面的表9中。制备薄膜时,将粘度为5.1mPa.s(2%的水溶液)的HMPC聚合物Methocel E5LV在23℃下加入到去离子水中,并将该溶液搅拌5分钟。向该溶液中加入预胶化淀粉Cerestar Polar Tex Instant 12640。将混合的组分剧烈搅拌约一小时直到淀粉完全分散和形成均匀混合物。向该混合物中加入镀钛的云母。将该混合物混合10分钟,之后加入月桂基硫酸钠表面活性剂并再混合15分钟。此后加入绿薄荷调味剂,并将浆液再充分混合40分钟至形成浆液乳剂。HPMC与淀粉的重量比为2∶1。然后将该乳剂在25℃下浇注在聚乙烯涂敷的纸上并在110℃下干燥至形成厚度为2.5微米的固体薄膜。然后用星形的冲压机(punch)冲压薄膜。
所得的星形薄膜碎片其最长的维度均为0.25英寸(6.35mm)。
表9银色薄膜基质 | |
成分 | Wt.% |
淀粉HPMC甘油植物油吐温80SLS糖精钠镀钛云母调味剂葡萄糖酸锌总计 | 21.040.05.03.01.01.00.33.824.60.3100 |
实施例14
[0109]该实施例举例说明一种组合物以及生产透明的绿色洁牙剂载体物质的方法。制备含表9中列出的组分的透明的绿色基质(base)洁牙剂组合物,其中制备含山梨醇和水的载体溶液并经受28-30英寸Hg施加的真空。将糖精钠和氟化物的混合物加入其中。随后,将绿色染料与载体混合。将该混合物在28-30英寸Hg施加的真空下脱气5分钟时间。然后在初步脱气之后加入Zeodent 115硅土研磨剂和Zeodent165、无定形硅土增稠剂和月桂基硫酸钠(SLS)。混合这些组分。混合约5分钟后,施加真空,认为该洁牙剂的制备完成。
表10绿色基质洁牙剂 | |
成分 | Wt.% |
PEG 600羧甲基纤维素钠山梨醇净化水氟化钠焦磷酸四钠糖精钠Zeodent 115Zeodent 165月桂基硫酸钠调味剂FD&C绿(2%溶液)总计 | 3.00.5574.06.3570.2430.500.304.08.S1.21.00.05100 |
实施例15
[0110]该实施例举例说明生产含绿色洁牙剂基质载体制剂和星形薄膜碎片的组合物的方法。为了制备该组合物,将实施例13中的星形薄膜碎片与实施例14中的透明绿色洁牙剂载体物质以0.3%(重量/重量)的薄膜∶载体比混合。此后将该组合物包装在标准的牙膏管内。
[0111]包装后,从管中挤压洁牙剂组合物的样品,挤出独特的绿色、美学上令人喜欢的带状组合物,其中悬浮有清晰可见的星形银色薄膜碎片,延伸至整个挤出的组合物中。
实施例16
[0112]该实施例举例说明红色、心形的薄膜碎片及其制备方法。使用按照实施例13的方法用含下面的表11中列出的组分的干膜制备的薄膜制备红色、心形的薄膜碎片。薄膜干燥后,将虫胶(100%非漂白的)应用至薄膜上。薄膜的最终厚度为3.0微米。然后将薄膜冲切成心形的薄膜碎片,它们的最长的维度各为0.125英寸(3.28mm)。
表11红色薄膜 | |
成分 | Wt.% |
HPMC玉米淀粉丙二醇吐温80植物油调味剂D&C#30镀氧化钛的云母总计 | 48.012.02.02.04.024.04.04.0100 |
实施例17
[0113]该实施例举例说明一种组合物和用于蓝色洁牙剂载体物质的生产方法。为了生产蓝色洁牙剂基质,按照实施例14描述的方法配制基质制剂,所不同的是以一种蓝色着色剂代替表10中的蓝色着色剂。
实施例18
[0114]该实施例举例说明含蓝色洁牙剂载体基质制剂和多个红色心形薄膜碎片两者的组合物、以及生产组合物的方法。
[0115]为了制备该组合物,将实施例16中的红色心形薄膜碎片与实施例17中的蓝色洁牙剂载体物质以0.3%(重量/重量)的薄膜∶载体比混合。轻轻混合用于将薄膜碎片散布至整个基质制剂中。此后将该组合物包装在标准的牙膏管内。
[0116]包装后,从管中挤压洁牙剂组合物的样品,挤出独特的蓝色、美学上令人喜欢的带状组合物,其中悬浮有清晰可见的心形红色薄膜碎片,延伸至整个挤出的组合物中。
实施例19
[0117]该实施例举例说明含高浓度香料的圆形薄膜碎片的组合物及其生产方法。
[0118]按照实施例13的方法制备含高浓度(23.75wt.%)香料的薄膜,所不同的是使用含表12中列出的组分的干膜。然后将干膜切成圆形的薄膜碎片。
表12 | |
成分 | Wt.% |
HPMC玉米淀粉吐温80丙二醇芸苔油调味剂镀钛云母氟化钠总计 | 48.012.02.02.04.023.758.00.243100 |
实施例20
[0119]该实施例举例说明提供香味突发(burst)的组合物的生产。在该实施例中,按照实施例15的方法将实施例19的多个薄膜碎片与实施例14的洁牙剂载体混合。
[0120]通过刷牙使用对所得组合物进行试验。当在牙齿上刷洗时,在刷洗引起薄膜碎片的机械破裂其香味成分立即释放之时该组合物释放一阵香味。
实施例20
[0121]该实施例举例说明含口腔护理有效量钙的薄膜碎片及其制备方法。按照实施例13公开的方法制备含口腔护理有效量的钙、厚度为2.5微米的薄膜碎片,所不同的是浆液含表13中列出的组分和薄膜碎片不必是星形的。
表13 | |
成分 | Wt.% |
HPMC乙酸钙吐温80丙二醇芸苔油调味剂镀钛云母总计 | 43.021.41.81.83.521.47.1100 |
实施例21
[0122]该实施例举例说明包括含氟化物的载体和多个含钙薄膜碎片两者的组合物、以及生产该组合物的方法。还公开了一些组合物性质的分析。
[0123]在该实施例中,按照实施例15的方法制备包括实施例20的薄膜碎片和含百万分之1100份(ppm)氟化物离子的市售氟化物牙膏的组合物。该组合物包含0.3%重量的薄膜碎片。然后将该组合物,称为″糊剂A,″,在120°F下老化2至8周且每隔一周分析氟化物含量。为了比较,对相同的牙膏但其中没有掺入薄膜碎片的,称为″糊剂B,″,也在相同的时间期间隔分析其氟化物含量。组合物中氟化物离子的存在通过以下方法测定:首先将载体与薄膜碎片分离,然后使用F-离子选择电极分析载体中氟化物的存在。
[0124]两种组合物的氟化物的测定如下面的表14所示。
表14 | |||||
周糊剂 | 1F(ppm) | 2F(ppm) | 3F(ppm) | 4F(ppm) | 8F(ppm) |
AB | 9351016 | 9621042 | 900986 | 9431036 | 8991040 |
[0125]表14列出的结果表明:与不含任何钙盐的糊剂B相比,含乙酸钙的糊剂A在8周分析期间内氟化物离子损失最少。在牙齿上刷洗时悬浮在洁牙剂中的薄膜迅速破碎由此钙离子将被释放出以与氟化物离子相互作用以增强在刷洗的牙齿上的氟化物离子的抗龋效力。
实施例22
[0126]该实施例举例说明含十六烷基吡啶鎓氯化物(CPC)的薄膜碎片及其制备方法。按照实施例13中公开的方法制备厚度为2.5微米的含口腔护理有效量的十六烷基吡啶鎓氯化物的薄膜碎片,所不同的是干膜含下面的表15中列出的组分和薄膜碎片不必是星形的。下面的表15中列出了含CPC的薄膜的组分。
表15 | |
成分 | Wt.% |
HPMCCPC吐温80丙二醇芸苔油调味剂镀钛云母总计 | 48.012.02.02.04.024.08.0100 |
实施例23
[0127]该实施例举例说明包括含月桂基硫酸钠(SLS)的载体和含十六烷基吡啶鎓氯化物(CPC)的多个薄膜碎片两者的组合物、以及生产组合物的方法。
[0128]在该实施例中,将实施例22的多个薄膜碎片与含SLS的载体如实施例21中的洁牙剂载体混合以生产包括含月桂基硫酸钠(SLS)的载体和含十六烷基吡啶鎓氯化物(CPC)的多个薄膜碎片两者的组合物。在该组合物中,CPC不会与存在于载体中的SLS反应。然而,在刷牙过程中CPC将释放,且SLS和CPC均可以对口腔卫生有效。
实施例24
[0129]该实施例以表16举例说明使用本发明公开的组合物可以输送的某些药物的各自的剂量。
表16
药物 | 剂量 |
马来酸扑尔敏 | 4mg. |
马来酸溴苯吡胺 | 4mg. |
右氯苯那敏 | 2mg. |
右溴苯那敏 | 2mg. |
盐酸丙吡咯啶 | 2.5mg. |
阿伐斯汀 | 8mg. |
马来酸哌吡庚啶 | 1mg. |
Loratidine | 10mg. |
盐酸苯肾上腺素 | 10mg. |
盐酸美沙芬 | 10-20mg. |
酮洛芬 | 12.5mg. |
琥珀酸舒马普坦 | 35-70mg. |
佐米曲坦 | 2.5mg. |
洛哌丁胺 | 2mg. |
法莫替丁 | 10mg. |
尼古丁 | 2mg. |
盐酸苯海拉明 | 25mg. |
盐酸伪麻黄碱 | 30mg. |
[0130]本文中描述的实施例及其它实施方案为示例性的并不旨在限制描述本发明的组合物和方法的整个范围。可以在本发明的范围内对具体的实施方案、物质、组合物以及方法进行等效变化、修饰和改变,可取得基本相似的结果。
Claims (27)
1.一种口腔或个人的护理组合物,其包含载体内携带的薄膜,其中所述薄膜含有功能物质。
2.一种口腔或个人的护理组合物,其包含载体内的多个薄膜碎片,其中所述碎片明显可辨别且具有重复的形状。
3.一种口腔护理组合物,其包含有多个薄片状的碎片分布于其中的载体,其中所述碎片含基质和功能物质。
4.一种口腔护理组合物,其包含在载体内携带的多个明显可辨别的薄片状碎片,其中所述碎片的纵横比为至少约5∶1。
5.一种制备口腔护理组合物的方法,其中该组合物中包含有多个薄片状的碎片分布于其中的载体,所述方法包括:
(a)提供所述的载体;
(b)将所述薄片状的碎片加入到所述载体中以形成混合物;和
(c)匀化所述混合物。
6.一种口腔护理组合物,其包含载体内携带的多个明显可辨别的碎片,其中所述碎片的厚度小于约100微米且长度大于约600微米。
7.一种在载体内包含多个碎片的口腔护理组合物,其中所述碎片具有非随机的形状,且厚度小于约100微米,长度大于约600微米。
8.一种在载体内含多个碎片的口腔护理组合物,其中所述碎片具有非随机的形状且纵横比至少为约5。
9.一种用于增强个人的健康、卫生或外观的组合物,其包含有多个纵横比至少为约5∶1的碎片分布于其中的载体,其中所述碎片含基质和功能物质。
10.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片含有选自纤维素醚、甲基丙烯酸酯、聚乙烯吡咯烷酮及其混合物的水溶性聚合物。
11.权利要求1-9中任一项的组合物、方法或方法,其中所述载体和所述功能物质中之一或两者含有选自研磨剂、抗龋剂、牙石控制剂、抗牙斑剂、牙周活性剂、呼吸新鲜剂、恶臭控制剂、增白剂、预防色斑的活性剂、唾液刺激剂及其组合的治疗活性剂。
12.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片包含多个含第一治疗活性剂的第一薄膜碎片和多个含不同于所述第一治疗物质的第二治疗活性剂的第二薄膜碎片。
13.权利要求1-9中任一项的组合物、方法或方法,其中所述功能物质为香料。
14.权利要求1-9中任一项的组合物、方法或方法,其中所述载体适合用于洁牙剂中,且所述薄膜含有选自阳离子的抗微生物剂、钙盐、氟化物盐类、蛋白质及其混合物的相容性增强的活性剂。
15.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片含有含所述功能物质的控释组合物。
16.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片的溶出度值为至少约5秒且不超过约200秒。
17.权利要求1-9中任一项组合物、方法或方法,其中所述薄膜或碎片包含多个具有第一溶出度值的第一薄膜碎片和多个另一种的第二薄膜碎片,其中第二薄膜碎片的溶出度值明显不同于所述的第一溶出度值。
18.权利要求1-9中任一项的组合物、方法或方法,其中所述载体包括凝胶、糊剂、胶体或原纤网络。
19.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片基本上为薄片状,厚度为约0.1mils至约10mils,且长度为至少约0.2mm且不超过约2.5mm。
20.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片的纵横比为至少约5∶1至约500∶1。
21.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片明显可辨别。
22.权利要求2-9中任一项的组合物、方法或方法,其中所述碎片为非随机的形状或重复的形状中的一种或两种。
23.权利要求22的组合物、方法或方法,其中所述形状基本上为正方形。
24.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片包含多个第一碎片和多个第二碎片,其中所述第一碎片的形状不同于所述第二碎片。
25.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片含选自颜料、沉淀色料、染料及其混合物的制剂着色剂。
26.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片包含多个具有第一色的第一薄膜碎片和多个具有第二色的第二薄膜碎片,其中第二薄膜碎片的第二色明显不同于所述的第一色。
27.权利要求1-9中任一项的组合物、方法或方法,其中所述薄膜或碎片包含多层,且其中所述薄膜或碎片含聚合物薄膜或碎片和在所述薄膜或碎片的至少一个表面上的包衣。
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2002
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- 2003-12-18 US US10/739,803 patent/US20040136924A1/en not_active Abandoned
- 2003-12-19 NZ NZ540970A patent/NZ540970A/en not_active IP Right Cessation
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- 2003-12-19 CN CN200810088729.3A patent/CN101278888B/zh not_active Expired - Fee Related
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- 2003-12-29 CL CL200302767A patent/CL2003002767A1/es unknown
- 2003-12-30 GT GT200300303A patent/GT200300303A/es unknown
- 2003-12-30 MY MYPI20035035A patent/MY155909A/en unknown
-
2004
- 2004-06-03 US US10/860,377 patent/US20050019273A1/en not_active Abandoned
- 2004-12-16 US US11/014,571 patent/US9918909B2/en active Active
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2005
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2007
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2013
- 2013-06-04 US US13/910,060 patent/US9827172B2/en not_active Expired - Lifetime
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2014
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CN1913862B (zh) * | 2003-12-16 | 2010-11-17 | 高露洁-棕榄公司 | 口腔和个人护理组合物及方法 |
CN104352054B (zh) * | 2006-03-10 | 2016-05-25 | 高露洁-棕榄公司 | 套件 |
TWI449506B (zh) * | 2006-03-10 | 2014-08-21 | Colgate Palmolive Co | 以共同特徵使不同產品產生關聯的方法 |
TWI396554B (zh) * | 2009-05-26 | 2013-05-21 | Colgate Palmolive Co | 增進可溶性鋅的量之口腔保健調配物 |
CN102448425A (zh) * | 2009-05-26 | 2012-05-09 | 高露洁-棕榄公司 | 提高可溶锌量的口腔护理制剂 |
CN103096979A (zh) * | 2010-01-29 | 2013-05-08 | 高露洁-棕榄公司 | 用于恶臭控制的口腔护理制剂 |
CN103096979B (zh) * | 2010-01-29 | 2017-08-04 | 高露洁-棕榄公司 | 用于恶臭控制的口腔护理制剂 |
CN102958495A (zh) * | 2010-06-30 | 2013-03-06 | 高露洁-棕榄公司 | 香料在刷牙期间从多层膜释放 |
CN102958567A (zh) * | 2010-06-30 | 2013-03-06 | 高露洁-棕榄公司 | 用于递送香料的多层膜 |
CN102958567B (zh) * | 2010-06-30 | 2015-09-02 | 高露洁-棕榄公司 | 用于递送香料的多层膜 |
CN104053426A (zh) * | 2011-12-16 | 2014-09-17 | 高露洁-棕榄公司 | 多相口腔护理组合物 |
US9750825B2 (en) | 2011-12-16 | 2017-09-05 | Colgate-Palmolive Company | Multiphase oral care compositions |
CN109803728A (zh) * | 2016-10-17 | 2019-05-24 | 高露洁-棕榄公司 | 具有增强的外观和形式的口腔护理组合物 |
Also Published As
Publication number | Publication date |
---|---|
US20050019273A1 (en) | 2005-01-27 |
US9918909B2 (en) | 2018-03-20 |
RU2307644C2 (ru) | 2007-10-10 |
US20080138369A1 (en) | 2008-06-12 |
US20080160056A1 (en) | 2008-07-03 |
EP2193777A1 (en) | 2010-06-09 |
US20050106112A1 (en) | 2005-05-19 |
US20040136924A1 (en) | 2004-07-15 |
CL2003002767A1 (es) | 2005-02-04 |
US6669929B1 (en) | 2003-12-30 |
US20040126332A1 (en) | 2004-07-01 |
AR098141A2 (es) | 2016-05-04 |
RU2005124283A (ru) | 2006-02-10 |
US9498410B2 (en) | 2016-11-22 |
CN101278888A (zh) | 2008-10-08 |
GT200300303A (es) | 2004-08-13 |
ZA200505363B (en) | 2006-09-27 |
US20130272973A1 (en) | 2013-10-17 |
US7763235B2 (en) | 2010-07-27 |
MY155909A (en) | 2015-12-15 |
US8475771B2 (en) | 2013-07-02 |
NZ540970A (en) | 2008-10-31 |
US9827172B2 (en) | 2017-11-28 |
ES2355820T3 (es) | 2011-03-31 |
CN101278888B (zh) | 2015-04-08 |
CN1756524B (zh) | 2013-11-06 |
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