CN1764433B - 用于牙齿增白的水凝胶组合物 - Google Patents
用于牙齿增白的水凝胶组合物 Download PDFInfo
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- CN1764433B CN1764433B CN2004800082063A CN200480008206A CN1764433B CN 1764433 B CN1764433 B CN 1764433B CN 2004800082063 A CN2004800082063 A CN 2004800082063A CN 200480008206 A CN200480008206 A CN 200480008206A CN 1764433 B CN1764433 B CN 1764433B
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Abstract
提供一种组合物,其中,所述组合物包含可水溶胀的、不溶于水的聚合物,亲水聚合物和能与所述亲水聚合物氢键键合的补充低聚物的掺混物以及增白剂,较好是过氧化物。所述组合物具有作为牙齿增白组合物的应用,并施加到需要增白的牙齿上,然后在达到增白程度后除去。在某些实施方式中,所述组合物是半透明的。也公开了制备和使用所述组合物的方法。
Description
技术领域
本发明涉及用于牙齿护理的水凝胶组合物,更具体地是涉及用于增白个体牙齿的新型水凝胶组合物。
技术背景
在社会上普遍存在牙齿变色的现象,估计三个成年人中就会出现两例。牙齿变色认为是美观上的瑕疵和缺陷,并因自我意识对个人生活产生负面影响,甚至有意识地抑制微笑。在呈现干净洁白牙齿是基本条件的处境和职业中,牙齿变色是尤其令人苦恼或棘手的。
牙齿包括牙质内层和有稍许孔隙的硬珐琅质外层。所述外层是牙齿的保护层。牙齿的本色是不透明到半透明的白色或乳白色。当牙齿接触化合物(如丹宁酸和其它多酚化合物)时,牙齿会着色。这些化合物截留或结合到牙齿表面上的蛋白质层上,并渗透到珐琅质中,甚至渗透到牙质中。有时,着色来自牙齿中的物质,如四环素,若个体年纪小时服用,它会沉积到牙齿中。
表面着色通常可以通过机械清洁牙齿来除去。但是,变色的珐琅质或牙质不适应机械的牙齿清洁方法,并需要化学方法(会渗入牙齿结构中)除去色斑。牙齿变色的最有效处理方法是包含氧化剂的组合物,如过氧化氢,它能与产生变色的色原分子反应,并使它们变得无色或可溶于水,或者两者都出现。
因此,牙齿增白组合物通常分为两类:(1)在着色牙齿表面上机械搅动,通过磨蚀表面的色斑来除去牙齿色斑的凝胶体、糊剂或液体,包括牙膏;(2)通过化学工艺进行牙齿漂白的凝胶体、糊剂或液体,它们与着色的牙齿表面接触一指定时间,之后除去所述制剂。在一些情况下,使用辅助化学方法(可以是氧化或酶解)来补充所述机械方法。
一些牙齿用组合物如牙粉、牙膏、凝胶和粉末包含释放活性氧或过氧化氢的漂白剂。这种漂白剂包括碱金属和碱土金属的过氧化物、过碳酸盐和过硼酸盐,或包含过氧化氢的复合物。而且,已知碱金属或碱土金属的过氧化物盐可用于牙齿增白。
在许多牙齿增白组合物配方师可以获得的过氧化物中,几乎专门使用过氧化氢(及其加成物或缔合配合物,如过氧化脲和过碳酸钠)。虽然对其与牙齿色原相互作用的具体本质缺乏了解,但是熟知过氧化氢的化学性质。认为过氧化氢通过氧化着色分子中的不饱和碳-碳、碳-氧以及碳-氮键破坏了牙齿中的色原,由此使它们无色或可溶。
相关的一类化合物(过氧酸)已经用作洗衣用洗涤剂中,以有效地增白衣服,这主要归功于其在溶液中的稳定性以及对某些类型的着色分子的专门结合能力。可以使用许多稳定的固体过氧酸,包括二过氧化十二烷酸和单过氧化邻苯二甲酸的镁盐。其它过氧酸类如过氧乙酸可以作为包含平衡分布的乙酸、过氧化氢、过氧乙酸和水的溶液获得。或者,可以将过氧化物供体如过硼酸钠或过碳酸钠与过氧酸前体一起配制。在接触水时,所述过氧化物供体释放过氧化氢,然后和过氧酸前体反应,形成实际的过氧酸。在原位产生的过氧酸的例子包括过氧乙酸(来自过氧化氢和四乙酰基乙二胺)以及过氧化壬酸(来自过氧化氢和壬酰氧基苯磺酸酯)。
在口腔护理组合物中也已经使用过氧酸来使着色的牙齿增白。美国专利No.5279816说明了使牙齿增白的方法,所述方法包括施用具有酸性pH的包含过氧乙酸的组合物。EP 545594A1说明了过氧乙酸在制备用于牙齿增白的组合物中应用。所述过氧乙酸在所述组合物中存在,或者在使用过程中通过混合过氧化物源和过氧乙酸前体在原位产生。例如,美国专利No.5302375说明了通过混合水、乙酰基水杨酸和可溶于水的碱金属过碳酸盐在赋形剂中原位产生过氧乙酸的组合物。
所述最常用的牙齿增白剂是过氧化脲(CO(NH2)2H2O2),也称为脲过氧化氢,过氧化氢脲以及强双氧水-脲。临床牙医已经用过氧化脲作为口腔杀菌剂好几十年了,且牙齿漂白在长期接触时观察到有副作用。10%过氧化脲的柜台(over thecounter)组合物可以由Marion Laboratories以GLY-和由Reed andCarnrick以获得,它们是低粘度组合物,必须放置在牙托或类似容器中,使之和牙齿接触。能将舒适-合适的牙托长时间固定在位的漂白凝胶可以商标从South Jordan,Utah的Ultradent Products,Inc.获得。
为了使这种组合物固定在位,所述组合物必须是一种粘性液体或凝胶。使用牙托也要求所述牙托舒适和合适,使牙托不会向人的牙齿或牙龈施压,或者造成刺激。这种增白组合物必须进行配制,使之足够粘稠,防止被唾液稀释。
在将个体牙齿增白的方法中,职业牙医由患者牙列制成的牙印模为患者定制牙齿漂白牙托,并开出使用分送到漂白牙托中的氧化凝胶的处方,并间歇地戴上约两周到6个月,这取决于牙齿着色的严重程度。这些氧化组合物通常包装在小的塑料注射器或管中,由患者直接将其分送到定制的牙齿漂白牙托中,固定在嘴中,接触时间大于约60分钟,有时也长达8-12小时。漂白的缓慢速度大部分取决于制剂的真正性质,制剂逐步释放以维持氧化组合物的稳定性。
例如,美国专利No.6368576(Jensen)说明了牙齿增白组合物,它们较好和牙托一起使用,使所述组合物固定在和要处理的牙齿表面相邻的位置上。这些组合物描述为粘性基质材料,通过混合足够量的增粘剂如羧基聚亚甲基和溶剂如甘油、聚乙二醇或水来形成。
在另一实施方式中,美国专利No.5718886(Pellico)说明了一种呈凝胶组合物形式的牙齿增白组合物,它包含分散在无水凝胶状载体(包括多元醇)中的过氧化脲、增稠剂和黄原胶。
美国专利No.6419905(Hernandez)说明了另一实施例,说明了包含过氧化脲(0.3-60%)、木糖醇(0.5-50%)、钾盐(0.001-10%)和氟盐(0.15-3%)的组合物的应用,上述物质配制在包含0.5-6重量%合适胶凝剂的凝胶中。
在美国专利No.5989569和6045811(Dirksing)中说明了粘附到牙齿上的牙齿增白组合物。在这些专利中,所述凝胶包含30-85%甘油或聚乙二醇,10-22%的脲/过氧化氢配合物、0-12%的羧基聚亚甲基、0-1%氢氧化钠、0-100%三乙醇胺(TEA)、0-40%水、0-1%香料、0-15%柠檬酸钠和0-5%乙二胺四乙酸。按照Dirksing的观点,所述优选凝胶的粘度在低剪切速度(小于1秒-1)下为200-1000000厘泊,并且足够粘,这样就不需要使用牙托。
目前获得的牙齿漂白组合物存在导致50%以上患者产生牙齿过敏的明显缺点。由于这些组合物中存在甘油、丙二醇和聚乙二醇,牙齿过敏是流体在牙质小管中移动(被牙齿中神经末梢所感觉到)所导致的。在牙齿接触热、冷、过甜物质以及其它病因药剂之后,会导致不同程度的牙齿过敏。
如目前所实践的,延长牙齿和漂白组合物的接触时间除牙齿过敏以外还有许多不利影响。这些不利影响包括在pH小于5.5时从珐琅质层滤去钙,漂白剂穿透完整珐琅质和牙质并危及牙髓组织,以及唾液稀释漂白组合物,使之从牙托中滤去,之后被使用者摄取。
一些氧化组合物(通常具有相对高浓度的氧化剂)在牙科医院中在牙医或牙科保健员的监控下直接施加到患者的牙齿表面上。理论上,这种牙齿增白对策产生的效果更快,患者的总体满意度更好。但是,由于这些所谓“院内”组合物中包含高浓度的氧化剂,因此若操作不当会危及患者和从业者。患者的软组织(牙龈、嘴唇和其它粘膜表面)必须首先通过使用打孔的橡胶片(已知为橡胶隔片)防止可能接触活性氧化剂,这样只有牙齿凸出。或者,通过用可聚合的组合物覆盖所述软组织,将所述软组织和增白工艺中所用的氧化剂隔离;上述组合物根据牙龈轮廓进行定型,之后暴露在高强度光源下固化。一旦所述软组织已经隔离并收到保护,从业者可以直接将氧化剂置于着色牙齿表面上一段指定时间,或者直到牙齿颜色发生显著变化。使用院内牙齿增白剂所获得的一般效果是牙色约为2-3(如VITA Shade Guide,VITA Zahnfarbik所测得的)。
在VITA Shade Guide中牙色范围从很浅(B1)变化到很深(C4)。总共16个牙色构成了这两端之间整个颜色范围(以亮度登记计)。患者对牙齿增白方法的满意度随所达到的牙色变化的量而增大,通常可接受的最小变化是VITA色宜约为4-5。
至于牙齿增白的牙齿护理产品,要求提供使用粘合剂水凝胶的牙齿护理产品,它包含用于除去个体牙齿色斑的增白剂。要求组合物不需要使用牙托来使漂白剂和牙齿接触。这种产品理论上导致牙齿过敏最小或不会导致牙齿过敏,使增白剂泄漏最小或消除泄漏,所述泄漏的增白剂会被使用者摄取或者损伤或刺激嘴的牙龈或粘膜,提供更长的戴着持续时间,缓慢溶解牙齿增白剂、提高功效并且患者能很好地耐受。也要求提供一种牙齿增白护理产品,它是固体组合物和自粘合剂,但是它不会粘到使用者的手指上,或者它是非固体(例如,液体或凝胶),当干燥时会形成薄膜。本发明解决了这些需求。
发明概述
本发明一方面涉及一种组合物,它包含可水溶胀的、不溶于水的聚合物,亲水聚合物和能与所述亲水聚合物氢键键合或静电键合的补充低聚物的掺混物以及增白剂。
在优选的实施方式中,所述可水溶胀的、不溶于水的聚合物是纤维素酯或者丙烯酸酯基聚合物或共聚物;所述亲水聚合物是聚(N-乙烯基内酰胺)、聚(N-乙烯基酰胺)、聚(N-烷基丙烯酰胺)或它们的共聚物和掺混物;所述能与亲水聚合物氢键键合的补充低聚物是聚亚烷基二醇或者羧基封端的聚亚烷基二醇;所述增白剂是过氧化物。
所述组合物通常包含低分子量的增塑剂,也可以包含选自填料、防腐剂、pH调节剂、软化剂、增稠剂、着色剂(例如,颜料、染料、折射粒子等)、香料(例如,甜味剂、香料)、稳定剂、增韧剂和防粘剂中的至少一种添加剂。
在使用所述组合物的优选实施方式中,所述组合物是牙齿增白组合物,施加到需要增白的牙齿上,然后当达到增白程度之后除去。在某些实施方式中,所述牙齿增白组合物是半透明的,当使用者满意所达到的增白程度时除去所述组合物。
本发明另一方面涉及一种组合物,它包含可水溶胀的、不溶于水的聚合物,亲水聚合物和能与所述亲水聚合物氢键键合的补充低聚物的掺混物以及选自过氧化物、亚氯酸金属盐、过硼酸盐、过碳酸盐、过氧酸及其组合的试剂。
本发明另一方面涉及制备水凝胶薄膜的方法,所述水凝胶薄膜适于加入牙齿增白组合物中。这种方法包括制备可水溶胀的、不溶于水的聚合物,亲水聚合物、能与所述亲水聚合物氢键或静电键合的补充低聚物在溶剂中的溶液或凝胶;将一层溶液沉积到基材上,在其上形成涂层;将涂布的基材加热至约80-100℃的温度保持约1-4小时,由此在基材上形成水凝胶薄膜。
在形成牙齿增白组合物的另一方法中,所述方法包括通过挤出机熔融加工可水溶胀的、不溶于水的聚合物,亲水聚合物、能与所述亲水聚合物氢键键合或静电键合的补充低聚物的混合物,形成挤出的组合物;其特征在于,所述组合物以所需厚度的薄膜挤出到合适的基材上。
所述方法还包括将增白剂加到水凝胶薄膜上,由此提供牙齿增白组合物。
相比现有技术,本发明所述粘合剂牙齿增白组合物提供许多显著优点。具体是,所述组合物:
(1)使操作简易;
(2)在制造过程中容易改性,可控制和优化如粘合性、吸收性、半透明性和溶胀性的性质;
(3)可以配制,使粘性在湿气存在下增大或降低,使所述组合物被弄湿之后才具有粘性;
(4)使所述增白剂从组合物漏到使用者嘴中最少;
(5)可以制成半透明的形式,使使用者无需除去牙齿上的水凝胶组合物就可以看到增白程度;
(6)对牙龈或嘴中粘膜的损伤最小;
(7)戴上舒适且不引人注目;
(8)容易从牙齿上除去,且不留下任何残留物;
(9)适于长时间戴着或作用;
(10)缓释和控释所述增白剂。
发明详述
I.定义和命名
在详细说明本发明以前,应理解除非另有所述,本发明决不限于具体的水凝胶材料或制造方法,它们可以变化。也应理解本文所用的术语仅用于说明具体的实施方式,决不是进行限制。必须注意在本说明书和附带权利要求书中,除非文章中明显说明,所述单数形式“一个”、“一种”和“所述”包括复数对象。因此,例如对象“亲水聚合物”不仅包括单一亲水聚合物,也包括两种或多种不同亲水聚合物的组合或混合物,对象“增塑剂”包括两种或多种不同增塑剂的组合或混合物以及单一的增塑剂等。
在说明并要求保护本发明中,按照以下所述的定义可以使用以下术语。
“疏水”和“亲水”聚合物的定义是基于在100%相对湿度下聚合物吸收的水蒸汽量来确定的。按照这一分类,疏水聚合物在100%相对湿度(“rh”)下仅吸收至多1重量%水,而中等亲水的聚合物吸收1-10重量%水,亲水聚合物能吸收10重量%以上的水,而吸湿聚合物吸收20%以上的水。“可水溶胀的”聚合物是当浸没在水性介质中时所吸收的水量大于其本身重量至少25重量%,较好是其本身重量至少50重量%的聚合物。
本文中,术语“交联的”是指包括分子内和/或分子间交联的组合物,不论其来自共价或非共价键合。“非共价”键合包括氢键键合和静电(离子)键合。
术语“聚合物”包括线型和支链聚合物结构,也包括交联的聚合物以及共聚物(它们可以交联或不交联的),因此包括嵌段共聚物、交替共聚物、无规共聚物等。那些在本文中称为“低聚物”的化合物是分子量低于约1000Da,较好是低于约800Da的聚合物。
术语“水凝胶”以常规的含义使用,是指可水溶胀的聚合物基质,它可以吸收大量的水,形成弹性凝胶,其中,“基质”是通过共价或非共价交联固定在一起的大分子三维网状结构。在置于水性环境中时,干燥的水凝胶溶胀至交联度容许的程度。
术语“牙齿增白组合物”是指包含本文所述水凝胶和增白剂的组合物。
术语“增白剂”通常是指氧化剂,如过氧化物或亚氯酸盐,这在下文中将更详细地说明。在一些情况下,所述增白剂可以是酶或其它除去牙齿色斑的催化剂。所述增白剂包括一种或多种额外的增白剂、表面活性剂、防牙菌斑、防牙垢剂和研磨剂。所述增白剂可以具有其它治疗好处。
术语“粘性”和“粘的”是等价的。但是在本文中,术语“基本上不粘的”、“稍粘的”和“粘的”可以使用PKI或TRBT粘性确定方法(如下所述)测得的值来定量。“基本上不粘的”是指水凝胶组合物的粘性值小于约25g-cm/秒,“稍粘的”是指水凝胶组合物的粘性值约为25-100g-cm/秒;“粘的”是指水凝胶组合物的粘性值至少为100g-cm/秒。
术语“不溶于水的”是指其在水的溶解度小于5重量%,较好是小于3重量%,更好是小于1重量%(在20℃的水中测量)的化合物或组合物。
在本文中,术语“半透明”是指能透射光的材料,使得可以透过所述材料看到物体或图像。本文所述半透明材料可以是或不是“透明的”,透明是指所述材料在光学上透明。术语“半透明的”是指材料不是“不透明的”,不透明时透过所述材料不能看到物体和图像。
II.组合物
本发明组合物包含可水溶胀的、不溶于水的聚合物,亲水聚合物和能与所述亲水聚合物氢键键合的补充低聚物的掺混物以及增白剂。所述可水溶胀的、不溶于水的聚合物(即当浸没在水性液体中时能溶胀的聚合物,但是在所需pH范围(通常小于pH5.5)内不会溶于水中),是纤维素酯或者丙烯酸酯基聚合物或共聚物,即丙烯酸或丙烯酸酯聚合物或共聚物(“丙烯酸酯”聚合物)。当浸没在水或水性溶液中时,所述聚合物通常溶胀其本身重量的至少25重量%,较好是至少50重量%。在一些使用某些亲水聚合物的实施方式中,所述组合物可以溶胀至其干重的1400重量%。
所述组合物较好是牙齿增白组合物,其中,所述增白剂起到使其上施涂所述组合物的牙齿表面变白的作用。但是,所述增白剂具有其它应用,例如,治疗剂或其它类型的药疗化妆剂(cosmeceutical agent),例如,亮肤剂(skin lightening)。因此,本文所述组合物发现了作为施涂到体表(例如,牙齿、指甲、皮肤、粘膜等)上以治疗病症的药物组合物。例如,过氧化氢也具有抗生素和消痤疮性质,以及增白剂。因此,本发明也通过将本发明包含过氧化氢的组合物施加到体表上来治疗感染或痤疮。其它病症包括(仅用于说明,决不是进行限制)真菌感染、痤疮、伤口、亮肤等。
所述亲水聚合物通常是分子量相对较高的聚合物,所述补充低聚物通常是分子量相对较低的聚合物。对于固体组合物,所述可水溶胀的、水不溶的聚合物占所述组合物的约1-20重量%,较好约6-12重量%;所述亲水聚合物占所述组合物的约20-80重量%,较好是约40-60重量%;所述补充低聚物占所述组合物的约10-50重量%,较好是15-35重量%;所述增白剂占所述组合物的0.1-60重量%,较好是约1-30重量%。所述补充低聚物最好占所述亲水聚合物/补充低聚物掺混物的约10-80重量%,较好是约20-50重量%。
在一些情况下,所述补充低聚物也起到低分子量增塑剂的作用。或者,可以加入不同的化合物作为其它分子量低的增塑剂,若包含的话,约占所述组合物的30-35重量%。
对于非固体的组合物,所述可水溶胀的、不溶于水的聚合物占所述组合物的约0.1-40重量%,较好是约0.1-20重量%,更好是约2-6重量%;所述亲水聚合物占所述组合物的约0.1-20重量%,较好是约1-20重量%,更好是约4-10重量%;所述补充低聚物占所述组合物的约0.05-20重量%,较好约0.1-20重量%,更好约0.5-10重量%;所述增白剂占所述组合物的约0.1-60重量%,较好约1-40重量%。所述补充低聚物最好占所述亲水低聚物/补充低聚物掺混物的约1-85重量%,较好约5-50重量%。
所述粘附曲线可以根据聚合物的类型、掺混物中的组成比例和水含量来确定。选择所述可水溶胀的、不溶于水的聚合物,根据水合作用提供所需的粘附曲线。即,当所述可水溶胀的。不溶于水的聚合物是纤维素酯,所述组合物通常在接触水之前(例如,接触湿表面)是粘的,但是随着所述组合物吸收水份而逐渐失去粘性。当所述可水溶胀的、不溶于水的聚合物是丙烯酸酯聚合物或共聚物时,所述组合物在和水接触之前通常是不粘的,但是在接触湿表面时变粘。
当浸没在水性液体中但不溶于水中时,所述可水溶胀的、不溶于水的聚合物能至少溶胀一定程度。所述聚合物包括纤维素酯,例如乙酸纤维素、乙酸丙酸纤维素(CAP)、乙酸丁酸纤维素(CAB)、丙酸纤维素(CP)、丁酸纤维素(CB)、丙酸丁酸纤维素(CPB)、二乙酸纤维素(CDA)、三乙酸纤维素(CTA)等。这些纤维素酯如美国专利No.1698049、1683347、1880808、1880560、1984147、2129052和3617201所述,并使用本领域已知的技术制备或购得。本文合适的购得的纤维素酯包括CA320、CA398、CAB381、CAB551、CAB553、CAP482、CAP 504,所有均从Eastman Chemical Company,Kingsport,Tenn购得。这种纤维素酯的数均分子量通常约为10000-75000。
通常,所述纤维素酯包含纤维素和纤维素酯单体单元的混合物,例如,市售的乙酸丁酸纤维素包含乙酸纤维素单体单元以及丁酸纤维素单体单元以及未酯化的纤维素单体单元,而乙酸丙酸纤维素包含如丙酸纤维素的单体单元。本文优选的纤维素酯是乙酸丙酸纤维素组合物和乙酸丁酸纤维素组合物,具有丁酰基、丙酰基、乙酰基和未酯化(OH)纤维素含量,如下所述:
乙酰基(%) | OH(%) | MW(g/mol) | Tg(℃) | Tm(℃) | ||
乙酸丁酸纤维素 | 17-25%丁酸酯 | 2.0-29.5 | 1.1-4.8 | 12000-70000 | 96-141 | 130-240 |
乙酸丙酸纤维素 | 42.5-47.7%丙酸酯 | 0.6-1.5 | 1.7-5.0 | 15000-75000 | 142-159 | 188-210 |
也列出了所述优选的分子量、玻璃化转变温度(Tg)和熔点(Tm)。而且,合适的纤维素聚合物的本征粘度通常约为0.2-0.3分升/克,较好约1-1.6分升/克,如0.5g样本在100毫升60/40重量%的苯酚/四氯乙烷溶液中在25℃的温度下所测得的。当使用溶剂浇注技术来制备的时候,应选择所述可水溶胀的、不溶于水的聚合物,提供更大的内聚强度,由此便于成膜(通常例如,乙酸丙酸纤维素可以将内聚强度提高到超过乙酸丁酸纤维素的程度)。
其它优选的可水溶胀的聚合物是丙烯酸酯聚合物,通常由丙烯酸、甲基丙烯酸、丙烯酸甲酯、丙烯酸乙酯、甲基丙烯酸甲酯、甲基丙烯酸乙酯和/或其它乙烯基单体来形成。合适的丙烯酸酯共聚物是以商品名“Eudragit”从Rohm Pharma(Germany)购得的共聚物。所述“Eudragit”系列E、L、S、RL、RS和NE共聚物可溶解在有机溶剂、水性分散体中,或作为干粉末。优选的丙烯酸酯聚合物是甲基丙烯酸和甲基丙烯酸甲酯的共聚物,如Eudragit L和Eudragit S系列聚合物。尤其优选这些共聚物是Eudragit L-30D-55和Eudragit L-100-55(后一聚合物由Eudragit L-30D-55喷雾干燥形成,可用水重新形成Eudragit L-30D-55),以及Eudragit RS 100。所述EudragitL-30D-55和Eudragit L-100-55共聚物的分子量约为135000Da,游离羧基和酯基的比例约为1∶1。所述共聚物通常不溶于pH低于5.5的水性流体中。另一种尤其合适的甲基丙烯酸-甲基丙烯酸甲酯共聚物是Eudragit S-100,它和Eudragit L-30D-55不同,游离羧基和酯基的比例约为1∶2。Eudragit S-100不溶于pH低于5.5的水性流体中,但是不像Eudragit L-30D-55,Eudragit S-100在pH=5.5-7.0的水性流体中的溶解度差。这种共聚物在pH7.0和以上可溶。也可以使用Eudragit L-100,它在Eudragit L-30D-55和Eudragit S-100的溶解度曲线之间具有与pH相关的溶解度曲线,其程度为在pH小于6.0时不溶。本领域那些技术人员应意识到EudragitL-30D-55、Eudragit L-100-55、L-100和S-100可以用其它可接受的共聚物(具有类似的与pH相关的溶解性特征)替换。其它合适的丙烯酸酯聚合物是以商品名“Kollicoat”从BASF AG(Germany)购得那些甲基丙烯酸/丙烯酸乙酯共聚物。例如,Koll icoat MAE具有和Eudragit L-100-55相同的分子结构。
当所述可水溶胀的聚合物是丙烯酸或丙烯酸酯聚合物,提供水凝胶,它可以可逆地进行干燥,即在除去水和任何其它溶剂之后,所述干燥的水凝胶可以通过加入水来再形成其原来的状态。此外,用丙烯酸/丙烯酸酯可水溶胀的聚合物制备的亲水水凝胶在和水接触之前通常基本上是不粘的,但是在和湿表面接触时变粘,这种表面可存在于口中,如牙齿表面上。在和水接触之前不粘的性质使得能在水凝胶变粘性前定位或重新定位在所选表面上。一旦水合,所述水凝胶变粘并粘到牙齿的表面上。
此外,包含丙烯酸酯的组合物在将水凝胶组合物浸没到水或其它水性液体中时在小于5.5的pH下通常溶胀约400-1500%,虽然可以选择所述丙烯酸酯聚合物和亲水聚合物/补充低聚物掺混物的比例,使在水性环境中的溶胀比例和程度具有预定的pH相关性。这种特征也可以倒过来加入增白剂或其它试剂,如往所述组合物中加入过氧化物、过氧酸、亚氯酸盐、稳定剂、香料等。
相反,在施加到湿表面上之前,加入作为可水溶胀的聚合物的纤维素酯使水凝胶具有粘性,但是在吸收水之后变得不粘。应理解,当为了最终除去牙齿上的产品需要降低粘性时,需要这种组合物。
所述水凝胶组合物的第二组分是亲水聚合物和能与所述亲水聚合物氢键键合并任选能与亲水聚合物离子或共价连接的补充低聚物的掺混物。合适的亲水聚合物包括来自N-乙烯基内酰胺单体、羧基乙烯基单体、乙烯基酯单体、羧基乙烯基单体的酯、乙烯基酰胺单体和/或羟基乙烯基单体的重复单元。这种聚合物包括例如聚(N-乙烯基内酰胺)、聚(N-乙烯基丙烯酰胺)、聚(N-烷基丙烯酰胺)、取代和未取代的丙烯酸和甲基丙烯酸、聚合物(例如,聚丙烯酸和聚甲基丙烯酸)、聚乙烯醇(PVA)、聚乙烯基胺、其共聚物以及它们与其它类型亲水单体(例如,乙酸乙烯酯)的共聚物。
本文所用聚(N-乙烯基内酰胺)较好是N-乙烯基内酰胺单体单元的未交联的均聚物或者与N-乙烯基内酰胺单体单元(占聚(N-乙烯基内酰胺)共聚物的总单体单元的大部分)的共聚物。用于本发明的优选聚(N-乙烯基内酰胺)通过聚合一种或多种以下N-乙烯基内酰胺单体来制备:N-乙烯基-2-吡咯烷酮、N-乙烯基-2-戊内酰胺和N-乙烯基-2-己内酰胺。和N-乙烯基内酰胺单体单元一起使用的非-N-乙烯基内酰胺共聚单体的非限制性例子包括N,N-二甲基丙烯酰胺、丙烯酸、甲基丙烯酸、羟基乙基甲基丙烯酸酯、丙烯酰胺、2-丙烯酰氨基-2-甲基-1-丙磺酸或其盐以及乙酸乙烯酯。
聚(N-烷基丙烯酰胺)包括例如聚(甲基丙烯酰胺)和聚(N-异丙基丙烯酰胺)(PNIPAM)。
羧基乙烯基单体聚合物通常由丙烯酸、甲基丙烯酸、巴豆酸、异巴豆酸、衣康酸和酐、1,2-二羧酸如马来酸或延胡索酸、马来酸酐或其它混合物形成,优选这一类中的亲水聚合物包括聚丙烯酸和聚甲基丙烯酸,最优选聚丙烯酸。
本文优选的亲水聚合物如下:聚(N-乙烯基内酰胺)类,尤其是聚乙烯基吡咯烷酮(PVP)和聚乙烯基己内酰胺(PVCap)、聚(N-乙烯基乙酰胺)类,尤其是聚乙酰胺本身,羧基乙烯基单体的聚合物,尤其是聚丙烯酸和聚甲基丙烯酸,其共聚物和掺混物。尤其优选PVP和PVCap。
所述亲水聚合物的分子量并不关键,但是,亲水聚合物的数均分子量通常约为100000-2000000,更好是约500000-1500000。所述低聚物是补充到亲水聚合物上,因为它能氢键键合上去。较好的是,所述补充低聚物用羟基、氨基或羧基封端。所述低聚物的玻璃化转变温度Tg通常约为-100℃到-30℃,熔点Tm低于约20℃。所述低聚物也可以是无定形的。亲水聚合物和低聚物的Tg值的差较好大于约50℃,更好大于约100℃,最好约为150-300℃。所述亲水聚合物和补充低聚物应相容,即能形成均匀掺混物,具有单一Tg,是未掺混组分Tg之间的中间值。
所述补充低聚物的分子量通常约为45-800,较好是约45-600。所述补充低聚物较好是分子量低的聚亚烷基二醇(分子量300-600),如聚乙二醇400,它也可以起到低分子量增塑剂的作用。或者,可以将不同的化合物作为其它低分子量增塑剂加入,其中,可以使用以下所述任意低分子量的增塑剂。在本发明的一个实施方式中,所述补充低聚物是互补低分子量或低聚物增塑剂,每分子中至少包含两个官能团,所述官能团能和亲水聚合物氢键键合。
合适补充低聚物的例子包括但不限于低分子量的多元醇(例如,甘油)、单体和低聚亚烷基二醇,如乙二醇和丙二醇、醚醇类(例如,乙二醇醚)、碳酸、来自丁二醇到辛二醇的烷烃二醇,包括聚亚烷基二醇的羧基封端和氨基封端的衍生物。在本文中优选,任选羧基封端的,聚亚烷基二醇,所述分子量约为300-600的聚乙二醇是最佳的补充低聚物。从以上所述应理解,单一化合物(例如,低分子量的聚亚烷基二醇,如分子量约为300-600的聚乙二醇)起到补充低聚物和低分子量增塑剂的作用。
如在美国专利公报No.2002/0037977“Preparation of Hydrophilic PressureSensitive Adhesives Having Optimized Adhesive Properties”中所述的,上述掺混物中亲水聚合物和补充低聚物的比例影响粘合强度和内聚强度。如在上述专利申请中所述的,所述补充低聚物将亲水聚合物/补充低聚物掺混物的玻璃化转变降至比Fox等式预计的更低,预计值由等式(1)给出
式中,Tg预计是亲水聚合物/补充低聚物掺混物的预计的玻璃化转变温度,ωpol是亲水聚合物在掺混物中的重量分数,ωpl是补充低聚物在掺混物中的重量分数,Tgpol是亲水聚合物的玻璃化转变温度,Tgpl是补充低聚物的玻璃化转变温度。如专利申请中所述的,通过选择所述组分及其相对量,给出与Tg预计的预计偏差,由亲水聚合物和补充低聚物制备具有最佳粘合强度和内聚强度的粘合剂组合物。通常,为了使粘合性最大,与Tg预计的预计偏差将是最大的负偏差;而为了使粘合性最小使任意与Tg预计的负偏差最小。
当所述补充低聚物本身作为增塑剂时,通常不需要掺入附加的增塑剂。但是,在组合物中可以任选加入低分子量的增塑剂,在一些情况下是有利的。合适的低分子量增塑剂包括邻苯二甲酸二烷基酯、邻苯二甲酸二环烷基酯、邻苯二甲酸二芳基酯、以及混合的邻苯二甲酸烷基芳基酯,例如,邻苯二甲酸二甲酯、邻苯二甲酸二乙酯、邻苯二甲酸二丙酯、邻苯二甲酸二(2-乙基己酯)、邻苯二甲酸二异丙酯、邻苯二甲酸二戊酯和邻苯二甲酸二辛酯;磷酸烷基酯和磷酸芳基酯,如磷酸三丁酯、磷酸三辛酯、磷酸三甲苯基酯和磷酸三苯酯;柠檬酸烷基酯和柠檬酸酯如柠檬酸三甲酯、柠檬酸三乙酯、柠檬酸三丁酯、柠檬酸乙酰基三乙酯和柠檬酸三己酯;己二酸二烷基酯如己二酸二辛酯(DOA);还有己二酸二(2-乙基己酯)、己二酸二乙酯、己二酸二(2-甲基乙酯)和己二酸二己酯;酒石酸二烷基酯,如酒石酸二乙酯和酒石酸二丁酯;癸二酸二烷基酯如癸二酸二乙酯、癸二酸二丙酯和癸二酸二壬酯;琥珀酸二烷基酯如琥珀酸二乙酯和琥珀酸二丁酯;乙醇酸烷基酯、甘油酸烷基酯(alkyl glycerolate)、二醇酯和甘油酯如二乙酸甘油酯、三乙酸甘油酯(三醋精)、单乳酸二乙酸甘油酯、乙醇酸甲基邻苯二甲酰乙酯、乙醇酸丁基邻苯二甲酰丁酯、乙二醇二乙酸酯、乙二醇二丁酸酯、三乙二醇二乙酸酯、三乙二醇二丁酸酯和三乙二醇二丙酸酯;以及它们的混合物。用于连续亲水相的优选低分子量增塑剂是柠檬酸三乙酯、邻苯二甲酸二乙酯和己二酸二辛酯,最优选己二酸二辛酯。
通过在制造过程中调整一个或多个参数容易控制本发明组合物的性质。例如,可以在制造过程中控制所述组合物的粘合强度,以提高、降低或消除粘合性。这可以通过改变不同组分的类型和/或量,或者通过改变制造方式来完成。而且,就制造工艺而言,使用常规熔融挤出方法制备的组合物通常(虽然不一定)比使用溶液铸塑技术制备的组合物的粘性稍低。而且,通过选择不同可水溶胀的聚合物,以及在那些包含连续亲水相的组合物中,通过调整可水溶胀的、不溶于水的聚合物和亲水聚合物/互补增塑剂掺混物的比例,可以改变水凝胶组合物在接触水时溶胀的程度。这些组合物的外观可以从清澈、透明变为半透明、变为不透明。此外,通过改变亲水相中组分的相对量(例如,降低纤维素酯的量)或者改变制造方法(相比熔融挤出,使用溶液铸塑更容易制得半透明水凝胶),可以使某些组合物变得半透明。在这种方式中,所述半透明组合物允许使用者观察到所述增白过程,同时确定何时牙齿已经足够白了。
上述水凝胶组合物包含增白剂,当施加到牙齿上时起到输递系统的作用。释放“负载于”本发明水凝胶组合物中的增白剂通常包括通过溶胀-控制扩散机理吸收水和解吸附所述试剂。包含增白剂的水凝胶组合物可例如以类似于局部药物制剂的方式使用。
合适的牙齿增白剂包括过氧化物、亚氯酸金属盐、过硼酸盐、过碳酸盐、过氧酸以及组合。合适的过氧化物包括过氧化氢、过氧化钙、过氧化脲以及混合物。所述优选的过氧化物是过氧化氢和过氧化脲。其它合适的过氧化物包括有机过氧化物,包括但不限于二烷基过氧化物,如过氧化叔丁基和2,2-二(叔丁基过氧)丙烷,二酰基过氧化物如过氧化苯甲酰基和过氧化乙酰基,过酸酯如过苯甲酸叔丁酯和过-2-乙基己酸叔丁酯,过氧二碳酸酯如过氧二碳酸二(十六烷基)酯和过氧二碳酸二环己酯,过氧化酮如过氧化环己酮和过氧化甲乙酮,以及氢过氧化物如氢过氧化枯烯和氢过氧化叔丁酯。所述增白剂较好是过氧化物,如过氧化氢或过氧化脲,最好是过氧化氢。
合适的亚氯酸金属盐包括亚氯酸钙、亚氯酸钡、亚氯酸镁、亚氯酸锂、亚氯酸钠和亚氯酸钾;次氯酸盐和二氧化氯。所述优选的亚氯酸盐是亚氯酸钠。
III.任选的添加剂
所述组合物也包括用于处理生理环境(包括牙齿和牙周组织)的任意药物活性试剂。在本文中,“药物活性试剂”是从所述组合物中释放的任意物质,用于治疗不利的生理环境。适于用本方法治疗的不良生理环境(包括牙齿和牙周组织)包括口臭、牙周和口腔感染、牙周炎、龋齿或蛀牙、牙龈炎以及其它牙周疾病。
所述药物活性试剂可以是例如非甾族消炎药/止痛药,甾族消炎药,局部麻醉剂、杀菌剂/消毒剂、抗生素、杀真菌剂、牙齿脱敏剂,氟化物防蛀牙药/防烂牙药,防牙垢/防结石剂,抑制牙菌斑、结石和龋齿形成的酶,研磨剂如焦磷酸盐,金属螯合剂如乙二胺四乙酸、四钠盐,抗氧化剂如丁基化羟基苯甲醚,丁基化羟基甲苯,用于局部输递到牙齿和牙周组织上的营养补充剂等。
合适的非甾族消炎剂/止痛剂包括对乙酰氨基酚、水杨酸甲酯、水杨酸一甘醇酯、阿司匹林、甲灭酸、氟灭酸、消炎痛、双氯酚酸钠、阿氯芬酸、双氯酚酸钠、布洛芬、氟比洛芬、芬替酸(fentizac)、丁苯羟酸、吡罗昔康、保泰松、羟保松、氯非宗、喷他佐辛、甲嘧啶唑和盐酸噻拉米特。
合适的甾族消炎剂包括氢化可的松、氢化泼尼松、地塞米松、去炎舒松、肤氢松、醋酸氢化可的松、醋酸氢化泼尼松、甲泼尼龙、醋酸地塞米松、倍他米松、戊酸倍他米松、氟米松、氟轻缩松(flourometholone)、布地缩松和二丙酸倍氯米松。
合适的局部麻醉剂包括盐酸待布卡因、待布卡因、盐酸利多卡因、利多卡因、苯坐卡因、盐酸对丁基(buthyl)氨基苯甲酸2-(二乙氨基)乙酯、盐酸普鲁卡因、盐酸四卡因、盐酸氯普鲁卡因、盐酸羟基普鲁卡因(oxyprocaine)、甲哌卡因、盐酸可哔因和皮哌吡卡因盐酸盐。
合适的杀菌剂/消毒剂包括硫柳汞(thimerosol)、苯酚、百里酚、氯扎氯胺、苄索氯铵、洗必太、providone iodide、氯化十六烷基吡啶鎓、丁香酚和溴化三甲铵。
合适的抗生素包括盘尼西林、甲氧西林、苯甲异恶唑青霉素、头孢噻吩、头孢噻啶(cefalori din)、红霉素、林可霉素、四环素、氯四环素、土霉素、甲烯土霉素、氯霉素、卡那霉素、链霉素、庆大霉素、杆菌肽和环丝氨酸。
合适的杀真菌药包括两性霉素、克霉唑、益康唑、氟康唑、灰黄霉素、伊曲康唑、酮康唑、咪康唑、制霉菌素、盐酸特比萘芬(terbinafine)、十一碳烯酸和十一烷酸锌。
合适的牙齿脱敏剂包括硝酸钾和氯化锶。合适的氟化物防蛀牙药/防烂牙药包括氟化钠、氟化钾和氟化铵。
其它增白剂包括防牙垢/防结石剂,包括磷酸盐,如焦磷酸盐、多磷酸盐、聚膦酸酯(例如,乙烷-1-羟基-1,1-二磷酸酯、1-氮杂环庚烷-1,1-二膦酸酯和直链烷基二磷酸酯)及其盐;直链羧酸和柠檬酸钠锌以及它们的混合物。优选的焦磷酸盐是焦磷酸二碱金属盐、焦磷酸四碱金属盐,以及焦磷酸二氢二钠(Na2H2P2O7)的水合或无水形式、焦磷酸四钠(Na4P2O7)和焦磷酸四钾(K4P2O7)。焦磷酸盐更详细的说明见Krik&Othmer,Encyclopedia of clinical Technology,第三版,17卷,Wiley-InterscierncePublishers(1982)。任选地,增白剂也包括溶解牙垢的试剂,如甜菜碱、胺氧化物和季铵盐类,如美国专利No.6315991(Zofchak)所述。
在所述组合物中也可以使用抑制牙菌斑、结石或龋齿形成的酶药剂。所述酶药剂可以和增白剂一起储存,或者它们可以位于本文所述多层系统中的不同层上。合适的酶包括:分解唾液蛋白质(吸收在牙齿表面上并形成薄膜或第一层牙菌斑)的蛋白酶,通过溶解蛋白质和脂质(形成细菌细胞壁和膜的结构组分)来破坏细菌的脂肪酶,葡聚糖酶,葡糖水解酶(glucanohydrolase),糖苷内切酶,以及破坏细菌骨架结构(形成细菌粘附到牙齿上的基质)的粘蛋白酶,以及防止因碳水化合物-蛋白质配合物(会结合钙)分解而导致结石发展的淀粉酶。优选的酶包括任何市售的蛋白酶、葡聚糖酶,葡糖水解酶,糖苷内切酶,淀粉酶,mutanase,脂肪酶,粘蛋白酶以及它们相容的混合物。在一些实施方式中,可以使用酶增白剂。
任选地,酶增白剂是过氧化酶,使过氧化酶在原位产生。当酶增白剂或防牙菌斑剂加入所述组合物中时,所述组合物应使所述酶保持其活性形式,例如,pH应大致中性,过氧化物可以忽略,或者包含在单独的层中。
用于局部输递到牙齿和牙周组织上合适的营养补充剂包括维生素(例如,维生素C和D、硫胺、核黄素、泛酸钙、烟酸、叶酸、烟酰胺、吡哆醇、氰钴胺、对-氨基苯甲酸和生物类黄酮)和无机物(例如,钙、磷,氟化物、锌、锰和钾)以及它们的混合物。在Drug Facts and Comparisons(loose leaf drug information service),Wolters Kluer Company,St.Louis,Mo.,1997,第3-17页中公开了本发明所用的维生素和无机物。
所述组合物也包括任何美容活性剂。在本文中,“美容活性剂”包括从组合物中释放出来以改变牙齿或牙周组织外观或者给使用者提供社交所需特征如清新口气的任意物质。例如,美容活性剂可以是口气清新剂或者起到牙齿增白或漂白作用的试剂。认识到在一些文化或在西方社交的某些阶段中,牙齿的颜色是重要的或者合乎需要的,所述美容活性剂也可以是任何给牙齿提供颜色或着色的试剂。
在所述组合物中可以加入其它增白剂。例如,也可以存在表面活性剂如去污剂,并和上述增白剂一起发挥作用,给牙齿提供更亮洁的外观。
在任意这些实施方式中,本发明牙齿增白组合物较好包含用于增白牙齿的过氧化物,也可以包括常规添加剂如填料、防腐剂、pH调节剂、软化剂、增稠剂、着色剂、颜料、染料、折射颗粒、稳定剂、增韧剂、药物试剂、香料或口气清新剂和渗透促进剂。在那些要降低或消除粘性的实施方式中,也可以使用常规防粘剂。选择这些添加剂及其量,使它们不会明显影响牙齿增白组合物所需的化学和物理性质,也不会影响所述组合物中包含的牙齿增白剂的输递。这种额外成分包含着色化合物、食物添加剂、香料、甜味剂和防腐剂。
可以使用任何天然或合成的食用香料或食物添加剂,如在Chemicals Used inFood Processing,Pub.No.1274,National Academy of Sciences,第63-258页中所述的那些。合适的食用香料包括本领域已知的冬青、薄荷、荷兰薄荷、薄荷醇、水果香料、香草、肉桂、辣椒、香料油、油树脂,以及它们的混合物。所用食用香料的量通常取决于偏好,取决于香料类型、单独香料以及所需的强度。较好的是,所述组合物包含约0.1-5重量%的食用香料。
本发明所用甜味剂包括蔗糖、果糖、阿斯巴甜、木糖醇和糖精。较好的是,所述组合物包含约0.001-5.0重量%的甜味剂。
合适的基材可以是半透明的,当戴上时所述组合物不显眼。但是,所述基材或组合物可以任选有色的,当戴上时使所述组合物显眼。较好的是,若需要着色,所述颜色可以存在基材中。例如,所述基材可以具有明亮或活跃的颜色,使消费者感到愉悦。因此,所述基材包含有色化合物,如染料、颜料或当加入形成基材的材料中时可以提供颜色的物质。
例如,通常和接触人体的食物、药物或化妆品一起使用的着色化合物,尤其是允许用于食物的色素添加剂(归为“可证明的”或“免检的”)可用于将基材着色。用于将基材着色的着色化合物来自天然源如蔬菜、矿石或动物,或者可以是天然衍生物的人造相似物。
目前根据用于食物和摄取药物的食品、药物和化妆品法(Food Drug&CosmeticAct)准用的着色化合物包括FD&C红No.3(四碘代荧光素的钠盐)、Food红17(6-羟基-5-{(2-甲氧基-5-甲基-4-磺基苯基)偶氮}-2-萘磺酸的二钠盐)、Food黄13(喹酞酮或2-(2-喹啉基)茚满二酮的一磺酸和二磺酸的混合物的钠盐)、FD&C黄No.5(4-对磺基苯基偶氮-1-对磺基苯基-5-羟基吡唑-3-羧酸的钠盐)、FD&C黄No.6(对磺基苯基偶氮-B-萘酚(napthol)-6-单磺酸的钠盐)、FD&C绿No.3(4-{[4-(N-乙基-对磺基苄基氨基)-苯基]-(4-羟基-2-锍-苯基)-亚甲基}-[1-(N-乙基-N-对磺基苄基)-3,5-环己二亚胺]的二钠盐)、FD&C蓝No.1(二苄基二乙基-二氨基三苯基甲醇三磺酸酐的二钠盐);FD&C蓝No.2(靛蓝的二磺酸的钠盐)、FD&C红No.40、OrangeB和Citrus红No.2以及它们各种比例的组合。
免于FDA认证的着色化合物包括胭脂树橙提取物,β-阿朴胡萝卜素醛,β-胡罗卜素,甜菜根粉,角黄素,焦糖色,胡萝卜籽油,胭脂虫红提取物(洋红色),烘烤的、部分脱酯的、煮熟的棉籽粉,葡糖酸亚铁,果汁,葡萄色素提取物,葡萄皮提取物(enocianina),红辣椒,红辣椒油树脂,核黄素,藏红花色素,姜黄,姜黄油树脂,蔬菜汁以及它们各种比例的组合。
用于所述组合物的着色化合物的形式较好包括干燥形式的添加剂,但是也包括色淀形式,它和包含基材的材料相容。在本发明的方法中可以使用以粉末、颗粒、液体或其它专门用途的形式提供的可溶于水的染料。较好的是,染料的“色淀”或不溶于水的形式可用于将基材着色。例如,若使用着色化合物的悬浮液,可以使用色淀形式的添加剂。合适的不溶于水的染料色淀(通过将FD&C染料的钙盐或铝盐填充到氧化铝上来制得)包括FD&C绿#1色淀,FD&C蓝#2色淀,FD&C R&D#30色淀和FD&C#黄15色淀。
其它合适的着色化合物包括无毒的、不溶于水的无机颜料,如二氧化钛、氧化铬绿、群蓝和群青粉红(ultramarine pink)以及氧化铁。这种颜料的粒度较好约为5-1000微米,更好是约250-500微米。
基材中的着色化合物的浓度较好约为0.05-10重量%,更好是约为0.1-5重量%。
在基材中可以存在一种以上的着色化合物,以提供多种颜色。这些多彩色可以形成条状、点状、螺旋状或任何其它消费者感到愉悦的图案。所述着色化合物也可以和其它外观增强物质如闪光颗粒一起使用。
较好加入吸收填料,控制当粘合剂在牙齿表面上时的水合程度。这种填料可以包含微晶纤维素、滑石、乳糖、高岭土、甘露醇、胶体二氧化硅、氧化铝、氧化锌、氧化钛、硅酸镁、硅酸铝镁、疏水淀粉、硫酸钙、硬脂酸钙、磷酸钙、磷酸钙二水合物、粘土如合成锂皂石、织造和非织造纸和棉花材料。其它合适的填料是惰性的,即基本上不吸水的,且包括例如聚乙烯类、聚丙烯类、聚氨酯聚醚酰胺共聚物、聚酯类和聚酯共聚物、尼龙和人造丝。优选的填料是胶体二氧化硅,例如,Cab-O-(CabotCorporation.Boston MA)。
防腐剂包括例如对-氯-间甲酚、苯基乙醇、苯氧基乙醇、氯代丁醇、4-羟基苯甲酸甲酯、4-羟基苯甲酸丙酯、氯化苄烷铵、氯化十六烷基吡啶鎓、双氯苯双胍己烷二乙酸酯或葡糖酸酯、乙醇和丙二醇。
用作pH调节剂的化合物包括但不限于甘油缓冲剂、柠檬酸盐缓冲剂、硼酸盐缓冲剂、磷酸盐缓冲剂,或者也可以包括柠檬酸-磷酸盐缓冲剂,确保水凝胶组合物的pH与嘴中的环境相容,不会从牙齿表面浸出无机物。为了使增白效果最佳,且不会使牙齿流失无机物,在所述组合物中可以包含钙盐和/或氟盐。
合适的软化剂包括柠檬酸酯,如柠檬酸三乙酯或柠檬酸乙酰基三乙酯、酒石酸酯如酒石酸二丁酯、甘油酯如二乙酸甘油酯和三乙酸甘油酯、邻苯二甲酸酯如邻苯二甲酸二丁酯和邻苯二甲酸二乙酯、和/或亲水表面活性剂,较好是亲水非离子表面活性剂,如糖的部分脂肪酸酯、聚乙二醇脂肪酸酯、聚乙二醇脂肪醇醚以及聚乙二醇脱水山梨糖醇-脂肪酸酯。
本文中,优选的增稠剂是天然存在的化合物或其衍生物,包括例如胶原,半乳甘露聚糖,淀粉,淀粉衍生物和水解产物,纤维素衍生物如甲基纤维素、羟丙基纤维素、羟乙基纤维素以及羟丙基甲基纤维素,胶体硅酸,以及糖类如乳糖、蔗糖、果糖和葡萄糖。也可以使用合成增稠剂如聚乙烯醇、乙烯基吡咯烷酮-乙酸乙烯酯共聚物、聚乙二醇类以及聚丙二醇类。
所述基材也可以埋入或用装饰物如珠、莱茵石等进行装饰,只要这些装饰物不会影响组合物适当变形到牙齿上所需的基材粘弹性,如上所述。所述基材也呈现怡人的或者吸引消费者的字母、文字或图像。
IV.制造方法
本发明所述组合物通常是可熔融挤出的,因此,可以使用简单的掺混与挤出方法来制备。称出所述组合物的组分,然后例如使用Brabender或Baker Perkins掺混机进行混合,通常并不一定在高温下,例如约90-140℃。若需要的话可以加入溶剂或水。所得组合物可以使用单螺杆或双螺杆挤出机挤出或粒化。或者,所述组合物的组分可以一次性熔融,然后在挤出前混合。较好的是,所述组合物直接挤到合适基材如背衬层或可剥离的衬垫上,然后压制。对于大多数的应用,所得包含水凝胶的薄膜的厚度约为0.050-0.80mm,更好是约0.37-0.47mm。
或者,通过溶液铸塑、在合适溶剂中通常以约35-60%(重量/体积)的浓度混合所述组合物组分来制备所述组合物,至于上述溶剂,例如尤其优选挥发性溶剂如乙酸乙酯或低级烷醇类(例如,乙醇、异丙醇等)。如上所述,所述溶液铸塑到合适的基材如背衬层或剥离衬垫上。混合与铸塑较好在室温下进行。然后,所述涂布薄膜的基材在约80-100℃,最好在约90℃下烘烤约1-4小时,最好约2小时。因此,本发明一个实施方式是制备适于加入本发明组合物中的水凝胶薄膜的方法,它包括以下步骤:制备可水溶胀的、不溶于水的聚合物、亲水聚合物以及能与亲水聚合物氢键键合的补充低聚物在溶剂中的溶液;将一层溶液沉积到基材上,在其上形成涂层;并将涂布的基材加热到约80-100℃约1-4小时,由此在基材上形成水凝胶薄膜。
当需要粘的水凝胶组合物时,熔融挤出是优选的方法,虽然仍可以使用溶液铸塑。对于基本上不粘的组合物的制备方法,优选溶液铸塑。而且,熔融挤出可用于本发明的任意组合物。而且,可以使用熔融挤出或溶液铸塑技术来制备半透明的组合物,虽然这些实施方式通常优选溶液铸塑。因此,本发明另一实施方式是形成包含连续亲水相的组合物的方法,它包括以下步骤:通过挤出机熔融加工可水溶胀的、不溶于水的聚合物、亲水聚合物以及能与亲水聚合物氢键键合的补充低聚物的混合物,形成挤出的组合物;将所述组合物以所需厚度的薄膜挤出,在合适基材上形成,并且当冷却时,在薄膜上加上过氧化物水溶液,使增白剂浓度约为1-20重量%。
本发明也预计有一种多层体系,它包括一种或多种额外的水凝胶或非水凝胶层。例如,要求包含在储存过程中和增白剂不相容的其它活性剂。在这种方式中,一层可以是包含增白剂的水凝胶层,其它层包含其它活性剂。这些其它层可以由本文所述的水凝胶组合物制得,或者由本领域已知的任一其它生物相容的制剂(例如,聚异丁烯、二甲基硅氧烷、乙烯-乙酸乙烯酯、聚乙酸乙烯酯、乙酸纤维素、丁酸纤维素、丙酸纤维素、乙基纤维素和不溶于水的丙烯酸酯类)制得。此外,根据所述层的顺序,要求具有粘性层(例如,直接位于牙齿上的层)和不粘的层(例如,离嘴唇最近的外层)。具有多层体系的另一优点是最外层所用聚合物的比例可以变化,以获得不粘的层,避免在产品中使用单独的背衬层。
在一个实施方式中,所述组合物包括:在施加到牙齿表面上之后作为组合物外表面的外基层,附于其上的牙齿接触粘合层(通常可以是本发明的粘合剂组合物,任选包含其它增白剂),以及可除去的剥离衬垫。在除去剥离衬垫之后,例如,所述组合物施加到要处理的牙齿表面上,并置于牙齿表面上,使接触牙齿的层保持接触状态。在另一实施方式中,所述组合物在没有背衬层或剥离衬垫的条件下包装。因此,一旦从包装取出,所述组合物就准备施加到牙齿表面上。
所述基材是主要结构元件,在制造或使用过程中为组合物提供支承。用于基材的材料应是惰性的,不能吸收水凝胶组合物。而且,用于基材的材料应使所述器件按牙齿的轮廓,舒适地戴在嘴中,不会磨擦或刺激嘴唇或舌头。用于基材的材料的例子包括聚酯类、聚乙烯、聚丙烯、聚氨酯类和聚醚酰胺类。所述基材的厚度较好约为15-250微米,若需要的话,可以着色、金属化或者提供适于书写的无光泽饰面。
在一个实施方式中,虽然所述基材较好并不一定要闭塞的(即,不透气的),且不会使组合物中的增白剂透过所述层泄漏并接触口腔和牙龈的粘膜。当准备使用时,所述组合物要预先润湿,使粘性增大,并将组合物粘附到牙齿上。这一实施方式的一个好处就是所述增白剂基本上不会透过基材泄漏,也不会刺激那些对增白剂或任何令人不快的香味或感觉过敏的个体。
其它合适的基材材料可以是非聚合物材料,如蜡(例如,微晶或石蜡)或蜡/泡沫层压物。蜡是分子量低的直链烃,其熔点约为48-75℃,分子量约为300-1400g/mol,通常由Fischer-Tropsch合成反应制得。微晶石蜡是柔韧的,在外观上类似于无定形物,其拉伸强度比石蜡高,晶粒则比石蜡小。微晶蜡的熔点通常约为60-95℃,分子量约为580-700g/mol,主要包含支链烃和一些环状化合物,虽然可存在直链烃。所述基材材料也可以是开孔泡沫材料,如聚氨酯、聚苯乙烯或聚乙烯泡沫材料。
或者,在另一实施方式中,所述基材是不闭塞的,因此可以在牙齿上就位,原位完全水合。
所述剥离衬垫是一次性的元件,用于在施用前保护所述体系。所述剥离衬垫由不渗透增白剂和水凝胶组合物的材料形成,容易从接触粘合剂上剥离。剥离衬垫通常用硅酮或氟碳化合物处理,并通常由聚酯类和聚对苯二甲酸乙二酯制得。
优选的组合物通常使用丙烯酸酯聚合物(作为不溶于水的、可水溶胀的聚合物)和聚乙烯吡咯烷酮和聚乙二醇的掺混物(作为亲水聚合物和能与所述亲水聚合物氢键键合的补充低聚物的掺混物)来制备。
所述组合物的粘合剂薄膜通过在约100-170℃的温度下热熔和混合上述组分来制造。所述薄膜以所需厚度挤到合适基材上。或者,所述组分可以溶解在单一溶剂或混合溶剂中,所述溶液可以铸塑到剥离或背衬薄膜上。然后,蒸发所述溶剂,制得水凝胶薄膜。
一种将增白剂加入所述组合物中的方法包括将所需增白剂水溶液层铺到合适基材上的水凝胶表面上,或者直接将增白剂置于基材上。然后,所述剥离衬垫安装到组合物表面上,形成三明治结构,所述包含增白剂的溶液吸收到所述组合物中(由于其水溶胀性)。或者,将基材上层铺的组合物浸没在包含所需浓度增白剂的溶液中,所述溶液吸收到所述组合物中。通过测量吸收液体时重量增加的比率,可以确定和控制加入组合物中增白剂的百分数。
将增白剂加入组合物中的另一途径是将固体或溶液形式的增白剂加入溶解在溶剂中的组合物中。然后,所述混合物按常规铸塑到合适基材上并干燥,虽然当使用这种加入方法时需要较低的干燥温度。以这种方式制得的组合物可以在室温下干燥约1小时到几天。
一般薄膜厚度约为0.050-0.80mm,较好是0.25-0.50mm。所述薄膜的厚度并不关键,可以按照加入所述薄膜中的增白剂浓度、薄膜接触牙齿的时间长短、佩戴者要求的舒适程度以及所需矫正的着色程度而变化。
V.使用方法
在实践中,通过从其包装中取出产品,除去剥离衬垫(当有时)并将粘合剂层施加到要增白的牙齿(或,若使用增白剂的另一应用,则施加到任何身体表面上)上,来简单使用所述组合物。本文所述牙齿增白体系可以各种大小提供,使所述组合物施加到整个牙齿上,或者牙齿的任意部分上,以及同时施加到任意数目的牙齿上。在使用者施涂所述组合物所需时间时,所述基材(当闭塞时)降低或防止增白剂从组合物泄漏。所述组合物保持在所需位置上最少几分钟、几小时、一整天或过夜,然后在达到所需增白效果时除去。若需要的话,可以提供半透明的组合物,在戴上时不会显得突兀或引人注意。
所述组合物可以长时间戴,但是通常戴上约10分钟到24小时。对于牙齿增白应用,优选的时间是约10分钟到8小时(例如,过夜),优选为30分钟到约1小时。
使用者可以通过手指和拇指的指尖对基材施加正常的手压,任选在施用前润湿所述组合物,围绕上齿或下齿使所述组合物成形。假定平均成人的手指或拇指指尖的表面积约为1平方厘米,则手指和拇指指尖产生的正常压力约为100000-150000帕斯卡(即,约3磅-1.36千克)/平方厘米。所述压力通常由各手指和拇指的指尖施加到所述组合物上约1或2秒。一旦除去手指和拇指指尖施加到基材上的压力,所述组合物呈牙齿表面的形状,并附着在牙齿表面上,并邻接在其上组合物成形的软组织。
当使用者准备除去所述组合物时,所述组合物可以通过将其从牙齿表面或其它身体表面上剥离来简单除去。若需要的话,所述组合物可以再次粘附另一增白时间。留下的残留物最少,可以食用一般的刷牙方法来除去。
在本发明的一个实施方式中,所述组合物是固体,是压敏粘合剂并吸收水。
所述组合物也可以作为非固体组合物施加,例如作为液体或凝胶施加。例如,使用者可以从管子中将组合物挤到手指上,将其施涂到牙齿上;直接从管子中将所述组合物挤到牙齿上,通过牙刷或其它施涂器施涂所述组合物等。在蒸发溶剂之后,所述液体或凝胶组合物干燥,在牙齿表面上形成基质型聚合物薄膜或者凝胶。在这种液体或凝胶薄膜成形器组合物的一个实施方式中,所述水凝胶包含足够的水或其它溶剂,提供可流动的性质。在这一组合物的另一实施方式中,所述液体或凝胶组合物的聚合物组分可溶于室温及冷藏温度(约4℃)下的水-乙醇混合物中,并在溶剂蒸发时混溶。在这种液体或凝胶薄膜成形器组合物的另一实施方式中,所述聚合物组合物在乙醇-水混合物中的下临界溶液温度约为36℃。所得薄膜(在溶剂蒸发之后)较好在体温下不溶于唾液或溶解缓慢,使过氧化氢和牙齿珐琅质接触长时间。最后,所述过氧化氢在液体或凝胶组合物以及在干燥时的聚合物薄膜中稳定。
除非另有所述,本发明的实施将使用聚合物化学、粘合剂制造以及水凝胶制备中的常规技术,这些技术均在本领域技术人员的范围内。在文献中详细说明了这种技术。
应理解,虽然已经结合优选的具体实施方式说明了本发明,但是以上说明以及以下实施例仅用于说明本发明,决不是用于限制本发明的范围。其它方面、优点和修改对本发明所涉及领域的那些技术人员来说显而易见。
阐述以下实施例,为本领域那些技术人员提供全部内容,并说明如何制造和使用本发明的化合物,这决不是限制发明人所要求的发明范围。已经设法确保有关数字(例如,量、温度等)的准确,但是应考虑一些误差和偏差。除非另有所述,份数以重量份计,温度以℃计,压力为大气压或接近大气压。
在实施例中可以使用缩写和商品名:
Eudragit L-100-55 甲基丙烯酸共聚物,(Rohm America Inc.)
Eudragit RS 100 甲基丙烯酸共聚物,(Rohm America Inc.)
PEG 聚乙二醇400
PVP 90聚乙烯吡咯烷酮(BASF)
实施例
实施例1
固体组合物的制备方法
使用熔融挤出方法由以下成分制备一个实施方式的用于牙齿增白的组合物:
Eudragit L-100-55 9重量%
PVP 44重量%
PEG 22重量%
过氧化氢 6重量%
水、稳定剂、pH调节剂 19重量%
如下所述,所述成分在Brabender单螺杆挤出机中熔融加工:首先在100-150℃的温度下将Eudragit L-100-55加入挤出机中,之后加入PVP和PEG。所述组合物挤到两个聚对苯二甲酸乙二酯剥离衬垫之间,厚度为0.35mm。将过氧化氢溶液加入挤出的薄膜中。
实施例2
过氧化氢在体外从固体组合物中释放
研究过氧化氢在pH7.0的缓冲液中在体外从本发明牙齿增白组合物中的释放情况,并和市售产品(Crest WhitestripsTM,Proctor&Gamble Co.,Cincinnati,OH的产品,称为“Crest产品”)释放的过氧化物比较。在薄聚乙烯薄膜上的Carbopol956凝胶中,所述Crest产品包含5.3%过氧化氢。
比较过氧化氢从包含3%、6%或9%过氧化物的组合物(如实施例1所述配制)中的体外释放情况和过氧化氢从Crest产品中释放的情况。所述试验组合物或Crest产品允许过氧化物通过滤纸释放到溶液中,并使用标准分析技术测量所述过氧化物。对于Crest产品,所观察的过氧化物含量在约30分钟内降至基线。这一数据类似于公布的数据(Pagel P.A.等(2000)Vital Tooth Whitening with aNovel Hydrogen Peroxide Strip System:Design,Kinetics,and ClinicalResponse。Compendium,Suppl.第21卷:S10-S15)。
本发明所述牙齿增白组合物以与初始浓度成正比的速度释放过氧化物。也发现,在所有测试过氧化物含量的时刻(5分钟、30分钟和60分钟),本发明组合物释放过氧化物的速度都比Crest产品快。从包含6%过氧化物(接近所述Crest产品)的组合物中释放过氧化物的速度分别约为Crest产品在各时间点时的释放速度的7.5、24和10倍。从包含3%过氧化物的组合物中释放过氧化物的速度分别约为Crest产品在各时间点时的释放速度的3、7和5倍。
实施例3
固体组合物的功效
使用以下步骤测试所述牙齿增白组合物的功效。将所述组合物施加到一组下齿上,一天一次,每次1小时,连续6天,由此测试按实施例1所述步骤制得牙齿增白组合物的功效。在用牙齿增白组合物处理牙齿之前和之后用专门的牙色标(Professional Tooth Shade Guide)测量受试者牙齿的牙色。在第一天,受试者牙色为等级12,并在用牙齿增白组合物处理1小时之后,牙色的等级为10。在第二天用牙齿增白组合物处理1小时之后,受试者的牙色为等级8。在第三天处理1小时之后,受试者的牙色为等级5。类似地,在第四天处理1小时之后,受试者的牙齿为灰度4/5。在第5天,经过1小时处理之后,受试者牙色为等级2/3。在第6天再经过一个半小时处理之后达到最浅的牙色,牙色为2。因此,所述牙齿增白组合物的功效是显而易见的,在处理1小时内就有可测量的效果。
实施例4
制备非固体组合物
由以下成分(配方A)制备牙齿增白组合物:
去离子水 35.0重量%
乙醇 35.0重量%
Eudragit L-100-55 4.00重量%
PEG 1.00重量%
PVP 7.00重量%
过氧化脲 18.00重量%
柠檬酸钠 0.13重量%
如下所述,在装有涂布Teflon的桨叶(直径2英寸)的Cole-Parmer高扭矩低速实验室用混合器中混合所述组合物。将去离子水和乙醇混合,之后加入PEG。然后在剧烈搅拌条件下加入柠檬酸钠。在剧烈搅拌(500-600rpm)下缓慢加入(2-5分钟)Eudragit L-100-55粉末。在约5-10分钟(不一定要等到Eudragit溶解)之后,缓慢加入PVP粉末(在5分钟内)。将高搅拌速度保持5-10分钟。加入过氧化脲粉末(在1-2分钟),所述混合物搅拌制得均匀的溶液(在800-900rpm下约30分钟)。然后,所述溶液储存2-5小时,以排除气泡。
实施例5
制备非固体组合物
由以下成分(配方B)制备牙齿增白组合物:
去离子水 35.0重量%
乙醇 35.0重量%
Eudragit L-100-55 2.50重量%
PEG 1.92重量%
PVP 6.00重量%
过氧化脲 18.00重量%
柠檬酸钠 0.08重量%
甲基纤维素A4C 1.50重量%
如下所述,在装有涂布Teflon的桨叶(直径2英寸)的Cole-Parmer高扭矩低速实验室用混合器中混合所述组合物。将去离子水和乙醇混合,之后加入PEG。然后在剧烈搅拌条件下加入柠檬酸钠。在剧烈搅拌(500-600rpm)下缓慢加入(在5分钟内)Eudragit L-100-55粉末,之后在剧烈搅拌(500-600rpm)下缓慢加入(在5分钟内)加入甲基纤维素A4C粉末。在约10分钟之后,缓慢加入PVP粉末(在5分钟内)。将高搅拌速度保持5-10分钟。加入过氧化脲粉末(在1-2分钟),所述混合物搅拌制得均匀的溶液(在500-800rpm下约30-60分钟)。然后,所述溶液储存2-5小时,以排除气泡。
实施例6
非固体组合物的体外溶解的对比研究
比较按实施例4(配方A)和5(配方B)所述步骤制备的非固体牙齿增白组合物的溶解性与市售产品(Simply WhiteTM透明增白凝胶(Colgate-Palmolive Company,NewYork,NY的产品,称为“高露洁”产品)的溶解性,它包含18.0重量%过氧化脲。通过楔形显微干涉测量技术研究所述溶解过程。
发现配方A可以形成明显的相边界,将溶胀的聚合物组合物和聚合物溶液分隔。在相边界上,可以观察到聚合物浓度(因此,聚合物粘度)明显降低。在高露洁产品/水相互扩散区域中没有发现存在这种边界,其干涉图案是典型的全混溶系统,所述聚合物浓度(因此,聚合物粘度)从组合物基质向水的方向平滑降低。发现配方B具有多相(胶体)特性。在不透明凝胶和半透明水溶液之间形成明显的相边界。也发现配方B具有“溶解更快”的部分和“溶解更慢”的部分。所述溶解更慢的部分形成相对较薄的层,它包围所述不透明的多相溶胀凝胶。相比高露洁产品,配方A和配方B在接触水介质时能形成连续的整体粘稠溶胀凝胶涂层,通过明显的相边界和液体溶液分隔。在4.6-7.5的不同pH的水介质中可以观察到形成配方A和配方B的相边界。
使用配方A和B,形成将溶胀聚合物和聚合物溶液分隔的明显相边界。在高露洁-水相互扩散区域中没有发现存在这种边界,其干涉图案是典型的全混溶系统,所述聚合物浓度(因此,聚合物粘度)从配方A和配方B的基质向水的方向平滑降低。
对高露洁和配方A和B而言,水进入配方A或B以及配方A或B进入水中的有效传质常数是相当的。但是,与高露洁产品相反,在产品中可以观察到形成了将溶胀完整凝胶和水溶液分隔的明显相边界。所述相边界的有效扩散系数比水进入配方A或B以及配方A或B进入水的有效扩散系数低1-2个数量级。在水性介质中由配方A或B形成的溶胀凝胶层能起到具有持续溶解速度的保护涂层的作用。所述溶胀凝胶也提供机械支撑,延长配方A和B在牙齿表面上的停留时间。
对于配方A和配方B,所述组合物渗入水中的动力学在实际上是相同的,而对于配方B,相边界转移的动力学较慢。高露洁产品和配方A和B的有效传质常数是相当的。但是,在配方A和配方B中,观察到将溶胀的完整凝胶和液体溶液分隔的明显相边界。
在真正的戴上环境中,配方A和B的侵蚀(因此,其戴上时间)很大程度上取决于以下两个因素:1)组合物和水(唾液)的相互自由扩散过程,以及2)在戴上时间内施加在涂层上的随机机械剪切应力(即,因嘴唇移动产生的磨擦)。前一因素可以认为是限制的理想(未受干扰的)过程,而后者以明显和随机的方式影响戴上持续时间,这是因为各涂层的断裂现象明显改变了初始相互扩散条件(即,涂层的厚度和组合物成分)。初步戴着研究表明配方A和B能保留在牙齿上10-15分钟,而高露洁产品保持在牙齿上2-3分钟。
实施例7
比较非固体组合物的体外功效
由实施例4所述步骤制得的非固体牙齿增白组合物(配方A)的体外功效与高露洁产品的溶解进行比较。
将配方A的组合物和高露洁产品施加到杯子的茶斑壁上,以演示“第一”处理。在30秒之后,将水加入所述杯子中,覆盖涂布的表面。在30分钟之后,除去水,并用水清洗杯子,除去壁上残留的凝胶涂层。将各组合物施加到相同的位置,演示“第二”处理,由此重复所述实验。
通过数码相机捕捉处理区域的图像,并使用Scion Image软件将所获得的图像转化成256pxl灰度级图像。所述图像标上灰度,使1pxl值对应绝对白色,256值对应绝对的黑色。因此,中间的pxl值(2-255)对应中间的颜色,暗度从1增至256。也使用Scion Image软件测量所述处理区域的色密度(pxl/pxl2)。以下结果证实配方A的组合物增白效果比市售高露洁产品更好。初始茶斑颜色不那么均一解释了配方A所观察到的标准偏差更高。
平均密度(pxl/pxl
2
)(S.D.)
处理之前 第一次处理之后 第二次处理之后
高露洁产品 194.3(3.8) 185.7(6.2) 178.0(6.6)
配方A 198.3(5.2) 178.6(8.2) 167.6(9.0)
除了仅进行“第一”处理以外,使用按照实施例5所述步骤制备的非固体牙齿增白组合物(配方B)重复这一实验。
平均密度(pxl/pxl
2
)(S.D.)
处理之前 第一次处理之后
高露洁产品 116.9(6.6) 89.4(6.79)
配方B 117.3(5.1) 79.6(7.3)
如以上体外数据可见,配方A组合物的增白效果明显优于高露洁产品,配方B组合物的性质介于高露洁产品和配方A之间。
实施例8
过氧化氢从非固体组合物中的体外释放
比较过氧化氢从实施例4(配方A)的非固体牙齿增白组合物中的释放和高露洁产品的溶解。所述高露洁产品浇注在剥离衬垫上,并在室温下干燥一天。所得高露洁产品的薄膜约300-400微米厚,将该薄膜置于玻璃烧杯中,并加入200ml去离子水。所述配方A的组合物浇注到烧杯底部。在2-3分钟之后,加入200ml去离子水。在经过适当时间之后,将溶液和溶胀残留物准确分离,并按照USP滴定法确定过氧化氢的浓度。从高露洁产品和配方A释放的过氧化氢量如下所示。
过氧化氢释放的百分数(wt/wt)
时间(分钟) 1 2 3 5 10 15 20 30
高露洁产品 --- 38.7 --- 47.7 72.4 78. 796.8 ---
配方A 35.0 35.9 59.5 67.5 71.9 --- 79.2 90.0
相比高露洁产品,过氧化氢从配方A形成的薄膜中释放的曲线是持续的,其特征在于,在第一个5分钟内加速传递活性试剂。在和水接触10分钟时,配方A释放的过氧化氢比高露洁产品少。在和水接触20分钟时,高露洁产品不包含过氧化氢,而制剂A包含初始加入的过氧化氢的20%。很明显,过氧化氢键合到配方A的聚合物上比键合到高露洁产品中更强。通过比较释放和薄膜溶解数据,也可以得出结合到配方A薄膜中的过氧化氢可以分类为疏松结合的过氧化氢或强结合的过氧化氢的结论。这一点和其中所有过氧化氢松结合的高露洁产品不同。
实施例9
比较非固体组合物的体外功效
比较配方A和配方B的非固体牙齿增白组合物的体外功效和高露洁产品的溶解。使用根据Vita色标值的等级比较所述配方A和配方B的增白效果和高露洁产品的增白效果。所述研究是随机的、平行组的双盲探索性研究。征召11名受试者参与所述研究,所述受试者在最少4到6个前上颔牙上有根据Vita色标值的等级A3或更暗。
所有11个受试者随机分配到基于上颔中切牙的vita色的三组处理组中一组中。受试者在14天使用过程中接受足够的产品,并在两周内每天使用所述产品两次。基于Vita评价和受试者陈述,很明显,从处理的第七天以后配方A和B以及高露洁产品均提供了统计学上明显的增白效果。配方A观察到最好的增白效果。配方B显示其增白效果介于配方A和高露洁产品之间。配方A证实相比高露洁产品,其牙齿增白效果出现得更早。
实施例10
制备非固体组合
由下列成分制备牙齿增白组合物:
PVP 0.33重量%
PEG 0.17重量%
Eudragit RS 100 35.00重量%
柠檬酸三丁酯 7.00重量%
过氧化氢 10.00重量%
乙醇 17.00重量%
乙酸乙酯 22.5重量%
乙酸异戊酯 1.00重量%
甲酸乙酯 7.00重量%。
Claims (47)
1.一种非固体组合物,它包含:
(a)2-6重量%的可水溶胀的、不溶于水的聚合物;
(b)4-10重量%的亲水聚合物和0.5-10重量%的能与所述亲水聚合物氢键键合的补充低聚物的掺混物;
(c)增白剂;
其中,所述可水溶胀的、不溶于水的聚合物是丙烯酸酯基聚合物;所述亲水聚合物选自聚(N-乙烯基内酰胺)类、聚(N-乙烯基酰胺)类、聚(N-烷基丙烯酰胺)类、聚丙烯酸类、聚甲基丙烯酸类、聚乙烯醇、聚乙烯基胺以及它们的共聚物和掺混物;所述补充低聚物选自多元醇、单体亚烷基二醇、聚亚烷基二醇、羧基封端的聚亚烷基二醇、氨基封端的聚亚烷基二醇、醚醇类、烷烃二醇类和碳酸。
2.如权利要求1所述的组合物,其特征在于,所述丙烯酸酯基聚合物是丙烯酸酯基共聚物,所述聚亚烷基二醇是低聚亚烷基二醇。
3.如权利要求1所述的组合物,其特征在于,所述丙烯酸酯基聚合物选自丙烯酸、甲基丙烯酸、丙烯酸甲酯、丙烯酸乙酯、甲基丙烯酸甲酯或甲基丙烯酸乙酯的聚合物。
4.如权利要求3所述的组合物,其特征在于,所述丙烯酸酯基聚合物是丙烯酸酯基共聚物,选自丙烯酸、甲基丙烯酸、丙烯酸甲酯、丙烯酸乙酯、甲基丙烯酸甲酯或甲基丙烯酸乙酯的共聚物。
5.如权利要求1所述的组合物,其特征在于,所述可水溶胀的、不溶于水的聚合物是甲基丙烯酸和丙烯酸乙酯的共聚物。
6.如权利要求5所述的组合物,其特征在于,所述共聚物的游离羧基和酯基的比例为1∶1-1∶2。
7.如权利要求1所述的组合物,其特征在于,所述亲水聚合物选自聚(N-乙烯基内酰胺)类、聚(N-乙烯基酰胺)类、聚(N-烷基丙烯酰胺)类以及它们的共聚物和掺混物。
8.如权利要求7所述的组合物,其特征在于,所述亲水聚合物是聚(N-乙烯基内酰胺)。
9.如权利要求7所述的组合物,其特征在于,所述亲水聚合物是聚(N-乙烯基内酰胺)均聚物。
10.如权利要求1所述的组合物,其特征在于,所述聚(N-乙烯基内酰胺)选自聚乙烯吡咯烷酮、聚乙烯基己内酰胺及其掺混物。
11.如权利要求10所述的组合物,其特征在于,所述聚(N-乙烯基内酰胺)是聚乙烯吡咯烷酮。
12.如权利要求10所述的组合物,其特征在于,所述聚(N-乙烯基内酰胺)是聚乙烯基己内酰胺。
13.如权利要求1所述的组合物,其特征在于,所述亲水聚合物的数均分子量为100000-2000000。
14.如权利要求1所述的组合物,其特征在于,所述亲水聚合物的数均分子量为500000-1500000。
15.如权利要求1所述的组合物,其特征在于,所述补充低聚物的分子量为45-800。
16.如权利要求15所述的组合物,其特征在于,所述补充低聚物的分子量为45-600。
17.如权利要求1所述的组合物,其特征在于,所述补充低聚物选自聚亚烷基二醇和羧基封端的聚亚烷基二醇。
18.如权利要求17所述的组合物,其特征在于,所述补充低聚物选自聚乙二醇和羧基封端的聚乙二醇。
19.如权利要求17所述的组合物,其特征在于,所述补充低聚物是聚乙二醇。
20.如权利要求1所述的组合物,其特征在于,所述增白剂选自过氧化物、亚氯酸金属盐、以及它们的组合。
21.如权利要求20所述的组合物,其特征在于,所述过氧化物是过硼酸盐、过碳酸盐或过氧酸。
22.如权利要求20所述的组合物,其特征在于,所述增白剂是选自过氧化氢、过氧化钙、过氧化脲和它们混合物中的过氧化物。
23.如权利要求20所述的组合物,其特征在于,所述过氧化物是有机过氧化物。
24.如权利要求23所述的组合物,其特征在于,所述有机过氧化物选自二烷基过氧化物、二酰基过氧化物、过酸酯、酮过氧化物以及氢过氧化物。
25.如权利要求24所述的组合物,其特征在于,所述过酸酯是过二碳酸酯。
26.如权利要求24所述的组合物,其特征在于,所述二烷基过氧化物是过氧化叔丁基或2,2-二(叔丁基过氧)丙烷。
27.如权利要求24所述的组合物,其特征在于,所述二酰基过氧化物是过氧化苯甲酰基或过氧化乙酰基。
28.如权利要求24所述的组合物,其特征在于,所述过酸酯是过苯甲酸叔丁酯或过-2-乙基己酸叔丁酯。
29.如权利要求24所述的组合物,其特征在于,所述过二碳酸酯是过氧二碳酸二(十六烷基)酯或过氧二碳酸二环己酯。
30.如权利要求24所述的组合物,其特征在于,所述酮过氧化物是过氧化环己酮或过氧化甲乙酮。
31.如权利要求24所述的组合物,其特征在于,所述氢过氧化物是氢过氧化枯烯或氢过氧化叔丁基。
32.如权利要求20所述的组合物,其特征在于,所述增白剂是选自亚氯酸钙、亚氯酸钡、亚氯酸镁、亚氯酸锂、亚氯酸钠、亚氯酸钾的亚氯酸金属盐、次氯酸盐和二氧化氯。
33.如权利要求1所述的组合物,它还包含香料。
34.如权利要求33所述的组合物,其特征在于,所述香料选自冬青、薄荷、荷兰薄荷、薄荷醇、水果香料、香草、肉桂、辣椒、香料油、油树脂,以及它们的混合物。
35.如权利要求1所述的组合物,它还包含选自蔗糖、果糖、阿斯巴甜、木糖醇和糖精的甜味剂。
36.如权利要求1所述的组合物,它还包含选自填料、防腐剂、pH调节剂、软化剂、增稠剂、着色剂、颜料、染料、折射粒子、香料、甜味剂、稳定剂、增韧剂、防粘剂和渗透促进剂中的至少一种添加剂。
37.如权利要求1所述的组合物,其特征在于,选择可水溶胀的、不溶于水的聚合物,亲水聚合物和补充低聚物的相对量,使所述组合物半透明。
38.如权利要求1所述的组合物,它包含0.1-60重量%增白剂。
39.如权利要求1所述的组合物,其特征在于,所述组合物在接触水介质时能形成连续的整体粘稠溶胀凝胶涂层,通过明显的相边界和液体溶液分隔。
40.如权利要求1所述的组合物,其特征在于,所述组合物是液体或凝胶组合物,该液体或凝胶组合物的聚合物组分可溶于室温及4℃的冷藏温度下的水-乙醇混合物中。
41.一种仅用于美容的增白牙齿的方法,所述方法包括:
将权利要求1所述的组合物施加到需要增白的牙齿上;
当达到所需增白程度后除去所述组合物。
42.如权利要求41所述的方法,其特征在于,在施加到牙齿上之前润湿所述组合物。
43.如权利要求41所述的方法,其特征在于,在经过预定时间后达到所需增白程度,其中,所述预定时间为10分钟到24小时。
44.如权利要求43所述的方法,其特征在于,所述预定时间为10分钟到8小时。
45.如权利要求44所述的方法,其特征在于,所述预定时间为30分钟到1小时。
46.如权利要求41所述的方法,其特征在于,所述组合物可戴上10分钟到24小时。
47.如权利要求41所述的方法,其特征在于,所述组合物作为液体或凝胶施加。
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US8182473B2 (en) | 1999-01-08 | 2012-05-22 | Palomar Medical Technologies | Cooling system for a photocosmetic device |
US6517532B1 (en) | 1997-05-15 | 2003-02-11 | Palomar Medical Technologies, Inc. | Light energy delivery head |
US6273884B1 (en) | 1997-05-15 | 2001-08-14 | Palomar Medical Technologies, Inc. | Method and apparatus for dermatology treatment |
US6096328A (en) * | 1997-06-06 | 2000-08-01 | The Procter & Gamble Company | Delivery system for an oral care substance using a strip of material having low flexural stiffness |
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Also Published As
Publication number | Publication date |
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US20170252275A1 (en) | 2017-09-07 |
CA2515128A1 (en) | 2004-08-26 |
RU2358783C2 (ru) | 2009-06-20 |
JP2010248264A (ja) | 2010-11-04 |
KR20050103491A (ko) | 2005-10-31 |
MXPA05008359A (es) | 2006-05-04 |
AU2004211937B2 (en) | 2010-06-24 |
US9532935B2 (en) | 2017-01-03 |
US9687428B2 (en) | 2017-06-27 |
CA2515128C (en) | 2013-10-01 |
EP2279725A3 (en) | 2011-07-27 |
EP1589939B1 (en) | 2013-11-13 |
EP2279725A2 (en) | 2011-02-02 |
AU2004211937A1 (en) | 2004-08-26 |
JP5502263B2 (ja) | 2014-05-28 |
RU2005127587A (ru) | 2006-02-27 |
WO2004071323A2 (en) | 2004-08-26 |
EP2279725B1 (en) | 2019-11-06 |
JP2013049732A (ja) | 2013-03-14 |
US20150139919A1 (en) | 2015-05-21 |
US8840918B2 (en) | 2014-09-23 |
JP2006516654A (ja) | 2006-07-06 |
US20170071833A1 (en) | 2017-03-16 |
WO2004071323A3 (en) | 2004-10-14 |
US10179096B2 (en) | 2019-01-15 |
CN1764433A (zh) | 2006-04-26 |
US20030152528A1 (en) | 2003-08-14 |
EP1589939A2 (en) | 2005-11-02 |
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