CN113116733A - 牙齿包裹材料及其牙齿用套件、使用方法及牙齿美白方法 - Google Patents
牙齿包裹材料及其牙齿用套件、使用方法及牙齿美白方法 Download PDFInfo
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- CN113116733A CN113116733A CN202110042576.4A CN202110042576A CN113116733A CN 113116733 A CN113116733 A CN 113116733A CN 202110042576 A CN202110042576 A CN 202110042576A CN 113116733 A CN113116733 A CN 113116733A
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- dental
- adhesive layer
- pullulan
- pvp
- tooth
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Abstract
本发明涉及牙齿包裹材料及其牙齿用套件、使用方法及牙齿美白方法,该牙齿包裹材料包含粘合层和支撑层,其特征在于,上述牙齿用包裹材料不包含有效成分。本发明可以通过应用难以用于牙齿美白剂中的多种香来改善使用者的使用感。
Description
[技术领域]
本发明涉及牙齿用包裹材料、包含其的牙齿用套件及其使用方法,更具体地,提供将单独的牙齿用有效成分涂敷在牙齿表面后能够覆盖其的牙齿用包裹材料、包含其的用于向牙齿递送口腔用有效成分的套件以及利用其的向牙齿递送口腔用有效成分的方法。
[背景技术]
虽然有许多用于口腔护理的多种剂型、多种使用方法的产品,但由于口腔特性,在潮湿的环境、咀嚼和交谈时会受到影响,因此通过多种剂型及方式难以确保应用于牙齿或牙龈的有效成分在期望的时间内与期望的部位充分接触的时间。想要通过将药物以多种剂型(例如液状、固体状、喷雾状等)涂敷于口腔内牙齿或牙龈的目标部位来获得期望的效果,但由于口腔特性,存在以下趋势:由于始终多湿或诸如说话或咀嚼等的物理动作,有效成分无法停留在目标部位直至期望的接触时间,因此无法获得期望的效果。
通常,为了方便使用,在市面上销售贴片形式的牙齿附着用产品,但这种定型的牙齿美白贴片不可避免地需要用于存储药物的一定厚度以上的厚度,以便递送一定量的对牙齿美白有效的美白剂,但由于这种厚度,贴片的柔韧性降低,从而对齿列不均的人或下牙的附着带来不便。另外,对于牙齿美白用贴片,存在以下问题:对于最常用作牙齿美白成分的过氧化物,香成分与过氧化物的相容性不好,因此在业界中,只能限制使用牙齿美白用产品中使用的香成分的种类和量。虽然消费者在能直接感受到味道的口腔产品中对味道和香的要求相当大,但实情是在业界中无法提供能够解决这些问题的合适的方案。
另一方面,对于牙齿美白技术,在1990年之前,为了保护牙龈等周边组织,通过以下方式实现牙齿美白手术:将符合口腔的橡皮障(rubber dam)放入口腔中并在牙科诊所(in office)由专科医生将高浓度(30%)的过氧化氢涂敷于牙齿,然后施加光/热,之后,以out of office方式,通过将药物(美白用凝胶等)涂敷于匹配牙齿的牙托(mouth tray)内然后装入牙托,或者将药物涂敷于牙齿并装入牙托来实现牙齿美白,但所有这些均具有许多不便,例如时间、费用等。此后,提出代替使用牙托,将牙齿美白剂直接涂敷于牙齿或条带,然后将薄而透明且柔韧性好的聚乙烯条带附着于牙齿的牙齿美白剂递送系统。然而,这些由于高浓度的过氧化物凝胶容易沾在手或舌头、牙龈等上而使用不便,并且由于上述条带的厚度较厚而在使用时存在不便。
[发明内容]
[要解决的课题]
本发明要实现的课题是开发一种新的牙齿用药物递送系统、优选套件,其利用涂敷于口腔的组合物和能够覆盖上述组合物的伸长性优异且厚度薄的牙齿用包裹材料。
另外,本发明要实现的课题是提供一种使用在涂敷上述组合物后能够覆盖上述组合物的牙齿用包裹材料的口腔内药物递送方法。
另外,本发明要解决的课题是当用作牙齿美白用途时,与现有的牙齿美白用贴片不同,包含本发明的牙齿用包裹材料的套件将因过氧化物导致相容性显著降低的多种香产品应用于牙齿美白用产品中。
本发明要解决的另一个课题是提供一种使用性便利并且解决将包裹材料从离型纸(PET层)上揭下时由于薄厚度而容易卷起的问题的牙齿用包裹材料。
[课题的解决方案]
本发明的一个实施例提供牙齿用包裹材料、包含其的用于向牙齿递送口腔用有效成分的套件以及利用其的向牙齿递送口腔用有效成分的方法。上述套件可以是包含牙齿用包裹材料和牙齿美白用组合物的牙齿美白用套件。本发明的另一个实施例提供牙齿用包裹材料、包含其的牙齿美白用套件以及利用其的牙齿美白方法。上述牙齿美白用套件可以是包含牙齿用包裹材料和牙齿美白用凝胶的包裹材料(wrap)-凝胶牙齿美白用套件。上述牙齿美白用套件包含牙齿用包裹材料和牙齿美白用凝胶,还可以包含用于使用上述套件的说明书。上述说明书可以向使用者具体说明牙齿用包裹材料的使用方法和牙齿美白用凝胶的使用方法。
本发明的另一个实施例可以提供一种包含牙齿用包裹材料和可以应用于牙齿的牙齿用有效成分的牙齿用套件。例如,上述牙齿用有效成分可以包含龋齿预防成分、牙齿知觉过敏症预防成分等,并且在不损害本发明目的的范围内可以进一步包含其他成分而没有限制。
在下文中,更详细地说明。
对于本说明书中使用的“约”和“大约”,厚度的误差范围可视为±1μm左右,含量的误差范围可视为±0.1重量%左右。
除非另有说明,否则本说明书中的含量是指重量%。另外,除非另有说明,否则总重量以干燥的包裹材料的粘合层的总重量为基准。
本发明提供了牙齿用包裹材料、包含其的用于向牙齿递送口腔用有效成分的套件、利用其的向牙齿递送口腔用有效成分的方法,和/或使用上述套件来美白牙齿的方法。
说明上述牙齿用包裹材料。
本发明的一个实施例提供一种包含粘合层和支撑层的牙齿用包裹材料,并且上述牙齿用包裹材料不包含口腔用有效成分。在本发明的一个实施例中,牙齿用包裹材料可以具有柔韧性足以缠绕期望的牙齿部位的薄的贴片(patch)、条带(strip)、膜(film)或薄膜形式。本发明的牙齿用包裹材料覆盖牙齿后剩余的部分可以折叠到牙齿背面,因此口腔内的异物感较小。
上述牙齿用包裹材料具有非常薄的厚度,并且可以具有大约30μm至100μm、优选40μm至70μm、更优选50μm至60μm左右的厚度。上述牙齿用包裹材料中包含的支撑层的厚度可以大约为10μm至20μm,或12μm至18μm。
上述厚度可以用在业界中通常测量厚度的测微计测量,例如,可以利用MitutoyoMicrometer(三丰测微计)测量。本发明的牙齿用包裹材料容易紧贴在牙齿上,附着时异物感较小,并且可以长时间使用,因此即使在睡觉期间附着也可以减少不便。在研究本发明的过程中,本发明的发明人着眼于由于首次要装载的药物量,口腔用贴片或条带的厚度变厚这一点,从而构思了单独提供药物并且使条带的厚度变薄的技术。
上述牙齿用包裹材料可以包含粘合层(adhesive layer)和支撑层(backinglayer)。除此之外,必要时,在不超过本发明的牙齿用包裹材料的厚度的范围内可以进一步包含其他层。上述牙齿用包裹材料可以还包含离型纸,并且上述离型纸是为了保护粘合层而提供的,并且在使用时从粘合层上去除。上述牙齿用包裹材料的粘合层可以混合并使用选自由HPMC(羟丙基甲基纤维素)、PVP(聚乙烯吡咯烷酮)、EC(乙基纤维素)和Pullulan(普鲁兰)组成的组中的一种以上的聚合物、更优选2种以上的聚合物,但可以不包含聚季铵盐、明胶、海藻酸钠、结冷胶或其混合物。优选地,上述牙齿用包裹材料的粘合层可以包含普鲁兰和PVP的混合物。当上述聚合物包含在粘合层中时,可以解决由于牙齿用包裹材料的薄厚度而可能发生的问题,即,从离型纸上揭下粘合层时包裹材料卷起的问题和包裹材料干燥后容易破碎的问题。当将普鲁兰和PVP的混合物包含在粘合层中时,为了实现本发明的目的,相对于干燥的粘合层的总重量,上述普鲁兰的含量可以为0.01重量%至3重量%,优选为0.05重量%至1重量%,相对于干燥的粘合层的总重量,上述PVP的含量可以为30重量%至60重量%,优选为40重量%至50重量%。
上述包裹材料可以还包含香料。对于上述香料,可以使用通常用于口腔用产品中的多种香料而没有限制,特别是,可以使用之前由于与过氧化物的相容性存在问题而无法使用的相对容易氧化的花、水果香料等的香料。除了在过氧化氢中稳定的薄荷或留兰香系列的香料之外,具有容易氧化的问题的花香和水果香也可以包含在本发明的套件中。与现有的牙齿美白产品相比,本发明的一个实施例中包含的香料可以使用更多的量,并且相对于粘合层的总重量,含量可以为3重量%至15重量%,4重量%至10重量%,或5重量%至8重量%。由于本发明的牙齿用包裹材料与过氧化氢分离,因此对剂型稳定性的影响较小,因此与普通牙齿美白产品相比,可以使用大量的香料。
在另一个实施例中,上述牙齿用包裹材料由粘合层和支撑层组成,并且上述粘合层还可以仅包含PVP而不包含EC和HPMC来形成。
在本实施例中,上述牙齿用包裹材料由粘合层和支撑层组成,并且上述粘合层包含PVP作为聚合物,并且对于上述粘合层的干燥减量(Loss on drying),当将60mm×25mm大小的包裹材料在105℃下干燥10分钟时,可以测量为相对于粘合层的总重量为5至20%,优选为8至15%。当具有上述范围时,可能有利于实现本发明的目的。在本发明中,干燥减量(Loss on Drying;LOD)可以通过下式获得。
干燥减量(LOD)(%)=(干燥前的重量-干燥后的重量)/干燥前的重量×100(%)
对于上述牙齿用包裹材料,粘合层中使用PVP作为粘合层形成聚合物而没有EC和HPMC时,可以通过调节为了防止由于薄厚度而卷起的现象而一起使用的增塑剂的种类和含量来使用。认为当将包裹材料从离型纸上揭下时,由于离型纸与包裹材料之间的粘合力导致支撑层和包含PVP的粘合层的拉伸水平不同而卷起,并且首次确认了为了解决这一问题,在降低离型纸与包裹材料之间的粘合力的同时,需要良好地粘贴在牙齿上的特性。上述增塑剂可以是选自聚丙二醇、甘油、聚乙二醇、山梨糖醇或其混合物中的任意一种,可以不使用蓖麻油,并且优选地,可以使用甘油来解决由于薄的牙齿用包裹材料的特性而导致包裹材料卷起的问题。甘油特别容易最佳地调节包含PVP的包裹材料与离型纸之间的粘合力,并且可以使包裹材料从离型纸上脱落时卷起的现象最小化,并且可以用作有利于层压粘合层和支撑层的增塑剂。
优选地,关于甘油和PVP的重量比,对于PVP和甘油,当PVP:甘油为1:0.5以上时,PVP和甘油形成的粘合层与支撑层的层压没有问题,当PVP:甘油超过1:0.8时,即使在干燥后也可能出现过度的黏腻,因此甘油和PVP的重量比可以优选具有PVP:甘油为1:0.5~0.8的重量比。当甘油和PVP的含量比率脱离上述范围时,包裹材料与离型纸之间的粘合力变强,从而将包裹材料从离型纸上揭下时,卷起现象可能加剧。
为了防止由于牙齿用包裹材料的薄厚度而卷起的现象,在另一个实施例中,上述牙齿用包裹材料由粘合层和支撑层组成,并且上述粘合层可以仅包含PVP而不包含EC和HPMC来形成,并且上述粘合层可以以玻璃态(glassy state)保持。上述玻璃态可以意指在干燥状态下没有粘合力或强度较弱,但因少量水分而水化,同时凝胶化的状态。例如,对于玻璃态,用TA/TX analyzer测量相对于干燥状态的黏腻,从而可以评价为与干燥状态的粘合力相比,湿润状态的粘合力增加的程度,例如,可以理解为与干燥状态相比黏腻增加130至300%左右的状态。
除了上述聚合物、增塑剂和/或香料之外,必要时,上述牙齿用包裹材料还可以包含表面活性剂、甜味剂、pH调节剂等。
上述表面活性剂可以使用可用于口腔产品的表面活性剂而没有限制,并且上述表面活性剂可以选自HCO-40(聚氧乙烯氢化蓖麻油,PEG-40Hydrogenated castor oil)、斯盘20(SPAN 20,sorbitan monolaurate)、斯盘40(SPAN 40,sorbitan monopalmitate)、斯盘60(SPAN 60,sorbitan monostearate)、斯盘80(SPAN 80,sorbitan monooleate)、斯盘85(SPAN 85,sorbitan trioleate)、聚乙二醇、聚环氧乙烷、月桂醇聚醚磺基琥珀酸酯二钠、椰油基甜菜碱、癸基葡糖苷、巴巴苏油酰胺丙基甜菜碱、椰油酰胺丙基甜菜碱、诸如吐温20、吐温40、吐温60、吐温80等吐温(Tween,POE sorbitan fatty acid ester)系、或其混合物。考虑到所使用的聚合物的特性,优选地可以使用HCO-40(聚氧乙烯氢化蓖麻油,PEG-40Hydrogenated castor oil)。为了防止由于通过溶剂浇铸(solvent casting)涂覆膜时周边部分因表面张力而卷起的现象而导致涂覆不均匀的现象,相对于牙齿用包裹材料的总重量,上述表面活性剂的含量可以为4重量%至7重量%,4.5重量%至6.5重量%,或4.8重量%至6重量%。
上述甜味剂可以包括葡萄糖醇、糖精、三氯蔗糖、甜菊苷、乙酰磺胺、阿斯巴甜、木糖醇或其混合物,但不限于这些种类。在不损害本发明目的的范围内可以适当包含。
上述pH调节剂可以包括选自由氢氧化钠、氢氧化钾、磷酸钠、磷酸二钠、磷酸三钠、焦磷酸钠、柠檬酸钠和EDTA-4Na组成的组中的一种以上,优选地可以包含适当的量,使得粘合层的pH为8~11。首先涂敷于牙齿表面的凝胶的pH可以为酸性(约pH 3.5~4.5),此时,一起使用碱性包裹材料(大约pH 10至11左右)时,随着凝胶的pH升高粘度上升,由此能够使牙齿用包裹材料良好地保持在牙齿表面上。
上述牙齿用包裹材料不包含有效成分,并且有效成分可以通过单独的剂型或手段来提供。
在本发明的另一个实施例中,粘合层中仅单独包含PVP而没有EC和HPMC时,为了实现目标粘合力,粘合层中可以进一步包含选自羧甲基纤维素、乙酸纤维素、虫胶(shellac)及其混合物中的一种以上的聚合物。上述PVP和上述选自羧甲基纤维素、乙酸纤维素、虫胶及其混合物中的一种以上的聚合物可以以1:0.1至0.2的重量比包含在上述粘合层中。在上述范围内时,可以使粘合层与离型纸粘合后揭下包裹材料的过程中发生的卷起现象最小化。
考虑到所有物理障碍(例如,与舌尖或食物等的摩擦等)、湿度等,本发明的牙齿用包裹材料可能需要特定的粘合力以在口腔的特殊条件下使用。本发明的牙齿用包裹材料可以使用TA/TX analyzer来测量粘合力。
离型纸与包裹材料的粘合力如下评价。
将离型纸用双面胶带附着于机器的底面,然后用贴有双面胶带的圆筒形尖端(直径5mm)按压以附着支撑层和尖端,并测量包裹材料从离型纸上脱落时的力。包裹材料的大小为10mm x 25mm。按压包裹材料的时间为5sec,按压力为1000gf,揭下的速度为10mm/sec,并且在25℃常温下包裹材料从离型纸上脱落时,可以具有150至450gf,优选地可以具有180至400gf。
构成上述牙齿用包裹材料的支撑层通过层叠在粘合层上而提供,并且可以是不透水性膜。可以是聚丙烯、聚乙烯、聚氨酯或聚乙酸乙烯酯、乙基纤维素、聚甲基丙烯酸甲酯、甲基丙烯酰基乙基甜菜碱/甲基丙烯酸酯共聚物或其混合物,其中,优选地可以为聚乙烯。上述支撑层中不包含用于制备浸湿性膜或可食性膜的成分,并且可以不包含例如,淀粉、果胶(pectin)、海藻酸(Alginate)、角叉菜胶、壳聚糖、纤维素或作为其衍生物的羟丙基甲基纤维素(HPMC)、普鲁兰等。上述聚乙烯优选地可以为低密度聚乙烯(LDPE)。上述聚乙烯具有比其他膜更优异的人体安全性,经济,伸长率高且不易撕裂(拉伸强度优异)并且与其他不透水性材料不同,容易与包含亲水性玻璃质聚合物的上述粘合层附着,因此可以特别有利地用于本发明的薄结构的包裹材料中。上述支撑层可以具有0.5至2kgf的拉伸强度,并且当具有上述范围的拉伸强度时,可以减少从离型纸上揭下时包裹材料的卷起。上述拉伸强度可以通过测量将支撑层(例如,PE膜)切割成橫长25mm,纵长超过60mm,并在拉伸强度测定仪(Zwick)上固定使得纵长为60mm,然后以每分钟30mm的速度拉伸直到支撑层断裂为止的最大力(kgf)来获得。
上述牙齿用包裹材料可以提供为包含含有有效成分的有效成分层的贴片的一个构成要素。上述“有效成分层”可以包含递送至牙齿的有效成分。上述有效成分层是在干燥状态下没有粘合力或强度较弱,但在期望的部位因少量水而水化,同时产生粘合力或者在开始水化的同时开始释放美白剂的干式类型(dry type),但也可以以通过自身粘度而可附着在牙齿上的凝胶状态提供。上述牙齿用包裹材料可以通过层叠在上述有效成分层的背面上而提供。上述牙齿用包裹材料可以是包含袋的压花图案。上述压花图案中存在袋(pocket),从而可以增加有效成分层与牙齿用包裹材料之间的粘合力,还可以增加药物的装载量。
本发明提供了包含上述牙齿用包裹材料的牙齿用套件。
上述牙齿用套件作为用于向牙齿递送口腔用有效成分的套件而提供。可以包含上述牙齿用包裹材料作为第一构成,包含应用于牙齿的口腔用有效成分的组合物作为第二构成。在另一个实施例中,上述牙齿用套件可以包含上述牙齿用包裹材料作为第一构成,包含应用于牙齿的口腔用有效成分的组合物作为第二构成,以及说明使用上述套件的方法的使用说明书作为第三构成。上述第一构成、第二构成和第三构成不应被理解为说明顺序,而应被理解为用于表达单独的分离的构成的手段。
上述有效成分是发挥目标效果的成分,例如,在牙齿美白用途中是指牙齿美白成分,在龋齿预防用途中是指龋齿预防成分,在牙齿知觉过敏症预防用途中是指牙齿知觉过敏症预防成分。特别是,牙齿美白成分是在业界中为了牙齿美白效果而使用的普通成分,可以包括过氧化物,并且上述过氧化物可以不包含在上述牙齿用包裹材料中。由于牙齿用包裹材料中不包含诸如过氧化物等有效成分,因此可以一起使用由于与过氧化物等的相容性而无法使用的香料、其他有效成分辅助剂(例如,牙齿美白辅助剂等)。
包含上述口腔用有效成分的组合物可以包含牙齿美白用组合物、口腔疾病预防用组合物等。上述牙齿美白用组合物包括牙齿美白成分,并且上述牙齿美白成分可以包括过氧化氢、过氧化脲(carbamide peroxide)、过氧化钙、过硼酸盐、过碳酸盐、过氧酸、过硫酸盐、亚氯酸钙、亚氯酸钡、亚氯酸镁、亚氯酸锂、亚氯酸钠或其混合物,并且可以使用在业界中用于牙齿美白的成分而没有限制,并且不能解释为必须限于上述成分。口腔疾病预防用功效成分可以是口腔干燥症、去除口臭、牙龈炎、牙周或龋齿的治疗或预防成分,或改善或缓解牙齿知觉过敏症的成分,并且可以使用在业界中用于预防或治疗口腔内疾病的成分而没有限制。可以包括例如抗微生物剂,其包括三氯生(triclosan)、洗必泰(chlorhexidine)、阿来西定(alexidine)、海克替啶(hexetidine)、血根碱(sanguinarine)、苯扎氯铵、水杨酰苯胺(salicylanilide)、溴化度米芬(domiphenbromide)、氯化十六烷基吡啶(cetylpyridinium chloride,CPC)、氯化十四烷基吡啶(tetradecylpyridinium chloride,TPC)或其混合物;抗炎症剂,其包括阿司匹林、酮咯酸(ketorolac)、氟比洛芬(flurbiprofen)、吡罗昔康(piroxicam)、甲氯芬那酸(meclofenamic acid)或其混合物;或硫胺素(thiamine)、核黄素(riboflavin)、烟酸(nicotinic acid)、泛酸(pantothenic acid)、吡哆醇(pyridoxine)、生物素、叶酸、维生素B12、硫辛酸(lipoic acid)、抗坏血酸、维生素A、维生素D、维生素E、维生素K或其混合物;或其混合物,但不限于此。另外,玉米不皂化滴定提取物、木兰提取物、没药、娜檀、洋甘菊、聚甲酚磺醛、积雪草滴定提取物、肉豆蔻提取物、右泛醇(dexpanthenol)、β-谷甾醇(β-sitosterol)、乙酰水杨酸(acetyl salicylic acid)等的有效预防和改善牙周疾病的药物可以单独或以一定比的混合物包含。可以包含改善或缓解牙齿知觉过敏症症状的成分,其包含单独或以2种以上的氯化锌、磷酸钾、二磷酸钾、氯化钙、草酸、草酸钾、草酸铁(ferricoxalate)、维生素E等。
牙齿用套件中包含的包含口腔用有效成分的组合物可以包括所有将药物递送至口腔内时使用的普通剂型,例如凝胶、糊剂、液状、喷雾剂或软膏等,但考虑到使用便利性、与厚度非常薄的牙齿用包裹材料一起使用时的附着力、药物装载可能性、涂抹性和从容器中的排出性等,可以优选为凝胶剂型。凝胶剂型的牙齿用组合物可以包括例如卡波姆、PVP等的粘合剂成分,特别是,当考虑到本发明的目的时,优选为卡波姆。基于上述组合物的总重量,上述卡波姆的含量可以为0.5至10重量%,优选为1至8重量%,可以为1.5至5重量%。当在上述含量范围内时,与牙齿用包裹材料的附着力、涂抹性等优异。本发明的牙齿用组合物涂抹于牙齿表面时,为了均匀涂抹且轻柔地涂展,可以具有酸性pH,并且优选地,可以为pH 3至6,优选约pH 4至5。特别是,在涂敷有上述组合物的牙齿表面附着牙齿用包裹材料时,由于pH上升而促进过氧化氢分解,同时随着凝胶的流动性降低,附着力可能上升。上述组合物可以进一步包含帮助药效成分的效果上升的辅助剂。例如,可以混合并包含过氧化氢、甘油、卡波姆、氢氧化钠和糖精钠等的成分。
存储包含上述口腔用有效成分的组合物的容器可以定量使用,并且没有特别限制,只要其是能够阻断与外部氧气接触的形式即可,优选地,可以优选为具有阻断阀的注射泵(syringe pump)。
上述套件在牙齿用包裹材料中不包含口腔用有效成分,特别是过氧化物,因此可以将与过氧化物的相容性差并且长时间接触时在流通过程中变质而无法使用的香料组合物包含在包裹材料中。因此,可以通过套件将香料和过氧化物一起应用于口腔内,因此可以将更多种香料用于牙齿美白用套件中。本发明的一个实施例可以提供一种牙齿美白用套件,其包含选自由柠檬、罗勒、桉树和伯爵茶等组成的组中的任意一种以上的香料,并且上述香料与过氧化物一起存在于口腔内。
在本发明的一个实施例中,上述套件可以进一步包含关于使用套件的方法的使用说明书或指南书。上述说明书或指南书可以包括关于从注射泵中排出凝胶的适当方法的指南、关于包含凝胶的注射泵的使用方法的指南、关于凝胶的使用量的指南以及关于将包裹材料附着而使用的方法的指南等。
关于凝胶的使用量和使用方法的指针可以包括以下。
从注射泵中排出0.2至0.6g或0.3至5.5g左右的凝胶,然后薄薄地涂敷于牙齿表面使得不接触牙龈,并且将包裹材料从离型纸上揭下,然后附着于牙齿表面,剩余的部位折叠到牙齿背面。上述包裹材料涂敷在牙齿上后,进行吸气使得能够去除残留在牙齿表面的唾液或水分。吸气的时间可以为一秒左右。上述包裹材料在涂敷后可以保持30分钟至60分钟。
除此之外,上述套件可以包括涂抹上述凝胶的工具(例如,海绵、刷子、橡胶材质的敷抹器等),并且上述工具也可以以与存储凝胶的容器结合的形式提供。在另一个实施例中,本发明的用于向牙齿递送口腔用有效成分的套件包括:a)包含粘合层和层叠在上述粘合层上的支撑层的牙齿用包裹材料,该粘合层包含选自由HPMC(羟丙基甲基纤维素)、PVP(聚乙烯吡咯烷酮)、EC(乙基纤维素)和Pullulan(普鲁兰)组成的组中的任意一种以上而不包含口腔用有效成分,以及b)存储包含口腔用有效成分的组合物的容器,上述容器可以进一步包含将a)的组合物涂敷于牙齿表面的工具。
关于涂敷上述凝胶的工具的使用方法的指南书也可以包含在上述套件中。上述套件还可以包含用于在将凝胶涂敷于牙齿表面之前去除残留在牙齿表面上的水分或唾液的工具。例如,利用具有良好水分吸收力的材料的敷抹器擦拭牙齿表面后,涂敷凝胶,并且通过上述敷抹器使凝胶和包裹材料良好地附着于牙齿表面。
本发明的另一个实施例提供了向牙齿递送口腔用有效成分的方法以及使用其的牙齿美白方法。
一个实施例可以包括:S1)将包含口腔用有效成分的组合物处理于牙齿的步骤;和
S2)用包含粘合层和层叠在上述粘合层上的支撑层的牙齿用包裹材料包裹经上述口腔用有效成分处理过的牙齿的步骤,该粘合层包含选自由HPMC(羟丙基甲基纤维素)、PVP(聚乙烯吡咯烷酮)、EC(乙基纤维素)和Pullulan(普鲁兰)组成的组中的任意一种以上而不包含口腔用有效成分。
另一个实施例提供了一种牙齿美白方法,其包括:S1)将包含牙齿美白用成分的组合物处理于牙齿的步骤;和
S2)用包含粘合层和层叠在上述粘合层上的支撑层的牙齿用包裹材料包裹经上述组合物处理过的牙齿的步骤,该粘合层包含选自由HPMC(羟丙基甲基纤维素)、PVP(聚乙烯吡咯烷酮)、EC(乙基纤维素)和Pullulan(普鲁兰)组成的组中的任意一种以上而不包含牙齿美白用成分。
另一个实施例可以进一步包括在S1)步骤之前去除牙齿表面的水分和/或唾液的步骤,但这种去除步骤可能不是必须的步骤。对于包裹上述牙齿的步骤,根据目的,可以包裹1个、2个、3个、4个、5个、6个、7个或8个或其以上的牙齿。上述包裹是指覆盖牙齿表面的形式,并且覆盖牙齿表面后剩余的部分还可以折叠到牙齿背面。
[发明效果]
本发明可以通过应用难以用于牙齿美白剂中的多种香料来改善使用者的使用感。在本发明中,将包裹材料从离型纸(PET层)上揭下时,尽管厚度薄,但仍可以容易地从离型纸上脱落而不易卷起。
本发明的牙齿美白用套件即使将包裹材料整晚附着在牙齿表面上,异物感也较小,并且容易保持附着在牙齿表面上的状态。
由于上述牙齿用包裹材料中不包含过氧化物,因此可以将与过氧化物的相容性差并且长时间接触时在流通过程中变质而无法使用的香料组合物包含在包裹材料中。因此,可以通过套件将香料和过氧化物一起应用于口腔内,因此可以将更多种香料用于牙齿美白用套件中。
[附图说明]
图1是示意性地示出了根据本发明的一个实施例的包含牙齿美白用凝胶和牙齿附着用包裹材料的套件的图。
图2是示意性地示出了球胶粘性(Ball tackiness)测量方法的图。
图3用图显示了将包裹材料从PET上揭下时的力的测量过程。
图4是示出测量包裹材料的卷起程度的过程的示意图。
[具体实施方式]
在下文中,为了更具体地说明本发明,将列举以下实施例等来说明。然而,根据本发明的实施例可以变形为多种不同形式,并且本发明的范围不应被解释为限于以下描述的实施例。本发明的实施例是为了帮助对本发明的具体理解而示例性提供的。除非另有说明,否则本说明书中记载的%可以理解为意指重量%。
[牙齿用凝胶-包裹材料药物递送系统]
如下,准备了包含凝胶和包裹材料的套件。对于本套件,凝胶中包含牙齿美白用有效成分,并且上述包裹材料包含香料而不包含牙齿美白用有效成分。下表1示出了凝胶的组成,表2示出了包裹材料的粘合层的组成。
[表1]
成分 | 凝胶 |
过氧化氢 | 6.0 |
甘油 | 20.0 |
卡波姆 | 1.8 |
氢氧化钠 | 0.08 |
糖精钠 | 0.1 |
纯净水 | 补足100 |
[表2]
制备方法如下。
凝胶-将除中和剂以外的原料投入配合槽中,均匀搅拌,并确认没有未溶解的或结合成块的,然后中和卡波姆以增加粘度。博勒飞粘度计(RV)Spindle No.7,20rpm,旋转15秒后,将粘度调节至20,000至480,000cps范围。
包裹材料-将原料投入配合槽中并均匀搅拌,然后利用逗号涂布机涂敷至一定厚度,并吹入干燥的热风(40~60℃)以干燥,然后层压支撑层(低密度聚乙烯(LDPE))。(Solvent casting)
[使用方法]
分别制备具有上述表1和2的组成的凝胶和包裹材料,并用于牙齿美白。上述凝胶定量使用,并存储在带有阻断阀的注射泵中以防止漏液。将从上述注射泵排出的一定量的凝胶涂敷于牙齿表面。一次使用0.2~0.6g左右时,不仅对牙齿表面,而且由于凝胶流入牙齿缝隙中,因此对齿间美白也有效。
包裹材料从离型纸(release liner)上脱离后附着于牙齿表面。
[胶粘性测量]
使用TA/TX analyzer测量。利用双面胶带将包裹材料产品的支撑层附着于机器的底面,然后从粘合层上揭下离型纸并测量球胶粘性。(干/湿)
图2示意性地示出了实验方法。
润湿方法:利用喷雾器喷一次纯净水。
按压时间(5sec),按压力(5gf),揭下的速度(10mm/sec)
根据处方的粘合力示于表3中。
[表3]
*F Max(gf):直到脱落时的最大力,F Min(gf):直到脱落时的最小力
根据湿润与否的粘合力示于表4中。
[表4]
测量从PET上揭下包裹材料时的力,并且实验方法示于图3中。
使用了TA/TX analyzer。
-将包裹材料产品的离型纸用双面胶带附着于机器的底面,然后用贴有双面胶带的圆筒形尖端(直径5mm)按压以附着支撑层和尖端,并测量包裹材料从离型纸上脱落时的力,并使尖端粘贴到包裹材料尺寸(10mm X 25mm)的一侧末端。
-按压时间(5sec),按压力(1000gf),揭下的速度(10mm/sec)
[表5]
[包裹材料卷起程度比较]
实验方法如下,如图4所示。
1.将包裹材料均匀地切割成橫长70mm且纵长20mm,然后用双面胶带将离型纸粘贴到机器底面以进行固定。
2.利用胶带粘贴Zwick万能试验机和包裹材料的支撑层
3.以一定速度拉动以从离型纸上揭下包裹材料。(13mm/sec)
4.不再展开包裹材料并测量长度
利用表2的包裹材料的卷起结果示于下表6中。
[表6]
编号 | 剥离后长度(mm) |
包裹材料1 | 44 |
包裹材料2 | 63 |
包裹材料3 | 62 |
包裹材料4 | 68 |
包裹材料1在剥离时容易卷起,因此长度变短。如上述表6可确认的那样,观察到包裹材料1在从离型纸揭下时,卷曲严重,包裹材料4则卷曲现象显著减少。
Claims (17)
1.一种牙齿用包裹材料,其包含粘合层和支撑层,该牙齿用包裹材料的特征在于,
所述牙齿用包裹材料不包含有效成分。
2.根据权利要求1所述的牙齿用包裹材料,其中,所述粘合层包含选自由HPMC(羟丙基甲基纤维素)、PVP(聚乙烯吡咯烷酮)、EC(乙基纤维素)和Pullulan(普鲁兰)组成的组中的任意一种以上。
3.根据权利要求2所述的牙齿用包裹材料,其中,所述粘合层包含选自由PVP(聚乙烯吡咯烷酮)和Pullulan(普鲁兰)组成的组中的任意一种以上。
4.根据权利要求2所述的牙齿用包裹材料,其中,所述粘合层包含PVP(聚乙烯吡咯烷酮)和Pullulan(普鲁兰)的混合物,
其中,相对于干燥的粘合层的总重量,所述Pullulan(普鲁兰)的含量为0.01重量%至3重量%,相对于干燥的粘合层的总重量,所述PVP(聚乙烯吡咯烷酮)的含量为30重量%至60重量%。
5.根据权利要求1所述的牙齿用包裹材料,其特征在于,所述牙齿用包裹材料包含相对于粘合层的总重量为3重量%至15重量%的香料。
6.根据权利要求3所述的牙齿用包裹材料,其中,所述粘合层不包含EC(乙基纤维素)和HPMC(羟丙基甲基纤维素)而包含PVP(聚乙烯吡咯烷酮)。
7.根据权利要求6所述的牙齿用包裹材料,其特征在于,所述粘合层还包含甘油作为增塑剂。
8.根据权利要求7所述的牙齿用包裹材料,其特征在于,所述PVP和甘油以PVP:甘油为1:0.5~0.8的重量比包含在所述粘合层中。
9.根据权利要求6所述的牙齿用包裹材料,其特征在于,所述粘合层包含相对于粘合层的总重量为4重量%至7重量%的表面活性剂。
10.根据权利要求6所述的牙齿用包裹材料,其特征在于,所述粘合层还包含选自羧甲基纤维素、乙酸纤维素、虫胶及其混合物中的一种以上的聚合物。
11.根据权利要求10所述的牙齿用包裹材料,其特征在于,PVP和所述选自羧甲基纤维素、乙酸纤维素、虫胶及其混合物中的一种以上的聚合物以1:0.1至0.2的重量比包含在所述粘合层中。
12.根据权利要求1所述的牙齿用包裹材料,其特征在于,所述牙齿用包裹材料是包含袋的压花图案。
13.根据权利要求1所述的牙齿用包裹材料,其中,所述牙齿用包裹材料的厚度为30μm至100μm。
14.一种用于向牙齿递送口腔用有效成分的套件,其包含:
a)包含粘合层和层叠在所述粘合层上的支撑层的牙齿用包裹材料,所述粘合层包含选自由HPMC(羟丙基甲基纤维素)、PVP(聚乙烯吡咯烷酮)、EC(乙基纤维素)和Pullulan(普鲁兰)组成的组中的任意一种以上而不包含口腔用有效成分;和
b)包含口腔用有效成分的组合物。
15.根据权利要求14所述的套件,其中,所述套件还包含c)关于使用的说明书。
16.根据权利要求14所述的套件,其特征在于,所述b)包含口腔用有效成分的组合物包含相对于组合物的总重量为0.5重量%至10重量%的卡波姆。
17.一种牙齿美白方法,包含:
S1)将包含牙齿美白用成分的组合物处理于牙齿的步骤;和
S2)用包含粘合层和层叠在所述粘合层上的支撑层的牙齿用包裹材料包裹经所述组合物处理过的牙齿的步骤,所述粘合层包含选自由HPMC(羟丙基甲基纤维素)、PVP(聚乙烯吡咯烷酮)、EC(乙基纤维素)和Pullulan(普鲁兰)组成的组中的任意一种以上而不包含牙齿美白用成分。
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KR20230042452A (ko) | 2023-03-28 |
US20210212907A1 (en) | 2021-07-15 |
CA3106007A1 (en) | 2021-07-13 |
US11857652B2 (en) | 2024-01-02 |
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