CN102764271B - 双组分口腔护理产品 - Google Patents
双组分口腔护理产品 Download PDFInfo
- Publication number
- CN102764271B CN102764271B CN201210249396.4A CN201210249396A CN102764271B CN 102764271 B CN102764271 B CN 102764271B CN 201210249396 A CN201210249396 A CN 201210249396A CN 102764271 B CN102764271 B CN 102764271B
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- Prior art keywords
- component
- salt
- phosphate
- fluoride
- weight
- Prior art date
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- 230000009977 dual effect Effects 0.000 title description 7
- 239000000203 mixture Substances 0.000 claims abstract description 69
- 150000003839 salts Chemical group 0.000 claims abstract description 23
- 150000001413 amino acids Chemical class 0.000 claims abstract description 22
- 210000004268 dentin Anatomy 0.000 claims abstract description 14
- 208000002193 Pain Diseases 0.000 claims abstract description 5
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims description 21
- 239000004475 Arginine Substances 0.000 claims description 18
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 17
- -1 phosphate anion Chemical class 0.000 claims description 16
- 229910052791 calcium Inorganic materials 0.000 claims description 13
- 239000011575 calcium Substances 0.000 claims description 13
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 12
- 229910019142 PO4 Inorganic materials 0.000 claims description 8
- 150000002500 ions Chemical class 0.000 claims description 6
- 230000007935 neutral effect Effects 0.000 claims description 6
- 239000010452 phosphate Substances 0.000 claims description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 5
- 238000002360 preparation method Methods 0.000 claims description 5
- 229940085991 phosphate ion Drugs 0.000 claims description 4
- 239000002244 precipitate Substances 0.000 claims description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical class [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 3
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- 238000007599 discharging Methods 0.000 claims 1
- 230000008030 elimination Effects 0.000 claims 1
- 238000003379 elimination reaction Methods 0.000 claims 1
- YRWWOAFMPXPHEJ-OFBPEYICSA-K sodium L-ascorbic acid 2-phosphate Chemical compound [Na+].[Na+].[Na+].OC[C@H](O)[C@H]1OC(=O)C(OP([O-])([O-])=O)=C1[O-] YRWWOAFMPXPHEJ-OFBPEYICSA-K 0.000 claims 1
- 229940048058 sodium ascorbyl phosphate Drugs 0.000 claims 1
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- 230000002708 enhancing effect Effects 0.000 abstract description 6
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- 229940091249 fluoride supplement Drugs 0.000 description 17
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 16
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- XEFQLINVKFYRCS-UHFFFAOYSA-N Triclosan Chemical compound OC1=CC(Cl)=CC=C1OC1=CC=C(Cl)C=C1Cl XEFQLINVKFYRCS-UHFFFAOYSA-N 0.000 description 10
- 239000003795 chemical substances by application Substances 0.000 description 10
- FGIUAXJPYTZDNR-UHFFFAOYSA-N potassium nitrate Chemical compound [K+].[O-][N+]([O-])=O FGIUAXJPYTZDNR-UHFFFAOYSA-N 0.000 description 10
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 238000000034 method Methods 0.000 description 9
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- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
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- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 5
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- RYJDNPSQBGFFSF-WCCKRBBISA-N (2s)-2-amino-5-(diaminomethylideneamino)pentanoic acid;carbonic acid Chemical compound OC(O)=O.OC(=O)[C@@H](N)CCCNC(N)=N RYJDNPSQBGFFSF-WCCKRBBISA-N 0.000 description 4
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 4
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 4
- 241000590002 Helicobacter pylori Species 0.000 description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 4
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 4
- 229910052700 potassium Inorganic materials 0.000 description 4
- 239000011591 potassium Substances 0.000 description 4
- 229960003975 potassium Drugs 0.000 description 4
- 239000000377 silicon dioxide Substances 0.000 description 4
- 239000011734 sodium Substances 0.000 description 4
- 239000004094 surface-active agent Substances 0.000 description 4
- 239000002202 Polyethylene glycol Substances 0.000 description 3
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- NPYPAHLBTDXSSS-UHFFFAOYSA-N Potassium ion Chemical compound [K+] NPYPAHLBTDXSSS-UHFFFAOYSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 239000003082 abrasive agent Substances 0.000 description 3
- ORILYTVJVMAKLC-UHFFFAOYSA-N adamantane Chemical compound C1C(C2)CC3CC1CC2C3 ORILYTVJVMAKLC-UHFFFAOYSA-N 0.000 description 3
- 229910001573 adamantine Inorganic materials 0.000 description 3
- 229910052783 alkali metal Inorganic materials 0.000 description 3
- 150000001340 alkali metals Chemical class 0.000 description 3
- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 3
- 150000001450 anions Chemical class 0.000 description 3
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- 150000001875 compounds Chemical class 0.000 description 3
- 238000000586 desensitisation Methods 0.000 description 3
- XPPKVPWEQAFLFU-UHFFFAOYSA-J diphosphate(4-) Chemical compound [O-]P([O-])(=O)OP([O-])([O-])=O XPPKVPWEQAFLFU-UHFFFAOYSA-J 0.000 description 3
- 230000009429 distress Effects 0.000 description 3
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- 229910052588 hydroxylapatite Inorganic materials 0.000 description 3
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- 208000015181 infectious disease Diseases 0.000 description 3
- OSWPMRLSEDHDFF-UHFFFAOYSA-N methyl salicylate Chemical compound COC(=O)C1=CC=CC=C1O OSWPMRLSEDHDFF-UHFFFAOYSA-N 0.000 description 3
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Classifications
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- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/20—Halogens; Compounds thereof
- A61K8/21—Fluorides; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/44—Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
牙用组合物,其例如消除或充分减轻与牙本质过敏有关的不适和疼痛并表现出增强的抗龋和再矿化益处,该组合物含有含钙源的第一组分、含阴离子源的第二组分,并且所述组分中的至少一种含有游离形式或盐形式的碱性氨基酸,使所述第一组分和第二组分保持彼此分开,直到被分配并组合而施用于牙齿。
Description
本申请是以下申请的分案申请:申请日:2009年2月6日;申请号:200980104640.4(PCT/US2009/033295);发明名称:“双组分口腔护理产品”。
技术领域
本申请要求于2008年2月8日提交的序列号为61/027,422的美国申请的权益,通过引用将其内容并入本文。
本发明涉及双组分洁齿剂配制物,其中该配制物中的活性组分在使用之前彼此隔离。在一个实施方式中,本发明涉及脱敏洁齿剂组合物,其消除或减轻与牙本质过敏有关的不适和疼痛,更具体地涉及脱敏牙用组合物,其含有游离形式或盐形式的碱性氨基酸和钙离子组分以及阴离子组分,该牙用组合物显示出意想不到的增强的防蛀(anticavity)和再矿化(remineralization)性能。
背景技术
牙本质过敏定义为对牙本质表面的物理刺激(如暴露的牙本质的热量(热或冷)刺激、渗透刺激、触觉刺激及热量、渗透及触觉刺激的组合)产生反应的急性局部化牙痛。
通常归因于牙龈退缩或牙釉质损失的牙本质暴露经常导致过敏。本领域已经确定,向表面开放的牙本质小管与牙本质过敏具有高度相关性,Abs,J.Clin.Periodontal.14,280-4(1987)。牙本质小管从牙髓通向牙骨质。当牙根的表面牙骨质被侵蚀时,牙本质小管变得暴露于外部环境。暴露的牙本质小管为传送流体流到牙髓神经提供通道,由温度、压力和离子梯度变化引起该传送。
本领域已知,钾盐有效治疗牙本质过敏。例如美国专利No.3,863,006公开了含有诸如硝酸钾之类的钾盐的牙膏在刷牙数周后使牙齿脱敏。本领域技术人员相信,位于敏感牙本质下面的牙髓神经附近的细胞外钾浓度的升高对含有硝酸钾的局部施用口腔产品的治疗性脱敏效果负责。由于钾离子被动扩散进入以及离开开放性牙本质小管,因此有必要反复施用活性成分,以在牙髓神经附近建立必需的浓度。
据信,改善的疼痛缓解得自在牙本质表面上使用钾盐结合逐渐矿化(其完全或部分闭塞牙本质小管)。完全闭塞将显著减少刺激疼痛的小管内的流体流。认为牙本质小管的部分闭塞增加钾离子在牙齿内部的递送,因为向内的扩散流量相比向外的流体流更少依赖小管半径(由于正的牙髓压)(参见D.H.Pashley和WGMathews,Archs.OralBiol.(1993)38,577-582)。因此,这种增强的钾递送应当增强缓解。
长久以来还已知,在洁齿剂中包含释放氟离子的化合物(fluoridereleasingcompound)作为抗龋剂,并且已经确定,这些化合物有效降低龋齿的发生率。常规使用的氟化物化合物是氟化钠、一氟磷酸钠和氟化亚锡。氟化物化合物的有效性主要是由于氟离子,其改善牙釉质的耐酸性并且在去矿化仅轻微进行时,在其早期阶段加速腐烂牙(decayedteeth)的再钙化或再矿化。通过再矿化,可减少或消除先前存在的牙齿腐烂和龋齿,从而减少在牙齿结构中先前存在的龋齿状况(cariousconditions)。改善牙釉质耐酸性的效果被认为是由于下述事实:氟离子被并入羟磷灰石的晶格中,羟磷灰石是牙釉质的主要成分,或者换句话说,氟离子部分氟化羟磷灰石并同时修复晶格的不规则性。
氟化物治疗的有效性取决于可用来沉积在受治疗牙釉质上的氟离子量。因此,配制在使用洁齿剂形成的刷牙溶液中提供最大氟离子利用率的洁齿剂组合物是合意的。
精氨酸和其它碱性氨基酸已被提议用于口腔护理,据信在抗击龋洞(cavity)形成和牙齿敏感方面具有明显益处。然而,将这些碱性氨基酸与具有口腔护理益处的无机物(例如氟化物和钙)组合,以形成具有可接受的长期稳定性的口腔护理产品已经证明具有挑战性。具体而言,碱性氨基酸可提高pH并促进能够与氟离子反应而形成不溶性沉淀物的钙离子的离解。此外,较高的pH具有引起刺激的可能性。然而,在中性pH或酸性pH下,利用精氨酸碳酸氢盐(本领域教导其是优选的)的系统可释放二氧化碳,这导致容器膨胀并爆裂。此外,可预期降低pH至中性或酸性条件将降低配制物的功效,因为精氨酸可形成对牙齿表面具有较差亲和性的不溶性精氨酸-钙络合物,并且此外,降低pH将降低配制物可能具有的对缓冲口中致龋乳酸的任何影响。部分因为存在尚未解决的配制障碍,部分因为在本领域精氨酸通常被认为是氟化物的潜在替代物而不是共活性剂(co-active),因此很少有动机制备包含精氨酸和氟化物两者的口腔护理产品。其它障碍可能是由于添加抗微生物剂所造成的。市售基于精氨酸的牙膏(如和)例如含有精氨酸碳酸氢盐和碳酸钙,但是不含氟化物也不含任何抗微生物剂。
尽管现有技术公开了各种口腔组合物在治疗牙本质过敏、龋齿和牙釉质去矿化(demineralization)方面的用途,但是对在此类治疗中提供改进性能的其它组合物和方法仍存在需要。
发明内容
根据本发明,提供用于治疗牙本质过敏的口腔组合物和方法,其显示出改善的防蛀(anticavity)和再矿化性能,所述组合物含有钙离子源组分、阴离子源组分,并且所述组分中的至少一种含有碱性氨基酸,每种组分任选地含于口腔可接受的载体中,使所述第一和第二组分保持彼此分开(maintainedseparatefromeachother),直至被分配并组合(combined),以施用于需要缓解牙本质过敏的牙齿,由此在向牙齿反复施用所述组合物时,使用者经历增强的牙本质过敏缓解并伴随改善的抗蛀性(resistancetocavities)。
在另一实施方式中,本发明包括改进口腔健康的方法,其包括向需要其的对象的口腔施用有效量的口腔组合物,例如,一种方法,以便:
a.减少或抑制龋齿的形成,
b.减少、修复或抑制早期牙釉质损伤,例如,如通过定量光导荧光(QLF)或电子龋齿测量(electricalcariesmeasurement)(ECM)所检测的损伤,
c.减少或抑制牙齿的去矿化并促进其再矿化,
d.减轻牙齿过敏,
e.减少或抑制龈炎,
f.促进口中溃疡(sores)或伤口(cuts)愈合,
g.降低产酸细菌水平,
h.增加精氨酸水解细菌(arginolyticbacteria)的相对水平,
i.抑制口腔中微生物生物膜的形成,
j.在糖攻击(sugarchallenge)后使牙菌斑pH升高和/或保持在至少pH5.5的水平,
k.减少牙菌斑累积,
l.治疗干口(drymouth),
m.例如通过减少经由口腔组织的全身感染的可能性来增强全身健康,包括心血管健康,
n.增白牙齿,
o.减少牙齿侵蚀,
p.使牙齿对致龋细菌免疫,和/或
q.清洁牙齿和口腔。
具体实施方式
“氟离子源”定义为可溶性氟(solublefluoride)或未共价键合的氟来源。
“阴离子源”定义为氟离子源、磷酸根离子源或其混合物。
“钙源”定义为容易与磷酸根离子反应而沉淀Ca3(PO4)2的钙来源或与氟化物反应产生CaF2的钙来源或氟化磷酸钙盐的混合物来源。
“磷酸根离子源”定义为未共价键合的磷酸根来源。
本发明的组合物是双组分组合物,其包含例如pH为约5至约9.9的包含钙离子源的第一洁齿剂组分;和包含阴离子源的第二洁齿剂组分,其例如缓冲至使pH保持在基本中性的pH水平,例如约6.5至约7,所述组合物具有存在于第一和第二洁齿剂组分之一或两者中的游离形式或盐形式的碱性氨基酸。这两种组分优选以大约相等的重量比组合,以致通过刷牙将所述组分组合并施用于牙齿时,任一组分内任何具体成分的浓度占到约一半。优选将两种组分配制为具有类似的物理特性,以致该两种组分在分开容纳(housed)于多室管或泵装置中时,可以通过挤出而以所需的预定量同时递送。
在本发明的双组分洁齿剂中,制备一种洁齿剂组分,其具有碱性pH和并且其组成与具有缓冲的中性pH的另一组分类似。将碱性组分的pH调节至约8.5至约9.7,优选约9至约9.5的pH。组合的洁齿剂组分的pH在约7.5至约8.6(优选约7.5至约8.5)的范围内。
将碱性试剂,例如碱金属化合物包括氢氧化钠、氢氧化钾、碳酸氢钠、碳酸钠、N-硅酸钠(34.6%硅酸钠水溶液,得自PQCorporation);碱性氨基酸;或碱性氨基酸的碳酸氢盐,如精氨酸碳酸氢盐(argininebicarbonate),以按组分重量计约0.5%至约15%(优选约1%至约8%,最优选约1%至约5%)的量并入双组分洁齿剂中的碱性pH洁齿剂组分中。也可以使用上述碱金属化合物的混合物。氢氧化钠是优选的碱性试剂。在本发明的组合物和方法中可以使用的碱性氨基酸不仅包括天然存在的碱性氨基酸,例如精氨酸、赖氨酸和组氨酸,还包括在分子中具有羧基和氨基的任意碱性氨基酸,其是水溶性的并且提供pH为约7或更大(例如至少约8)的水溶液。
因此,碱性氨基酸包括但不限于精氨酸、赖氨酸、瓜氨酸(citrullene)、鸟氨酸、肌酸、组氨酸、二氨基丁酸、二氨基丙酸,它们的盐或它们的组合。在具体实施方式中,碱性氨基酸选自精氨酸、瓜氨酸和鸟氨酸。
在某些实施方式中,碱性氨基酸是精氨酸(例如1-精氨酸)或其盐。
本发明的组合物有意用于在口中局部使用,因此用于本发明中的盐以所提供的量和浓度对于此类使用应当是安全的。合适的盐包括本领域已知为药学上可接受盐的盐,通常认为药学上可接受的盐以所提供的量和浓度是生理学上可接受的。生理学上可接受的盐包括衍生自药学上可接受的无机酸或碱或有机酸或碱的那些盐,例如由形成生理学上可接受的阴离子的酸形成的酸加成盐,例如盐酸盐或氢溴酸盐;以及由形成生理学上可接受的阳离子的碱形成的碱加成盐,例如衍生自诸如钾和钠之类的碱金属或诸如钙和镁之类的碱土金属的那些盐。可以使用本领域已知的标准程序获得生理学上可接受的盐,例如通过使足够碱性的化合物(例如胺)与提供生理学上可接受的阴离子的合适的酸反应获得。在一些实施方式中,碱性氨基酸用酸(例如盐酸、磷酸或碳酸)中和,以形成盐或偏盐(partialsalt),之后与钙、氟化物或其它反应性性组分一起配制。
在各种实施方式中,碱性氨基酸的存在量为总组合物重量的约0.5wt.%至约20wt.%、总组合物重量的约1wt.%至约10wt.%,例如总组合物重量的约1.5wt.%、3.75wt.%、5wt.%或7.5wt.%。
本发明洁齿剂组合物的载体制备中所用的湿润剂通常是湿润剂的混合物,所述湿润剂例如甘油、山梨糖醇和分子量在约200至约1000范围内的聚乙二醇,但是也可以使用湿润剂的其它混合物和单一湿润剂。湿润剂含量为洁齿剂组分重量的约10%至约50%,优选约20%至约40%。水分含量为约20重量%至约50重量%,优选约30重量%至约40重量%。
在洁齿剂载体制备中所用的增稠剂包括有机增稠剂和无机增稠剂。可以包括在洁齿剂组分中的无机增稠剂包括无定形二氧化硅,例如得自HuberCorporation的Zeodent165以及来自W.R.Grace的Sylox15。
天然及合成树胶和胶体有机增稠剂也可以用于制备本发明的洁齿剂组分。此类增稠剂的实例是角叉菜胶(爱尔兰藓)、黄原胶、羧甲基纤维素钠、淀粉、聚乙烯吡咯烷酮、羟乙基丙基纤维素、羟丁基甲基纤维素、羟丙基甲基纤维素和羟乙基纤维素。
可以约0.5重量%至约5重量%(优选约1重量%至约3重量%)的浓度将无机增稠剂并入本发明的洁齿剂组合物中。可以约0.1重量%至约3重量%(优选约0.4重量%至约1.5重量%)的浓度将有机增稠剂并入本发明的组合物中。
可将表面活性剂并入洁齿剂组合物中,以提供发泡性能。优选表面活性剂在性质上为阴离子或非离子的。阴离子表面活性剂的合适实例是高级烷基硫酸盐,例如月桂基硫酸钾或月桂基硫酸钠(其是优选的);高级脂肪酸单甘油酯单硫酸盐,例如氢化椰油脂肪酸的单硫酸化单甘油酯的盐;烷基芳基磺酸盐,例如十二烷基苯磺酸钠;高级脂肪磺基乙酸酯、1,2二羟基丙磺酸盐的高级脂肪酸酯。
表面活性剂通常以约0.5重量%至约10重量%,优选约1重量%至约5重量%的浓度存在于本发明的洁齿剂组分组合物中。
可将磨料并入本发明的洁齿剂组合物中,优选的磨料是含硅物质,例如二氧化硅。优选的二氧化硅是沉淀的无定形水合二氧化硅,例如由CrosfieldChemicals销售的SorbosilAC-35或来自HuberCompany的Zeodent115,但是也可以使用其它磨料,包括羟磷灰石、偏磷酸钠、偏磷酸钾、磷酸三钙、磷酸钙二水合物、无水磷酸氢钙、焦磷酸钙、正磷酸镁、磷酸三镁、碳酸钙、碳酸氢钠、氧化铝三水合物、硅酸铝、煅烧氧化铝和膨润土。
本发明洁齿剂组合物中的磨料浓度通常为约5重量%至约40重量%,优选约10重量%至约25重量%。
脱敏钾离子的来源通常是水溶性钾盐,包括硝酸钾、柠檬酸钾、氯化钾、碳酸氢钾和草酸钾,其中优选硝酸钾。通常以约1重量%至约20重量%(优选约3重量%至约10重量%)的浓度将钾盐并入一种或多种洁齿剂组分中。
活性成分的水平将基于递送系统的性质以及特定的活性物质而变化。例如,碱性氨基酸可以以例如约0.1至约20wt%(以游离碱的重量表示)的水平存在,例如,对于漱口剂,约0.1至约3wt%;对于消费者用牙膏,约1至约10wt%;或者对于专业或处方治疗产品,约7至约20wt%。氟化物可以以例如约25至约25,000ppm的水平存在,例如,对于漱口剂,约25至约250ppm;对于消费者用牙膏,约750至约2,000ppm;或者对于专业或处方治疗产品,约2,000至约25,000ppm。抗菌剂的水平将类似地变化,其中牙膏中使用的水平例如是漱口剂中使用的水平的约5至约15倍。例如,三氯生漱口剂可以含有例如约0.03wt%三氯生,而三氯生牙膏可以含有约0.3wt%三氯生。
有用于本发明实践中的具有防牙垢功效的焦磷酸盐包括水溶性盐,例如二碱金属焦磷酸盐或四碱金属焦磷酸盐,例如Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7和K2H2P2O7。焦磷酸盐包括水溶性碱金属三聚磷酸盐,例如三聚磷酸钠和三聚磷酸钾。
以约0.5至约2重量%(优选约1.5至约2重量%)的浓度将焦磷酸盐并入本发明的洁齿剂组合物中,以约1至约7重量%的浓度将聚磷酸盐并入本发明的洁齿剂组合物中。
着色剂(例如颜料和染料)可用于本发明的实践中。颜料包括无毒的水不溶性无机颜料,例如二氧化钛和氧化铬绿、群青蓝和群青粉、和氧化铁,以及通过在氧化铝上延展FD&C染料的钙盐或铝盐制备的水不溶性染料色淀,例如FD&C绿#1色淀、FD&C蓝#2色淀、FD&CR&D#30色淀和FD&C#黄15色淀。颜料具有约5至约1000微米的粒度,优选为约250至约500微米,并且以约0.5至约3重量%的浓度存在。
在本发明实践中使用的染料通常是目前在食品、药品和化妆品法案(FoodDrug&CosmeticAct)下证明合格的用于食品和摄入药物中的食品色素添加剂,包括染料,例如FD&C红No.3(四碘荧光素的钠盐)、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-6-单磺酸盐的钠盐)、FD&C绿No.3(4-{[4-(N-乙基-对-磺基苄氨基)-苯基]-(4-羟基-2-锍苯基)-亚甲基(mewthylene)}-[1-(N-乙基-N-对-磺基苄基)--3,5-环己二烯亚胺的二钠盐]-、FD&C蓝No.1(靛蓝的二苄基二乙基二氨基三苯基甲醇三磺酸的二钠盐),以及它们的各种比例的混合物。在本发明中实现最有效结果的染料浓度以总重量的约0.0005%至约2%的量存在于洁齿剂组合物中。
使用本发明的双组分洁齿剂实施方式可以得到带条纹的洁齿剂产品,其中将对比颜色的着色剂并入待被分配的每一种洁齿剂组分中;当以建议量使用着色剂时,其在药学上和生理学上是无毒的。在本发明实践中使用的着色剂包括上面讨论的颜料和染料两者。
任何合适的调味或甜味物质也可以并入本发明的洁齿剂组合物中。合适的调味成分的实例是调味油,例如留兰香(spearmint)油、薄荷油、冬青油、黄樟油、丁香油、鼠尾草油、桉树油、马郁兰油、肉桂油、柠檬油和柑橘油,以及水杨酸甲酯。合适的甜味剂包括蔗糖、乳糖、麦芽糖、山梨糖醇、木糖醇、环己基氨基磺酸钠、紫苏糖(perillatine)和糖精钠。合适地,调味剂和甜味剂可一起占所述配制物的约0.01%至约5%或更多。
抗菌剂是基于酚和双酚化合物、卤代二苯醚(如三氯生)、苯甲酸酯和N-碳酰苯胺的非阳离子抗菌剂;以及阳离子抗菌剂,例如二葡萄糖酸洗必泰(chlorhexidinedigluconate)。此类抗菌剂可以特定组分重量的约0.03%至约1%的量存在。
当非阳离子抗菌剂或抗菌剂包含在任何洁齿剂组分中时,也优选包含约0.05%至约5%的增强所述抗菌剂向口腔表面递送和保留以及增强其在口腔表面上的保留的试剂。用于本发明中的此类试剂公开在美国专利No.5,188,821和5,192,531中;并且其包括合成的阴离子聚合聚羧酸酯,例如马来酐或马来酸与另一种可聚合烯键式不饱和单体的约1∶4至约4∶1共聚物,优选分子量(M.W.)为约30,000至约1,000,000的甲基乙烯基醚/马来酐,最优选约30,000至约800,000。这些共聚物例如以Gantrez.可得,例如AN139(M.W.500,000)、AN119(M.W.250,000),优选S-97药品级(M.W.700,000),可得自ISPTechnologies,Inc.,BoundBrook,N.J.08805。增强剂当存在时,以约0.05重量%至约3重量%的量存在。
为制备本发明的洁齿剂组分,通常将湿润剂(例如丙二醇、聚乙二醇成分)与任意的有机增稠剂、甜味剂、颜料(例如二氧化钛)和作为抗牙垢成分被包含的任何聚磷酸盐一起分散。然后将水与任意的抗菌剂(如三氯生)、任意的抗菌增强剂(如Gantrez)和任意的抗牙垢附加剂一起加入到该分散体中。在第一中性pH组分中添加氟离子源脱敏剂和磷酸盐缓冲剂。在第二组分中添加调节pH至碱性水平的成分,例如氢氧化钠。混合这些成分,直到获得每种组分的均相。之后,添加无机增稠剂、二氧化硅磨料、调味剂和表面活性剂成分,在约20至约100mmHg真空下高速混合各成分。在每种组分的情况下,得到的产品都是均匀的半固体可挤压膏状产品。
洁齿剂组合物可以膏或凝胶的形式通过刷牙而施用于过敏牙齿表面,或使用柔软涂刷,通过以液体涂剂形式直接刷在牙齿表面上而被局部施用。
活性成分的水平将基于递送系统的性质以及特定的活性物质而变化。例如,碱性氨基酸可以例如约0.1至约20wt%(以游离碱的重量表示)的水平存在,例如对于漱口剂,约0.1至约3wt%;对于消费者用牙膏,约1至约10wt%;或对于专业或处方治疗产品,约7至约20wt%。氟化物可以例如约25至约25,000ppm的水平存在,例如,对于漱口剂,约25至约250ppm;对于消费者用牙膏,约750至约2,000ppm;或者对于专业或处方治疗产品,约2,000至约25,000ppm。抗菌剂的将水平类似地变化,其中牙膏中使用的水平例如是漱口剂中使用的水平的约5至约15倍。例如,三氯生漱口剂可以含有例如约0.03wt%三氯生,而三氯生牙膏可以含有约0.3wt%三氯生。
增强口腔健康也提供全身健康的益处,因为口腔组织是全身感染的入口。良好的口腔健康与包括心血管健康在内的全身健康相关。本发明的组合物和方法提供特别的益处,因为碱性氨基酸(尤其精氨酸)是供应NO合成途径并因此增强口腔组织中的微循环的氮源。提供酸性较弱的口腔环境也有助于降低胃的不良应激(distress)并创立对幽门螺旋杆菌(Heliobacter)较为不利的环境,幽门螺旋杆菌与胃溃疡相关。高度表达特异性免疫细胞受体(例如T-细胞受体)特别需要精氨酸,因此精氨酸能够增强有效的免疫应答。本发明的组合物和方法因此有用于增强包括心血管健康在内的全身健康。
将本发明的多组分洁齿剂组合物实施方式包装在合适的分配容器中,在该容器中将各组分保持物理分开,并且分开的组分从中可以被同时分配,作为组合带状物施用于牙刷上。此类容器在本领域是已知的。此类容器的实例是双室分配容器,例如泵或管,其具有可折叠(collapsible)的侧壁,如美国专利No.4,487,757和4,687,663所公开;其中,管体(tubebody)由可折叠的塑料网(例如聚乙烯或聚丙烯)形成,其带有在容器体内定义隔室的部分,在隔室中被物理分开的组分得以贮存,并通过合适的分配出口从中得到分配。
增强口腔健康也提供全身健康的益处,因为口腔组织是全身感染的入口。良好的口腔健康与包括心血管健康在内的全身健康相关。本发明的组合物和方法提供特别的益处,因为碱性氨基酸(尤其精氨酸)是供应NO合成途径并因此增强口腔组织中的微循环的氮源。提供酸性较弱的口腔环境也有助于降低胃的不良应激并创立对幽门螺旋杆菌较为不利的环境,幽门螺旋杆菌与胃溃疡相关。高度表达特异性免疫细胞受体(例如T-细胞受体)特别需要精氨酸,因此精氨酸能够增强有效的免疫应答。本发明的组合物和方法因此有用于增强包括心血管健康在内的全身健康。
如通篇所用,范围用作简略表达(shorthand),用于描述该范围内的每个值。可选择该范围内的任意值作为该范围的端点。另外,本文引用的所有参考文献通过引用以其整体并入本文。在本公开中的定义与所引用参考文献的定义相冲突的情况下,以本公开为准。应理解,当描述配制物时,可以根据其成分对它们进行描述,这在本领域是常见的,尽管在制备、贮存和使用实际配制物时,这些成分可能彼此反应,此类产品有意被所述配制物覆盖。
下述实施例进一步描述和说明本发明范围内的示例性实施方式。提供所述实施例仅仅用于举例说明,并非被解释为限定本发明,因为在不背离其精神和范围的情况下,很多变化是可能的。除本文显示和描述的那些修改之外,本发明的各种修改对本领域技术人员而言是显而易见的,并有意落在所附权利要求内。
实施例I
制备本发明的双组分(组分A和B)脱敏洁齿剂,称为″洁齿剂X″、组分A和组分B。当以等量组合用于刷牙时,洁齿剂X将有效地提供增强的防蛀和再矿化性能。组分A和组分B的成分列在下表I中。
表1
在制备洁齿剂X时,制备组分A和组分B,其中将甘油、聚乙二醇和有机增稠剂在常规混合器中分散,直到混合物变成浆液(slurry),该浆液外观匀滑。将色料和甜味剂分散在该浆液中,之后添加水。然后将L-精氨酸分散在浆液中并通过添加磷酸进行中和。还添加硝酸钾。在这些组分混合之后,然后将二氧化硅、磷酸二钙和山梨酸钾组分添加至单独(individual)组分中,然后将其充分混合。最后将氟化物、月桂基硫酸钠、调味剂和颜料添加至单独的洁齿剂组分中,之后在真空下混合另外5-15分钟,以制备得到的组分产品。
将双组分包装在双室管中,以防止A中的氟化物与B中的钙之间发生反应。双室管允许将该两相作为带有条纹的牙膏一起分配。
提供为可溶性氟化钠的氟化物连同高水平的钙、磷酸盐和精氨酸导致这些成分在牙齿表面上具有高度利用率,在牙齿表面上,它们有效降低去矿化、促进再矿化以及修复对牙釉质的损害,所述损害导致牙齿过敏,并最终形成牙齿的龋洞。
Claims (6)
1.以下双组分在制备用于消除或减轻与牙本质过敏有关的不适和疼痛的组合物中的用途:
(1)包含钙源的第一组分,所述第一组分具有8.5-9.7的碱性pH值,和
(2)包含阴离子源的第二组分,所述第二组分具有6.5-7的基本中性pH值,
所述组分中的至少一种含有碱性氨基酸,分开容纳所述第一和第二组分,使所述第一组分和第二组分保持彼此分开,直至被分配并组合,
其中所述阴离子源包含氟离子源、磷酸根离子源或其混合物;所述钙源包括容易与磷酸根离子反应而沉淀Ca3(PO4)2的钙来源,或与氟化物反应产生CaF2的钙来源,或氟化磷酸钙盐的混合物;并且所述第一组分和所述第二组分以相等的重量比例存在。
2.权利要求1所述的用途,其中每种组分含有精氨酸。
3.权利要求1所述的用途,其中所述氟离子源递送250ppm至25,000ppm的氟离子浓度。
4.权利要求1所述的用途,其中所述氟离子源包含可释放氟离子的盐。
5.权利要求1所述的用途,其中所述磷酸根离子源包含可释放磷酸根的盐。
6.权利要求5所述的用途,其中所述可释放磷酸根的盐是磷酸钠盐。
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- 2009-02-06 CN CN2009801046404A patent/CN101938975B/zh not_active Expired - Fee Related
- 2009-02-06 TW TW098103784A patent/TWI457141B/zh not_active IP Right Cessation
- 2009-02-06 CA CA2710604A patent/CA2710604C/en not_active Expired - Fee Related
- 2009-02-06 MX MX2010007740A patent/MX2010007740A/es unknown
- 2009-02-06 JP JP2010546019A patent/JP5584629B2/ja not_active Expired - Fee Related
- 2009-02-06 CN CN201210249396.4A patent/CN102764271B/zh not_active Expired - Fee Related
- 2009-02-06 RU RU2010137324/15A patent/RU2476200C2/ru not_active IP Right Cessation
- 2009-02-06 AR ARP090100432A patent/AR070586A1/es unknown
- 2009-02-06 TW TW103121297A patent/TWI552762B/zh not_active IP Right Cessation
- 2009-02-06 EP EP20090707335 patent/EP2249770A4/en not_active Ceased
- 2009-02-06 AU AU2009212324A patent/AU2009212324B2/en not_active Ceased
- 2009-02-06 US US12/866,639 patent/US20110059029A1/en not_active Abandoned
- 2009-02-06 MY MYPI2010002607A patent/MY157315A/en unknown
- 2009-02-06 BR BRPI0907102A patent/BRPI0907102A2/pt active Search and Examination
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2010
- 2010-09-02 CO CO10108727A patent/CO6300924A2/es not_active Application Discontinuation
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2014
- 2014-07-18 JP JP2014147534A patent/JP2014221814A/ja active Pending
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Also Published As
Publication number | Publication date |
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EP2249770A4 (en) | 2014-02-19 |
WO2009100268A3 (en) | 2009-11-05 |
CN101938975B (zh) | 2012-09-05 |
RU2010137324A (ru) | 2012-03-20 |
US20110059029A1 (en) | 2011-03-10 |
CA2710604A1 (en) | 2009-08-13 |
CA2710604C (en) | 2014-07-08 |
CN101938975A (zh) | 2011-01-05 |
EP2249770A2 (en) | 2010-11-17 |
MY157315A (en) | 2016-05-31 |
TW200948385A (en) | 2009-12-01 |
MX2010007740A (es) | 2010-08-06 |
AR070586A1 (es) | 2010-04-21 |
RU2476200C2 (ru) | 2013-02-27 |
TW201442734A (zh) | 2014-11-16 |
TWI552762B (zh) | 2016-10-11 |
JP5584629B2 (ja) | 2014-09-03 |
BRPI0907102A2 (pt) | 2016-05-03 |
JP2011511795A (ja) | 2011-04-14 |
WO2009100268A2 (en) | 2009-08-13 |
CN102764271A (zh) | 2012-11-07 |
AU2009212324B2 (en) | 2011-12-08 |
TWI457141B (zh) | 2014-10-21 |
JP2014221814A (ja) | 2014-11-27 |
CO6300924A2 (es) | 2011-07-21 |
AU2009212324A1 (en) | 2009-08-13 |
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