CN104853727B - 包含氧化锌和三甲基甘氨酸的口腔护理产品 - Google Patents
包含氧化锌和三甲基甘氨酸的口腔护理产品 Download PDFInfo
- Publication number
- CN104853727B CN104853727B CN201280077893.9A CN201280077893A CN104853727B CN 104853727 B CN104853727 B CN 104853727B CN 201280077893 A CN201280077893 A CN 201280077893A CN 104853727 B CN104853727 B CN 104853727B
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- CN
- China
- Prior art keywords
- composition
- zinc
- zinc oxide
- acid
- trimethylglycine
- Prior art date
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- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 title claims abstract description 129
- KWIUHFFTVRNATP-UHFFFAOYSA-N glycine betaine Chemical compound C[N+](C)(C)CC([O-])=O KWIUHFFTVRNATP-UHFFFAOYSA-N 0.000 title claims abstract description 76
- 239000011787 zinc oxide Substances 0.000 title claims abstract description 64
- 239000000203 mixture Substances 0.000 claims abstract description 165
- 150000003839 salts Chemical class 0.000 claims abstract description 34
- 210000000214 mouth Anatomy 0.000 claims abstract description 30
- 238000004519 manufacturing process Methods 0.000 claims abstract description 14
- 239000011701 zinc Substances 0.000 claims description 52
- 239000002253 acid Substances 0.000 claims description 50
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 45
- 229910052725 zinc Inorganic materials 0.000 claims description 45
- 238000010790 dilution Methods 0.000 claims description 39
- 239000012895 dilution Substances 0.000 claims description 39
- -1 trimethylglycine Compound Chemical class 0.000 claims description 39
- 239000003795 chemical substances by application Substances 0.000 claims description 32
- 238000002360 preparation method Methods 0.000 claims description 32
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical group Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 21
- 210000003298 dental enamel Anatomy 0.000 claims description 20
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims description 18
- 239000000606 toothpaste Substances 0.000 claims description 18
- 229940034610 toothpaste Drugs 0.000 claims description 18
- 229910019142 PO4 Inorganic materials 0.000 claims description 17
- 208000002925 dental caries Diseases 0.000 claims description 15
- 239000010452 phosphate Substances 0.000 claims description 14
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 13
- 208000002064 Dental Plaque Diseases 0.000 claims description 11
- 238000000227 grinding Methods 0.000 claims description 11
- 230000015572 biosynthetic process Effects 0.000 claims description 10
- 239000000843 powder Substances 0.000 claims description 10
- 210000003296 saliva Anatomy 0.000 claims description 10
- 239000004094 surface-active agent Substances 0.000 claims description 10
- 239000000080 wetting agent Substances 0.000 claims description 10
- 208000007565 gingivitis Diseases 0.000 claims description 9
- 239000002562 thickening agent Substances 0.000 claims description 9
- 239000000047 product Substances 0.000 claims description 8
- 230000009467 reduction Effects 0.000 claims description 8
- 241000894006 Bacteria Species 0.000 claims description 7
- 201000002170 dentin sensitivity Diseases 0.000 claims description 7
- 239000011159 matrix material Substances 0.000 claims description 7
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims description 6
- 206010020751 Hypersensitivity Diseases 0.000 claims description 6
- 208000026935 allergic disease Diseases 0.000 claims description 6
- 229920006318 anionic polymer Polymers 0.000 claims description 6
- 206010006326 Breath odour Diseases 0.000 claims description 5
- 208000032139 Halitosis Diseases 0.000 claims description 5
- 125000000129 anionic group Chemical group 0.000 claims description 5
- 239000003153 chemical reaction reagent Substances 0.000 claims description 5
- 235000009508 confectionery Nutrition 0.000 claims description 5
- 239000003292 glue Substances 0.000 claims description 5
- 230000009610 hypersensitivity Effects 0.000 claims description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 4
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 4
- 239000006071 cream Substances 0.000 claims description 4
- 239000000796 flavoring agent Substances 0.000 claims description 4
- 235000019634 flavors Nutrition 0.000 claims description 4
- 235000013599 spices Nutrition 0.000 claims description 4
- JIAARYAFYJHUJI-UHFFFAOYSA-L zinc dichloride Chemical compound [Cl-].[Cl-].[Zn+2] JIAARYAFYJHUJI-UHFFFAOYSA-L 0.000 claims description 4
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 3
- 229910021529 ammonia Inorganic materials 0.000 claims description 3
- 239000011575 calcium Substances 0.000 claims description 3
- 229910052791 calcium Inorganic materials 0.000 claims description 3
- 238000004040 coloring Methods 0.000 claims description 3
- 239000001103 potassium chloride Substances 0.000 claims description 3
- 235000011164 potassium chloride Nutrition 0.000 claims description 3
- 239000002390 adhesive tape Substances 0.000 claims description 2
- 230000002421 anti-septic effect Effects 0.000 claims description 2
- 238000005282 brightening Methods 0.000 claims description 2
- 239000000872 buffer Substances 0.000 claims description 2
- 238000005660 chlorination reaction Methods 0.000 claims description 2
- 230000001629 suppression Effects 0.000 claims description 2
- 239000011592 zinc chloride Substances 0.000 claims description 2
- 235000005074 zinc chloride Nutrition 0.000 claims description 2
- 229960001939 zinc chloride Drugs 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims 2
- 201000005581 enamel erosion Diseases 0.000 claims 1
- 239000002244 precipitate Substances 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 58
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 45
- 150000001875 compounds Chemical class 0.000 description 40
- 238000001556 precipitation Methods 0.000 description 29
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- 239000000523 sample Substances 0.000 description 20
- 229940091249 fluoride supplement Drugs 0.000 description 16
- 230000008901 benefit Effects 0.000 description 15
- 238000005189 flocculation Methods 0.000 description 15
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- 239000000499 gel Substances 0.000 description 14
- 239000000463 material Substances 0.000 description 13
- 239000002245 particle Substances 0.000 description 13
- 238000012545 processing Methods 0.000 description 13
- 239000011734 sodium Substances 0.000 description 13
- 239000000243 solution Substances 0.000 description 13
- 210000004268 dentin Anatomy 0.000 description 12
- 229910052708 sodium Inorganic materials 0.000 description 12
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 11
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 description 11
- 238000002156 mixing Methods 0.000 description 10
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- 150000003751 zinc Chemical class 0.000 description 10
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- 150000002500 ions Chemical class 0.000 description 9
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- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 description 8
- 230000008859 change Effects 0.000 description 8
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- 239000001257 hydrogen Substances 0.000 description 8
- 229910052739 hydrogen Inorganic materials 0.000 description 8
- 239000003921 oil Substances 0.000 description 8
- 235000019198 oils Nutrition 0.000 description 8
- NBIIXXVUZAFLBC-UHFFFAOYSA-N phosphoric acid Substances OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 8
- PUZPDOWCWNUUKD-UHFFFAOYSA-M sodium fluoride Chemical compound [F-].[Na+] PUZPDOWCWNUUKD-UHFFFAOYSA-M 0.000 description 8
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 7
- 238000004140 cleaning Methods 0.000 description 7
- 229920001577 copolymer Polymers 0.000 description 7
- 229910052757 nitrogen Inorganic materials 0.000 description 7
- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 description 7
- 239000000126 substance Substances 0.000 description 7
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- 235000001014 amino acid Nutrition 0.000 description 6
- 239000002585 base Substances 0.000 description 6
- JUNWLZAGQLJVLR-UHFFFAOYSA-J calcium diphosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])(=O)OP([O-])([O-])=O JUNWLZAGQLJVLR-UHFFFAOYSA-J 0.000 description 6
- 239000000460 chlorine Substances 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 6
- 238000011065 in-situ storage Methods 0.000 description 6
- FPYJFEHAWHCUMM-UHFFFAOYSA-N maleic anhydride Chemical compound O=C1OC(=O)C=C1 FPYJFEHAWHCUMM-UHFFFAOYSA-N 0.000 description 6
- 239000000178 monomer Substances 0.000 description 6
- 229910052700 potassium Inorganic materials 0.000 description 6
- 239000002243 precursor Substances 0.000 description 6
- 235000019818 tetrasodium diphosphate Nutrition 0.000 description 6
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 5
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 5
- 239000011149 active material Substances 0.000 description 5
- 150000001413 amino acids Chemical class 0.000 description 5
- 229940043256 calcium pyrophosphate Drugs 0.000 description 5
- HOPSCVCBEOCPJZ-UHFFFAOYSA-N carboxymethyl(trimethyl)azanium;chloride Chemical compound [Cl-].C[N+](C)(C)CC(O)=O HOPSCVCBEOCPJZ-UHFFFAOYSA-N 0.000 description 5
- 239000008367 deionised water Substances 0.000 description 5
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- 239000012467 final product Substances 0.000 description 5
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- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 4
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 4
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Abstract
本文描述了口腔护理组合物,其包含氧化锌和游离或口腔可接受盐形式的三甲基甘氨酸的混合物。还提供制造和使用所述组合物的方法。
Description
背景
牙侵蚀涉及由于来自非细菌源的酸侵蚀而导致的对牙齿结构的脱矿化和损坏。侵蚀最初发现于釉质,并且若未受到抑制,则可进入下层牙质。牙侵蚀可由酸性食品和饮品、暴露于氯化泳池水和回流的胃酸引起或增剧。牙釉质为带负电的表面,其自然地趋向吸引带正电的离子如氢和钙离子,同时排斥带负电的离子如氯离子。取决于唾液周围的相对pH,牙釉质将失去或得到带正电的离子如钙离子。通常唾液的pH介于7.2-7.4。当pH降低且氢离子的浓度变得相对高时,氢离子将替代釉质中的钙离子形成磷酸氢(磷酸),所述磷酸氢损坏釉质并产生多孔的、海绵样的粗糙表面。若唾液在长时间保持酸性,则再矿化可能不会发生,且牙齿将继续损失矿物质,导致牙齿弱化并最终损失结构。
牙质的超敏性是响应于牙质表面的物理刺激的急性局部牙痛,所述物理刺激如通过温度(热或冷)渗透、温度的触觉组合、暴露的牙质的渗透和触觉刺激所引起。牙质的曝露通常是由于牙龈的回缩或釉质的损失,这经常导致超敏性。对表面开放的牙质小管与牙质的超敏性高度相关。牙质小管从牙髓导向牙骨质。当牙根的表面牙骨质受到侵蚀时,牙质小管变得暴露于外界环境。暴露的牙质小管提供将流体流传送至牙髓神经的路径,通过温度、压力和离子梯度的变化诱导传送。
重金属离子如锌对酸侵蚀有抵抗性。在电化序中锌排位高于氢,使得金属锌在酸性溶液中将反应以释放氢气,因为锌进入溶液形成二价阳离子Zn2+。显示了锌在牙斑和龋齿研究中具有抗菌特性。
将可溶性锌盐如柠檬酸锌用于洁牙剂组合物,见于例如美国专利6121315,但其具有若干缺点。锌离子在溶液中赋予使人不愉悦的涩的口感,所以提供锌的有效水平并且还具有可接受的感官特性的制剂一直难以实现。最终,锌离子将与阴离子表面活性剂(如月桂基硫酸钠)反应,从而阻碍起泡和清洁。
已将氧化锌用作牙膏的成分。虽然它显示出多种口腔护理功效,但它的性能受到氧化锌有限溶解度的限制。氧化锌具有低溶解度,在30℃下约0.16mg每100ml水。因此,可作为可溶性物类有效递送的氧化锌受到量的限制。以常规粉末形式递送的氧化锌对于口腔内部的牙齿或粘膜表面不具有强亲合力。因此,递送的氧化锌将会在处理时期结束时,当用户吐出牙膏、漱口水时被冲掉。
N,N,N-三甲基甘氨酸(TMG或甘氨酸甜菜碱)具有季铵结构。在中性pH下,化合物作为两性离子存在,形成分子的季铵和羧基部分之间的内盐。在强酸的存在下,它将形成酸加成盐,例如盐酸盐。起初将所述化合物与糖用甜菜分离并作为膳食补充用于动物饲料和作为实验室试剂稳定剂,例如用于聚合酶链反应中。存在对它在口腔护理产品中用以处理口干的报告,例如US6156293,和用于止汗剂产品,例如US6969510。
虽然现有技术公开了多种用于处理牙质超敏性、龋齿和釉质侵蚀以及脱矿质作用的口腔组合物,但仍存在对在这些处理中提供改进性能的另外的组合物和方法的需求。
概述
虽然氧化锌在现有技术的制剂中以有限的溶解度存在,但如今发现,氧化锌可与游离形式和酸加成形式两者的TMG形成可溶性络合物。该络合物在被置于制剂中时向釉质和/或牙质表面提供有效浓度的锌离子,从而防止侵蚀、减少细菌的群集和生物膜发展并向牙齿提供增强的光亮。此外,在使用期间稀释时,制剂提供可堵塞牙质小管的沉淀,从而减少牙齿的敏感性。此外,在使用期间稀释时,制剂提供固体材料的涂层,其主要为牙齿表面上的锌盐和一些TMG。固体材料对牙齿表面的强亲合力允许更好的直接性,并允许由此受控释放活性物质质。这出乎意料,至少部分是因为通常在稀释下期望更好的增溶作用。
虽然与常规的具有氧化锌的制剂相比提供了锌的有效递送,但包含氧化锌和TMG的制剂不呈现与常规的使用可溶性锌盐的锌基口腔护理产品相关的差的味道和口感、差的氯化物递送和差的起泡与清洁。
由氧化锌和酸加成形式的TMG形成的可溶性络合物特别地有效。所述酸可以为任何酸,优选氢卤酸。TMG可按它的酸加成形式作为一种预先前存在的实体如TMG盐酸盐来提供,或可通过以各种比率例如1:5-5:1(TMG的摩尔数对可由酸释放的质子的摩尔数)混合TMG和酸来原位形成。由氧化锌和酸加成形式的TMG形成的可溶性络合物可在用水稀释时导致沉淀。可将所述沉淀可采用游离悬浮固体的形式和/或附着于牙齿和粘膜表面用于随后的释放。相反,由氧化锌和游离形式的TMG形成的可溶性络合物在用水稀释时不太能产生沉淀。
因此,在一个实施方案中,本发明提供包含氧化锌和游离或酸加成形式的TMG的络合物,例如锌-TMG-HCl络合物,例如通过在水溶液中将氧化锌和三甲基甘氨酸盐酸盐组合形成。
在另一实施方案中,本发明提供口腔护理组合物,例如漱口剂、口腔凝胶或洁齿剂组合物,其包含与游离或酸加成形式的TMG结合的氧化锌,例如包含上述络合物。组合物可任选进一步包含氟化物源和或另外的磷酸盐源。可按合适的口腔护理制剂配制所述组合物,例如常规的洁齿剂、口腔凝胶或漱口剂基质,例如包含一种或多种研磨剂、表面活性剂、起泡剂、维生素、聚合物、酶、湿润剂、增稠剂、抗微生物剂、防腐剂、香料和/或着色剂。
本发明进一步提供使用本发明的组合物以减少和抑制釉质的酸侵蚀、清洁牙齿、减少细菌产生的生物膜和牙斑、减少牙龈炎、减少口臭、提供口干缓解、抑制牙齿腐烂和牙洞形成和减少牙质超敏性的方法,所述方法包含对牙齿施用本发明的组合物。本发明进一步提供使用本发明的组合物通过将涂层赋予牙齿上来增白牙齿的方法,其中所述涂层比天然牙齿更白。
本发明其它适用领域将由以下提供的详细说明而变得显而易见。应明白,虽然详细说明和具体实施例指出了本发明的优选实施方案,但它仅旨在用于说明目的而非旨在限制本发明的范围。
详述
以下优选实施方案的说明本质上仅为示例性的,且绝非旨在限制本发明、它的应用或用途。
如用于文本的“三甲基甘氨酸”是指N,N,N-三甲基甘氨酸,且所述术语在本文中可交换使用。
因此在第一实施方案中,本发明提供口腔护理组合物(组合物1),其包含氧化锌与游离或口腔可接受的酸加成盐形式的三甲基甘氨酸(TMG)的混合物或由此制备,例如,
1.1. 组合物1,其中制剂中锌的水平基于元素按重量计为0.05-4%,例如1-2%,例如0.5-1.5%,例如约1%。
1.2. 组合物1或1.1,其中以口腔可接受的酸加成盐的形式(例如盐酸盐形式)提供TMG,或其中通过以1:5-5:1摩尔比(TMG的摩尔数对由酸释放的质子的摩尔数)提供TMG和酸(如HCl)作为单独的实体来原位形成TMG。
1.3. 任何前述组合物,其中所述氧化锌与TMG的摩尔比为1:1-1:10,例如约1:5。
1.4. 任何前述组合物,其中所述锌与TMG的摩尔比为5:1-1:2,例如约1:1。
1.5. 任何前述组合物,其中pH为pH5-pH6。
1.6. 任何前述组合物,其中所述制剂包括在水溶液中结合氧化锌和三甲基甘氨酸盐酸的步骤。
1.7. 任何前述组合物,其中以氢卤酸盐形式提供TMG,且氧化锌和TMG形成选自锌-TMG-卤化物络合物、锌-卤化物络合物和它们的混合物的可溶性络合物,例如其中所述卤化物选自氟化物、氯化物、溴化物和它们的混合物。
1.8. 任何前述组合物,其中提供氢卤酸盐形式的TMG,且氧化锌和TMG形成两种可溶性络合物,一种具有化学组成Zn2O8H6X2且另一种具有化学组成Zn2O8H5X2-TMG,其中X选自Cl、F、Br和它们的混合物。
1.9. 任何前述组合物,其中以盐酸盐的形式提供TMG,且氧化锌和TMG形成选自锌-TMG-氯化物络合物、锌-氯化物络合物和它们的混合物的可溶性络合物。
1.10. 任何前述组合物,其中提供盐酸盐形式的TMG,且氧化锌和TMG形成两种可溶性络合物,一种具有化学组成Zn2O8H6Cl2且另一种具有化学组成Zn2O8H5Cl2-TMG。
1.11. 任何前述组合物,其中在施用所述组合物后,完全或部分地原位形成包含氧化锌和TMG的络合物。
1.12. 任何前述组合物,其中在配制所述组合物后,完全或部分地原位形成包含氧化锌和TMG的络合物。
1.13. 任何前述组合物,其包含酸,例如盐酸,例如使得混合物的pH为5-6。
1.14. 任何前述组合物,其进一步包含碱性氨基酸,例如赖氨酸或精氨酸。
1.15. 任何在基本上无水的载体中的前述组合物,例如包含少于10%的水的载体。
1.16. 任何以牙膏、凝胶、漱口剂、粉末、乳霜、条或胶形式的前述组合物。
1.17. 任何在口腔可接受的基质中的前述组合物,例如漱口剂、凝胶或洁齿剂基质。
1.18. 任何洁齿剂形式的前述组合物,例如其中所述氧化锌和TMG以有效量,例如以0.05-4重量%锌的量,例如约0.5-3重量%,例如约1重量%锌存在于洁齿剂基质中。
1.19. 组合物1.1,其中所述洁齿剂基质包含研磨剂,例如有效量的二氧化硅研磨剂,例如10-30%,例如约20%。
1.20. 漱口剂形式的组合物1,例如其中所述氧化锌以有效量存在,例如0.05-4重量%锌的量,例如约1重量%锌。
1.21. 任何前述组合物,其进一步包含有效量的氟离子源,例如提供500-3000ppm的氟化物。
1.22. 任何前述组合物,其进一步包含有效量的氟化物,例如其中所述氟化物为选自以下的盐:氟化亚锡、氟化钠、氟化钾、单氟磷酸钠、氟硅酸钠、氟硅酸铵、氟化胺(例如N'-十八烷基三亚甲基二胺-N,N,N'-三(2-乙醇)-二氢氟化物)、氟化铵、氟化钛、六氟硫酸盐和它们的组合。
1.23. 任何前述组合物,所述组合物包含有效量的一种或多种碱性磷酸盐,例如钠、钾或钙盐,例如选自碱性二元磷酸盐和碱性焦磷酸盐,例如选自以下的碱性磷酸盐:磷酸二氢钠、磷酸氢二氢钾、磷酸二钙二水合物、焦磷酸钙、焦磷酸四钠、焦磷酸四钾、三聚磷酸钠和这些中任意两个或更多个的混合物,例如以述组合物的重量计1-20%的量,例如2-8%,例如大约5%。
1.24. 任何前述组合物,其包含缓冲剂,例如磷酸钠缓冲剂(例如磷酸氢钠和磷酸二钠)。
1.25. 任何前述组合物,所述组合物包含湿润剂,其选自例如甘油、山梨醇、丙二醇、聚乙二醇、木糖醇和它们的混合物,例如其包含至少20%,例如20-40%,例如25-35%的甘油。
1.26. 任何前述组合物,其包含一种或多种表面活性剂,其选自例如阴离子、阳离子、两性离子和非离子的表面活性剂和它们的混合物,其包含例如阴离子表面活性剂,例如选自月桂基硫酸钠、月桂基硫酸钠醚和它们的混合物的表面活性剂,例如以约0.3重量%-4.5重量%的量,例如1-2%月桂基硫酸钠(SLS);和/或两性离子表面活性剂,例如甜菜碱表面活性剂,例如椰油酰胺丙基甜菜碱,例如以约0.1重量%-约4.5重量%的量,例如0.5-2%的椰油酰胺丙基甜菜碱。
1.27. 任何前述组合物,其进一步包含粘度改性量的一种或多种多糖胶,例如黄原胶或角叉菜胶、二氧化硅增稠剂和它们的组合。
1.28. 任何前述组合物,其包含胶条或片。
1.29. 任何前述组合物,其进一步包含香料、香精和/或色素。
1.30. 任何前述组合物,其包含有效量的一种或多种抗菌剂,例如包含选自以下的抗菌剂:卤化二苯醚(例如三氯生)、草本提取物和精油(例如迷迭香提取物、茶提取物、木兰提取物、麝香草酚、薄荷醇、桉树醇、香叶醇、香芹酚、柠檬醛、日柏酚、儿茶酚、水杨酸甲酯、表儿茶素没食子酸酯、表儿茶素、没食子酸、密斯瓦克(miswak)提取物,沙棘提取物),双胍防腐剂(例如氯己定、阿立西啶或奥替尼啶)、季铵化合物(例如西吡氯铵(CPC)、苯扎氯铵、十四烷基氯化吡啶鎓(TPC)、N-十四烷基-4-乙基氯化吡啶鎓(TDEPC))、苯酚杀菌剂、海克替啶、奥替尼啶、血根碱、聚维酮碘、地莫匹醇、salifluor、金属离子(例如锌盐例如柠檬酸锌、亚锡盐、铜盐、铁盐)、血根碱、蜂胶和氧化剂(例如过氧化氢、缓冲的过硼酸钠或过碳酸钠)、邻苯二甲酸和及其盐、单过氧邻苯二甲酸(monoperthalic acid)及其盐和酯、硬酯酸抗坏血酸酯、油酰基肌氨酸、烷基硫酸盐、磺基琥珀酸二辛酯、水杨酰苯胺、度米芬、地莫匹醇、辛哌醇和其它哌啶基衍生物、烟酸制剂、亚氯酸盐和任何前述的混合物,例如包含三氯生或西吡氯铵。
1.31. 任何前述组合物,其包含抗菌有效量的三氯生,例如0.1-0.5%,例如约0.3%。
1.32. 任何前述组合物,其进一步包含例如选自以下的增白剂:过氧化物、金属亚氯酸盐、过硼酸盐、过碳酸盐、过氧酸、次氯酸盐以及它们的组合。
1.33. 任何前述组合物,其进一步包含过氧化氢或过氧化氢源,例如过氧化脲或过氧化物盐或络合物(例如像过氧磷酸盐、过氧碳酸盐、过硼酸盐、过氧硅酸盐或过硫酸盐,例如过氧磷酸钙、过硼酸钠、过氧化碳酸钠、过氧磷酸钠和过硫酸钾)。
1.34. 任何前述组合物,其进一步包含干扰和或防止细菌的附着的试剂,例如对羟基苯甲酸乙酯(solbrol)或壳聚糖。
1.35. 任何前述组合物,其进一步包含选自以下的钙和磷酸盐的源:(i)钙-玻璃络合物,例如磷硅酸钠钙,和(ii)钙-蛋白质络合物,例如酪蛋白磷肽-无定形磷酸钙。
1.36. 任何前述组合物,其进一步包含可溶性钙盐,例如选自硫酸钙、氯化钙、硝酸钙、乙酸钙、乳酸钙和它们的组合。
1.37. 任何前述组合物,其进一步包含生理或口腔可接受的钾盐,例如有效减少牙质敏感性的量的硝酸钾或氯化钾。
1.38. 任何前述组合物,其进一步包含阴离子聚合物,例如合成阴离子聚合多羧酸盐,例如其中所述阴离子聚合物选自1:4-4:1的马来酐或酸与另一种可聚合的乙烯式不饱和单体的共聚物,例如其中所述阴离子聚合物为平均分子量(M.W.)为约30000-约1000000,例如约300000-约800000的甲基乙烯基醚/马来酸酐(PVM/MA)共聚物,例如其中所述阴离子聚合物为所述组合物重量的约1-5%,例如约2%。
1.39. 任何前述组合物,其进一步包含口气清新剂、香精和/或香料。
1.40. 任何前述组合物,其用于减少和抑制釉质的酸侵蚀、清洁牙齿、减少细菌产生的生物膜和牙斑、减少齿龈炎、抑制牙齿腐烂和牙洞形成和减少牙质超敏性。
1.41. 任何前述组合物,其通过包含在水介质中混合氧化锌和三甲基甘氨酸盐酸盐的步骤的方法来生产。
1.42. 任何前述组合物,其中在用水稀释时,例如稀释到锌相对于水低于1%的水平,形成锌沉淀物。
本发明进一步提供方法以减少和抑制釉质的酸侵蚀、清洁牙齿、减少细菌产生的生物膜和牙斑、减少齿龈炎、提供口干缓解、减少口臭、抑制牙齿腐烂和牙洞形成,改善白度和减少牙质超敏性,所述方法包含对牙齿施用有效量的本发明的组合物,例如任何组合物1及其后的组合物。
本发明进一步提供制造包含氧化锌和TMG的组合物(例如任何组合物1及其后的组合物)的方法,所述方法包含在水介质中将氧化锌和口腔可接受的TMG的酸加成盐(例如TMG-HCl)组合的步骤。
例如在多种实施方案中,本发明提供方法,以(i)减少牙齿的过敏,(ii)减少牙斑积聚,(iii)减少或抑制去矿化和促进牙齿的再矿化,(iv)抑制口腔内微生物生物膜形成,(v)减少或抑制牙龈炎,(vi)促进口腔内溃疡或创口的愈合,(vii)减少产酸菌的水平,(viii)提高非生龋和/或非牙斑形成细菌的相对水平,(ix)减少或抑制龋齿的形成,(x)减少、修复或抑制釉质的预-龋损伤,例如,通过定量的光诱导荧光色谱(QLF)或电学龋齿测量(ECM)检测,(xi)处理、减轻或减少口干,(xii)清洁牙齿和口腔,(xiii)减少侵蚀,(xiv)使牙齿变白;(xv)减少牙垢积累,(xvi)减少口臭,和/或(xvii)促进全身健康,包括心血管健康,例如通过减少经由口腔组织的全身感染的可能性,其包括将如上所述的任意组合物1及其后的组合物施用到有需要的人的口腔内,例如,每天一次或多次。本发明还提供了组合物1及其后的组合物在任何这些方法中的用途。
本发明进一步提供氧化锌和游离或口腔可接受的盐形式的TMG(例如三甲基甘氨酸盐酸盐)制造口腔护理组合物(例如任何组合物1及其后的组合物)的用途。
在一些实施方案中,本发明的组合物提供在5秒后牙质敏感性的缓解。在一些实施方案中,本发明的组合物提供在10秒后牙质敏感性的缓解。在一些实施方案中,本发明组合物提供在15秒后牙质敏感性的缓解。在一些实施方案中,本发明组合物提供在30秒后牙质敏感性的缓解。在一些实施方案中,本发明组合物提供在60秒后牙质敏感性的缓解。
本发明进一步提供氧化锌连同游离或口腔可接受的盐形式(即,酸加成形式)的TMG来减少和抑制釉质的酸侵蚀、清洁牙齿、减少细菌产生的生物膜和牙斑、减少齿龈炎、抑制牙齿腐烂和牙洞形成和降低牙质超敏性的用途;(ii)选自以下的锌氨基酸卤化物前体在组合物制造中的用途:(a)氧化锌和氨基酸卤化物和/或(b)氧化锌、氨基酸和任选氢卤酸,所述组合物用于减少和抑制釉质的酸侵蚀、清洁牙齿、减少细菌产生的生物膜和牙斑、降低齿龈炎、减少口臭、提供口干缓解、抑制牙齿腐烂和牙洞形成并降低牙质超敏性。
发现锌和TMG的相互作用将氧化锌转化为高度可溶的络合物。优选地,TMG为酸加成盐形式,例如盐酸盐形式。络合物以例如相当于约1%或更多的锌水平的浓度高度可溶于水中。但当水中增大稀释时,例如水中锌的浓度为0.1-1%,例如约0.5%,络合物离解且络合物中的锌离子恢复为不可溶的形式,所述形式基本上不含氧化锌。在实验中,其中使用氧化锌和氨基酸如赖氨酸形成络合物,还观察到在稀释时的沉淀,但沉淀为氧化锌,所以沉淀的形成基本上不含氧化锌是意外的。
不希望受限于理论,注意到,溶液中存在至少两种络合物。至少一种络合物衍生自没有与TMG相互作用的锌,且至少一种络合物衍生自与TMG相互作用的锌。一种络合物的结构为Zn2O8H5Cl2,且另一种的结构为Zn2O8H5Cl2-TMG。
这种在增大的稀释下动态减少的溶解度为不寻常且意外的。在刷或漂洗或与唾液组合时的稀释促进在给药的牙齿上锌沉淀物的沉积,这起阻塞牙质小管的作用,从而减少超敏性并还向釉质提供锌,这减少了酸侵蚀、生物膜和牙斑形成。
将理解,虽然锌和TMG可主要为前体材料的形式(例如氧化锌和TMG-HCl)或络合物的形式,但可存在一定平衡度,使得事实上在络合物中的材料的比例相较于在前体形式中的比例可取决于精确的制剂条件、材料浓度、pH、存在或不存在水、存在或不存在其它荷电分子等等而变化。
将理解,络合物也可以是混合物的形式。氧化锌和TMG可形成络合物的一种类型,而氧化锌和酸加成形式的TMG可形成另一种。这些络合物可按不同的比例存在,特别是当TMG和来自酸的质子以不相等的摩尔量提供时。
可将活性物质质以任何口腔护理制剂的形式递送,例如牙膏、凝胶、漱口水、粉末、乳霜、条、胶或任何本领域已知的其它。
若活性物质以漱口剂的形式递送,期望益处的人员使用原液和通过唾液自然稀释原液来漂洗将引发锌的沉淀。或者,该人员可混合原液与适量的含水稀释剂(例如提供相对于水约0.1–1%浓度的锌)并用所述混合物漂洗。
在另一个实施方案中,制备混合物并立即将其移至保持牙托(retaining tray),如用于固定增白凝胶的那些,且该人员可戴上牙托经有效期的时间。与混合物接触的牙齿将受到处理。对于使用保持牙托,混合物可以是低粘度液体或凝胶的形式。
在另一实施方案中,将原液或原液与水的混合物以凝胶制剂施用于牙齿,例如其中凝胶可留在牙齿上经长时间以有效处理。
在另一实施方案中,将活性物质提供于牙膏中。在刷牙时,活性物质由唾液和水稀释,导致沉积物和阻塞性颗粒的沉淀和形成。
可通过调节原液中络合物的浓度和改变原液与水的比例调整由制剂沉淀的速率。更稀释的配方导致更快的沉淀并因此当期望快速处理时为优选。
本发明的口腔护理组合物的益处有许多。本发明的口腔护理组合物通过提供锌离子和可在口腔中释放锌离子的含锌化合物,提供抗微生物、抗牙斑、抗牙龈炎、抗恶臭、抗龋和抗牙垢的益处。阻塞颗粒和表面沉积物为含锌盐的化合物,所述含锌盐的化合物可将锌离子释放到口腔中并提供如以上认识到的多种益处。由于沉积而形成于牙齿表面上的涂层可增强牙齿表面的白度,从而提供增白的益处。另外的益处包括但不受限于抗附着、抗牙周炎和抗骨损失和促进伤口愈合。
第二个益处为锌离子的抗侵蚀特性,所述锌离子通过氧化和水解在牙齿表面上形成抗侵蚀沉积物。表面沉积物和阻塞性颗粒可与酸反应和中和酸,从而防护牙齿表面免受酸侵蚀的影响。还注意到,当表面沉积物和阻塞性颗粒中和酸时,可释放有益的锌离子,提供除抗侵蚀之外的口腔护理益处。
第三益处为因闭塞导致的抗敏感性益处。牙质小管的闭塞导致敏感性的缓解。
第四个益处是与TMG相关的益处。TMG由于它的两性离子特性提供了缓冲效果,抵消了可损坏牙齿的酸,并因此可提供抗龋齿的益处。此外,已认识到TMG提供了口干缓解。
在具体的实施方案中,本发明提供包含氧化锌、TMG和阴离子物类例如卤化物(例如氯化物)的离子络合物。在具体的实施方案中,本发明提供通过在含水介质中将氧化锌和TMG HCl组合形成的络合物来形成方便地称为ZnO-TMG HCl络合物的络合物。
在另一个实施方案中,本发明提供包含ZnO-TMG HCl络合物的口腔护理制剂,例如根据组合物1及其后组合物的组合物,其包含例如漱口水、凝胶、牙膏、乳霜、粉末、条或胶形式的ZnO-TMG HCl络合物。
在一个实施方案中,若期望的制剂为漱口剂形式,则预期双组分递送系统。第一组分为ZnO-TMG HCl络合物的浓缩溶液,且第二组分基本上为水。两种组分由给予者/用户在处理之前立即混合。或者,预期漱口水形式的单组分递送系统,其中所述系统包含ZnO-TMGHCl络合物的浓缩溶液,和通过给予者/用户以在典型的口腔护理处理中自然涉及的水和/或由用户产生的唾液的形式提供稀释剂。
在其它实施方案中,本发明还涉及用于在长时间内在口腔内部递送锌离子和TMG的受控释放系统和方法,所述方法包含给予根据组合物1及其后组合物的组合物。
在具体的实施方案中,组合物1及其后的组合物提供来自氧化锌和TMG的络合物(例如锌-TMG-氯化物络合物),和/或氧化锌和游离或酸加成盐形式的TMG(例如TMG-HCl)作为络合物前体,所述络合物前体可与水原位反应形成络合物。所述原位形成提供制剂的简易性。在另一个实施方案中,允许使得由前体形成络合物的水来自唾液和/或接触到施用后的组合物的漂洗水。
在具体的实施方案中,提供酸加成盐形式(例如氢卤酸盐,例如三甲基甘氨酸盐酸盐)的TMG,所述TMG与氧化锌在含水介质中形成复合的络合物。
因为本文中各种锌盐和络合物的摩尔数目或重量百分数将基于具体的盐或络合物形式而变化,所以不论其盐或络合物形式,本文中我们经常按重量计或按摩尔数计表示制剂中总锌量。在一些实施方案中,组合物中锌的总量为所述组合物的0.05-8重量%。在其它实施方案中,锌的总量为所述组合物的至少0.1、至少0.2、至少0.3、至少0.4、至少0.5、或至少1-8重量%。在其它实施方案中,组合物中锌的总量小于组合物的5、小于4、小于3、小于2或小于1-0.05重量%。例如在一些实施方案中,组合物中锌的总量可为约1%。
活性剂:本发明的组合物可包含不同的试剂,其对于保护和提高釉质和牙齿结构的强度和完整性,和/或减少细菌和相关的牙齿腐烂和/或牙龈疾病有活性,包括锌-TMG-卤化物络合物或除此以外。本文使用的活性成分的有效浓度取决于特定的剂和使用的递送体系。应理解,牙膏在使用时例如通常与水稀释,而漱口液通常不会。因此,牙膏中活性成分的有效浓度通常比漱口液所需的高,为5-15倍。浓度也取决于所选的确切的盐或聚合物。例如,当提供盐形式的活性剂时,反离子将影响盐的重量,使得,如果反离子较重,按重量计需要更多的盐以在最终产物中提供相同浓度的活性离子。当存在精氨酸时,其存在水平可为,例如约0.1-约20重量%(表示为游离碱的重量),例如对于消费者牙膏来说,为约1-约10重量%,或对于专业的或处方处理产品来说,为约7-约20重量%。当存在氟化物时,其存在水平可为,例如约25-约25,000ppm,例如对于消费者牙膏来说,约750-约2,000ppm,或对于专业的或处方处理产品来说,约2,000-约25,000ppm。抗菌剂水平将类似地变化,用于牙膏的水平例如大于用于漱口液,为约5-约15倍。例如,三氯生牙膏可包含约0.3重量%的三氯生。
氟离子源:口腔护理组合物还可包括一种或多种氟离子源,例如,可溶的氟化物盐。可使用多种产生氟化物离子的材料作为本发明组合物中可溶氟化物的来源。适合的产生氟化物离子的材料的实例见美国专利号3,535,421,Briner等人;美国专利号4,885,155,Parran,Jr.等人和美国专利号3,678,154,Widder等人。代表性的氟离子源包括但不限于氟化亚锡、氟化钠、氟化钾、单氟磷酸钠、氟硅酸钠、氟硅酸铵、氟化胺、氟化铵和它们的组合。在某些实施方案中,氟离子源包括氟化亚锡、氟化钠、单氟磷酸钠以及它们的混合物。在某些实施方案中,本发明的口腔护理组合物还可包含氟化物离子或提供氟的成分的来源,其量足以供应约25ppm-约25,000ppm的氟化物离子,通常至少约500ppm,例如,约500-约2000ppm,例如,约1000-约1600ppm,例如约1450ppm。氟化物的适当水平取决于具体的应用。一般消费者使用的牙膏通常具有约1000-约1500ppm,儿童牙膏稍微少一些。专业应用的牙粉或涂层可具有多达约5,000,乃至约25,000ppm的氟化物。可在一个实施方案中将氟离子以组合物重量的约0.01重量%-约10重量%的水平加入本发明的组合物中,或在另一个实施方案中约0.03重量%-约5重量%,和在另一实施方案中约0.1重量%-约1重量%。提供适当水平的氟化物离子的氟化物盐的重量基于所述盐中反离子的重量将明显改变。
在各种实施方案中,氨基酸的存在量为总组合物重量的约0.5重量%-约20重量%,总组合物重量的约0.5重量%-约10重量%,例如就洁牙剂的情况而言,为总组合物重量的约1.5重量%,约3.75重量%,约5重量%或约7.5重量%,例如就漱口剂的情况而言,为约0.5-2重量%,例如约1%。
研磨剂:本发明的组合物,例如组合物1及其后的组合物,包括二氧化硅研磨剂,并且可包含其它的研磨剂,例如,磷酸钙研磨剂,例如磷酸三钙(Ca3(PO4)2)、羟磷灰石(Ca10(PO4)6(OH)2)或二水合磷酸二钙(CaHPO4•2H2O,本文有时也称作DiCal)或焦磷酸钙;碳酸钙研磨剂;或研磨剂例如偏磷酸钠、偏磷酸钾、硅酸铝、煅烧氧化铝、膨润土或其它的硅质材料,或它们的组合。
本文可使用的其它二氧化硅研磨磨光材料,以及其它的研磨剂,通常具有约0.1-约30微米,约5-约15微米的平均粒度。二氧化硅研磨剂可来自沉淀的二氧化硅或二氧化硅凝胶,例如美国专利号3,538,230,Pader等人和美国专利号3,862,307,Digiulio描述的二氧化硅干凝胶。具体的二氧化硅干凝胶由W. R. Grace & Co.,Davison ChemicalDivision以商品名Syloid®销售。沉淀的二氧化硅材料包括J.M.Huber Corp.以商标Zeodent®销售的那些,包括携带Zeodent 115和119标记的二氧化硅。这些二氧化硅研磨剂在Wason的美国专利号4,340,583中描述。在某些实施方案中,本发明的口腔护理组合物实践中可使用的研磨材料包括二氧化硅凝胶和沉淀的无定形二氧化硅,其具有小于约100cc/100g二氧化硅和约45cc/100g-约70cc/100g二氧化硅的油吸收值。使用ASTA擦除方法D281测定油吸收值。在某些实施方案中,二氧化硅为胶态微粒,其具有约3微米-约12微米,和约5-约10微米的平均粒度。在本发明的实践中可特别使用的低油吸收二氧化硅研磨剂由W.R. Grace & Co.,Baltimore,Md.21203的Davison Chemical Division以商标SylodentXWA®销售。Sylodent 650XWA®,其为由胶态二氧化硅颗粒组成的二氧化硅水凝胶,具有29重量%的水含量,平均为约7-约10微米直径,且小于约70cc/100g二氧化硅的油吸收为本发明实践可用的低油吸收二氧化硅研磨剂的实例。
发泡剂:当刷拭口腔时,本发明的口腔护理组合物也可包括提高产生的泡沫量的剂。提高泡沫量的剂的说明性实例包括但不限于聚氧乙烯和某些聚合物,包括但不限于藻酸盐聚合物。聚氧乙烯可提高泡沫的量和本发明的口腔护理载体组分产生的泡沫厚度。聚氧乙烯也通常称为聚乙二醇(“PEG”)或聚环氧乙烷。适合于本发明的聚氧乙烯具有约200,000-约7,000,000的分子量。在一个实施方案中,分子量为约600,000-约2,000,000,和在另一个实施方案中,为约800,000-约1,000,000。Polyox®为Union Carbide生产的高分子量聚氧乙烯的商标。聚氧乙烯存在的量可为本发明的口腔护理组合物的口腔护理载体组分的约1%-约90%,在一个实施方案中,为约5%-约50%,和在另一个实施方案中约10%-约20重量%。当存在时,口腔护理组合物中的发泡剂的量(即,单次剂量)为约0.01-约0.9重量%,约0.05-约0.5重量%,和在另一个实施方案中,约0.1-约0.2重量%。
表面活性剂:可用于本发明的组合物可包含阴离子表面活性剂,例如:
i. 高级脂肪酸甘油单酯单硫酸盐的水溶性盐,例如氢化椰油脂肪酸的单硫酸甘油单酯的钠盐,例如N-甲基N-椰油酰牛磺酸钠,椰油酸单甘油酯硫酸钠,
ii. 高级烷基硫酸盐,例如月桂基硫酸钠,
iii. 例如式CH3(CH2)mCH2(OCH2CH2)nOSO3X的高级烷基醚硫酸盐,其中m为6-16,例如,10,n为1-6,例如2、3或4,和X为Na或K,例如月桂醚-2硫酸钠(CH3(CH2)10CH2(OCH2CH2)2OSO3Na)。
iv. 高级烷基芳基磺酸盐例如十二烷基苯磺酸钠(月桂基苯磺酸钠)
v. 高级烷基磺基乙酸盐,例如月桂基磺基乙酸钠(十二烷基磺基乙酸钠),1,2二羟基丙烷磺酸盐的高级脂肪酸酯,磺基月桂酸盐(N-2-乙基月桂酸钾磺基乙酰胺)和月桂基肌氨酸钠。
“高级烷基”是指,例如C6-30烷基。在具体实施方案中,阴离子表面活性剂选自月桂基硫酸钠和月桂基醚硫酸钠。阴离子表面活性剂存在的有效量可为,例如,>制剂的0.01重量%,但是不是对口腔组织有刺激性的浓度,例如<10%,和为取决于具体的制剂和具体的表面活性剂的最优浓度。例如,漱口剂的使用浓度通常为用于牙膏的约十分之一。在一个实施方案中,存在于牙膏中的阴离子表面活性剂为约0.3%-约4.5重量%,例如约1.5%。本发明的组合物可任选地包含表面活性剂的混合物,例如,包含阴离子表面活性剂和其它表面活性剂(其可为阴离子的、阳离子的、两性离子的或非离子的)。通常,表面活性剂为在宽pH范围内相当稳定的那些。表面活性剂更完整地描述于例如美国专利号3,959,458,Agricola等人;美国专利号3,937,807,Haefele;和美国专利号4,051,234,Gieske等人。在某些实施方案中,本文可使用的阴离子表面活性剂包括烷基硫酸盐的水溶性盐(在烷基中具有约10-约18个碳原子)和具有约10-约18个碳原子的脂肪酸的磺酸单甘油酯的水溶性盐。月桂基硫酸钠、月桂酰肌氨酸钠和椰油甘油单酯磺酸钠为该类型的阴离子表面活性剂的实例。在一个具体实施方案中,本发明的组合物,例如组合物1及其后的组合物,包含月桂基硫酸钠。
可存在于本发明的组合物中的表面活性剂或相容的表面活性剂的混合物以总组合物的重量计可为约0.1%-约5.0%,在另一个实施方案中,约0.3%-约3.0%,和在另一个实施方案中,约0.5%-约2.0%。
牙垢控制剂:在本发明的各种实施方案中,组合物包含抗牙石(牙垢控制)剂。适合的抗牙石剂包括而不限于磷酸盐和多磷酸盐(例如焦磷酸盐)、聚氨基丙磺酸(AMPS)、六偏磷酸盐、柠檬酸锌三水合物、多肽、聚烯烃磺酸盐、聚烯烃磷酸盐、二磷酸盐。本发明因此可包含磷酸盐。在具体实施方案中,这些盐为碱性磷酸盐,即,碱金属氢氧化物或碱土金属氢氧化物的盐,例如,钠、钾或钙盐。本文所用的“磷酸盐”包括口腔可接受的单和多磷酸盐,例如,P1-6磷酸盐,例如单体分子磷酸盐例如一元、二元或三元磷酸盐;二聚磷酸盐例如焦磷酸盐;和多聚磷酸盐,例如,六偏磷酸钠。在具体实例中,所选的磷酸盐选自碱性二元磷酸盐和碱性焦磷酸盐,例如,选自磷酸氢二钠、磷酸氢二钾、二水合磷酸二钙、焦磷酸钙、焦磷酸四钠、焦磷酸四钾、三聚磷酸钠和这些中的任意两个或更多个的混合物。在具体实施方案中,例如组合物包含以下的混合物:焦磷酸四钠(Na4P2O7)、焦磷酸钙(Ca2P2O7)和磷酸氢二钠(Na2HPO4),例如,量为大约3-4%的磷酸氢二钠和大约0.2-1%的每种所述焦磷酸盐。在另一个实施方案中,组合物包含焦磷酸四钠(TSPP)和三聚磷酸钠(STPP)(Na5P3O10)的混合物,例如比例为约1-2%的TSPP和约7%-约10%的STPP。提供有效量的这些磷酸盐来减少釉质侵蚀、帮助清洁牙齿和/或减少牙齿上的牙垢累积,例如量为2-20%,例如,大约5-15%,按组合物的重量计。
矫味剂:本发明的口腔护理组合物还可包括矫味剂。用于本发明的实践的矫味剂包括但不限于精油以及不同的矫味醛、酯、醇和类似的材料。精油的实例包括以下的油:留兰香、胡椒薄荷、冬青、黄樟、丁香、鼠尾草、桉树、马郁兰、肉桂、柠檬、酸橙、葡萄柚和橙。也可使用薄荷醇、香芹酮和茴香脑这些化学品。某些实施方案使用胡椒薄荷薄荷油和留兰香油。矫味剂可在约0.1-约5重量%的浓度下结合到口腔组合物,例如约0.5-约1.5重量%。
聚合物:本发明的口腔护理组合物还可包括其它的聚合物以调节制剂粘度或提高其它成分的溶解度。这些其它的聚合物包括聚乙二醇、多糖(例如,纤维素衍生物例如羧甲基纤维素,或多糖胶例如黄原胶或角叉胶)。酸性聚合物,例如聚丙烯酸酯凝胶,可按它们的游离酸形式或部分或完全中和的水溶性碱金属(例如,钾和钠)或铵盐的形式提供。
可存在二氧化硅增稠剂,其在水性介质中形成聚合结构或凝胶。应注意这些二氧化硅增稠剂为物理和功能上不同于也存在于组合物中的颗粒二氧化硅研磨剂,因为该二氧化硅增稠剂非常精细分散并提供极少或无研磨作用。其它的增稠剂为羧乙烯基聚合物、角叉胶、羟乙基纤维素,和纤维素醚的水溶性盐(例如羧甲基纤维素钠和羧甲基羟乙基纤维素钠)。还可结合天然胶例如刺梧桐胶、阿拉伯胶和黄芪胶。胶态硅酸镁铝还可用作增稠组合物的组分来进一步提高组合物的质地。在某些实施方案中,以总组合物重量的约0.5%-约5.0%的量使用增稠剂。
本发明的组合物可包括阴离子聚合物,例如量为约0.05-约5%。已知这些剂通常用于用的牙粉,虽然不针对该特定应用,但可用于本发明的这些剂公开于美国专利号5,188,821和5,192,531;并包括合成的阴离子聚合多碳酸酯,例如马来酸酐或酸与另一种可聚合乙烯属不饱和单体的1:4-4:1共聚物,优选具有约30,000-约1,000,000分子量(M.W.)的甲基乙烯基醚/马来酸酐,最优选约300,000-约800,000。这些共聚物可得自例如Gantrez.,例如AN 139(M.W.500,000)、AN 119(M.W.250,000),和优选S-97药用级(M.W.700,000),可由ISP Technologies, Inc.,Bound Brook,N.J.08805获得。当存在时,增强剂存在的量为约0.05-约3重量%。其它的有效聚合物包括以下那些,例如:马来酸酐与丙烯酸乙酯、甲基丙烯酸羟乙酯、N-乙烯基-2-吡咯烷酮或乙烯的1:1共聚物,后者可得自例如Monsanto EMA No.1103,M.W.10,000和EMA级别61,和丙烯酸与甲基丙烯酸甲酯或甲基丙烯酸羟乙酯、丙烯酸甲酯或丙烯酸乙酯、异丁基乙烯基醚或N-乙烯基-2-吡咯烷酮的1:1共聚物。通常适合的是,含有活化碳-碳烯属双键和至少一个羧基的聚合烯属或乙烯属不饱和羧酸,即,含有在聚合中易于起作用的烯属双键的酸,因为它存在于单体分子中或者在相对于羧基的α-β位或作为末端亚甲基基团的一部分。这些酸的说明为丙烯酸、甲基丙烯酸、乙基丙烯酸、α-氯丙烯酸、巴豆酸、β-酰基氧基丙酸、山梨酸、α-氯代山梨酸、肉桂酸、β-苯乙基丙烯酸、粘康酸、衣康酸、柠康酸、中康酸、戊烯二酸、乌头酸、α-苯基丙烯酸、2-苄基丙烯酸、2-环己丙烯酸、当归酸、伞形酸、富马酸、马来酸和酐。其它的不同烯属单体可与这些羧酸单体(包括乙酸乙烯酯、氯乙烯、马来酸二甲酯等)共聚。为了水溶性,共聚物包含足够羧酸盐基团。另一类型的聚合剂包括含有经取代的丙烯酰胺的均聚物和/或不饱和磺酸的均聚物和它们的盐的组合物,特别地,其中聚合物基于选自丙烯酰胺基烷基磺酸的不饱和磺酸,例如具有约1,000-约2,000,000分子量的2-丙烯酰胺2甲基丙磺酸,描述于美国专利号4,842,847,1989年6月27日,Zahid。聚合剂的另一个有用的类别包括聚氨基酸,其含有阴离子表面活性氨基酸部分,例如天冬氨酸、谷氨酸和磷丝氨酸,例如美国专利号4,866,161,Sikes等人所公开。
水:口腔组合物可包含显著水平的水。市售口腔组合物制剂所用的水应去离子并不含有机杂质。组合物中水的量包括添加的游离水,加上与其它材料一起引入的量。
湿润剂:在口腔组合物的某些实施方案中,也期望加入湿润剂以阻止组合物暴露于空气时硬化。某些湿润剂还可给予期望的甜度或风味至牙粉组合物。适合的湿润剂包括食用多元醇,例如甘油、山梨糖醇、木糖醇、丙二醇以及其它的多元醇和这些湿润剂的混合物。在本发明的一个实施方案中,主要的湿润剂为甘油,其存在水平可大于25%,例如25-35%,约30%,连同5%或更少的其它湿润剂。
其它的任选成分:除了以上所述的组分,本发明的实施方案可包含许多任选的牙粉成分,其中的一些如下所述。任选的成分包括例如但不限于粘合剂,起泡剂,增香剂,增甜剂,其它的抗牙斑试剂,研磨剂和着色剂。这些和其它任选组分进一步描述于美国专利号5,004,597,Majeti;美国专利号3,959,458,Agricola等人;和美国专利号3,937,807,Haefele,所有通过引用结合入本文。
除非另作说明,本说明书中给出的组合物成分的所有百分数都基于100%的总组合物或制剂重量按重量计。
除非另外具体确定,用于本发明的组合物和制剂中的成分优选化妆品可接受的成分。“化妆品可接受”意思是适用于用于局部施用于人类皮肤的制剂。化妆品可接受的赋形剂是例如适用于按本发明制剂中预期的量和浓度外部施用的赋形剂,并包括例如由美国食品和药物管理局“公认为安全”(GRAS)的赋形剂。
如本领域惯例,参考其成分来描述和请求保护如本文提供的组合物和制剂。如对于本领域技术人员明显的是,所述成分可在一些情况下彼此反应,使得最终制剂的真实组成可能与列出的成分不精确对应。因此,应明白,本发明延伸至所列出的成分的组合的产物。
如通篇所用,范围用作描述每个和所有在该范围内的值的简写。在该范围内的任何值可选作该范围的端点。另外,本文引用的所有参考文献在此通过引用以其全部并入。在本公开中的定义和引用的参考文献的定义冲突的情况下,以本公开为准。
除非另有说明,本文或说明书中其它地方表示的所有百分数和量应理解为是指按重量计的百分数。给定的量基于材料的有效重量。
实施例
实施例1
如以下制备样品1,ZnO-TMG。在室温下,将50mL的去离子水慢慢地加入含有4.0712g(0.05003mol)氧化锌粉末和5.8595g(0.05002摩尔)游离形式的TMG(CAS# 107-43-7)的烧瓶中。将混合物搅拌过夜约20小时。通过离心除去未反应的氧化锌,随后通过0.45微米的膜过滤。最终产物为透明溶液。
表1
如以下制备样品2,ZnO-TMG-HCl。在室温下,将50mL的去离子水慢慢地加入含有4.0712g(0.05003mol)氧化锌粉末和7.6832g(0.05002摩尔) TMG-HCl (CAS# 207-5)的烧瓶中。将混合物搅拌过夜约20小时。通过离心除去未反应的氧化锌,随后通过0.45微米的膜过滤。最终产物为透明溶液。
表2
如以下制备样品3,ZnO-TMG-HCl。通过将7.68g(0.0500摩尔)的TMG-HCl (CAS#590-46-5)溶解在50mL的去离子水中制备1M TMG-HCl溶液。在室温下,将4.07g(0.0500mol)的氧化锌粉末慢慢地加到TMG-HCl溶液中。将混合物搅拌过夜约20小时。通过离心除去未反应的氧化锌,随后通过0.45微米的膜过滤。最终产物为透明溶液。
表3
对在稀释时形成沉淀或絮凝的能力和速率评估每个样品。对于该分析,制备各种稀释比(例如2倍-32倍)的样品并保持在37℃。定期监测这些样品并记录它们产生沉淀/絮凝的效率。
稀释实验表明,ZnO-TMG-HCl (样品2和3)产生沉淀/絮凝,并因此优选用于在牙质表面上沉积固体颗粒。絮凝/沉淀的速率取决于稀释比,所述稀释比与水和原液以期望的比例混合时锌的初始浓度有关。
使用ZnO-TMG-HCl样品2进行第一稀释实验。通过基于体积以不同比例混合原液和水制备稀释液,生产具有2倍(1:1的原液和水)、4倍、8倍、16倍和32倍的稀释液的样品。将稀释的样品保持在37℃,并监测絮凝/沉淀发生的速率。混合一小时后,在使用2倍、4倍和8倍稀释液的系统中观察到可见的沉淀。
使用ZnO-TMG-HCl样品3进行第二稀释实验。通过基于体积以不同的比例混合原液和水再一次制备稀释液,生产具有2倍(1:1的原液和水)、4倍、8倍、16倍和32倍的稀释液的样品。将稀释的样品保持在37℃,并监测絮凝/沉淀发生的速率。混合24小时后,在具有2倍、4倍和8倍稀释液的系统中观察到可见的沉淀。在24小时处理时期结束时测量经稀释的系统的pH值,且它们对于具有2倍、4倍、8倍、16倍和32倍稀释液的系统pH值分别为5.57、5.69、5.89、6.06、6.28。这些pH值很好地在适于口腔护理应用的5.5-10的范围内。
使用ZnO-TMG样品1进行第三稀释实验。通过基于体积以不同比例混合原液和水再次制备稀释液,生产具有2倍(1:1的原液和水)、4倍、8倍、16倍和32倍的稀释液的样品。将稀释的样品保持在37℃,并监测絮凝/沉淀发生的速率。混合1小时后,不能在任何样品中观察到可见的沉淀。
产生絮凝/沉淀的制剂可用于将活性剂沉积在口腔表面上,包括牙齿和粘膜表面。在这方面,可使用2倍-8倍的稀释液。如果在不同的浓度下制备原液,则可以使用产生相同有效的锌载量的稀释液。在实际的制剂中,当然,制剂中锌的浓度将低于相对于水的稀释液浓度,因为总的制剂将包含除水之外的组分。在浓度范围的低端和高端的制剂趋向于需要更长时间的处理且不属于生产沉淀/絮凝的最可靠的方法。
也可将不产生凭肉眼可辨别的絮凝/沉淀的制剂用于将活性剂沉积在口腔表面上。不能产生明显的絮凝/沉淀可能是由于不适宜的稀释比或不充足的处理持续时间。然而,所述制剂可能仍然能产生颗粒,如胶态颗粒。虽然这些颗粒在处理持续时间内不形成沉淀,但它们可在口腔表面上形成表面沉积物。在这方面,稀释比和/或处理持续时间的有效范围比由上述稀释实验可直接推断的更宽。
在一些实施方案中,在稀释时形成的沉淀或颗粒包含一种或多种类型锌盐和TMG。在一些实施方案中,锌盐主要不含氧化锌并为可至少部分溶于口腔的形式。在一些实施方案中,锌盐的一个类型为氢氧化锌。在一些实施方案中,TMG还存在于沉淀物或颗粒中,或作为其整体组分,或作为杂质。
ZnO-TMG-HCl相较于可仅由ZnO递送的提供了相对高的溶解锌水平,且此外在稀释时向牙齿表面(如牙质和釉质表面)提供局部和富集的递送。所递送的材料以固体涂层的形式存在。所述涂层改善牙齿表面的白度。所述涂层可阻断牙质小管,提供敏感性的缓解。所述涂层可中和酸,提供抗侵蚀益处。所述涂层可在唾液中和/或在酸试验(acid challenge)时分解,以及在长时间内释放锌离子和TMG,提供所有与锌和TMG相关的益处。
实施例2
如以下制备包含ZnO-TMG HCl、1450ppm氟化物和磷酸盐的测试洁齿剂:
表4
成分 | 重量% |
PEG600 | 3 |
CMC-7 | 0.65 |
黄原胶 | 0.2 |
山梨糖醇 | 27 |
甘油 | 20 |
糖精 | 0.3 |
焦磷酸四钠 | 0.5 |
焦磷酸钙 | 0.25 |
磷酸二氢钠 | 3.5 |
氟化钠 | 0.32 |
二氧化钛 | 0.5 |
二氧化硅研磨剂 | 8 |
二氧化硅增稠剂 | 8 |
TMG-HCl | 5 |
月桂基硫酸钠 | 1.5 |
增香剂 | 1.2 |
ZnO | 2 |
水 | 足量 |
实施例3
以下提供稳定的漱口水制剂:
表5
实施例4
如以下制备样品4,ZnO-TMG-HCl。将15.3604g (0.1000摩尔)的TMG-HCl (CAS#590-46-5)在搅拌下溶于100mL的去离子水。在室温下将8.1370g (0.09999摩尔)的氧化锌粉末慢慢地加入到TMG-HCl溶液中。将混合物搅拌过夜约16小时。通过离心除去未反应的氧化锌,随后通过0.45微米的膜过滤。最终产物为透明溶液。
表6
进行使用样品4的稀释试验以评估它在稀释时在短期内形成沉淀和/或絮凝的能力。
在稀释前,将样品4的原液和去离子水预热至37℃。通过基于体积以不同比例混合原液和水来制备稀释液,生产具有1.5倍(1mL原液和0.5mL水)、2倍(1mL原液和1mL水)、4倍(1mL原液和3mL水)、8倍(1mL原液和7mL水)、16倍(0.5mL原液和7.5mL水)和32倍(0.5mL原液和15.5mL水)稀释液的样品。在初始混合时,人工摇动样品以保持在环境条件(气温大约为24℃)下的有效混合。监测絮凝/沉淀发生的速率。
发现稀释液在不同速率下产生沉淀和/絮凝。1.5倍的稀释液自初始混合的约20秒内产生由肉眼可识别的絮凝。2倍的稀释液在约5秒内产生絮凝。4倍和8倍的稀释液在絮凝可由肉眼辨别前需要约10秒钟。16倍的稀释液需要约1分钟。32倍的稀释液直到初始混合2分钟后才产生由肉眼可辨别的絮凝。
还发现,可在温度低于37℃下获得类似的速率,这是典型用户的初始使用阶段的情况。为此,通过以上述体积混合样品4原液(预热至37℃)和水(于环境温度,约24℃)制备1.5倍和2倍的稀释液。稀释液的温度低于37℃。稀释液分别在相同的20秒和5秒时间框架内产生絮凝。
由这些短暂处理产生的絮凝也可附着于牙齿和粘膜表面并向目标表面递送含锌化合物和TMG。提及上述ZnO-TMG HCl样品(样品2和3)所讨论的所有益处都适用。
短期处理独特地适于口腔护理应用,特别当通过牙膏和漱口剂实施递送时。典型的用户将刷拭或漂洗少于2分钟。相较于需要过长的处理时期的情况,用户对该生活习惯的顺应性将得到极大改善。
还期望使用其它ZnO-TMG-HCl样品(即,样品2和3)对短期处理的功效。
虽然已经就包括实施本发明的当前优选模式的具体实施例描述了本发明,但本领域技术人员将理解,上述系统和技术存在许多变动和变更。应理解,在不脱离本发明范围下可使用其它实施方案,且可作出结构性和功能性的改良。因此,应如所附权利要求阐述,宽泛地解释本发明的范围。
Claims (16)
1.口腔护理组合物,其包含氧化锌和游离或口腔可接受的盐形式的三甲基甘氨酸的混合物,其中以盐酸盐形式提供三甲基甘氨酸,所述氧化锌与三甲基甘氨酸的摩尔比为1∶1。
2.权利要求1所述的组合物,其中氧化锌和三甲基甘氨酸形成选自锌-三甲基甘氨酸-氯化物络合物、锌-氯化物络合物和它们的混合物的可溶性络合物。
3.权利要求1所述的组合物,其中提供口腔可接受的酸加成盐形式的所述三甲基甘氨酸。
4.权利要求1、2或3所述的组合物,其中锌的量为0.05-4重量%。
5.权利要求1、2或3所述的组合物,其中所述氧化锌溶于所述口腔护理组合物,但在使用和用唾液稀释和/或漂洗时,提供锌沉淀。
6.权利要求1、2或3所述的组合物,其中制备所述氧化锌和三甲基甘氨酸的混合物,随后将其结合到所述口腔护理组合物中。
7.权利要求1、2或3所述的组合物,其形式为牙膏、漱口剂、粉末、乳霜、条或胶。
8.权利要求1、2或3所述的组合物,其进一步包含有效量的氟离子源。
9.权利要求1、2或3所述的组合物,其包含口腔可接受基质,所述基质包含选自以下的成分:研磨剂、缓冲剂、湿润剂、表面活性剂、增稠剂、胶条或片、口气清新剂、调味剂、香料、着色剂、抗菌剂、增白剂、干扰或防止细菌附着的试剂、钙源、磷酸盐源、口腔可接受的钾盐、阴离子聚合物和它们的两种或更多种的组合。
10.权利要求1、2或3所述的组合物,其中所述混合物的pH为pH5-pH8。
11.权利要求1、2或3所述的组合物,其用于减少和抑制釉质的酸侵蚀、清洁牙齿、增白牙齿、减少细菌产生的生物膜和牙斑、减少齿龈炎、抑制牙齿腐烂和牙洞形成和/或减少牙质的超敏性。
12.离子络合物,其包含氧化锌、三甲基甘氨酸和阴离子物类,所述阴离子物类为氯化物。
13.氧化锌连同游离或口腔可接受的盐形式的三甲基甘氨酸制造口腔护理产品的用途,其中以盐酸盐形式提供三甲基甘氨酸,所述氧化锌与三甲基甘氨酸的摩尔比为1∶1。
14.权利要求1-11中任一项所述的组合物在制备药物中的用途,所述药物用于通过对所述牙齿施用该组合物治疗或减少牙齿釉质侵蚀、清洁所述牙齿、减少细菌产生的生物膜和牙斑、减少齿龈炎、抑制牙齿腐烂和牙洞形成、减少口臭和/或减少牙质超敏性。
15.Zn2O8H5X2-三甲基甘氨酸,其中X为Cl。
16.权利要求1、2或3所述的组合物,其形式为凝胶。
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CA2892422A1 (en) | 2014-06-26 |
ZA201503690B (en) | 2017-09-27 |
KR20150097492A (ko) | 2015-08-26 |
US9901523B2 (en) | 2018-02-27 |
MX352556B (es) | 2017-11-29 |
AU2012397270A1 (en) | 2015-06-11 |
MX2015007675A (es) | 2015-09-07 |
BR112015014758A2 (pt) | 2017-07-11 |
AU2012397270B2 (en) | 2015-08-06 |
JP5976955B2 (ja) | 2016-08-24 |
BR112015014758B1 (pt) | 2019-04-09 |
TWI507210B (zh) | 2015-11-11 |
EP2934446B1 (en) | 2016-12-07 |
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