CN101938970A - 牙齿密封剂 - Google Patents
牙齿密封剂 Download PDFInfo
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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
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0216—Solid or semisolid forms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K6/00—Preparations for dentistry
- A61K6/20—Protective coatings for natural or artificial teeth, e.g. sealings, dye coatings or varnish
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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
- A61K8/19—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
- A61Q11/02—Preparations for deodorising, bleaching or disinfecting dentures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
- A61K2800/22—Gas releasing
- A61K2800/222—Effervescent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/41—Particular ingredients further characterized by their size
- A61K2800/412—Microsized, i.e. having sizes between 0.1 and 100 microns
Abstract
本发明提供治疗敏感牙齿的方法,其包括将包含碱性氨基酸的密封剂组合物附着于人的牙齿,并使碱性氨基酸随时间而缓慢释放,以便减轻慢性和/或急性牙齿敏感;以及提供组合物及使用方法。
Description
本申请要求2008年2月8日提交的序列号为61/027,425的美国申请的权益,通过引用将其内容并入本文。
发明领域
本发明涉及牙齿密封剂组合物,其包含游离形式或盐形式的碱性氨基酸,其可用于帮助防止牙齿去矿化(demineralization),缓解患者牙齿的疼痛和/或敏感,并提供其他益处。密封剂可包括聚合物涂料、涂剂(varnish)和泡沫体,以涂布牙齿和/或牙科设备,持续延长的时期。
背景
龋齿由细菌引起的牙齿去矿化形成。在龋齿的早期,牙齿上形成白斑,若该疾病未被阻止并逆转,则牙釉质表面发生破坏,形成损伤。然后这可导致腐烂,最终使牙齿断裂。众所周知,利用各种因素可减少龋齿的发展,所述因素如饮食和口腔卫生措施,对牙齿进行抗微生物治疗以及提供氟化物。
牙齿敏感也是影响儿童和成人的常见问题。一般地,牙齿敏感可能由以下因素引起:牙龈退缩、归因于侵蚀或磨损的牙本质暴露,或者包括牙根整平(root planning)的牙周手术。此类情况使组织的牙本质小管容易受到化学、细菌、机械或热刺激物的刺激。刺激物的例子包括热、冷和甜食。据信,牙齿敏感是牙髓的神经末梢受到流过暴露的牙本质小管的流体刺激的结果。
针对缓解与敏感牙齿有关的疼痛的治疗一般集中于阻止刺激物进入(access to)牙本质小管,从而防止其引起疼痛和敏感。已经开发出许多治疗,其包括施用无机或有机组分,所述组分设计用来堵塞或以其它形式阻断牙本质小管,持续有限时间。此类治疗的缺点是日常习惯,如吃某些食物(例如酸含量高的食物)或者刷牙,可抵消该治疗。最近试验揭示,增加的口中氟化物水平也可用作牙齿敏感的治疗(Toumba和Andreadis)。
目前施用预防龋齿用的氟化物的方法包括将饮用水氟化,摄入氟化物片剂,将氟化物并入漱口剂、牙膏和食物中,局部施涂氟化物溶液、凝胶和涂剂,最近将氟化物并入牙科材料和装置中。
有证据支持以下观念:频繁施用相对低浓度的氟离子(fluoride ion)来预防龋齿和治疗敏感牙齿。持续且控制地释放递送系统可能有助于实现该目标。
发明概述
在一个实施方式中,本发明提供牙用密封剂组合物,其包含游离形式或盐形式的碱性氨基酸(BAA)。密封剂组合物另外可包含氟化物。BAA优选为精氨酸,其为游离形式或口腔可接受的盐形式。
在另一个实施方式中,本发明涉及使用密封剂组合物中游离形式或盐形式的碱性氨基酸(BAA),优选在氟化物的存在下来治疗敏感牙齿的方法。该方法包括:(1)将释放BAA的密封剂组合物附着于人的牙齿;以及(2)使BAA随时间而缓慢释放,以便减轻慢性和/或急性牙齿敏感。优选地,该密封剂还用作释放氟化物的组合物。因为该方法依赖于BAA向口腔的释放,所以该方法还通过防止去矿化和保持坚固的牙釉质来防止将来与龋齿相关的疼痛。
本发明进一步提供改善口腔健康的方法,其包括使例如需要其的对象使用包含BAA的牙用密封剂组合物,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;
c.减少或抑制牙齿的去矿化并促进其再矿化(remineralization);
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(arginolytic bacteria)的相对水平;
i.抑制口腔内微生物生物膜的形成;
j.在糖攻击(sugar challenge)后使牙菌斑pH升高和/或保持在至少pH5.5的水平;
k.减少牙菌斑的累积;
l.治疗干口(dry mouth);
m.增白牙齿;
n.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;
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。
本发明进一步提供BAA在制备牙用密封剂中的用途,所述牙用密封剂例如用于治疗敏感牙齿的方法,或者用于上述任何方法。
除了释放BAA的密封剂组合物在预防龋齿中可能具有的任何效果之外,该密封剂组合物可用于缓解疼痛和/或牙齿敏感。该组合物可附着于牙齿,以提供缓释BAA的装置(device),用于将BAA释放入个体的唾液中。
在口内条件下,组合物的日溶解率(daily dissolution rate)(DDR)可为每日约0.1%至约100%。密封剂组合物的所需DDR将取决于所要求的BAA释放的持续时间。例如,若要求组合物经长时期(如1-2年)释放BAA,则DDR优选为约0.1%至约0.5%。然而,若仅需要释放BAA较短时期(如数小时、数日、数周或数月),则可使用释放更快速的密封剂,例如具有至多约100%的DDR。
“牙用密封剂组合物”是指附着于牙齿的组合物。所述组合物可作为喷雾剂(例如使用烃推进剂)施用。或者,所述组合物包含适合涂到牙齿上的聚合物或涂剂(varnish)。或者,可将所述组合物并入牙粘固粉或填充材料中。例如,可使所述组合物附着于牙齿,例如使用标准牙粘固粉附着于后臼齿,或者作为粉末添加到牙科材料(如银汞合金(dental amalgams))中,从而提供途径来补充释放入唾液中的BAA,以帮助预防或减少龋齿。粉末可包含在许多其他的牙科材料(如裂隙密封树脂(fissure sealant resins)或复合粘合材料)中,以在正畸矫治器中接合连接器(bonds)和托槽(brackets)。粉末应用可使用密封剂组合物,其DDR小于直接附着于牙齿的那些组合物,例如DDR为约0.1%至约1%。
本发明的这些及其他益处、优点和特征将从以下描述和所述权利要求书中变得更充分明显,或者可通过如下文所述的本发明实践而习知。
优选实施方式描述
本发明方法涉及将释放BAA的密封剂组合物附着于人的牙齿或牙科器械(如义齿),然后使BAA随时间而缓慢释放,以便降低慢性和/或急性牙齿敏感。根据一个优选的实施方式,释放BAA的密封剂组合物包含约5重量%至约75重量%BAA和约5重量%至约30重量%氟。
缓释BAA装置可在长达2年或更长时期内一贯地提高口内唾液中的BAA水平,现在还看上去在2周内完全缓解牙本质敏感症状,同时对成人保持长达6个月或更长的益处。对象报告,他们的牙本质敏感完全得到缓解。没有报告或观察到不良事件(adverse event)。牙菌斑和齿龈指数存在轻微增加趋势,但这不显著。
可用于本发明组合物和方法中的碱性氨基酸不仅包括天然存在出碱性氨基酸(如精氨酸、赖氨酸和组氨酸),而且包括分子中具有羧基和氨基的任何碱性氨基酸,其是水溶性的,并提供pH为7或更大的水溶液。
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、其盐或其组合。在一个具体的实施方式中,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,例如精氨酸碳酸氢盐、磷酸精氨酸或盐酸精氨酸。
本发明组合物有意用于消费,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在药学上可接受的盐,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,例如衍生自碱金属(如钾和钠)或碱土金属(如钙和镁)的那些盐。可使用本领域已知的标准程序获得生理学上可接受的盐,例如通过使具有足够碱性的化合物(如胺)与提供生理学上可接受的阴离子的合适的酸反应。
BAA的浓度将根据制剂而变化。在一个实施方式中,BAA(表达为游离碱重量的盐的量)占制剂重量的1%-40%,例如5%-20%,例如约10%。
本发明组合物可另外包含氟化物。代表性氟离子源包括但不限于氟化亚锡、氟化钠、氟化钾、一氟磷酸钠、氟硅酸钠、氟硅酸铵、氟化胺、氟化铵及其组合。在某些实施方式中,氟离子源包括氟化亚锡、氟化钠、一氟磷酸钠及其混合物。在一个具体的实施方式中,氟离子源(fluoride source)是氟化钠或一氟磷酸钠。氟化物可以有效量存在于制剂中,如常规牙用密封剂中所用的量,例如高于牙膏中的通常用量。其存在量例如可以是例如约2500ppm-约250000ppm(表达为氟离子水平),或者以组合物重量为基准计,为2%-25%,例如至少12%,例如15%-25%。
所述组合物可另外包含抗细菌剂,如三氯生;或抑制细菌附着的试剂。
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。范围内的任何值可选作该范围的端值。此外,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。应当理解,当描述制剂时,可根据其成分描述它们,如本领域中常见的那样,尽管在制备、储存和使用实际制剂中这些成分可能彼此反应,此类产品有意被所述制剂覆盖。
以下实施例进一步描述和阐释了本发明范围内的示例性实施方式。给出这些实施例仅用于举例说明,不应理解为对本发明的限制,因为有可能做出许多变化,而不背离本发明的精神和范围。除本文所显示和描述的那些之外,本发明的各种修改对于本领域技术人员来说应该是显而易见的,所述修改也落在所附权利要求书的范围内。
实施例
实施例1
如下制备含10重量%精氨酸碳酸氢盐的制剂:
表1
成分 (第1部分) %
水 适量
氟化钠 2.65
苹果酸 1.75
一磷酸钠 1.38
甲基椰油基牛磺酸钠 1
香料 0.6
糖精钠 0.35
苯甲酸钠 0.1
精氨酸碳酸氢盐 10
总计(第1部分) 100
第2部分
第1部分 93
烃推进剂混合物 7
总计 100
实施例2
如下制备包含10重量%精氨酸盐酸盐的涂剂制剂:
表2
成分 %
松香 22.01
90%乙醇 27.87
虫胶 21.5
乳香 11.82
氟化钠 4.98
糖精钠 0.68
覆盆子香料 0.65
白蜂蜡 0.48
盐酸精氨酸 10
总计 100
Claims (24)
1.治疗敏感牙齿的方法,其包括将包含游离形式或盐形式的碱性氨基酸(BAA)的密封剂组合物附着于需要其的人的牙齿;使BAA随时间而缓慢释放,以便减轻慢性和/或急性牙齿敏感。
2.如权利要求1所述方法,其中所述组合物另外包含氟化物。
3.如权利要求2所述方法,其中所述氟化物随时间而缓慢释放。
4.如权利要求3所述方法,其中氟离子包括在选自以下的化合物中:氟化铝、氟化氢钠、氟化钠、氟化钙、氟化镁和氟化钾。
5.如权利要求2所述方法,其中所述组合物中包括至少约12重量%的氟化物。
6.如权利要求2所述方法,其中所述组合物中包括约15重量%-约25重量%的氟化物。
7.如权利要求2所述方法,其中所述组合物的DDR为约0.1%-约100%。
8.如权利要求2所述方法,其中所述组合物的DDR为约0.1%-约0.5%。
9.如权利要求2所述方法,其中以粉末形式提供所述组合物。
10.如权利要求9所述方法,其中所述密封剂组合物的粉末形式包含粒度小于约38微米的粉末颗粒。
11.如权利要求10所述方法,其中所述密封剂组合物的粉末形式包含粒度小于约106微米的粉末颗粒。
12.如权利要求10所述方法,其中将所述粉末组合物并入一种或多种牙科材料中。
13.如权利要求12所述方法,其中所述牙科材料选自银汞合金、裂隙密封树脂、复合粘合材料、正畸矫治器、牙科修复材料、树脂涂剂和口腔手术植入物。
14.如权利要求2所述方法,其中所述组合物包含至少一种丸粒,所述丸粒可使用牙粘固粉附着于牙齿,其中所述至少一种丸粒包含BAA。
15.牙用密封剂组合物,其包含游离形式或盐形式的碱性氨基酸(BAA)。
16.如权利要求15所述密封剂组合物,其另外包含氟化物。
17.如权利要求15或16所述密封剂组合物,其中BAA包含游离形式或盐形式的精氨酸。
18.如权利要求15-17中任一项所述密封剂组合物,其包含氟化铝、氟化氢钠、氟化钠、氟化钙、氟化镁或氟化钾。
19.如权利要求15-18中任一项所述密封剂组合物,其中组合物中包括至少约12重量%的氟化物。
20.如权利要求15-19中任一项所述密封剂组合物,其中所述组合物的DDR为约0.1%-约100%。
21.如权利要求20所述密封剂组合物,其中所述组合物的DDR为约0.1%-约0.5%。
22.如权利要求15-21中任一项所述密封剂组合物,其中以粉末形式提供所述组合物。
23.如权利要求15-22中任一项所述密封剂组合物,其并入选自以下的牙科材料中:银汞合金、裂隙密封树脂、复合粘合材料、正畸矫治器、牙科修复材料、树脂涂剂和口腔手术植入物。
24.游离形式或盐形式的碱性氨基酸在制备牙用密封剂组合物中的用途。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US2742508P | 2008-02-08 | 2008-02-08 | |
US61/027425 | 2008-02-08 | ||
PCT/US2009/033312 WO2009100283A2 (en) | 2008-02-08 | 2009-02-06 | Tooth sealant |
Publications (1)
Publication Number | Publication Date |
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CN101938970A true CN101938970A (zh) | 2011-01-05 |
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CN2009801045327A Pending CN101938970A (zh) | 2008-02-08 | 2009-02-06 | 牙齿密封剂 |
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US (1) | US10391038B2 (zh) |
EP (1) | EP2249764B1 (zh) |
JP (2) | JP2011510095A (zh) |
CN (1) | CN101938970A (zh) |
AR (1) | AR070589A1 (zh) |
AU (1) | AU2009212339B2 (zh) |
BR (1) | BRPI0907103A2 (zh) |
CA (1) | CA2711262C (zh) |
CO (1) | CO6241091A2 (zh) |
MX (1) | MX2010007738A (zh) |
RU (1) | RU2493812C2 (zh) |
TW (1) | TWI376237B (zh) |
WO (1) | WO2009100283A2 (zh) |
ZA (1) | ZA201003694B (zh) |
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CN102406403A (zh) * | 2011-12-19 | 2012-04-11 | 吴江市江南不锈钢器材有限责任公司 | 一种杯套 |
CN104758311A (zh) * | 2015-04-24 | 2015-07-08 | 杭州维瓦科技有限公司 | 一种治疗牙齿过敏的组合物及制备方法 |
CN106361579A (zh) * | 2016-11-10 | 2017-02-01 | 李雨阳 | 一种牙齿表面自清洁抗粘附涂层的制作方法 |
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-
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- 2009-02-06 AU AU2009212339A patent/AU2009212339B2/en not_active Ceased
- 2009-02-06 MX MX2010007738A patent/MX2010007738A/es active IP Right Grant
- 2009-02-06 EP EP09708758.9A patent/EP2249764B1/en active Active
- 2009-02-06 JP JP2010544489A patent/JP2011510095A/ja active Pending
- 2009-02-06 TW TW98103776A patent/TWI376237B/zh not_active IP Right Cessation
- 2009-02-06 CA CA2711262A patent/CA2711262C/en not_active Expired - Fee Related
- 2009-02-06 CN CN2009801045327A patent/CN101938970A/zh active Pending
- 2009-02-06 RU RU2010137322/15A patent/RU2493812C2/ru not_active IP Right Cessation
- 2009-02-06 US US12/866,766 patent/US10391038B2/en active Active
- 2009-02-06 AR ARP090100435 patent/AR070589A1/es not_active Application Discontinuation
- 2009-02-06 WO PCT/US2009/033312 patent/WO2009100283A2/en active Application Filing
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2010
- 2010-05-24 ZA ZA2010/03694A patent/ZA201003694B/en unknown
- 2010-09-03 CO CO10109377A patent/CO6241091A2/es not_active Application Discontinuation
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102406403A (zh) * | 2011-12-19 | 2012-04-11 | 吴江市江南不锈钢器材有限责任公司 | 一种杯套 |
CN104758311A (zh) * | 2015-04-24 | 2015-07-08 | 杭州维瓦科技有限公司 | 一种治疗牙齿过敏的组合物及制备方法 |
CN106361579A (zh) * | 2016-11-10 | 2017-02-01 | 李雨阳 | 一种牙齿表面自清洁抗粘附涂层的制作方法 |
Also Published As
Publication number | Publication date |
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BRPI0907103A2 (pt) | 2016-05-03 |
JP2014088419A (ja) | 2014-05-15 |
EP2249764A2 (en) | 2010-11-17 |
AU2009212339B2 (en) | 2011-12-22 |
TW201000143A (en) | 2010-01-01 |
WO2009100283A2 (en) | 2009-08-13 |
RU2493812C2 (ru) | 2013-09-27 |
AR070589A1 (es) | 2010-04-21 |
ZA201003694B (en) | 2014-11-26 |
JP2011510095A (ja) | 2011-03-31 |
EP2249764A4 (en) | 2012-02-22 |
CA2711262A1 (en) | 2009-08-13 |
RU2010137322A (ru) | 2012-03-20 |
WO2009100283A3 (en) | 2009-11-12 |
US20100316726A1 (en) | 2010-12-16 |
AU2009212339A1 (en) | 2009-08-13 |
US10391038B2 (en) | 2019-08-27 |
MX2010007738A (es) | 2010-08-10 |
TWI376237B (en) | 2012-11-11 |
CO6241091A2 (es) | 2011-01-20 |
CA2711262C (en) | 2015-06-23 |
EP2249764B1 (en) | 2019-07-31 |
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