TW201340986A - 口腔保健組成物（二） - Google Patents
口腔保健組成物（二） Download PDFInfo
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- TW201340986A TW201340986A TW101148571A TW101148571A TW201340986A TW 201340986 A TW201340986 A TW 201340986A TW 101148571 A TW101148571 A TW 101148571A TW 101148571 A TW101148571 A TW 101148571A TW 201340986 A TW201340986 A TW 201340986A
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- zirconium
- complex
- hydrophobic carrier
- amino acid
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Abstract
本發明係關於包含懸浮於疏水性載體中之鋯胺基酸絡合物的組成物；及其製造及使用之方法。
Description
本發明係關於包含懸浮於疏水性載體中之鋯胺基酸絡合物之組成物；及其製造及使用之方法。
鋯胺基酸絡合物使用於口腔保健配製物尚未報導。
本發明之某些具體例係提供實質上無水之口腔組成物，其包含有效數量之懸浮於疏水性載體中的鋯胺基酸絡合物。
於某些具體例中，本發明係提供預防、降低或抑制牙質敏感症之方法，其包括施用有效數量之包含懸浮於疏水性載體中之鋯胺基酸絡合物的口腔組成物至需要其之個體的口腔。
其他具體例係提供用於降低流體通過牙本質小管之流速的方法，其包括施用有效數量之懸浮於疏水性載體中的鋯胺基酸絡合物至需要其之個體的口腔。
如本文中所用之「實質上無水」一詞意指沒有水份係有意地加至該組成物，但微量的水可經由其他組成份或加工導入而存
在，但僅以不會過早觸發該組成物中之活化劑(類)的活性，及/或降低該組成物之穩定性的數量。
本發明之某些具體例係提供包含有效數量之懸浮於疏水性載體中的鋯胺基酸絡合物之實質上無水之口腔組成物，用來預防、降低或抑制牙質敏感症。
於某些具體例中，該鋯胺基酸絡合物係選自於鋯甘胺酸絡合物、鋯丙胺酸絡合物、鋯精胺酸絡合物，及鋯賴胺酸絡合物、鋯蘇胺酸絡合物、鋯白胺酸絡合物、鋯色胺酸絡合物、鋯苯基丙胺酸絡合物、鋯纈胺酸絡合物、鋯甲硫胺酸絡合物；及其二種或多種之組合物。於某些具體例中，該鋯胺基酸絡合物為鋯甘胺酸絡合物。
於某些具體例中，該疏水性載體係選自於MCT、聚乙二醇、丙二醇、矽酮流體，及其二種或多種之組合物。於某些具體例中，該疏水性載體為MCT。
於某些具體例中，該疏水性載體為植物油及/或矽酮油。中鏈甘油三酸酯(MCTs)宜作為該疏水性載體。MCTs典型地為鏈長約6至約12個碳。MCTs可為植物油。辛酸/癸酸之甘油三酸酯為用於本發明中較佳之MCT的非限制性實例。
於某些具體例中，該鋯胺基酸絡合物係以該組成物總重量之約0.01重量%至約20重量%之數量存在。於某些具體例中，該鋯胺基酸絡合物係以該組成物總重量之自約0.1重量%至約5重量%之濃度存在。於某些具體例中，該鋯胺基酸絡合物係以該組成物總重量之自約1重量%至約3重量%之濃度存在。於某些具體例中，該鋯胺基酸絡合物係以該組成物總重量之約2重量%之濃度存在。
於本發明之目的時，該「鋯胺基酸絡合物」一詞意欲包括絡合物，其中胺基酸組份具有多個離子化氮原子且為兩性離子形式。以兩性離子形式之其他分子亦可形成含鋯絡合物。此等化合物之一，例如為{[3-(十二烷醯胺基)丙基](二甲基)銨基}醋酸酯通常稱為椰基醯胺基丙基甜菜鹼。因此，本發明之某些具體例係提供
包含鋯甜菜鹼絡合物之組成物。
於某些具體例中，該鋯胺基酸絡合物係以顆粒的形式懸浮於疏水性載體中。於某些具體例中，該疏水性載體包含該組成物總重量之自約5至約99%。於其他具體例中，該疏水性載體包含該組成物總重量之自約30至約80%。然而於其他具體例中，該疏水性載體包含該組成物總重量之自約70至約75%。
當給藥時，本發明之組成物可以任何型式有效地抑制、降低或預防(於本文中統稱為「治療」)牙質敏感症。
本發明之組成物可藉已知於此方面技藝中之任何適當方式來給藥。於某些具體例中，將有效數量之懸浮於疏水性載體中的鋯胺基酸絡合物給藥至需要其之個體的口腔。
於某些具體例中，該鋯胺基酸絡合物係藉a)鋯(Zr)：胺基酸：無機酸以1：約1至約15：約1.5至約3之莫耳比混合而形成混合物；b)任意過濾該混合物；且c)任意乾燥該混合物而形成。
本發明之某些具體例係包含氟化物離子來源。於某些具體例中，該氟化物離子來源係選自於：氟化亞錫、氟化鈉、氟化鉀、磷酸一氟鈉、矽酸氟鈉、矽酸氟銨、氟化胺(例如，N'-十八基三亞甲基二胺-N,N,N'-三(2-乙醇)-二氫氟化物)、氟化銨、氟化鈦、六氟硫酸鹽，及其二種或多種之組合物。於某些具體例中，該氟化物離子來源係以該組成物總重量之約0.01重量%至約2重量%之數量存在。
於某些具體例中，該組成物進一步包含磨蝕劑。於某些具體例中，該磨蝕劑係選自於碳酸氫鈉、磷酸鈣(例如，磷酸二鈣二水合物)、硫酸鈣、沉澱碳酸鈣、矽石(例如，水合矽石)、氧化鐵、礬土(例如，包埋礬土)、珍珠岩、矽酸鋯、塑膠粒子，例如聚乙烯，及其二種或多種之組合物。於某些具體例中，該磨蝕劑係以該組成物總重量之約15重量%至約70重量%之數量存在。
某些具體例係包含陰離子表面活化劑選自於：a.高級脂肪酸一甘油酸酯一硫酸酯之水溶性鹽(例如，氫化椰子油脂肪酸之一硫酸酯化一甘油酸酯之鈉鹽，如N-甲基N-椰
醯牛磺酸鈉、椰基一甘油酸酯硫酸鈉)，b.高級烷基硫酸鹽，例如，月桂基硫酸鈉，c.高級烷基醚硫酸鹽，例如，式CH3(CH2)mCH2(OCH2CH2)nOSO3X，其中m為6-16，例如10，n為1-6，例如2、3或4，且X為Na或K(例如第十二烷基-2硫酸鈉(CH3(CH2)10CH2(OCH2CH2)2OSO3Na))，d.高級烷基芳基磺酸鹽(如十二烷基苯磺酸鈉(月桂基苯磺酸鈉))，e.高級烷基磺基醋酸鹽(如月桂基磺基醋酸鈉(十二基磺基醋酸鈉)、1,2二羥基丙烷磺酸酯之高級脂肪酸酯、磺基椰基月桂酸酯(sulfocolaurate)(N-2-乙基月桂酸酯鉀磺基乙醯胺)及月桂基肌胺酸鈉)，f.及其混合物。以「高級烷基」意指例如，C6-30烷基。於特別之具體例中，該陰離子表面活化劑係選自於月桂基硫酸鈉及月桂基硫酸醚鈉(sodium ether lauryl sulfate)。於某些具體例中，該陰離子表面活化劑係以自約0.3%至約4.5%按重量之數量存在。
1.0.1.任何前面之組成物，其進一步包含至少一種濕潤劑。
1.0.2.任何前面之組成物，其進一步包含至少一種濕潤劑選自於丙三醇、山梨糖醇、木糖醇及其組合物。
1.0.3.任何前面之組成物，其進一步包含至少一種聚合物。
1.0.4.任何前面之組成物，其進一步包含至少一種聚合物選自於聚乙二醇、聚乙烯基甲基醚順式丁烯二酸共聚物、多糖(例如，纖維酸衍生物，例如羧基甲基纖維素，或多糖膠，例如黃原膠或角叉菜膠)，及其二種或多種之組合物。
1.0.5.任何前面之組成物，其包含膠條或斷片。
1.0.6.任何前面之組成物，其進一步包含調味料、香氣及/或顏料。
1.0.7.任何前面之組成物，其進一步包含抗細菌劑選自於鹵化二苯醚(例如三氯生(triclosan))、草藥萃出物及精油(例如，迷迭
香萃出物、茶萃出物、木蘭萃出物、百里酚、醇、桉樹腦、櫳牛兒醇、香芹酚、檸檬醛、日檜醇、兒茶酚、水楊酸甲酯、表棓兒茶酸沒食子酸酯、表棓兒茶酸、沒食子酸、薩爾瓦多拉桃(miswak)萃出物、沙棘萃出物)、雙胍(bisguanide)殺菌劑(例如，氯己啶(chlorhexidine)、阿來西啶(alexidine)或奥替尼啶(octenidine))、季銨化合物(例如，十六基鈚錠氯化物(CPC)、苯烷銨氯化物(benzalkonium chloride)、十四基鈚錠氯化物(TPC)、N-十四基-4-乙基鈚錠氯化物(TDEPC))、酚殺菌劑、海克替啶(hexetidine)、奥替尼啶、血根鹼、波維酮(povidone)碘、地莫品諾(delmopinol)、沙利弗(salifluor)、金屬離子(例如，鋅鹽如檸檬酸鋅、亞錫鹽、銅鹽、鐵鹽)、血根鹼、蜂膠及充氧劑(oxygenating agents)(例如，過氧化氫、緩衝過氧硼酸鈉或過氧碳酸鈉)、酞酸及其之鹽、單鄰苯二羧酸(monoperthalic acid)及其之鹽及酯、抗壞血酸硬脂酸酯、油醯肌胺酸、烷基硫酸酯、二辛基磺基琥珀酸酯、水楊醯替苯胺、度米氛溴化物(domiphen bromide)、地莫品諾、辛哌醇(octapinol)及其他六氫吡啶基衍生物、尼辛(nicin)製劑、亞氯酸鹽；及其二種或多種之組合物。
本發明之某些具體例進一步包含該組成物總重量之約0.01至約5重量%數量之抗細菌劑。某些具體例進一步包含該組成物總重量之0.01至1重量%之數量的三氯生。
某些具體例係包含鈣及磷酸鹽之來源，其係選自於(i)鈣-玻璃絡合物，例如磷矽酸鈉鈣，及(ii)鈣-蛋白質絡合物，例如酪蛋白磷胜肽-無定形磷酸鈣。其他具體例包含可溶性鈣鹽，例如選自於硫酸鈣、氯化鈣、硝酸鈣、醋酸鈣、乳酸鈣，及其組合物。
尚有另外之具體例包含有效減輕牙質敏感性數量之口腔上可接受之鉀鹽，例如硝酸鉀或氯化鉀。某些具體例包含自約0.1%至約7.5%之口腔上可接受之鉀鹽，例如硝酸鉀及/或氯化鉀。
某些具體例為牙膏形式。於某些具體例中，該牙膏包含精胺酸鹽，例如精胺酸氫氯化物、精胺酸磷酸鹽或精胺酸碳酸氫鹽。
於某些具體例中，該牙膏任意包含一種或多種水、磨蝕
劑、表面活化劑、起泡劑、維生素、聚合物、酵素、濕潤劑、增稠劑、抗微生物劑、防腐劑、調味料、著色劑及/或其二種或多種之組合物。
某些具體例係包含口氣清新劑、香氣或調味料。其他具體例包含抗結石劑。於某些具體例中，該抗結石劑為聚磷酸鹽，例如焦磷酸鹽、三聚磷酸鹽，或六偏磷酸鹽，例如以鈉鹽形式。
某些具體例係提供方法，其係用於：a.降低或抑制齲齒形成，b.降低或抑制牙齒之去礦化且促進再礦化作用，c.降低或抑制初期琺瑯質病灶，d.降低或抑制牙齦炎，e.降低產酸細菌之含量，f.增加放線細菌(arginolytic bacteria)之相對含量，g.抑制微生物之生物膜於口腔中形成，h.於糖挑戰後，提高及/或保持牙菌斑pH於至少約pH 5.5之程度，i.降低牙菌斑累積，j.增白牙齒，k.改進全身健康，l.降低牙齒之侵蝕，m.免疫或保護牙齒對抗致齲細菌，及/或n.清潔牙齒及口腔。
於某些具體例中，該疏水性載體無需實質溶解此等粒子而能夠懸浮該鋯胺基酸絡合物粒子。適當疏水性載體之實例為中鏈甘油三酸酯(MCTs)、丙二醇、聚乙二醇、矽酮流體、蓖麻油，及其混合物。其他溶劑，其能夠溶解該鋯胺基酸絡合物者可任意存在於該配製物中，只要其不會不利地影響該組成物，例如治療牙質敏感症之功效。
MCTs為丙三醇之中鏈(6至12個碳)脂肪酸三酯，其典型地以油的形式。此等油可藉由熟知技術合成而製備，或可由天然
來源藉已知適當之天然油如棕櫚油或椰子油熱或溶劑分餾技術，產生富含所欲甘油三酸酯之餾份而得到。範例之低熔點、低分子量甘油三酸酯油為椰子油或棕櫚油之低分子量餾份，其為富含辛酸與癸酸之混合酯。此等油係市售可得，如米蓋歐(Miglyol)812可得自於SASOL公司(德國)、克達莫(CRODAMOL)GTCC-PN可得自於克洛達公司(Croda Inc.Parsippany，N.J.)，或尼歐比(Neobees)M-5油可得自於PVO國際公司(Boonton，N.J)。椰子油係由大約66%之中鏈甘油三酸酯所組成。MCTs之其他豐富的來源包括棕櫚仁油及樟樹核果。於MCTs中所發現之脂肪酸為中鏈脂肪酸。於MCTs中所發現之中鏈脂肪酸(及相關之碳數)為己酸(C6)、辛酸(C8)、癸酸(C10)及月桂酸(C12)。於另一個具體例中，此等脂肪酸於由椰子油所導生之市售MCT產物中之大約比率為2(C6)：55(C8)：42(C10)：1(C12)。
於某些具體例中，該組成物可進一步包括一種或多種氟化物離子來源，例如，可溶性氟化物鹽。代表性氟化物離子來源包括，但不侷限於，氟化亞錫、氟化鈉、氟化鉀、磷酸一氟鈉、矽酸氟鈉、矽酸氟銨、氟化胺、氟化銨，及其組合物。於特定具體例中，該氟化物離子來源包括氟化亞錫、氟化鈉、磷酸一氟鈉以及其組合物。
於特別之具體例中，本發明之口腔保健組成物可含有氟化物離子來源或提供氟之組成份，其係以足夠用於供應約25 ppm至約25,000 ppm，通常至少約500 ppm，例如約500至約2000 ppm，例如約1000至約1600 ppm，例如約1450 ppm氟化物離子之數量。氟化物之適當含量係依特別之施用而定。漱口水例如，通常具有約100至約250 ppm氟化物。牙膏，於一般消費者使用時通常具有約1000至約1500 ppm，而兒童牙膏具有稍微少些。專業應用之潔牙劑或塗層可具有多達約5,000或甚至約25,000 ppm氟化物。
氟化物離子來源可加至本發明之組成物中於一個具體例中以約0.01重量%至約10重量%之含量，或於另一個具體例中約0.03重量%至約5重量%，且於另一個具體例中約0.1重量%至約1
重量%，以該組成物重量計。用於提供適當氟化物離子含量之氟化物鹽的重量明顯地係根據於該鹽中平衡離子之重量而變化。
於某些具體例中，本發明之組成物可包含磷酸鈣磨蝕劑，例如磷酸三鈣(Ca3(PO4)2)、羥基磷灰石(Ca10(PO4)6(OH)2)，或磷酸二鈣二水合物(CaHPO4‧2H2O，本文中有時亦稱為DiCal)或焦磷酸鈣。某些具體例可包括一種或多種附加之磨蝕劑，例如矽石磨蝕劑如具有平均粒子尺寸多至約20微米之沉澱矽石，如矽歐頓(Zeodent)115®，其係由J.M.胡柏銷售。其他有用之磨蝕劑亦包括偏磷酸鈉、偏磷酸鉀、矽酸鋁、煅燒礬土、膨潤土或其他矽質材料，或其組合物。
有用於本文中之矽石磨蝕性擦亮材料以及其他磨蝕劑通常具有平均粒子尺寸於約0.1及約30微米間，於約5及約15微米間之範圍。該矽石磨蝕劑可來自於沉澱矽石或矽石凝膠，如矽石乾凝膠，其係說明於美國專利案號3,538,230(頒給帕德等)及美國專利案號3,862,307(頒給迪吉里歐)中，二者係併入本文中參考。特定之矽石乾凝膠係以商品名稱塞洛德(Syloid)®由W.R.葛蕾絲公司大維森化學部門銷售。該沉澱矽石材料包括那些由J.M.胡柏公司以商品名稱矽歐頓®銷售者，其包括攜帶命名矽歐頓115及119之矽石。此等矽石磨蝕劑係說明於美國專利案號4,340,583(頒給華生)中，其係併入本文中參考。
於特定具體例中，該矽石為具有平均粒子尺寸約3微米至約12微米，及約5至約10微米之膠體粒子。
於特別之具體例中，該磨蝕材料包含很大比例之極小粒子，例如具有d50<5微米，例如具有d50為約3至約4微米之小粒子矽石(SPS)，例如索波矽(Sorboril)AC43®(伊奈歐斯公司)。此等小粒子於目標在降低敏感症之配製物中特別有用。該小粒子組份可併入次大粒子之磨蝕劑中呈現。於特定具體例中，例如該配製物包含約3至約8%之SPS及約25至約45%之習用磨蝕劑。
特別有用於本發明實行中之低油吸收矽石磨蝕劑為商業命名賽洛頓(Sylodent)XWA®由W.R.葛蕾絲公司之大維森化學部
門(巴地摩爾市，Md.21203)銷售者。賽洛頓650 XWA®係由膠態矽石之粒子所組成之矽石水凝膠，其具有水含量29重量%，直徑平均約7至約10微米，且矽石之油吸收小於約70毫升/100克，其為有用於本發明實行中之低油吸收矽石磨蝕劑的實例。該磨蝕劑係以約10至約60重量%之濃度存在於本發明之口腔保健組成物中，於其他具體例中約20至約45重量%，且於另一個具體例中約30至約50重量%。
本發明之口腔保健組成物亦可包括試劑用來增加當口腔刷牙時所產生之泡沫的數量。
增加泡沫數量之試劑的闡明性實例包括，但不侷限於聚氧化乙烯及特定聚合物包括，但不侷限於藻朊酸酯聚合物。
該聚氧化乙烯可增加由本發明之口腔保健載體組份所產生之泡沫的數量及泡沫的厚度。聚氧化乙烯亦俗稱為聚乙二醇(「PEG」)或聚乙烯化氧。適合於本發明之聚氧化乙烯具有分子量約200,000至約7,000,000。於一個具體例中，該分子量為約600,000至約2,000,000且於另一個具體例中約800,000至約1,000,000。保粒歐(Polyox)®為商品名稱，其為聯合碳化物公司(Union Carbide)所生產之高分子量聚氧化乙烯。
該聚氧化乙烯可，以本發明之口腔保健組成物之口腔保健載體組份之約1%至約90%按重量之數量存在，於一個具體例中約5%至約50%且於另一個具體例中約10%至約20%。於該口腔保健組成物中之起泡劑的劑量(亦即，單一劑量)為約0.01至約0.9重量%，約0.05至約0.5重量%，且於另一個具體例中約0.1至約0.2重量%。
有用於本發明中之組成物可含有陰離子表面活化劑。該陰離子表面活化劑係以有效，例如該配製物之>0.01重量%，但不是以會刺激口腔組織之濃度，例如<10%之數量存在，且最佳之濃度係依特別配製物及特別表面活化劑而定。例如，所使用之濃度或漱口水典型地係為用於牙膏中之十分之一不等。於一個具體例中，該陰離子表面活化劑係以自約0.3%至約4.5%按重量，例如約
1.5%存在於牙膏中。
本發明之組成物可任意含有表面活化劑之混合物，其包含陰離子表面活化劑及其他表面活化劑，其可為陰離子性、陽離子性、兩性離子的或非離子性者。通常，表面活化劑為那些合理地於整個廣大之pH範圍內穩定者。表面活化劑係例如，於美國專利案號3,959,458(頒給亞利可拉等)；美國專利案號3,937,807(頒給海非爾)；及美國專利案號4,051,234(頒給吉斯凱等)中更詳細地說明，其係併入本文中參考。
於特別之具體例中，該組成物包含月桂基硫酸鈉。
表面活化劑或相容性表面活化劑之混合物可按重量，以該總組成物之約0.1%至約5.0%存在於本發明之組成物中，於另一個具體例中約0.3%至約3.0%及於另一個具體例中約0.5%至約2.0%。
本發明之口腔保健組成物亦可包含增香劑。使用於本發明之實行中的增香劑包括，但不侷限於，精油以及多種香味醛、酯、醇，及類似物質。精油之實例包括綠薄荷、薄荷、鹿蹄草、黃樟、丁香、鼠尾草、桉樹、黑角蘭、肉桂、檸檬、萊姆、葡萄柚，及柳橙之油。亦有用者為此等化學品如醇、香芹酮，及茴香腦。特定具體例係採用薄荷及綠薄荷之油。
該增香劑可合併於該口腔組成物中，以約0.1至約5重量%及約0.5至約1.5重量%之濃度。於個人口腔保健組成物劑量中之增香劑的劑量(亦即，單一劑量)為約0.001至0.05重量%且於另一個具體例中約0.005至約0.015重量%。
可使用之甜化劑包括蔗糖、葡萄糖、糖精、右旋糖、左旋糖、乳糖、甘露糖醇、山梨糖醇、果糖、麥芽糖、木糖醇、糖精鹽、索馬甜(thaumatin)、阿斯巴甜(aspartame)、D-色胺酸、二氫查耳酮、醋磺內酯(acesulfame)及環己基磺醯胺酸鹽(cyclamate)，特別蔗糖素(sucralose)、環己基磺醯胺酸鈉及糖精鈉，及其混合物。組成物宜含有自約0.1%至約10%之此等試劑，較佳自約0.1%至約1%，以該總組成物之重量計。
本發明之口腔保健組成物亦可任意包括一種或多種能夠
絡合鈣之螯合劑，其係於細菌之細胞壁中發現。該結合之鈣使細菌之細胞壁減弱且提高細菌之裂解。
適當用作為本發明中之螯合劑的另一組試劑為可溶性焦磷酸鹽。使用於本發明組成物中之焦磷酸鹽可為任何鹼金屬焦磷酸鹽。於特定具體例中，鹽類包括四鹼金屬焦磷酸鹽、二鹼金屬二酸焦磷酸鹽、三鹼金屬一酸焦磷酸鹽及其混合物，其中該鹼金屬為鈉或鉀。該鹽係以其等之水合或未水合形式二者使用。有用於本發明組成物中之焦磷酸鹽的有效數量通常係足夠用來提供至少約1.0重量%焦磷酸鹽離子，約1.5重量%至約6重量%，約3.5重量%至約6重量%之此等離子。
膠凝化礦物油為適當之疏水性黏度改良劑。於某些具體例中，該膠凝化礦物油宜為礦物油與聚乙烯，例如PLASTIGEL 5之摻合物，其為含5%聚乙烯於礦物油中之摻合物，且可得自於醫藥資源/萊恩實驗室公司(Lyne Laboratories Inc.of Brockton，MA)。其他適當之塑性凝膠可根據索氏等「製備聚乙烯-礦物油凝膠之新方法」之教示(J.Soc.Cosmetic Chemists)，16，359-363(1965)而製備。適當疏水性黏度改良劑除了膠凝化礦物油如塑性凝膠，可使用本發明揭示內容作為指南而識別。
本發明之口腔保健組成物亦任意包括一種或多種聚合物。聚合物可對該組成物提供特定之利益，例如當該組成物係以牙膏或凝膠之形式時，於製備的時候，經常需要添加一些增稠物質以提供該組成物想要之稠度，以提供於使用時想要之活性釋放特性，以提供儲存穩定性，及提供該組成物之穩定性等。可存在於本發明之組成物中之聚合物的典型實例包括聚乙二醇、聚乙烯基甲基醚順式丁烯二酸共聚物、多糖(例如纖維酸衍生物，例如羧基甲基纖維素，或多糖膠，例如刺梧桐膠(gum karaya)、阿拉伯膠、西黃蓍膠、黃原膠或角叉菜膠)。酸性聚合物，例如聚丙烯酸酯凝膠可，以其等之游離酸型式或部份或完全中和之水溶性鹼金屬(例如，鉀及鈉)或銨鹽提供。
特別當非陽離子抗細菌劑或抗細菌劑，例如三氯生包含於
任何潔牙組份中時，亦宜包含自約0.05至約5%之試劑，其係增強該試劑之傳送及保留至，及其保留於口腔表面上。此等試劑有用於本發明中者係揭示於美國專利案號5,188,821及5,192,531中；且包括合成陰離子聚合性聚羧酸酯，如順式丁烯二酸酐或酸與另一個聚合性乙烯不飽和單體之1：4至4：1共聚物，較佳為甲基乙烯基醚/順式丁烯二酸酐具有分子量(M.W.)約30,000至約1,000,000，最佳約30,000至約800,000者。此等共聚物可例如以甘特滋(Gantrez)取得。例如AN139(M.W.500,000)、AN119(M.W.250,000)且較佳為S-97醫藥等級(M.W.700,000)可得自於ISP技術公司(Bound Brook，紐約州08805)。當增強劑存在時，其係以自約0.05至約3%範圍按重量之數量存在。
特別種類之增稠劑或膠凝劑包括丙烯酸與季戊四醇之烷醚或蔗糖之烷醚，或碳聚物交聯之共聚物類。口腔上可接受之碳聚物市售可得自於B.F.古德里奇(Goodrich)。
於特定具體例中，增稠劑係以該總組成物之約0.1%至約15.0%按重量之數量使用，於另一個具體例中自約0.5%至約8%，於另一個具體例中自約0.5%至約5%。
於該口腔組成物之特定具體例內，亦需要併入濕潤劑以防止該組成物曝露於空氣中時變硬。特定濕潤劑亦可賦予想要之芳香或香味至潔牙組成物。該濕潤劑，以純濕潤劑為基準，通常於一個具體例中包括約15%至約70%或於另一個具體例中約30%至約65%，以該潔牙組成物之重量計。
適當之濕潤劑包括可食多元醇如丙三醇、山梨糖醇、木糖醇、丙二醇以及其他聚醇及此等濕潤劑之混合物。丙三醇與山梨糖醇之混合物可於特定具體例中用作為本文中牙膏組成物之濕潤劑組份。
除了上述組份，本發明之具體例可含有多種任意之潔牙組成份，其中一些說明於下。任意之組成份包括，例如，但不侷限於，膠黏劑、泡沫洗滌劑(sudsing agents)、增香劑或甜化劑、附加之抗噬菌斑劑、磨蝕劑，及著色劑。此等及其他任意之組份係於
美國專利案號5,004,597(頒給馬杰第)；美國專利案號3,959,458(頒給亞利可拉等)及美國專利案號3,937,807(頒給海非爾)中進一步說明，其全部係合併於本文中參考。
本發明之組成物可使用通常用於口腔產物領域中之方法製得。
如全文中所使用者，範圍係以簡略方式使用來說明該範圍內之各個及每一個數值。於該範圍內之任何數值可選擇作為該範圍之終點。此外，於本文中所引證之所有的參考，其等之全部內容合併於本文中參考。
萬一於本發明揭示內容中之定義與所引證之參考者發生衝突，則對照(controls)本發明之揭示內容。應瞭解當說明配製物時，其等可根據其等之組成份如常見於此方面技藝中者說明，儘管此等組成份於該實際配製物之製造、貯存及使用時可與另一個進行反應，且此等產物意欲涵蓋於所說明之配製物中。
下列之實例進一步說明且顯示本發明範圍內之闡明性具體例。該實例僅係為了闡明而給定且不能構成本發明之限制，如可在不背離本發明之精神及其範圍下逕行許多變化。
本發明之各種修正，除了本文中所顯示及說明者，對於熟知此方面技藝中之人士應顯而易知且意欲涵蓋於後附之申請專利範圍內。
ZG係依照於美國專利案號7,897,799及巴巴斯I.等所著論文(結晶生長與設計(Crystal Growth & Design)，2009(9)：5213-5219)中所概述之方法製備。將20微升ZG溶解於1毫升去離子水中以製備2% ZG溶液用於簡易實驗。將0.3毫升2% ZG溶液加至0.3毫升澄清之唾液，以測定當與唾液接觸時ZG是否可由溶液中沉澱。可觀察到大量沉澱且其不分散甚至於24小時後。該1：1唾液：2% ZG系統之pH為7.1。該實驗顯示ZG與人類唾液之組份
接觸時會沉澱。
為了測定該ZG沉澱物是否會封閉牙本質小管而製備牙本質盤。該盤係由抜出之人類臼齒獲得。將該盤於6%檸檬酸中蝕刻40秒鐘且於去離子水中音波分裂達30分鐘以打開牙本質小管。將各空盤於共焦之顯微鏡上造像且將每小管於100x125微米區域中所覆蓋之平均面積使用圖像分析軟體來計算。將每一個盤浸泡於澄清人類唾液中過夜。將該盤由該唾液中移除且將40微升之2% ZG溶液放在該盤上。於2分鐘後，將該盤用去離子水沖洗。將該盤用共焦之顯微鏡造像且將每小管於100x125微米區域中所覆蓋之平均%面積使用圖像分析軟體來計算。該覆蓋面積於處理前與後之降低%係於表1中報導。亦報導平均小管之直徑變化。
於表1(於上)中所說明之數據顯示當與唾液進行反應時ZG可沉澱，其數量足以封閉牙本質小管。
將2% ZG合併於二個疏水性載體中：第一個包含甘油；且第二個包含MCT(中鏈甘油三酸酯)。此等組成物各自於封閉牙本質小管之能力係使用液壓傳導來測定。
製備牙本質盤且將小管打開，如上所述者。將每一個盤浸泡於PBS中(磷酸鹽緩衝溶液)，其含有存在於唾液中的鹽。於處理前，將水通過經PBS浸泡之各個盤的流速予以測量。將65微升
2% ZG溶液加至該盤。於2分鐘後，將該ZG溶液移除且將該盤用400微升PBS沖洗5次。於一次處理後，將水通過該牙本質小管之流速予以測量。於流體流動中相對於基線之降低百分比(%)係於表2(於下)中報導。
於表2(於上)中所說明之數據顯示本發明之組成物係提供流過該牙本質小管之流體明顯降低很多，與類似配製之組成物其不含本案發明者所發現之本發明之組合物者相較。
Claims (14)
- 一種用於預防、降低或抑制牙質敏感症之實質上無水之口腔組成物，其包含有效數量之懸浮於疏水性載體中的鋯胺基酸絡合物。
- 如請求項第1項之組成物，其中該鋯胺基酸絡合物係選自於鋯甘胺酸絡合物、鋯丙胺酸絡合物、鋯精胺酸絡合物、鋯蘇胺酸絡合物、鋯賴胺酸絡合物、鋯白胺酸絡合物、鋯色胺酸絡合物、鋯苯基丙胺酸絡合物、鋯纈胺酸絡合物、鋯甲硫胺酸絡合物，及其二種或多種之組合物。
- 如請求項第1或2項之組成物，其中該鋯胺基酸絡合物為鋯甘胺酸絡合物。
- 如前述請求項中任一項之組成物，其中該疏水性載體包含組成份，其係選自於：油；蠟；矽酮；及其二種或多種之組合物。
- 如前述請求項中任一項之組成物，其中該疏水性載體包含油，其係選自於：植物油；矽酮油；及其組合物。
- 如前述請求項中任一項之組成物，其中該疏水性載體包含C6至C12甘油三酸酯。
- 如前述請求項中任一項之組成物，其中該疏水性載體包含MCT、聚乙二醇、矽酮流體、礦物油、丙二醇或其二種或多種之組合物。
- 如前述請求項中任一項之組成物，其中該疏水性載體包含MCT。
- 如前述請求項中任一項之組成物，其中該鋯胺基酸絡合物係以該組成物總重量之約0.01重量%至約20重量%之數量存在。
- 如前述請求項中任一項之組成物，其進一步包含磨蝕劑。
- 如前述請求項中任一項之組成物，其中該組成物為潄口劑或牙膏。
- 一種預防、降低或抑制牙質敏感症之方法，其包括施用有效數 量之前述請求項中任一項之組成物至需要其之個體的口腔。
- 一種封閉牙本質小管之方法，其包括將前述請求項中任一項之組成物投藥至需要其之個體。
- 一種懸浮於疏水性載體中之鋯胺基酸絡合物於製造用於預防、降低或抑制牙質敏感症之組成物的用途。
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| US5997850C1 (en) | 1997-10-29 | 2001-11-27 | Colgate Palmolive Co | Antiperspirant actives and formulations made therefrom |
| US6403067B1 (en) | 2000-05-19 | 2002-06-11 | Colgate-Palmolive Company | Stable emulsions for cosmetic products |
| KR20050073925A (ko) | 2004-01-12 | 2005-07-18 | 주식회사 엘지생활건강 | 치약 조성물 |
| RU2280437C2 (ru) * | 2004-08-05 | 2006-07-27 | Совместное открытое акционерное общество "Парфюмерно-косметическая фабрика "Модум - наша косметика" | Зубная паста с молочной сывороткой |
| US20060134020A1 (en) * | 2004-12-21 | 2006-06-22 | Robinson Richard S | Anti-caries oral care composition with a chelating agent |
| ES2418131T3 (es) * | 2007-09-21 | 2013-08-12 | Colgate-Palmolive Company | Sales de oxo-zirconio hexámero-octaaminoácido antitranspirantes |
| EP2229130A2 (en) * | 2007-12-13 | 2010-09-22 | 3M Innovative Properties Company | Remineralizing compositions and methods |
| US8632754B2 (en) * | 2009-08-03 | 2014-01-21 | Mcneil-Ppc, Inc. | Tooth sensitivity treatment compositions |
-
2011
- 2011-12-21 BR BR112014014941A patent/BR112014014941A2/pt not_active Application Discontinuation
- 2011-12-21 IN IN4600DEN2014 patent/IN2014DN04600A/en unknown
- 2011-12-21 WO PCT/US2011/066496 patent/WO2013105924A2/en not_active Ceased
- 2011-12-21 US US14/365,828 patent/US9125826B2/en active Active
- 2011-12-21 CA CA 2858043 patent/CA2858043A1/en not_active Abandoned
- 2011-12-21 CN CN201180075839.6A patent/CN103998010B/zh not_active Expired - Fee Related
- 2011-12-21 AU AU2011385369A patent/AU2011385369B2/en not_active Ceased
- 2011-12-21 JP JP2014548759A patent/JP2015500878A/ja active Pending
- 2011-12-21 EP EP11875263.3A patent/EP2793811B1/en not_active Not-in-force
- 2011-12-21 MX MX2014007532A patent/MX340344B/es active IP Right Grant
- 2011-12-21 HK HK15103993.4A patent/HK1203386A1/zh unknown
- 2011-12-21 RU RU2014129516/15A patent/RU2587058C2/ru active
- 2011-12-21 PL PL11875263T patent/PL2793811T3/pl unknown
- 2011-12-21 SG SG11201402930QA patent/SG11201402930QA/en unknown
-
2012
- 2012-12-20 AR ARP120104874 patent/AR089374A1/es unknown
- 2012-12-20 TW TW101148571A patent/TWI455729B/zh not_active IP Right Cessation
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2014
- 2014-06-09 PH PH12014501304A patent/PH12014501304B1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| SG11201402930QA (en) | 2014-07-30 |
| MX340344B (es) | 2016-07-05 |
| PL2793811T3 (pl) | 2017-01-31 |
| PH12014501304A1 (en) | 2014-09-15 |
| EP2793811A2 (en) | 2014-10-29 |
| CN103998010B (zh) | 2017-04-05 |
| HK1203386A1 (zh) | 2015-10-30 |
| EP2793811B1 (en) | 2016-07-27 |
| IN2014DN04600A (zh) | 2015-05-08 |
| WO2013105924A2 (en) | 2013-07-18 |
| MX2014007532A (es) | 2014-08-27 |
| AU2011385369B2 (en) | 2014-09-11 |
| AU2011385369A1 (en) | 2014-06-19 |
| WO2013105924A3 (en) | 2013-10-10 |
| TWI455729B (zh) | 2014-10-11 |
| US9125826B2 (en) | 2015-09-08 |
| AR089374A1 (es) | 2014-08-20 |
| CN103998010A (zh) | 2014-08-20 |
| CA2858043A1 (en) | 2013-07-18 |
| US20140341820A1 (en) | 2014-11-20 |
| RU2587058C2 (ru) | 2016-06-10 |
| RU2014129516A (ru) | 2016-02-10 |
| PH12014501304B1 (en) | 2014-09-15 |
| JP2015500878A (ja) | 2015-01-08 |
| BR112014014941A2 (pt) | 2017-06-13 |
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