TWI499430B - 抗侵蝕的牙膏組成物 - Google Patents
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Description
此專利申請案主張2009年12月17日申請之美國專利臨時申請案第61/287,292號的優先權,其係併入於此作為參考。
一種可減少牙齒琺瑯質酸侵蝕的抗侵蝕口腔保健組成物。更明確而言係提供含有優異抗侵蝕效益之氟離子源和磷酸鹽的牙膏組成物。
牙齒琺瑯質的侵蝕可導致疼痛、脫色、力學破壞,及易罹患齲齒。琺瑯質的化學侵蝕導因於口腔內的酸性物質。主要為蛋白質和礦物質的唾液成分以及表膜可共同對抗侵蝕。唾液內的礦物質和蛋白質有助於提供下調或轉移硬組織脫礦化之動態平衡的化學阻隔,同時該表膜則提供擴散阻隔以完成上述相同過程。此外,pH值和存在例如磷酸鹽和氟化物之物種有助於決定牙齒礦物質(tooth mineral)組成物的飽和程度及分解的驅動力。
許多目的的其中之一為口腔保健組成物有助於控制口腔內的pH值。一種控制口腔pH值的常見方法為在口腔保健組成物的配製中加入鹼化劑。該鹼化劑與酸反應以中和酸,形成水和鹽。此過程可升高口腔內的pH值。該鹼化劑具有中和等量酸的能力。口腔保健組成物內可併入限量的鹼化劑。除鹼化劑之外為使用緩衝系統。緩衝系統可根據其組成物被維持在一特定pH範圍內。口腔保健組成物內亦可安全地含有比純鹼化劑更高含量的緩衝系統。先前技術雖然已知為了維持pH值的目的而在口腔保健組成物中包含緩衝系統,但是這些緩衝系統卻無保護酸化琺瑯質侵蝕的足夠高緩衝能力。
一種利用包含口腔可接受載劑、氟化鹽和磷酸鹽緩衝液之多成分口腔保健組成物以預防牙齒侵蝕的組成物和方法。包含口腔可接受載劑、氟化鹽和磷酸鹽緩衝液的組成物,磷酸鹽緩衝液包含比例從12:88至18:82之單鹼式磷酸鈉和雙鹼式磷酸鈉,較佳為最終組成物的3.5至4.5%重量百分比。一種利用包含口腔可接受載劑、氟化鹽以及含12:88至18:82比例之單鹼式磷酸鈉和雙鹼式磷酸鈉,較佳為最終組成物3.5至4.5%重量百分比磷酸鹽緩衝液之組成物以減少牙琺瑯質酸侵蝕的方法。該組成物和方法藉由提供可中和口腔酸度、減少琺瑯質侵蝕之較高緩衝能力的組成物以達到保護琺瑯質不被侵蝕的目的。
全文中,使用縮寫表達在該範圍內之各個和每一個值的範圍。任何在該範圍內之值均可被選擇作為該範圍的界標。此外,所有在此引用的文獻係以作為參考的方式結合至本案。若本發明與所引述文獻的定義發生衝突時以本發明的揭示為準。此外,該組成物和方法可包含、實質上由,或由此處所述的元素所組成。
除非另有明述,否則應瞭解說明書中此處和他處表示的全部百分比和數量係指重量百分比。所示數量係根據原料的活性重量。此處所引述的特定值擬用以表示加減一定程度之差異以計入測量誤差的值。例如,10%的一數量為計入所屬技術領域中具有通常知識者所能判斷和瞭解的已知誤差,包括9.5%或10.5%。
各種具體實施例的口腔保健組成物較佳為潔齒劑的形式。本說明書全文中"潔齒劑"一詞意指牙膏、凝膠或液體配製物。該潔齒劑可為任何所欲形狀,例如包圍牙膏的深條紋、淺條紋、多層凝膠,或其任何組合。
本說明書全文中"載劑"或"水性載劑"意指用於此處的任何安全和有效材料。此類材料包括例如增稠劑、濕潤劑、離子活性成分、緩衝劑、抗牙石劑、打磨拋光材料、過氧化物源、鹼金屬重碳酸鹽、表面活性劑、二氧化鈦、著色劑、香料系統、甜味劑、抗菌劑、草藥劑、去敏劑、除污劑,及其混合物。
為製備抗侵蝕口腔保健組成物,較佳為將磷酸鹽緩衝液和氟化物源併入口腔可接受載劑內。
磷酸鹽緩衝液通常作為改變酸性溶液之pH的組合(請見PJ Niebergall,雷明登製藥科學和實務內之"離子溶液和電解質平衡",AR Gennaro編輯,2000年第二版)。可被用於形成磷酸鹽緩衝液組合之非限制磷酸鹽的實例包括X可為鈉或鉀的XH2
PO4
(單鹼式磷酸鹽)或X2
HPO4
(雙鹼式磷酸鹽)的可溶性磷酸鹽。單鹼式磷酸鹽和雙鹼式磷酸鹽的比例可從12:88至18:82,較佳為從14:86至18:82,更佳為16:84。該磷酸鹽緩衝液的重量百分比較佳為其緩衝成分之個別重量百分比的組合。最終組成物內磷酸鹽緩衝液的較佳重量百分比為從3.5至4.5%,最佳為3.75%。
釋氟離子鹽可被併入該口腔可接受載劑內,以及其特徵為其於水中的釋氟離子能力。較佳為使用能產生約1000至約9000,及較佳為約2500至約8800 ppm之氟化物離子的水溶性氟化鹽。釋氟離子鹽的適當實例包括水溶性無機金屬鹽,例如氟化鈉、氟化鉀、單氟磷酸鈉和氟化亞錫。氟化鈉、單氟磷酸鈉和氟化亞錫係較佳的釋氟離子鹽。
"口腔可接受載劑"一詞意指含有任何單一或下列成分之組合的任何潔齒劑、牙膏、漱口液、糖錠或喉錠:溶劑、鹼化劑、濕潤劑、增稠劑、表面活性劑、磨料、抗牙石劑、著色劑、調味劑、染料、含鉀鹽和抗菌劑。
口腔可接受載劑內可併入約0.5至約15%重量比,較佳為約1.0至約8%重量比及最佳為約1.0至約5.0%重量比組成物之例如鹼金屬化合物的鹼化劑包括氫氧化鈉、氫氧化鉀、重碳酸鈉、碳酸鈉、N-矽酸鈉(供應自PQ公司之34.6%水內3.22重量比的矽酸鈉)。亦可使用上述鹼金屬化合物的混合物。最佳的鹼化劑為氫氧化鈉。
用於製備口腔可接受載劑的濕潤劑通常為濕潤劑,例如甘油、山梨糖醇及分子量在200至1000間之聚乙二醇的混合物,但是亦可使用濕潤劑和單一濕潤劑的其他混合物。濕潤劑含量較佳為在約10至約50%重量比的範圍及較佳為約20至約40%重量比的潔齒劑成分。水含量為在約20至約50%重量比及較佳為約30至約40%重量比。
用於製備口腔可接受載劑的增稠劑包括有機和無機增稠劑。可用於口腔可接受載劑內的無機增稠劑包括非晶形矽例如供應自Huber公司的Zeodent 165和供應自W. R. Grace的Sylox 15。天然和合成膠及膠體的有機增稠劑亦可被用於製造潔齒劑成分。此類增稠劑的實例為卡拉膠(愛爾蘭苔)、三仙膠、羧甲基纖維素鈉、澱粉、聚乙烯吡咯啶酮、羥乙基丙基纖維素、羥丁基甲基纖維素、羥丙基甲基纖維素,及羥乙基纖維素。併入口腔可接受載劑內的無機增稠劑濃度可為0.5至5%重量比及較佳為1至3%重量比。併入組成物內的有機增稠劑濃度為0.1至3%重量比及較佳為0.4至1.5%重量比。
口腔可接受載劑內可併入表面活性劑以產生發泡性。該表面活性劑較佳為陰離子或非離子性。陰離子表面活性劑的適當實例為高級烷基硫酸鹽較佳為例如月桂基硫酸鉀或鈉、高級脂肪酸單硫酸單酸甘油酯例如氫化椰油脂肪酸的單硫酸化單甘油酯、烷基芳基磺酸鹽例如十二烷基苯磺酸鈉、高級脂肪磺基乙酸鹽、1,2-二羥基丙磺酸鹽的高級脂肪酸酯。口腔可接受載劑組成物內的表面活性劑濃度通常為0.5至10.0%重量比及較佳為1.0至5.0%重量比。
口腔可接受載劑內可併入磨料,及較佳的磨料為例如氧化矽的矽質材料。較佳的氧化矽為沈澱非晶形水合矽石,例如Crosfield化學公司販售的Sorbosil AC-35或取自Huber公司的Zeodent 115,但是亦可使用其他磨料包括羥基磷灰石、偏磷酸鈉、偏磷酸鉀、磷酸三鈣、二水磷酸鈣、無水磷酸二鈣、焦磷酸鈣、正磷酸鎂、磷酸三鎂、碳酸鈣、重碳酸鈉、三水合氧化鋁、矽酸鋁、燒結氧化鋁、氧化鈦和膨潤土。牙膏組成物內的磨料濃度通常為從5至40%重量比,及較佳為10至25%重量比。
去敏鉀離子源通常為水溶性鉀鹽包括硝酸鉀、檸檬酸鉀、氯化鉀、碳酸氫鉀和草酸鉀,其中較佳為硝酸鉀。併入一或多種潔齒劑成分內的鉀鹽濃度通常為1至20%重量比,及較佳為3至10%重量比。
實務中具有抗牙斑效果的焦磷酸鹽包括水溶性鹽例如二鹼或四鹼金屬焦磷酸鹽例如Na4
P207
(TSPP)、K4
P207'
Na2
P207'
、Na2
H2
P207
和K2
H2
P207'
聚磷酸鹽包括水溶性鹼金屬三聚磷酸鹽如三聚磷酸鈉和三聚磷酸鉀。併入潔齒劑組成物內的焦磷酸鹽濃度為0.5至2.0%重量比,及較佳為1.5至2%重量比,以及併入潔齒劑組成物內的聚磷酸鹽濃度為1.0至7.0%重量比。
例如色素和染料的著色劑可被用於實務中。色素包括無毒、水不可溶無機色素例如二氧化鈦和氧化鉻綠、群青藍和粉紅及氧化鐵,以及藉由延伸FD&C氧化鋁染料之鈣或鋁鹽所製備的水不可溶色澱例如FD&C綠色1號色澱、FD&C藍色2號色澱、FD&C R&D30號色澱和FD&C黃色15號色澱。該色素的粒徑範圍為5~1000微米,較佳為250~500微米,以及其濃度為0.5至3%重量比。
所使用染料通常為目前經由食品藥物和化妝品法核准之用於食品和吞服性藥物的食用色素添加劑,包括染料如FD&C紅色3號(四碘螢光黃的鈉鹽)、FD&C黃色5號(4-對磺基苯基偶氮-1-對磺基苯基-5-羥基吡唑-3甲酸的鈉鹽)、FD&C黃色6號(對磺基苯基偶氮-B-萘酚-6-單磺酸鹽的鈉鹽)、FD&C綠色3號(4-{[4-(N-乙基對磺酸芐基)苯基]-(4-羥基-2-鋶苯基)亞甲基}-[1-(N-乙基-N-對磺酸芐基)-G]-3,5-環己二烯亞胺的二鈉鹽)、FD&C藍色1號(二芐基二乙基二胺基三苯甲醇三磺酸靛錫的二鈉鹽),以及其各種比例的混合物。潔齒劑組成物內可產生最大效果的染料濃度為從總重量的0.0005至2%。
潔齒劑組成物內亦可併入任何適當調味劑或甜味劑材料。適當調味劑為調味油例如留蘭香油、薄荷油、冬青油、黃樟油、丁香油、鼠尾草油、桉葉油、馬鬱蘭油、肉桂檸檬油和橙油,以及甲基水楊酸油。適當甜味劑包括蔗糖、乳糖、麥芽糖、山梨糖醇、木糖醇(xylitol)、甜蜜素(sodium cyclamate)、紫蘇糖(perillatine),以及糖精鈉。調味劑和甜味劑的總共適當含量為從組成物的0.01至5%或更高。
抗菌劑為酚和雙酚類化合物型非陽離子抗菌劑、鹵化二苯醚如三氯沙(triclosan)、苯甲酸酯和羰醯胺苯以及陽離子抗菌劑如二葡糖酸沙威隆(chlorhexidine digluconate)。此類抗菌劑的含量為從組成物的約0.03至約1%重量比。
當任何潔齒劑成分含有非陽離子抗菌劑或抗菌劑時,其含量較佳為可增強傳遞及滯留於口腔表面之從約0.05至約5%的組成物。此類物質的用途已揭示於美國專利案號5,188,821和5,192,531;以及含有合成陰離子高分子聚羧酸鹽例如馬來酸酐或酸與另一可聚合乙烯化不飽和單體,較佳為具有約30,000至約1,000,000,最佳為約30,000至約800,000分子量(MW)之甲基乙烯基醚/馬來酸酐的1:4至4:1共聚物。這些共聚物可供應自例如Gantrez公司的AN 139(分子量500,000)、AN 119(分子量250,000),以及較佳為取自08805紐澤西州Bound Brook市ISP科技公司的醫藥級S-97(分子量700,000)。該增效劑的含量為從0.05至約3%的重量比。
為製備此處所述的組成物,將調味劑和甜味劑以及氟化物源、作為抗牙石成分的聚磷酸鹽和其他(包括例如糖精、氟化鈉、硝酸鉀、單鹼式磷酸鈉、雙鹼式磷酸鈉)溶解於水中成為第一部分組成物。該濕潤劑例如較佳為被分散於如羧甲基纖維素及/或黃原膠內之任何有機增稠劑的丙二醇和聚乙二醇成分,以及例如二氧化鈦的色素成為第二部分組成物。之後其較佳為將額外濕潤劑如山梨糖醇加入該第二部分組成物,然後混合直至形成均質漿液為止。將第一和第二部分相互混合,然後混合該混合物直至形成平滑凝膠為止。接著將形成凝膠置入真空攪拌器內,例如氧化矽的磨料可被加入該凝膠槽,然後在真空下高速混合10~20分鐘。表面活性劑(例如月桂基硫酸鈉)和其他香料可被加至真空筒內,然後在真空下將該成分再混合5~10分鐘。形成產物為均質、半固體、可擠壓牙膏產品。
潔齒劑組成物的製備方法已為技術中所習知。美國專利案號3,996,863、3,980,767、4,328,205和4,358,437中已揭示牙膏及其製造方法,其可被用於製造該潔齒劑。
可參考下列實例進一步說明本發明。該實例僅作為說明的用途並且不以任何方式侷限於本發明描述和主張的範圍內。
製備牙膏狀的本發明口腔保健組成物(牙膏X)。此口腔保健組成物的成分列於下表1。
牙膏X的製備方法如下:將糖精、氟化鈉、硝酸鉀、單鹼式磷酸鈉、雙鹼式磷酸鈉溶解於水中成為第一部分;將焦磷酸四鈉、有機增稠劑(CMC和三仙膠)和二氧化鈦分散於聚乙二醇600和甘油內而成為第二部分;將山梨糖醇加至第二部分,混合直至形成均質漿液為止;將第一部分加至第二部分和山梨糖醇混合物,混合直至形成平滑凝膠為止;將形成凝膠置入真空攪拌器內;然後將氧化矽加至凝膠筒並且在真空下高速混合10~20分鐘;接著將月桂基硫酸鈉和香料加至真空筒內並且在真空下混合5~10分鐘;進行pH滴定試驗以證明該牙膏X的緩衝效應優於含氟牙膏和市售抗侵蝕牙膏()。此試驗中,利用水以1:2比例稀釋該牙膏。以0.1 M HCl溶液滴定該牙膏漿液。
表2顯示將1克牙膏漿液降低至pH 6所需酸溶液的數量。結果顯示牙膏X的緩衝能力為一般含氟牙膏的約9倍,而證明牙膏X具有較強的酸中和能力。
在酸挑戰試驗中測試牙膏X對抗酸誘發琺瑯質侵蝕的保護能力。此試驗中,以5%檸檬酸將經研磨的琺瑯質處理10秒。然後將該經酸侵蝕琺瑯質暴露於牙膏漿液(1:1的牙膏:水)5分鐘。於酸處理前、酸處理後和牙膏處理後利用光度檢查法定量經研磨琺瑯質。表3為三種牙膏的磨損降低效果。該結果證明該三種受測組成物中本發明磷酸鹽緩衝系統具有最大降低磨損的效果。
從酸鹼滴定和光度檢查的結果證明含氟化物源之本發明口腔保健組成物具有獨特高磷酸鹽緩衝能力的組合,其可明顯改善暴露於酸時琺瑯質的侵蝕作用。
Claims (4)
- 一種單成分抗侵蝕牙膏,包含:a)口腔可接受載劑;b)氟化物離子源;以及c)含從16:84至1:14比例之單鹼式磷酸鈉和雙鹼式磷酸鈉的磷酸鹽緩衝液,該磷酸鹽緩衝液在最終產物內的重量百分比為介於3.75至4.5%重量比之間。
- 如申請專利範圍第1項之單成分抗侵蝕牙膏,其中該磷酸鹽緩衝液於最終產物內的重量百分比為3.75%重量比。
- 一種組成物用於製備降低牙齒侵蝕之口腔保健產品的用途,該組成物包含:(i)口腔可接受載劑;(ii)氟化物離子源;以及(iii)含從16:84至1:14比例之單鹼式磷酸鈉和雙鹼式磷酸鈉的磷酸鹽緩衝液,該磷酸鹽緩衝液在最終產物內的重量百分比為介於3.75至4.5%重量比之間。
- 如申請專利範圍第3項之用途,其中該磷酸鹽緩衝液於最終產物內的重量百分比為3.75%重量比。
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