TW201505659A - 口腔護理產品及其使用方法與製造 - Google Patents
口腔護理產品及其使用方法與製造 Download PDFInfo
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- TW201505659A TW201505659A TW103120785A TW103120785A TW201505659A TW 201505659 A TW201505659 A TW 201505659A TW 103120785 A TW103120785 A TW 103120785A TW 103120785 A TW103120785 A TW 103120785A TW 201505659 A TW201505659 A TW 201505659A
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- Prior art keywords
- composition
- arginine
- amount
- fluoride
- weight
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- 238000000034 method Methods 0.000 title abstract description 29
- 238000004519 manufacturing process Methods 0.000 title description 8
- 239000000203 mixture Substances 0.000 claims abstract description 334
- 150000001413 amino acids Chemical class 0.000 claims abstract description 64
- 150000003839 salts Chemical group 0.000 claims abstract description 41
- 239000003242 anti bacterial agent Substances 0.000 claims abstract description 23
- 229940024606 amino acid Drugs 0.000 claims description 63
- 239000004475 Arginine Substances 0.000 claims description 60
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 60
- 229960003121 arginine Drugs 0.000 claims description 60
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 58
- -1 fluoride ions Chemical class 0.000 claims description 42
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- XEFQLINVKFYRCS-UHFFFAOYSA-N Triclosan Chemical group OC1=CC(Cl)=CC=C1OC1=CC=C(Cl)C=C1Cl XEFQLINVKFYRCS-UHFFFAOYSA-N 0.000 claims description 41
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- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims description 33
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- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 29
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Abstract
本發明係關於含有有效量之呈游離或鹽形式之鹼性胺基酸以及抗菌劑之口腔護理組成物及使用和製造該等組成物之方法。
Description
本申請案主張2008年2月8日申請之美國專利第61/027,431號、2008年2月8日申請之美國專利第61/027,432號及2008年2月8日申請之美國專利第61/027,420號之權利,將該等案之內容以引用方式併入本文中。
本發明係關於含有呈游離或鹽形式之鹼性胺基酸以及抗菌劑如三氯沙之口腔護理組成物及使用和製造該等組成物之方法。
曾提出精胺酸及其他鹼性胺基酸可用於口腔護理並咸信其在對抗蛀孔形成及牙齒敏感性上具有顯著益處。然而,已證明這些鹼性胺基酸與具有口腔護理益處之礦物質,如氟化物及鈣組合以形成具有可接受長期安定性之口腔護理產品係受到質疑。具體言之,鹼性胺基酸可提高pH並幫助可與氟離子反應形成不溶沉澱物之鈣離子解離。此外,較高pH具有引發刺
激之可能性。然而,在中性pH或酸性pH下,利用精胺酸碳酸氫鹽(技術教學偏好使用的)之系統可釋放出二氧化碳,導致容器氣脹及爆炸。此外,可預期將pH降低至中性或酸性條件將因精胺酸可形成一對牙齒表面具有較差親和力之不溶精胺酸-鈣錯合物而降低調配物之效能,再者,降低pH可能降低調配物可具有對緩衝口中致齲齒乳酸之任何作用。部分因為這些未解決的調配物問題且部分因為技術上一般已將精胺酸視為氟化物之可能替代物而非共同作用者,製造包含精胺酸及氟化物之口腔護理產品的動機極微小。抗菌劑之添加可能引起其他問題。市售精胺酸基質牙膏,如(例如)ProClude®及DenClude®包含精胺酸碳酸氫鹽及碳酸鈣,但無氟化物或任何抗菌劑。
同時,抗菌劑,如三氯沙在牙膏中的價值已為許多牙科醫師所認可。然而,這些試劑必須以有效量遞送至牙齒及牙齦而且其溶解度、遞送及牙齒上之滯留係視調配物而定。例如,三氯沙(5-氯-2-(2,4-二氯苯氧基)酚)僅微溶於水中。
因此,對一提供鹼性胺基酸以及提供有益礦物質如氟化物及鈣之安定的口腔護理產品以及提供較佳抗菌劑遞送之產品有需求。
現在令人驚訝地發現鹼性胺基酸如精胺酸可大幅提高抗菌劑如三氯沙之溶解度、遞送、滯留及抗菌有效性。
本發明因此涵蓋口腔護理組成物及利用該等物之方法,其中該等口腔護理組成物可有效抑制或減少溶菌斑累積、減少生
酸(致齲齒)菌之量、再礦化牙齒並抑制或減少牙齦炎。本發明亦涵蓋清潔口腔之組成物及方法並提供促進口腔健康及/或如藉由降低經由口腔組織而全身感染之可能性而促進全身健康,包括心血管健康之較佳方法。
本發明因此包括一口腔護理產品(本發明組成物),如牙粉,其包含i 有效量呈游離或鹽形式之鹼性胺基酸,如精胺酸;ii 有效量之抗菌劑,如三氯沙;視情況,本發明另外包含一陰離子界面活性劑,如月桂基硫酸鈉;有效量之氟化物源,如可溶氟化物鹽;及/或陰離子聚合物,如甲基乙烯基醚與順丁烯二酸酐之共聚物。在一具體例中,本發明因此涵蓋一含有精胺酸鹽,如精胺酸鹽酸鹽、精胺酸磷酸鹽或精胺酸碳酸氫鹽;三氯沙;一陰離子界面活性劑,如月桂基硫酸鈉;可溶氟化物鹽,如單氟磷酸鈉或氟化鈉之牙膏。
在一具體例中,本發明涵蓋一另外包含微粒之本發明組成物(組成物1.1),該組成物具有低於約200,如低於約160,如約40至約140之RDA,其包含至少約5%,如至少約20%d50小於約5微米之微粒,如d50為約3至約4微米之矽石或d50為約0.5至約3微米之沉澱碳酸鈣。
在特佳具體例中,本發明組成物係呈牙粉形式,其包含有選自水、研磨劑、界面活性劑、發泡劑、維生素、聚合物、酶、保濕劑、增稠劑、抗菌劑、防腐劑、調味劑、著色劑及/或其組合中之一或多者之額外成分。
不欲受特定理論所限制,假設精胺酸之有益作用的重要因素在於精胺酸及其他鹼性胺基酸可被特定類型之細菌,如血鏈
球菌所代謝,其中該等細菌不是致齲齒菌並與致齲齒菌如轉糖鏈球菌競爭牙齒上及口腔中的位置。溶精胺酸菌可利用精胺酸及其他鹼性胺基酸產生氨,藉此提高其環境之pH,而致齲齒菌代謝糖而產生乳酸,其易降低溶菌斑pH並使牙齒去礦化,最終導致蛀孔。咸信隨時間規律使用本發明組成物將使溶精胺酸菌相對增加並使致齲齒菌相對減少,造成較高溶菌斑pH,實際上使牙齒對致齲齒菌及其有害作用免疫。咸信此pH提高作用在促進再礦化及強化牙齒琺瑯質方面機制上與氟化物作用不同並互補。
然而,與確切機制無關,令人驚訝地發現氟化物與鹼性胺基酸,如精胺酸之組合在根據本發明特定具體表現之口腔護理產品中在促進再礦化、修護癌前病變及提高口腔健康上產生超出且品質上不同於利用分別含有有效量之個別化合物的組成物所見者之意外益處。此外,已發現此作用可藉由小研磨劑顆粒的添加而進一步提高,其中該等研磨劑顆粒可用於幫助填補琺瑯質中之顯微裂痕及齒質中之微管。
亦驚訝地發現鹼性胺基酸之存在性可降低細菌對牙齒表面之黏附性,特別係鹼性胺基酸與陰離子界面活性劑組合提供時。
與本發明特別有關地,鹼性胺基酸實質上提高抗菌劑,如三氯沙之溶解度、釋放、遞送、沈積及有效性。
本發明因此另外涵蓋(i)減少或抑制齲齒之形成,(ii)如藉由定量光誘導螢光(QLF)或電阻抗齲齒測量(ECM)所偵測,降低、修護或抑制早期琺瑯質損傷,(iii)降低或抑制牙齒之去礦化並促進其再礦化,(iv)減少牙齒之過敏反應,(v)減少或抑制牙齦炎,(vi)促進口中疼痛發炎或刺痛之復原,(vii)降低生酸
菌之量(viii)增加溶精胺酸菌之相對量,(ix)抑制口腔中生物膜之形成,(x)在糖攻擊後,提高及/或保持溶菌斑pH在至少pH5.5之值,(xi)降低溶菌斑累積,(xii)治療、減輕或減少口腔乾燥;(xiii)如藉由降低經由口腔組織而造成全身感染之可能性而提高全身健康,包括心血管健康,(xiv)降低牙齒侵蝕,(xv)潔白牙齒,(xvi)使牙齒對致齲齒菌免疫或保護牙齒以防致齲齒菌;及/或(xvii)清潔牙齒及口腔之方法,其包括藉由施用本發明組成物於需其患者之口腔而將本發明組成物施用於口腔中。
本發明因此包含一口腔護理組成物(組成物1.0),其包含:i 有效量呈游離或鹽形式之鹼性胺基酸,如精胺酸;ii 有效量之抗菌劑,如三氯沙;及iii 視情況選用之陰離子界面活性劑,如月桂基硫酸鈉;有效量之氟化物源,如可溶氟化物鹽;及/或陰離子聚合物,如甲基乙烯基醚與順丁烯二酸酐之共聚物;例如下列組成物中之任一者:1.0.1 組成物1.0,其中該鹼性胺基酸係精胺酸、離胺酸、瓜胺酸、鳥胺酸、肌酸、組胺酸、二胺基丁酸、二胺基丙酸、其鹽及/或其組合。
1.0.2 組成物1.0或1.0.1,其中該鹼性胺基酸具有L-組態。
1.0.3 任何前述組成物係以含有該鹼性胺基酸之二或三肽之鹽形式所提供。
1.0.4 任何前述組成物,其中該鹼性胺基酸係精胺酸。
1.0.5 任何前述組成物,其中該鹼性胺基酸係L-精胺酸。
1.0.6 任何前述組成物,其中該鹼性胺基酸係部分或完全呈鹽形式。
1.0.7 組成物1.0.6,其中該鹼性胺基酸係精胺酸磷酸鹽。
1.0.8 組成物1.0.6,其中該鹼性胺基酸係呈精胺酸鹽酸鹽形式。
1.0.9 組成物1.0.6,其中該鹼性胺基酸係精胺酸硫酸鹽。
1.0.10 組成物1.0.6,其中該鹼性胺基酸係精胺酸碳酸氫鹽。
1.0.11 任何前述組成物,其中該鹼性胺基酸之鹽係在調配物中藉以一酸或一酸之鹽中和該鹼性胺基酸而原位形成。
1.0.12 任何前述組成物,其中該鹼性胺基酸之鹽係在與該氟化物鹽組合之前,藉由中和該鹼性胺基酸以形成預混物所形成。
1.0.13 任何前述組成物,其中該鹼性胺基酸係以對應於總組成物重量之約0.1至約20%,如約1重量%至約10重量%之量存在,其中該鹼性胺基酸之重量係以游離鹼形式算得。
1.0.14 組成物1.0.11,其中該鹼性胺基酸係以總組成物重量之約7.5重量%之量存在。
1.0.15 組成物1.0.11,其中該鹼性胺基酸係以總組成物重量之約5重量%之量存在。
1.0.16 組成物1.0.11,其中該鹼性胺基酸係以總組成物重量之約3.75重量%之量存在。
1.0.17 組成物1.0.11,其中該鹼性胺基酸係以總組成物重量之約1.5重量%之量存在。
1.0.18 任何前述組成物,其中該氟化物鹽係選自氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟矽酸鈉、氟矽酸銨、氟化胺(如N’-十八基三亞甲基二胺-N,N,N’-參(2-乙醇)-二氫氟化物)、氟化銨、氟化鈦、六氟硫酸鹽及其
組合。
1.0.19 任何前述組成物,其中該氟化物鹽係氟磷酸鹽。
1.0.20 任何前述組成物,其中該氟化物鹽係單氟磷酸鈉。
1.0.21 任何前述組成物,其中該氟化物鹽係氟化鈉。
1.0.22 任何前述組成物,其中該氟化物鹽係以總組成物重量之約0.01重量%至約2重量%之量存在。
1.0.23 任何前述組成物,其中該氟化物鹽提供總組成物重量之約0.1重量%至約0.2重量%之量的氟離子。
1.0.24 任何前述組成物,其中該可溶氟化物鹽提供約50至約25,000ppm之量的氟離子。
1.0.25 任何前述組成物,其係具有約100至約250ppm之可用氟離子之漱口水。
1.0.26 任何前述組成物,其係具有約750至約2000ppm之可用氟離子之牙粉。
1.0.27 任何前述組成物,其中該組成物包含約750至約2000ppm之氟離子。
1.0.28 任何前述組成物,其中該組成物包含1000至約1500ppm之氟離子。
1.0.29 任何前述組成物,其中該組成物包含約1450ppm之氟離子。
1.0.30 任何前述組成物,其中該pH係約6至約9,如約6.5至約7.4或約7.5至約9。
1.0.31 任何前述組成物,其中該pH係約6.5至約7.4。
1.0.32 任何前述組成物,其中該pH係約6.8至約7.2。
1.0.33 任何前述組成物,其中該pH係近中性。
1.0.34 任何前述組成物,其另外包含研磨劑或微粒。
1.0.35 前一組成物,其中該研磨劑或微粒係選自碳酸氫鈉、磷酸鈣(如磷酸二鈣二水合物)、硫酸鈣、碳酸鈣(如沉澱碳酸鈣)、矽石(如水合矽石)、氧化鐵、氧化鋁、珍珠岩、塑膠顆粒,如聚乙烯及其組合。
1.0.36 前一組成物,其中該研磨劑或微粒係選自磷酸鈣(如磷酸二鈣二水合物)、硫酸鈣、沉澱碳酸鈣、矽石(如水合矽石)及其組合。
1.0.37 任何前述組成物,其另外包含量為總組成物重量之約15重量%至約70重量%之研磨劑。
1.0.38 任何前述組成物,其另外包含至少約5重量%d50小於約5微米之小研磨劑顆粒部分。
1.0.39 任何前述組成物,其具有小於約150,如約40至約140之RDA。
1.0.40 任何前述組成物,其另外包含一防結石劑。
1.0.41 任何前述組成物,其另外包含一防結石劑,其為呈鈉鹽形式之聚磷酸鹽,如焦磷酸鹽、三聚磷酸鹽或六偏磷酸鹽。
1.0.42 任何前述組成物,其另外包含至少一種界面活性劑。
1.0.43 任何前述組成物,其另外包含至少一種選自月桂基硫酸鈉、椰油醯胺基丙基甜菜鹼及其組合。
1.0.44 任何前述組成物,其另外包含一陰離子界面活性劑。
1.0.45 任何前述組成物,其另外包含月桂基硫酸鈉。
1.0.46 任何前述組成物,其另外包含至少一種保濕劑。
1.0.47 任何前述組成物,其另外包含至少一種選自甘油、山梨醇、木糖醇及其組合之保濕劑。
1.0.48 任何前述組成物,其另外包含木糖醇。
1.0.49 任何前述組成物,其另外包含至少一種聚合物。
1.0.50 任何前述組成物,其另外包含至少一種選自聚乙二醇、聚乙烯基甲基醚順丁烯二酸共聚物、多醣(如纖維素衍生物,例如羧基甲基纖維素或多醣膠,例如三仙膠或鹿角菜膠)及其組合之聚合物。
1.0.51 任何前述組成物,其另外包含膠片或片段。
1.0.52 任何前述組成物,其另外包含調味劑、芳香劑及/或著色劑。
1.0.53 任何前述組成物,其另外包含水。
1.0.54 任何前述組成物,其包含選自下列各者之抗菌劑:鹵化二苯基醚(如三氯沙)、草本萃取物及精油(如迷迭香萃取物、茶萃取物、木蘭萃取物、瑞香草酚、薄荷腦、桉樹油、香葉草醇、香旱芹酚、檸檬醛、扁柏酚、兒茶酚、水楊酸甲基酯、沒食子兒茶素-3-沒食子酸酯、沒食子兒茶素、沒食子酸、miswak萃取物、沙棘萃取物)、雙胍殺菌劑(如氯己定、阿來西定或奧替尼啶)、四級銨化合物(如氯化十六基吡錠(CPC)、氯化苯二甲烴銨、氯化十四基吡錠(TPC)、氯化N-十四基-4-乙基吡錠(TDEPC)、酚系殺菌劑、海克西定、奧替尼啶、血根鹼、普維酮、地莫匹醇、salifluor、金屬離子(如鋅鹽,例如檸檬酸鋅、亞錫鹽、銅鹽、鐵鹽)、血根鹼、蜂膠及氧化劑(如過氧化氫、經緩衝之過氧硼酸鈉或過氧碳酸鹽)、苯二甲酸及其鹽、monoperthalic酸及其鹽和酯、硬脂酸抗壞血酸酯、油醯基肌胺酸、硫酸烷基酯、磺琥珀酸二辛基酯、柳醯胺苯、度米芬、地莫匹醇、辛哌醇及其他哌啶基衍生物、nicin製劑、亞氯酸
鹽及任何上述物之混合物。
1.0.55 任何前述組成物,其另外包含消炎化合物,如選自下列各者之宿主促發炎因子中至少一者的抑制劑:基質金屬蛋白(MMP)、環加氧酶(COX)、PGE2、介白素1(IL-1)、IL-1β轉化酶(ICE)、轉變生長因子β1(TGF-β1)、可誘導氧化氮合成酶(iNOS)、玻糖醛酸酶、細胞自溶酶、核因子κB(NF-κB)及IL-1受體相關激酶(IRAK),如選自阿斯匹靈、酮咯酸、氟比洛芬、異布洛芬、那普洛辛、吲哚美辛、阿斯匹靈、可多普洛菲、吡羅昔康、甲氯芬那酸、降二氫癒創木酸及其混合物。
1.0.56 任何前述組成物,其另外包含抗氧化劑,如選自由輔酶Q10、PQQ、維生素C、維生素E、維生素A、大茴香腦-dithiolethione及其混合物組成之群。
1.0.57 任何前述組成物,其包含溶解度差,如溶解度低於三氯沙之抗菌劑。
1.0.58 任何前述組成物,其中該抗菌劑包含三氯沙。
1.0.59 任何前述組成物,其包含三氯沙及木糖醇。
1.0.60 任何前述組成物,其包含三氯沙、木糖醇及沈澱碳酸鈣。
1.0.61 任何前述組成物,其另外包含三氯沙及Zn2+離子源,如檸檬酸鋅。
1.0.62 任何前述組成物,其另外包含量為總組成物重量之約0.01至約5重量%之抗菌劑。
1.0.63 任何前述組成物,其另外包含量為總組成物重量之約0.01至約1重量%之三氯沙。
1.0.64 任何前述組成物,其另外包含量為總組成物重量之約0.3重量%之三氯沙。
1.0.65 任何前述組成物,其另外包含增白劑。
1.0.66 任何前述組成物,其另外包含選自增白活性物之增白劑,其中該增白活性物係選自由過氧化物、金屬亞氯酸鹽、過硼酸鹽、過碳酸鹽、過氧酸、過亞氯酸鹽及其組合組成之群。
1.0.67 任何前述組成物,其另外包含過氧化氫或過氧化氫源,如過氧化脲或過氧化鹽或錯合物(如過氧磷酸鹽、過氧碳酸鹽、過硼酸鹽、過氧矽酸鹽或過硫酸鹽;例如過氧磷酸鈣、過硼酸鈉、碳酸鈉過氧化物、過氧磷酸鈉及過硫酸鉀)或過氧化氫聚合物錯合物如過氧化氫-聚乙烯基吡咯啶酮聚合物錯合物。
1.0.68 任何前述組成物,其另外包含一干擾或防止細菌黏附之試劑,如solbrol或甲殼素。
1.0.69 任何前述組成物,其另外包含一選自(i)鈣-玻璃錯合物如磷矽酸鈣鈉及(ii)鈣-蛋白質錯合物如酪蛋白磷酸肽-非晶質磷酸鈣之鈣及磷酸鹽之來源。
1.0.70 任何前述組成物,其另外包含一可溶鈣鹽,如選自硫酸鈣、氯化鈣、硝酸鈣、乙酸鈣、乳酸鈣及其組合。
1.0.71 任何前述組成物,其另外包含一有效降低齒質敏感性之量的生理上可接受鉀鹽,如硝酸鉀或氯化鉀。
1.0.72 任何前述組成物,其另外包含從約0.1%至約7.5%之生理上可接受鉀鹽,如硝酸鉀及/或氯化鉀。
1.0.73 任何前述組成物,其係一包含精胺酸鹽,如精胺酸鹽酸鹽、精胺酸磷酸鹽或精胺酸碳酸氫鹽;三氯沙;陰
離子界面活性劑,如月桂基硫酸鈉及可溶氟化物鹽,如單氟磷酸鈉或氟化鈉之牙膏。
1.0.74 任何前述組成物,其如以牙刷施用於口腔後可有效(i)減少或抑制齲齒之形成,(ii)如藉由定量光誘導螢光(QLF)或電阻抗齲齒測量(ECM)所偵測,降低、修護或抑制癌前病變,(iii)降低或抑制牙齒之去礦化並促進其再礦化,(iv)減少牙齒之過敏反應,(v)減少或抑制牙齦炎,(vi)促進口中疼痛發炎或刺痛之復原,(vii)降低生酸菌之量(viii)增加溶精胺酸菌之相對量,(ix)抑制口腔中生物膜之形成,(x)在糖攻擊後,提高及/或保持溶菌斑pH在至少pH5.5之值,(xi)降低溶菌斑累積,(xii)減少口腔乾燥;(xiii)清潔牙齒及口腔,(xiv)降低侵蝕,(xv)潔白牙齒,及/或(xvi)使牙齒對致齲齒菌免疫。
1.0.75 一種藉由組合任何前述組成物所提之成分所獲得或可獲得之組成物。
1.0.76 任何前述組成物,其係呈選自漱口水、牙膏、牙凝膠、牙粉、非研磨凝膠、慕絲、泡沫、口腔噴液、錠劑、口服錠、牙科用具及動物護理產品之形式。
1.0.77 任何前述組成物,其中該組成物係牙膏。
1.0.78 任何前述組成物,其中該組成物係視情況另外包含水、研磨劑、界面活性劑、發泡劑、維生素、聚合物、酶、保濕劑、增稠劑、抗菌劑、防腐劑、調味劑、著色劑及/或其組合中之一或多者的牙膏。
1.0.79 前述組成物1.0-1.0.76中任一者,其中該組成物係漱口水。
1.0.80 任何前述組成物,其另外包含口腔清新劑、芳香劑或
調味劑。
在另一具體例中,本發明涵蓋一如根據前述組成物1.0-1.0.80中任一者之本發明組成物(組成物1.1),其包含:i 有效量之鹼性胺基酸之鹽;ii 有效量之可溶氟化物鹽;iii 陰離子界面活性劑,如月桂基硫酸鈉;iv 陰離子聚合物,如甲基乙烯基醚與順丁烯二酸酐之共聚物;及v 抗菌劑,如三氯沙。
在另一具體例中,本發明涵蓋如根據前述組成物1.0-1.0.80中任一者之本發明組成物(組成物1.2),其包含:i 有效量之鹼性胺基酸之鹽;ii 抗菌劑,如三氯沙iii 有效量之可溶氟化物鹽;及iv 小研磨劑顆粒,而使該組成物具有小於約160,如約40至約140之RDA,其包含至少約5%,如至少約20%d50小於約5微米之研磨劑,如d50為約3至約4微米之矽石。
在另一具體例中,本發明涵蓋一種改善口腔健康之方法,其包括將有效量之組成物1.0、1.1或1.2之具體例中任一者之口腔組成物施用於需其受檢者之口腔中,如一種i 減少或抑制齲齒之形成,ii 如藉由定量光誘導螢光(QLF)或電阻抗齲齒測量(ECM)所偵測,降低、修護或抑制早期琺瑯質損傷,iii 降低或抑制牙齒之去礦化並促進其再礦化,iv 減少牙齒之過敏反應,v 減少或抑制牙齦炎,
vi 促進口中疼痛發炎或刺痛之復原,vii 降低生酸菌之量,viii 增加溶精胺酸菌之相對量,ix 抑制口腔中生物膜之形成,x 在糖攻擊後,提高及/或保持溶菌斑pH在至少pH5.5之值,xi 降低溶菌斑累積,xii 治療、減輕或減少口腔乾燥;xiii 如藉由降低經由口腔組織而造成全身感染之可能性而提高全身健康,包括心血管健康,xiv 潔白牙齒,xv 降低牙齒侵蝕,xvi 使牙齒對致齲齒菌免疫及/或xvii 清潔牙齒及口腔。
本發明另外包括精胺酸在本發明組成物之製造上的用途,如用於任何方法2所提之適應症中。
本發明另外提供一種含有呈游離或鹽形式之鹼性胺基酸及用於抗菌處理受檢者口腔之抗菌劑的口腔護理組成物。
本發明另外提供一種含有抗菌劑及呈游離或鹽形式以提高該抗菌劑至受檢者口腔之口腔面之遞送的口腔護理組成物。
本發明另外提供呈游離或鹽形式之鹼性胺基酸在含有抗菌劑之口腔護理組成物中用於提高該抗菌劑至受檢者口腔之口腔面之遞送的用途及呈游離或鹽形式之鹼性胺基酸在製造包含抗菌劑之藥劑中用於提高該抗菌劑至受檢者口腔之口腔面之遞送的用途。
本發明另外提供一種提高口腔護理組成物中抗菌劑至一受檢者口腔之口腔面之遞送的方法,該方法包括以含有抗菌劑
及呈游離或鹽形式之鹼性胺基酸之口腔護理組成物處理口腔之方法。
因此,熟諳口腔護理技術者可見口腔護理組成物,例如牙粉之調配物及使用可產生一提高該抗菌劑至牙齒之遞送之令人驚訝的技術作用及優勢,根據本發明一或多個態樣,其係針對活性組分或成分及較佳其在該組成物內之個別量之組合的提供。
該抗菌劑可選自鹵化二苯基醚(如三氯沙)、草本萃取物及精油(如迷迭香萃取物、茶萃取物、木蘭萃取物、瑞香草酚、薄荷腦、桉樹油、香葉草醇、香旱芹酚、檸檬醛、扁柏酚、兒茶酚、水楊酸甲基酯、沒食子兒茶素-3-沒食子酸酯、沒食子兒茶素、沒食子酸、miswak萃取物、沙棘萃取物)、雙胍殺菌劑(如氯己定、阿來西定或奧替尼啶)、四級銨化合物(如氯化十六基吡錠(CPC)、氯化苯二甲烴銨、氯化十四基吡錠(TPC)、氯化N-十四基-4-乙基吡錠(TDEPC)、酚系殺菌劑、海克西定、奧替尼啶、血根鹼、普維酮、地莫匹醇、salifluor、金屬離子(如鋅鹽,例如檸檬酸鋅、亞錫鹽、銅鹽、鐵鹽)、血根鹼、蜂膠及氧化劑(如過氧化氫、經緩衝之過氧硼酸鈉或過氧碳酸鹽)、苯二甲酸及其鹽、monoperthalic酸及其鹽和酯、硬脂酸抗壞血酸酯、油醯基肌胺酸、硫酸烷基酯、磺琥珀酸二辛基酯、柳醯胺苯、度米芬、地莫匹醇、辛哌醇及其他哌啶基衍生物、nicin製劑、亞氯酸鹽及任何上述物之混合物。
該組成物可另外包含一消炎化合物,如選自下列各者之宿主促發炎因子中至少一者的抑制劑:基質金屬蛋白(MMP)、環加氧酶(COX)、PGE2、介白素1(IL-1)、IL-1β轉化酶(ICE)、轉變生長因子β1(TGF-β1)、可誘導氧化氮合成酶(iNOS)、玻糖醛
酸酶、細胞自溶酶、核因子κB(NF-κB)及IL-1受體相關激酶(IRAK),如選自阿斯匹靈、酮咯酸、氟比洛芬、異布洛芬、那普洛辛、吲哚美辛、阿斯匹靈、可多普洛菲、吡羅昔康、甲氯芬那酸、降二氫癒創木酸及其混合物。該組成物可額外地或替代地另外包含一抗氧化劑,如選自由輔酶Q10、PQQ、維生素C、維生素E、維生素A、大茴香腦-dithiolethione及其混合物組成之群。
活性成分之量將可根據遞送系統之性質及特定活性物質而變化。例如,該鹼性胺基酸可以從如約0.1至約20重量%(以游離鹼之重量表示)之量,如漱口水之約0.1至約3重量%,如消耗性牙膏之約1至約10重量%或專業或處方治療產品之約7至約20重量%之量存在。氟化物可以如約25至約25,000ppm之量,例如漱口水之約25至約250ppm,消耗性牙膏之約750至約2,000ppm或專業或處方治療產品之約2,000至約25,000ppm之量存在。抗菌劑之量將隨牙膏中所用之量類似地變化,其係比漱口水中所用量大如約5至約15倍。例如,三氯沙漱口水可包含如約0.03重量%三氯沙,而三氯沙牙膏可包含約0.3重量%三氯沙。
本發明組成物及方法中可使用之鹼性胺基酸不只包括天然鹼性胺基酸,如精胺酸、離胺酸及組胺酸,亦包括任何分子中具有羧基及胺基之鹼性胺基酸,其係水溶性的並提供pH為約7或更大之水溶液。
因此,鹼性胺基酸包括(但不限於)精胺酸、離胺酸、瓜胺酸、鳥胺酸、肌酸、組胺酸、二胺基丁酸、二胺基丙酸、其鹽或其組合。在一特定具體例中,該鹼性胺基酸係選自精胺酸、
瓜胺酸及鳥胺酸。
在某些具體例中,該鹼性胺基酸係精胺酸,例如L-精胺酸或其鹽。
在一些具體例中,該鹼性胺基酸包含至少一精胺酸去亞胺酶系統中所產生之中間物。該精胺酸去亞胺酶系統中所產生之中間物可用於一口腔護理組成物中以提供溶菌斑中和而進行齲齒控制及預防。精胺酸係口腔中可找到之天然鹼性胺基酸。口腔中之精胺酸可為如下某些牙斑菌為存活所利用:血鏈球菌、格式鏈球菌、副血鏈球菌、倉鼠鏈球菌、米氏鏈球菌、咽峽炎鏈球菌、糞鏈球菌、內氏放線菌、溶齒放線菌、纖維二糖乳桿菌、短乳桿菌、發酵乳桿菌、牙齦卟啉單胞菌及齒螺旋體。此類有機體可能在酸性環境中死亡,而該酸性環境可能出現在生酸菌株及耐酸致齲齒菌株可能利用糖產生有機酸之接近牙齒面的區域處。因此,這些溶精胺酸菌株可將精胺酸分解形成氨以提供存活所需鹼性並另外緩衝溶菌斑並製造一不利於致齲齒系統之環境。
此類溶精胺酸有機體可藉由稱為”精胺酸去亞胺酶系統”之內部細胞酶途徑系統新陳代謝分解精胺酸,藉以在途徑中形成中間物。在此途徑中,L-精胺酸可藉精胺酸去亞胺酶而分解成L-瓜胺酸及氨。然後,L-瓜胺酸可在無機磷酸鹽之存在下藉由鳥胺酸胺甲醯基轉移酶而分解成L-鳥胺酸及磷酸胺甲醯基酯。胺甲酸酯激酶然後將磷酸胺甲醯基酯分解形成另一分子之氨及二氧化碳且在該程序中亦形成ATP(5’-三磷酸腺苷)。溶精胺酸菌可使用ATP作為生長之能量源。因此,使用時,精胺酸去亞胺酶系統可產生兩分子之氨。
在一些具體例中,已發現氨有助於中和牙菌斑pH以控制
及/或防止齲齒。
本發明一些具體例之口腔護理組成物可包含精胺酸去亞胺酶系統所產生之中間物。此類中間物可包含瓜胺酸、鳥胺酸及磷酸胺甲醯基酯。在一些具體例中,另一護理組成物包含瓜胺酸。在一些具體例中,該口腔護理組成物包含鳥胺酸。在一些具體例中,該口腔護理組成物包含磷酸胺甲醯基酯。在其他具體例中,該口腔護理組成物包含瓜胺酸、鳥胺酸、磷酸胺甲醯基酯及/或精胺酸去亞胺酶系統所產生之其他中間物之任何組合。
該口腔護理組成物可包含有效量之上述中間物。在一些具體例中,該口腔護理組成物包含約1毫莫耳/公升至約10毫莫耳/公升中間物。在其他具體例中,該口腔護理組成物包含約3毫莫耳/公升至約7毫莫耳/公升中間物。在其他具體例中,該口腔護理組成物包含約5毫莫耳/公升中間物。
本發明組成物係欲局部用於口中並因此用於本發明之鹽以所提供之量及濃度對此用途而言應係安全的。適合的鹽類包括技術中已知為醫藥上可接受鹽之鹽,其以所提供之量及濃度一般被視為係生理上可接受的。生理上可接受鹽包括彼等衍生自醫藥上可接受無機或有機酸或鹼之鹽,例如形成生理上可接受陰離子之酸所形成的酸加成鹽,如鹽酸鹽或溴化物鹽及形成生理上可接受陽離子之鹼所形成的鹼加成鹽,例如彼等衍生自鹼金屬如鉀及鈉或鹼土金屬如鈣及鎂者。生理上可接受鹽可利用技術上已知標準程序,例如藉足夠鹼性化合物如胺與提供生理上可接受陰離子之適合酸反應所獲得。
在各個具體例中,該鹼性胺基酸係以總組成物重量之約0.5重量%至約20重量%,總組成物重量之約1重量%至約10
重量%,例如總組成物重量之約1.5重量%、約3.75重量%、約5重量%或約7.5重量%之量存在。
RDA:RDA係放射能齒質磨損之縮寫,即磨損之相對量度。一般,以中子通量照射所抽出人類或牛的牙齒,將其安置在甲基丙烯酸甲基酯(骨膠)中,去除琺瑯質、插入刷洗機中並依美國牙醫協會(ADA)標準(參考牙刷,150克壓力,1500史托克,4比1之水-牙膏漿液)進行刷洗。然後測量並紀錄清洗水之放射性。對於實驗控制組,以焦磷酸鈣製成之ADA參考牙膏重複進行實驗,賦予此測量一100之值以校正相對級數。
該口腔護理組成物可另外包含一或多個氟離子源,如可溶氟化物源。種類繁多之氟離子產生物質可用於本發明組成物中作為可溶氟化物源。適合的氟離子產生物質之實例係在頒予Briner等人之美國專利第3,535,421號;頒予Parran,Jr等人之美國專利第4,885,155號;及頒予Widder等人之美國專利第3,678,154號中找到,將該等案以引用方式併入本文中。
代表性氟離子源包括(但不限於)氟化亞錫、氟化鈉、氟化鉀、單氟磷酸鈉、氟矽酸鈉、氟矽酸銨、氟化胺、氟化銨及其組合。在某些具體例中,該氟離子源包括氟化亞錫、氟化鈉、單氟磷酸鈉以及其混合物。
在某些具體例中,本發明口腔護理組成物亦可包含一量足以供應約25ppm至約25,000ppm之氟離子,一般至少約500ppm,如約500至約2000ppm,如約1000至約1600ppm,如約1450ppm之氟離子或供氟成分來源。氟化物之適當用量將視特定應用而定。例如,漱口水一般將具有約100至約250ppm氟化物。一般消費者用途之牙膏一般將具有約1000至約
1500ppm,其中小兒牙膏含量稍微較低。專業應用之牙粉或塗料可具如約5,000或甚至約25,000ppm般多之氟化物。
氟離子源在一具體例中可以該組成物之約0.01重量%至約10重量%之量或在另一具體例中以該組成物之約0.03重量%至約5重量%之量或在另一具體例中以該組成物之約0.1重量%至約1重量%之量加入本發明組成物中。提供適當量之氟離子之氟化物鹽的重量將根據該鹽中相反離子之重量而有顯著變化。
本發明組成物可包含磷酸鈣研磨劑,如磷酸三鈣(Ca3(PO4)2)、氫氧磷灰石(Ca10(PO4)6(OH)2)或磷酸二鈣二水合物(CaHPO4˙2H2O,有時在本文中亦稱為Dical)或焦磷酸鈣。或者,碳酸鈣及特別係沉澱碳酸鈣可用作研磨劑。
該等組成物可包含一或多種額外研磨劑,例如矽石研磨劑如平均粒徑高達約20微米之沉澱矽石,如J.M.Huber所販賣之Zeodent 115®。其他適用的研磨劑亦包含偏磷酸鈉、偏磷酸鉀、矽酸鋁、煅燒氧化鋁、膨潤土或其他含矽物質或其組合。
本文適用之矽石研磨拋光物質以及其他研磨劑一般具有範圍介於約0.1與約30微米,約介於5與約15微米之平均粒徑。矽石研磨劑可源自沉澱矽石或矽石凝膠,如頒予Pader等人之美國專利第3,538,230號及頒予Digiulio等人之美國專利第3,862,307號中所述之矽石乾凝膠,將兩案以引用方式併入本文中。特定矽石乾凝膠係由W.R.Grace & Co.,Davison化學部門以Syloid®之商標名稱販售。沉澱矽石物質包括彼等由J.M.Huber Corp.以Zeodent®之商標名稱販賣者,包括命名為Zeodent 115及119之矽石。這些矽石研磨劑係描述於頒予
Wason之美國專利第4,340,583號中,將該案以引用方式併入本文中。
在某些具體例中,適用於實施根據本發明口腔護理組成物之研磨物質包括油吸收值小於約100毫升/100克矽石且在約45毫升/100克矽石至約70毫升/100克矽石範圍內之矽膠及沉澱非晶質矽石。油吸收值係利用ASTM Rub-Out方法D281所量得。在某些具體例中,矽石係平均粒徑為約3微米至約12微米及約5微米至約10微米之膠體顆粒。
在特定具體例中,該等研磨物質包含大比率之極小顆粒,如具有小於約5微米之d50,例如,d50為約3至約4微米之小矽石顆粒(SPS),例如Sorbosil AC43®(Ineos)。此類小顆粒係特別適用於目標在於降低過敏反應之調配物。小顆粒組分可與第二大之顆粒研磨劑組合存在。在某些具體例中,例如,該調配物包含約3至約8%小顆粒,如SPS及約25%至約45%之慣用研磨劑。
特別適用於實施本發明之低油吸收矽石研磨劑係W.R.Grace & Co.之Davison化學部門,Baltimore,MD.21203以Syloden XWA®之商標名稱販售。Syloden 650 XWA®(一種由水含量為約29重量%、平均直徑為約7至約10微米且油吸收值小於約70毫升/100克矽石之膠體矽石顆粒所組成的矽石水凝膠)係適用於實施本發明之低油吸收矽石研磨劑的實例。該研磨劑在本發明口腔護理組成物中係以約10至約60重量%,在其他具體例中,約20至約45重量%且在另一具體例中,約30至約50重量%之濃度存在。
在一些具體例中,將該鹼性胺基酸摻入一具有基質調配物之牙粉組成物中,其中該調配物包含碳酸鈣且特別係沉澱碳酸
鈣作為研磨劑。L-精胺酸及精胺酸鹽如精胺酸碳酸氫鹽本身具有明顯苦味且在水溶液中亦會賦予魚腥味。因此,預期將L-精胺酸及精胺酸鹽以賦予防蛀孔效能並減輕敏感性之有效濃度摻入口腔護理產品如牙粉調配物中,一般以牙粉調配物之總重量計從2至10重量%之量摻入時,該等牙粉調配物之味道及口感相較於無L-精胺酸及精胺酸鹽添加之相同調配物則較差。
然而,根據本發明此態樣已驚訝地發現將L-精胺酸及精胺酸鹽添加至含有碳酸鈣之鹼性牙粉調配物中可明顯提高牙粉調配物之味道及口感屬性並增加消費者對產品之整體接受度。
本發明口腔護理組成物亦可包含一試劑以增加刷洗口腔時所產生之泡沫量。
增加泡沫量之試劑的說明性實例包括(但不限於)聚氧乙烯及包括(但不限於)褐藻酸鹽聚合物之某些聚合物。
聚氧乙烯可增加本發明口腔護理載體組份所產生之泡沫量及泡沫厚度。聚氧乙烯亦為普遍已知之聚乙二醇(“PEG”)或聚環氧乙烷。適合用於本發明之聚氧乙烯將具有約200,000至約7,000,000之分子量。在一具體例中,分子量將為約600,000至約2,000,000且在另一具體例中將為約800,000至約1,000,000。Polyox®係Union Carbide所製造之高分子量聚氧乙烯的商標名稱。
聚氧乙烯可以本發明口腔護理組成物之口腔護理載體組分之約1至約90重量%之量,在一具體例中以約5至約50重量%之量且在另一具體例中以約10至約20重量%之量存在。發泡劑在口腔護理組成物中之劑量(即單劑量)係約0.01至約
0.9重量%,約0.05至約0.5重量%且在另一具體例中係約0.1至約0.2重量%。
本發明口腔護理組成物中視情況所含之另一試劑係界面活性劑或相容界面活性劑之混合物。適合的界面活性劑係彼等在整個寬pH範圍內相當安定者,例如陰離子、陽離子、非離子或兩性離子界面活性劑。
適合的界面活性劑係更完整地描述於(例如)頒予Agricola等人之美國專利第3,959,458號;頒予Haefele等人之美國專利第3,937,807號;及頒予Gieske等人之美國專利第4,051,234號中,將該等案以引用方式併入本文中。
在某些具體例中,本文適用之陰離子界面活性劑包括烷基具有約10至約18個碳原子之硫酸烷基酯的水溶性鹽及具有約10至約18個碳原子之脂肪酸之磺酸化單甘油酯的水溶性鹽。月桂基硫酸鈉、月桂醯基肌胺酸鈉及椰子油酸單甘油酯磺酸鈉皆為此類型之陰離子界面活性劑的實例。亦可利用陰離子界面活性劑之混合物。
在另一具體例中,本發明適用之陽離子界面活性劑可廣泛地定義為具有含約8至約18個碳原子之長鏈烷基之脂族四級銨化合物的衍生物如月桂基三甲基氯化銨、十六基氯化吡錠、十六基三甲基溴化銨、二異丁基苯氧基乙基二甲基芐基氯化銨、椰子油酸烷基三甲基亞硝酸銨、十六基氟化吡錠及其混合物。
說明性陽離子界面活性劑係頒予Briner等人之美國專利第3,535,421號中所描述之四級銨氟化物,將該案以引用方式併入本文中。某些陽離子界面活性劑亦可在該等組成物中作為
殺菌劑。
可將可用於本發明組成物中之說明性非離子界面活性劑廣泛地定義為環氧烷基(親水性本質)與可為脂族或烷基芳族本質之有機疏水性化合物縮合所產生之化合物。適合的非離子界面活性劑實例包括(但不限於)Pluronics、烷基酚之聚環氧乙烷縮合物、衍生自環氧乙烷與環氧丙烷及伸乙二胺之反應產物縮合的產物、脂族醇之環氧乙烷縮合物、長鏈三級胺氧化物、長鏈三級膦氧化物、長鏈二烷基亞碸及此類物質之混合物。
在某些具體例中,可將適用於本發明中之兩性離子合成界面活性劑廣泛地描述成脂族四級銨、鏻及鋶化合物之衍生物,其中該等脂族基團可為直鏈或支鏈且其中脂族取代基中之一者包含約8至約18個碳原子且一者包含陰離子水溶基團,如羧基、磺酸鹽、硫酸鹽、磷酸鹽或膦酸鹽。適合用於包含在該組成物中之界面活性劑的說明性實例包括(但不限於)烷基硫酸鈉、月桂醯基肌胺酸鈉、椰油醯胺丙基甜菜鹼及聚山梨醇酯20及其組合。
在一特定具體例中,本發明組成物包含一陰離子界面活性劑,如月桂基硫酸鈉。
界面活性劑或相容界面活性劑之混合物可以總組成物之約0.1%至約5.0重量%,在另一具體例中以約0.3重量%至約3.0重量%且在另一具體例中以約0.5重量%至約2.0重量%存在於本發明組成物中。
本發明口腔護理組成物亦可包含一調味劑。可用於實施本發明之調味劑包括(但不限於)精油以及各種調味醛、酯、醇及類似物質。精油之實例包括綠薄荷、薄荷、冬青、黃樟、丁香、
鼠尾草、桉樹、馬鬱蘭、肉桂、檸檬、萊姆、葡萄柚及橙花之油。亦適用者為如薄荷腦、香旱芹酮及茴香腦之化學物質。某些具體表現使用薄荷及綠薄荷之油。
調味劑係以約0.1至約5重量%及約0.5至約1.5重量%之濃度摻入口腔組成物中。調味劑在個別口腔護理組成物中之劑量(即單劑量)係約0.001重量%至約0.05重量%,在另一具體例中係約0.005重量%至約0.015重量%。
本發明口腔護理組成物亦可視情況包含一或多種可錯合細菌之細胞壁中所發現之鈣的鉗合劑。此鈣接合弱化細菌之細胞壁並增加細菌溶解。
另一類適合用於本發明中作為鉗合劑之試劑為可溶焦磷酸鹽。用於本發明組成物中之焦磷酸鹽可為鹼金屬焦磷酸鹽中任一者。在某些具體例中,鹽包括四鹼金屬焦磷酸鹽、二鹼金屬二酸焦磷酸鹽、三鹼金屬單酸焦磷酸鹽及其混合物,其中該鹼金屬係鈉或鉀。該等鹽之水合及非水合形式皆適用。適用於本發明組成物中之焦磷酸鹽的有效量一般係足以提供至少約1.0重量%焦磷酸根離子,約1.5重量%至約6重量%,約3.5重量%至約6重量%之此類離子。
本發明口腔護理組成物亦視情況包含一或多種聚合物,如聚乙二醇、聚乙烯基甲基醚順丁烯二酸共聚物、多糖(如纖維素衍生物,例如羧基甲基纖維素或多糖膠,例如三仙膠或鹿角菜膠)。酸性聚合物,例如聚丙烯酸酯凝膠可以其游離酸或經部分或完全中和之水溶性鹼金屬(鉀或鈉)或銨鹽形式提供。
特別係非陽離子抗菌劑或抗菌劑如三氯沙係包含在任一
牙粉組分中時,較佳係亦包含從約0.05%至約5%促進該等試劑至口腔面之遞送及滯留且其於口腔面上滯留之試劑。此類適用於本發明之試劑係揭示於美國專利第5,188,821號及第5,192,531號;且包含合成陰離子聚合聚羧酸酯,如順丁烯二酸酐或酸與另一可聚合乙烯系不飽和單體,較佳係分子量(M.W.)為約30,000至約1,000,000,最佳係約30,000至約800,000之甲基乙烯基醚/順丁烯二酸酐之1:4至4:1共聚物。這些共聚物係(例如)可以Gantrez,如AN 139(M.W.500,000)、AN 119(M.W.250,000)且較佳係獲自ISP Technologies,Inc.,Bound Brook,N.J.08805之S-97醫藥級(M.W.700,000)獲得。該等促進劑在存在時係以範圍從約0.05至約3重量%之量存在。
其他操作聚合物包括彼等如順丁烯二酸酐與丙烯酸乙基酯之1:1共聚物、甲基丙烯酸羥基乙基酯、N-乙烯基-2-吡咯啶酮或乙烯,後者可(例如)以Monsanto EMA No.1103,M.W.10,000及EMA等級61獲得及丙烯酸與甲基丙烯酸甲基酯或甲基丙烯酸羥基乙基酯之1:1共聚物、丙烯酸甲基酯或丙烯酸乙基酯、異丁基乙烯基醚或N-乙烯基-2-吡咯啶酮。
一般適合者為含有一經活化碳對碳之烯烴雙鍵及至少一個羧基之經烯烴系或乙烯系聚合之不飽和羧酸,換言之,含有烯烴雙鍵之酸,其中該烯烴雙鍵因其在單體分子中係以相對於羧基之α-β位置或終端亞甲基團之一部分的形式存在而易在聚合反應中發揮作用。此類酸之說明實例係丙烯酸、甲基丙烯酸、乙基丙烯酸、α-氯丙烯酸、巴豆酸、β-丙烯醯氧基丙酸、山梨酸、α-氯山梨酸、肉桂酸、β-苯乙烯基丙烯酸、黏康酸、伊康酸、焦檸檬酸、中康酸、戊烯二酸、烏頭酸、α-苯基丙烯酸、2-芐基丙烯酸、2-環己基丙烯酸、白芷酸、繖形酸、反丁
烯二酸、順丁烯二酸及酐。其他可與此類羧酸單體共聚合之不同烯烴單體包括乙烯基乙酸酯、氯化乙烯、順丁烯二酸二甲基酯及類似物。共聚物包含足夠羧酸鹽基而具水溶性。
另一類型之聚合物試劑包括一含經取代丙烯醯胺之均聚物及/或不飽和磺酸及其鹽之均聚物的組成物,特別係頒予Zahid於1989年6月27日申請之美國專利第4,842,847號中所描述,其中聚合物係以選自丙烯醯胺烷磺酸之不飽和磺酸如分子量為約1,000至約2,000,000之2-丙烯醯胺2-甲基丙烷磺酸為基質,將該案以引用方式併入本文中。
另一適用類型之聚合物試劑包括聚胺基酸,特別係如頒予Sikes等人之美國專利第4,866,161號中所揭示彼等含有一定比例之陰離子表面活性胺基酸如天冬胺酸、麩胺酸及磷絲胺酸者,將該案以引用方式併入本文中。
製備口腔護理組成物時,有時必須添加一些增稠物質以提供所需稠度或安定或提高調配物的性能。在某些具體例中,該等增稠劑係羧基乙烯基聚合物、鹿角菜膠、羥基乙基纖維素及纖維素醚之水溶性鹽如羧基甲基纖維素鈉及羧基甲基羥基乙基纖維素鈉。亦可摻入天然膠如梧桐膠、阿拉伯膠及黃蓍樹膠。可使用膠體狀矽酸鎂鋁或細微矽石作為增稠組成物之組分以進一步改善組成物之組織。在某些具體例中,使用量為總組成物之約0.5重量%至約5.0重量%之增稠劑。
本發明口腔護理組成物亦可視情況包含一或多種酶。適用酶包括可用蛋白酶、葡萄糖水解酶、內切糖苷酶、澱粉酶、葡聚糖變構水解酶、脂酶及黏蛋白酶或其相容混合物中任一者。在某些具體例中,該酶係蛋白酶、聚葡糖酶、內切糖苷酶及葡
聚糖變構水解酶。在另一具體例中,該酶係木瓜酶、內切糖苷酶或聚葡糖酶與葡聚糖變構水解酶之混合物。適合用於本發明之額外酶係揭示於頒予Dring等人之美國專利第5,000,939號、美國專利第4,992,420號、美國專利第4,355,022號、美國專利第4,154,815號、美國專利第4,058,595號、美國專利第3,991,177號及美國專利第3,696,191號,將該等案全部以引用方式併入本文中。本發明中數種相容酶之混合物之酶在一具體例中構成約0.002%至約2.0%或在另一具體例中構成約0.05%至約1.5%或在另一具體例中構成約0.1%至約0.5%。
水亦可存在於本發明口腔組成物中。製備市售口腔組成物所用之水應經去離子且不含有機不純物。水通常構成組成物之剩餘部分並佔該口腔組成物之約10重量%至約90重量%,約20重量%至約60重量%或約10重量%至約30重量%。此水量包含所加之自由水加上隨其他物質如隨山梨醇或本發明任何組份所導入之量。
在某些口腔組成物之具體表現內,亦希望摻入保濕劑以防止組成物在暴露於空氣中後硬化。某些保濕劑亦可賦予牙粉組成物所需甜度或氣味。以純保濕劑計,該保濕劑在一具體例中一般佔該牙粉組成物之約15重量%至約70重量%或另一具體例中佔約30重量%至約65重量%。
適合的保濕劑包括食用多元醇如甘油、山梨醇、木糖醇、丙二醇以及其他多元醇和這些保濕劑之混合物。甘油與山梨醇之混合物可用於某些具體例中作為本文牙膏組成物之保濕劑組分。
除了上述組分之外,本發明具體表現可包含多種視情況選用之牙粉成分,其部分係描述於下。視情況選用之成分包括,例如(但不限於)黏附劑、泡沫劑、調味劑、甜味劑、額外抗斑劑、研磨劑及著色劑。這些及其他視情況選用之組分係另外描述於頒予Majeti等人之美國專利第5,004,597號;頒予Agricola等人之美國專利第3,959,458號及頒予Haefele等人之美國專利第3,937,807號,將該等案全部以引用方式併入本文中。
本發明組成物可利用口腔產品領域中常見之方法製成。
在一說明性具體例中,該口腔護理組成物係藉由以一酸,如磷酸、鹽酸或碳酸中和或部分中和凝膠相中之精胺酸並混合形成預混物1而製成。
將活性物質如(例如)維生素、CPC、氟化物、研磨劑及任何其他所需活性成分加入預混物1並混合形成預混物2。
最終產品為牙膏時,將牙膏基質,例如磷酸二鈣或矽石加入預混物2中並混合之。使最終漿液形成一口腔護理產品。
本發明在其方法態樣中包括將一安全且有效量之本文所述組成物施用於口腔中。
根據本發明組成物及方法係適用於一種藉由幫助修護及再礦化,特別係減少或抑制齲齒形成、降低或抑制牙齒之去礦化並促進其再礦化,減少牙齒之過敏反應並如藉由定量光誘導螢光(QLF)或電阻抗齲齒測量(ECM)所偵測,降低、修護或抑制早期琺瑯質損傷以保護牙齒之方法。
定量光誘導螢光係一可偵測早期損傷並縱向監測發展或退化之可見光螢光。正常牙齒可發出可見光之螢光;已去礦化
牙齒無法或僅發出較低程度之螢光。去礦化區域可經量化並可監測其發展。使用藍色雷射光以使牙齒自動發出螢光。已流失礦物質之區域具有較低螢光且相較於健康牙齒面出現較深顏色。利用軟體量化源自白點之螢光或與損傷有關之面積/體積。一般,僱用具有現有白點損傷之受檢者作為參加者。以實際牙齒進行活體內測量。在臨床實驗開始時測量損傷之面積/體積。結束6個月之產品使用期時測量損傷面積/體積之降低(改善)。經常將數據紀錄成相對於基線之改善百分比。
電阻抗齲齒測量係一種以電組為基礎用於測量牙齒之礦物質含量的技術。電導測量係利用去礦化後露出充液管及侵蝕琺瑯質電導之事實。隨牙齒流失礦物質,其因孔隙率提高而對電流的抗性降低。因此,患者牙齒之電導的增加指示去礦化。一般,在具有現有損傷之齒底面進行研究。以實際牙齒進行活體內測量。測量6個月處理前後之電阻變化。而且,利用接觸式探針完成對齒底面之典型齲齒分級。將硬度分成三等級:硬、皮質或軟。在此類研究中,一般將結果記錄為ECM測量之電阻(數值愈高愈佳)及以接觸式探針級數為基礎之損傷的硬度。
本發明組成物因此適用於一種相較於缺乏有效量之氟及/或精胺酸之組成物可降低早期琺瑯質損傷(如藉由QLF或ECM所量得)的方法。
本發明組成物另外適用於減少口腔中有害細菌之方法,例如減少或抑制牙齦炎、降低生酸菌之量、增加溶精胺酸菌之相對量、抑制口腔中生物膜之形成、在糖攻擊後,提高及/或保持溶菌斑pH在至少pH5.5之值、降低溶菌斑累積及/或清潔牙齒及口腔之方法。
最後,藉由提高口中pH並消除病源菌,本發明組成物適用於促進口中疼痛發炎或刺痛之復原。
當口腔組織可為全身感染之途徑時,促進口腔健康亦提供全身健康之益處。良好的口腔健康亦與全身健康,包括心血管健康有關。本發明組成物及方法提供特定益處,因為鹼性胺基酸,特別係精胺酸係供應NO合成途徑並因此提高口腔組織之微循環之氮源。提供一酸性較低之口腔環境亦有助於降低胃痛並產生一較不利於與胃潰瘍有關之幽門螺旋桿菌的環境。精胺酸特別係為特異免疫細胞受體,例如T-細胞受體之高表現所需要的,以致精胺酸可提高有效免疫反應。本發明組成物及方法因此適用於提高全身健康,包括心血管健康。
可將本發明組成物及方法併入用於護理口及牙齒之口腔組成物如牙膏、透明糊、凝膠、漱口水、噴液及口香糖中。
整體使用時,使用範圍作為簡略表達以描述該範圍內之各值及每一值。該範圍內之任一值皆可選作該範圍之端值。而且,可將本文所用之所有參考文獻之全文以引用方式併入本文中。在本發明揭示內容之定義與所用參考文獻之定義者有衝突的情況下,由本發明揭示內容控制。應了解當描述調配物時,如技術中常見般,可依據其成分描述之並欲以所述調配物涵蓋此類產品,儘管這些成分可能在實際調配物製造、儲存及使用時彼此反應。
下列實例進一步描述並說明本發明範疇內之說明性具體表現。該等實例僅供說明且不應將其理解為本發明限制,因為可能存在許多變化例而無悖離本發明精神及範疇時。除了彼等本文所示及所述者外,本發明各種改良對熟諳此技者而言應係顯而易見的並欲落在所附申請專利範圍內。
利用包含即0.3重量%之三氯沙、0.243重量%之氟化鈉、月桂基硫酸鈉及甲基乙烯基醚與順丁烯二酸酐(PVM/MA)之共聚物之市售製備調配物並於其中加入0、1%、3%及5%之L-精胺酸鹽酸鹽(pH 7.0)。
L-精胺酸摻入市售調配物中可將調配物之可溶三氯沙的可用量從約70%(0%精胺酸)提高至約80%(1%精胺酸)、85%(3%精胺酸)及95%(5%精胺酸)。
一般如Gaffar,A.等人於American Journal of Dentistry第3卷,1990年9月中所述般,該等調配物係在經設計用以測量經過24小時黏附在經牙膏處理之羥基磷灰石(HAP)盤之細菌的人造口模型中進行活體外試驗,但改良處為經唾液塗覆之羥基磷灰石盤在暴露於細菌中前係先經牙粉漿液處理。顯示將L-精胺酸摻入市售調配物中可提高三氯沙至該等盤之遞送約50%,30分鐘之攝取量從控制組之每盤近40微克三氯沙增加至5%精胺酸調配物之約60微克三氯沙。24小時後,控制盤每盤保留約10微克,相較於5%精胺酸調配物之約20微克,顯著提高。利用組胺酸或離胺酸取代精胺酸可獲得類似結果。
此遞送之提高直接使調配物之抗菌作用提高且利用5%精
胺酸相較於控制組在抑制黏性放線菌之生長上統計上可顯著降低約15%。
矽石基質中含有5%精胺酸之牙膏調配物之製備如下:藉將氟化鈉及糖精鈉溶於一部分配方量之H2O中以製備預混溶液(預混物I)。在另一容器中,將聚合物膠及二氧化鈦分散入保濕劑中。將預混物I加入凝膠相中且必要時加熱之。
藉先將L-精胺酸分散於一部分配方水中以製備另一預混溶液(預混物II)。然後將PVM/MA(Gantrez)加入L-精胺酸分散液中並混合之直到均勻。然後藉由加入足量無機酸或鹼將凝膠相之pH調整至中性pH。然後將預混物II加入保濕劑/聚合物膠溶液中以完成凝膠相。
將凝膠相轉移至適當製造容器中。將研磨劑加入凝膠相中並在真空下混合直到均勻。最後將三氯沙、調味劑及界面活性劑加入混合物中並在真空下混合直到均勻。配方組成:三氯沙加L-精胺酸
其他調配物之製備如下:
實例3-調配物對三氯沙攝取量及細菌黏附之效能
藉於37℃下將牙粉漿液施用在經唾液塗覆之羥基磷灰石盤上達一設定時間量以研究三氯沙之攝取量。該等盤經清洗以除去表面上之過量牙粉。然後溶解取自盤上之活性物質並以HPLC分析之。具有與上實例2之調配物II類似調配物之市售牙膏(即包含0.3重量%之三氯沙、0.243重量%之氟化鈉、月桂基硫酸鈉及甲基乙烯基醚與順丁烯二酸酐之共聚物,但不含之精胺酸)係正控制組。相較於調配物II之58.8的攝取量,此正控制組具有每盤32.7微克之三氯沙攝取量。具有精胺酸之產品因此具有比市售調配物高79.8%之攝取量。
在一抗黏附試驗中,調配物II(0.1845降低量)以少量不顯著之邊緣勝過正控制組(三氯沙不含精胺酸,0.1809降低量)並以較寬邊緣勝過調配物I(精胺酸不含三氯沙,0.1556降低量)。在該抗菌試驗中,調配物II(0.1980降低量)勝過正控制組(0.1789降低量)及調配物I(0.1891降低量)。
含有2%精胺酸碳酸氫鹽之調配物的製備如下:
在先前實例所述之攝取量分析中,相較於調配物C(不含精胺酸之對照組)之22.88微克,調配物A顯示盤上57.876微克之三氯沙。
本發明漱口水調配物係利用下列成分所製得:含有氟化物及三氯沙之精胺酸清洗液
令瞄準在測試牙粉調配物之感官屬性之消費者測試器面板經受不同牙粉調配物,其中該等調配物係在消費者重複使用牙粉調配物之雙盲消費者測試條件下使用。
令該面板使用慣用牙粉調配物,然後評估各項感官特徵。對於含有沉澱碳酸鈣(PCC)之鹼性牙粉調配物,亦測試用作安慰劑控制組之已知調配物且另外包含1、2、3或5重量%精胺酸碳酸氫鹽之對應調配物。令人驚訝地發現含精胺酸碳酸氫鹽之PCC調配物呈現消費者對氣味強度、冷卻及容易發泡屬性的接受度增加,此外另外包含2重量%精胺酸碳酸氫鹽之調配物呈現味道、刷洗時之味道及刷洗後之味道之整體愛好程度增加。而且,察覺另外包含精胺酸碳酸氫鹽之調配物在所有印象屬性,包括自覺效能、口/牙齒潔淨的感覺、產品適用性、味道及整體產品品質上明顯優於安慰劑控制組。
相反地,當測試具有磷酸二鈣而非沉澱碳酸鈣(PCC)基質之調配物時,精胺酸碳酸氫鹽之添加相較於無添加精胺酸碳酸氫鹽之相同調配物無法呈現明顯較佳之感官特徵。
該實例顯示鹼性胺基酸如精胺酸,特別係以碳酸氫鹽形式者之添加可在用於本發明口腔護理組成物中時令人驚訝地提高牙粉調味物之感官特徵,最特別地係具有沉澱碳酸鈣(PCC)之基質調配物者。
隔夜培養之血鏈球菌係在37℃下胰酪酶大豆培養液(Becton Dickinson,Sparks,MD)中生長。培養物以每次1毫升裝入已稱重管中在5000rpm下離心5分鐘裝入已稱重管中的方式以累積近5毫克之濕丸重量。然後令該丸再度懸浮於20毫升磷酸鉀緩衝液(JT Baker,Phillipsburg,NJ),pH4.0中以模擬細菌細胞之緊迫環境,在此環境下將製造氨以供細菌生存。最終濃度係每毫升5毫克。在此最終濃度中,隨0.1%最終濃度之蔗糖(VWR,West Chester,PA)加入5毫莫耳最終濃度之L-精胺酸、L-瓜胺酸或L-鳥胺酸。然後,在測定氨製造之前,使此混合物在37℃下搖晃水浴中培養30分鐘。
為了分析氨,使用獲自Diangnostic Chemicals Limited(Oxford,CT)之氨分析套件。此特殊套件之預定用途係用於活體外量化血漿中之氨,但程序係經修改以測定並量化溶菌斑及/或細菌中氨之製造。
下表顯示如上述般在pH4.0下利用血鏈球菌進行6個不同試驗之氨製造量值。結果確認精胺酸去亞胺酶系統所產生之中間物可用於製造細胞存活用之氨。
該實例顯示異於精胺酸之鹼性胺基酸對在口腔內製造氨係有效的並因此在用於本發明口腔護理組成物中時可增加溶菌斑pH。
Claims (27)
- 一種口腔護理組成物,其包含a. 有效量之呈游離或鹽形式之鹼性胺基酸;b. 有效量之抗菌劑;及c. 陰離子聚合物。
- 如申請專利範圍第1項之組成物,其另外包含一陰離子界面活性劑及/或有效量之氟化物源。
- 如申請專利範圍第1或2項之組成物,其中該鹼性胺基酸係精胺酸。
- 如前述申請專利範圍中任一項之組成物,其中該鹼性胺基酸係呈鹽形式並選自精胺酸磷酸鹽、精胺酸碳酸氫鹽及精胺酸鹽酸鹽。
- 如前述申請專利範圍中任一項之組成物,其中該抗菌劑係以總組成物重量之0.01至5重量%之量存在。
- 如申請專利範圍第5項之組成物,其中該抗菌劑係以總組成物重量之0.01至1重量%之量存在。
- 如前述申請專利範圍中任一項之組成物,其中該抗菌劑係三氯沙。
- 如前述申請專利範圍中任一項之組成物,其中該抗菌劑係選自於錫離子源與鋅離子源。
- 如前述申請專利範圍中任一項之組成物,其另外包含陰離子界面活性劑。
- 如申請專利範圍第9項之組成物,其中該陰離子界面活性劑以總組成物重量之0.01至10重量%之量存在。
- 如申請專利範圍第10項之組成物,其中該陰離子界面活 性劑以總組成物重量之0.3至4.5重量%之量存在。
- 如申請專利範圍第9至11項中任一項之組成物,其中該陰離子界面活性劑係選自月桂基硫酸鈉、月桂醇醚硫酸鈉及其混合物
- 如前述申請專利範圍中任一項之組成物,其中該陰離子聚合物為甲基乙烯基醚與順丁烯二酸酐之共聚物
- 如前述申請專利範圍中任一項之組成物,其中該鹼性胺基酸係以總組成物重量之0.1至20重量%之量存在。
- 如申請專利範圍第14項之組成物,其中該鹼性胺基酸係以總組成物重量之0.1至10重量%之量存在。
- 如前述申請專利範圍中任一項之組成物,其另外包含一量為總組成物重量之0.01至2重量%之可溶氟化物鹽
- 如申請專利範圍第1至15項中任一項之組成物,其另外包含一在總組成物重量中提供50至25,000ppm之氟離子之量的氟離子源。
- 如申請專利範圍第16或17項之組成物,其中該可溶氟化物鹽或氟離子源係選自氟化鈉、單氟磷酸鈉及其混合物
- 如前述申請專利範圍中任一項之組成物,其另外包含一研磨物質,該研磨物質包含至少佔總組成物重量之約5重量%之小顆粒部分,其中該等小顆粒部分之顆粒具有小於約5微米之d50。
- 如申請專利範圍第19項之組成物,其中該小顆粒部分至少佔總組成物重量之約20重量%。
- 如申請專利範圍第19或20項之組成物,其中該研磨物質係選自碳酸鈣、矽石及其混合物。
- 如申請專利範圍第1至18項中任一項之組成物,其另外 包含一選自矽石及碳酸鈣之微粒物質。
- 如前述申請專利範圍中任一項之組成物,其係一包含下列各者之牙劑a. 有效量選自精胺酸碳酸氫鹽、精胺酸磷酸鹽及精胺酸鹽酸鹽之鹼性胺基酸之鹽;b. 有效量之三氯沙;c. 有效量選自氟化鈉及單氟磷酸鈉之可溶氟化物鹽;d. 一陰離子界面活性劑;及e. 一甲基乙烯基醚與順丁烯二酸酐之共聚物。
- 如前述申請專利範圍中任一項之組成物,其另外包含一木糖醇。
- 如前述申請專利範圍中任一項之組成物,其中該放射能齒質磨損(RDA)係小於約150。
- 如前述申請專利範圍中任一項之組成物,其係呈另外包含水、研磨劑、界面活性劑、發泡劑、維生素、聚合物、酶、保濕劑、增稠劑、抗菌劑、防腐劑、調味劑、著色劑及/或其組合中之一或多者之牙膏形式。
- 一種如申請專利範圍第1至26項中任一項之組成物的用途,係用於製備治療下列有其需要的口腔保健產品:a. 減少或抑制齲齒之形成,b. 降低、修護或抑制早期琺瑯質損傷,c. 降低或抑制牙齒之去礦化並促進其再礦化,d. 減少牙齒之過敏反應,e. 減少或抑制牙齦炎,f. 促進口中疼痛或切口之復原,g. 降低生酸菌之量, h. 增加溶精胺酸菌之相對量,i. 抑制口腔中微生物之生物膜的形成,j. 在糖攻擊後,提高及/或保持溶菌斑pH在至少pH5.5之值,k. 降低溶菌斑累積,l. 治療、減輕或減少口腔乾燥;m. 潔白牙齒,n. 如藉由降低經由口腔組織而造成全身感染之可能性而提高全身健康,包括心血管健康,o. 降低牙齒侵蝕,p. 使牙齒對致齲齒菌免疫或保護牙齒以防致齲齒菌及/或q. 清潔牙齒及口腔。
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