JP2021506895A - 口腔用組成物及び使用方法 - Google Patents
口腔用組成物及び使用方法 Download PDFInfo
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- JP2021506895A JP2021506895A JP2020534244A JP2020534244A JP2021506895A JP 2021506895 A JP2021506895 A JP 2021506895A JP 2020534244 A JP2020534244 A JP 2020534244A JP 2020534244 A JP2020534244 A JP 2020534244A JP 2021506895 A JP2021506895 A JP 2021506895A
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- 235000019204 saccharin Nutrition 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
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- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
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- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 235000011008 sodium phosphates Nutrition 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 229910052712 strontium Inorganic materials 0.000 description 1
- CIOAGBVUUVVLOB-UHFFFAOYSA-N strontium atom Chemical compound [Sr] CIOAGBVUUVVLOB-UHFFFAOYSA-N 0.000 description 1
- 229910001631 strontium chloride Inorganic materials 0.000 description 1
- 229940013553 strontium chloride Drugs 0.000 description 1
- AHBGXTDRMVNFER-UHFFFAOYSA-L strontium dichloride Chemical compound [Cl-].[Cl-].[Sr+2] AHBGXTDRMVNFER-UHFFFAOYSA-L 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
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- 150000008163 sugars Chemical class 0.000 description 1
- 239000007939 sustained release tablet Substances 0.000 description 1
- 229940095064 tartrate Drugs 0.000 description 1
- LMBFAGIMSUYTBN-MPZNNTNKSA-N teixobactin Chemical compound C([C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CO)C(=O)N[C@H](CCC(N)=O)C(=O)N[C@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CO)C(=O)N[C@H]1C(N[C@@H](C)C(=O)N[C@@H](C[C@@H]2NC(=N)NC2)C(=O)N[C@H](C(=O)O[C@H]1C)[C@@H](C)CC)=O)NC)C1=CC=CC=C1 LMBFAGIMSUYTBN-MPZNNTNKSA-N 0.000 description 1
- JBQYATWDVHIOAR-UHFFFAOYSA-N tellanylidenegermanium Chemical compound [Te]=[Ge] JBQYATWDVHIOAR-UHFFFAOYSA-N 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002411 thermogravimetry Methods 0.000 description 1
- 230000008719 thickening Effects 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 229960000790 thymol Drugs 0.000 description 1
- 239000000606 toothpaste Substances 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 108700012359 toxins Proteins 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
- LADGBHLMCUINGV-UHFFFAOYSA-N tricaprin Chemical compound CCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCC)COC(=O)CCCCCCCCC LADGBHLMCUINGV-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
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- 239000011592 zinc chloride Substances 0.000 description 1
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- 239000011670 zinc gluconate Substances 0.000 description 1
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Abstract
Description
実施例配合物を、以下の方法にて調製した。水相成分を、全て水に溶解することによって互いに混合した。この水相を室温(約25℃)で約15分間撹拌して、全ての成分を溶解した。次に、調製した水相に油を添加するとともに、室温で更に3時間撹拌し続けた。
LECO熱重量分析装置(TGA)を使用して、サンプルの重量減少率を求め、口腔内における4時間水和状態(湿分)の保持を模擬再現した。このin−vitro試験では、厚さ約6mmの料理していない薄切りローストビーフを使用して、軟組織を再現した。直径1cmの円形生検パンチを料理していない薄切りローストビーフから採取して、円盤形状の組織切片サンプルを作製した。これらのサンプルを前秤量し、次いで市販の口腔乾燥症緩和製品又は実施例配合物のうちの1つに組織サンプルを浸漬することによってコーティングした。また、未コーティングのビーフのサンプルも、対照として分析した。約0.2gの試験材料をホイルライナー分析容器に秤量し、LECO TGA熱重量分析装置に入れた。次いで、実施例を体温(37℃)で4時間保持し、このステップの後に減少した揮発性成分(水)の率(%)を記録した。次に、温度を上昇させ、全ての揮発性材料を燃やし尽くし、総重量分率を得た。37℃、4時間のステップの時点の後の減少重量を、総揮発性成分で除算し、4時間で減少した総揮発性成分の率(%)として表した。以下の表に、LECO TGA熱重量分析装置でプログラムを実行するために使用される、時間/温度プロファイルの詳細を示す。
市販品及び実施例配合物のデータを、以下の表6A、表6B、及び表6Cにまとめる。これに3つの別個の分析日を反映した。より低い値が、揮発性成分の減少率(%)に望ましい。揮発性成分のより低い減少率とは、処理配合物によってより多くの水分保持が促進されることを意味しており、これは、口腔乾燥症の治療組成物にとって望ましい効果である。
実施例配合物の粘度を、TA Instruments製の、平行プレート固定具を備えたAR−G2 Magnetic Bearingレオメータで室温にて測定した。プレート同士の間に実施例配合物約1.4mLを入れ、プレートの間隙を、室温で測定するために1mmに設定した。粘度を、1.0、3.162、及び10(1/s単位)の剪断速度で記録した。各配合物について2回反復試験を行い、平均を報告した。
摩擦/潤滑について、10ニュートン(N)のロードセル付きのFORCEBOARD多目的摩擦試験機(Industrial Dynamics,Sweden AB)を使用して測定した。ヒツジの盲腸から作製したナチュラルラムスキンコンドーム(Trojan NATURALKAMB(商標)Luxury Condoms,Church&Dwight Co.,Inc.Ewing,NJ)を使用して、口腔の粘膜組織を再現した。コンドームを十分にすすぎ、余分な液体を使用前及び測定間に除去して、残留潤滑剤又は実施例試験配合物が確かに後続の測定を妨害しないようにした。コンドームをガラススライド上に置き、平滑にしてしわをなくし、バインダークリップを使用してFORCEBOARD摩擦試験機に固定した。シリンジを使用して、0.5mLの実施例試験溶液(又は他の比較サンプル、例えば水若しくはヒト唾液)を、FORCEBOARDの前方近くの(モータから最も遠くの)コンドームの表面上に計量した。次いで、コンドームの第2の層を手袋着用の指の周囲に固定し、覆われた指を、3Nの目標垂直力を適用しながらFORCEBOARDの表面に(モータに向かって)降ろした。この動きを各反復測定について6〜10回繰り返した。摩擦係数(垂直力2.9〜3.1Nで)について、FORCEBOARD Analyzerソフトウェア(Industrial Dynamics,Sweden)によって計算した。低い摩擦係数値は、滑りやすくなるということであるため、配合物により口腔乾燥症を治療するために望ましい特性である。
この方法では、高スループットMBECアッセイシステム(Innovotech(Calgary,AB Canada))を利用する。本方法では、関与する処理条件にさらした後のMBEC接種器ペグ上に残っている蛍光標識バイオフィルムの量を定量化することによって、バイオフィルムの破壊における処理の効能を評価する。アッセイは、ASTM E2799−12(MBEC(商標)アッセイを使用する、緑膿菌(Pseudomonas aeruginosa)のバイオフィルムに対する消毒効能を試験するための標準法)と同様であるが、関与する生物としてのミュータンス連鎖球菌使用のために修正されたものであり、バイオフィルムを試験材料にさらすための修正プロトコルを使用した。
ミュータンス連鎖球菌(ATCC25175)の終夜培養物については、滅菌接種ループを使用して、15mLの円錐管内の5mLのブレインハートインフージョン(BHI)培養液に少量の凍結原料を導入することによって、調製した。管により、37℃(静的、振盪せず)で12〜16時間増殖させた。終夜培養物の密度を濁度測定(OD600)によって推定し、1%のスクロース及び1μMのAlexa Fluor(登録商標)488デキストラン、10,000MW(Molecular Probes(登録商標)PN/D22910)を補充したBHI培地でOD600=0.01まで適切に希釈して、必要な96ウェルプレートを充填する適切な量の接種材料を得る。150μLの接種材料を、96ウェルMBEC(商標)Biofilm Inoculatorプレート(Innotech(登録商標)P&G Panel、ポリスチレン)の適切なウェルに添加する。MBEC接種器の蓋(ペグを各ウェルに浸漬するように位置決め)を、接種済みプレートの上に置く。プレートをパラフィルムで包み、潤れた紙タオルでプラスチック容器の底部を裏打ちすることによって加湿された密封プラスチック容器内でインキュベートする(37℃、250RPMで振盪)。バイオフィルムをペグ上で4時間かけて形成した後、バイオフィルムを実施例配合物にさらした。この修正アッセイでは、ペグ上で成長するバイオフィルムを、実施例配合物にアッセイ中2回、接種後7時間及び18時間でさらした。実施例配合物にさらすことについては、水中での更なる洗浄ステップによる処理サイクルとして行った。処理は、150μL/ウェルの実施例配合物又は150μL/ウェルの水で充填した様々な96ウェルプレートにペグを移すことによった。
1)試験材料(150μL/ウェル)に1分間さらすこと
2)水(200μL/ウェル)中で1分間すすぐこと
3)水(200μL/ウェル)中で1分間すすぐこと
4)水(200μL/ウェル)中で1分間すすぐこと
表9は、試験した各々の実施例配合物処理の平均相対蛍光読み取り値を示す。低い値は、高い値よりも高いバイオフィルム破壊活性を示す。処理陰性対照としてのPBSを含有するウェルの平均蛍光値に正規化された、相対蛍光(%)として、値を報告する。一貫性のために、各々のMBECプレートについて、PBS処理ウェルの適切な複製で実行した。データについて、同じ96ウェルプレートで実行するPBS対照で正規化する。
1.組成物であって、
組成物の総重量を基準にして、0.1重量%〜8重量%の、式(I):
組成物の総重量を基準にして、5重量%〜95重量%の1つ以上の植物系油と、
組成物の総重量を基準にして、5重量%〜80重量%の水と、
組成物の総重量を基準にして、0.01重量%〜1重量%の1つ以上の非イオン性芳香族フェノール防腐剤と、
を含み、
組成物が、4.5〜9.5のpHを有し、エマルジョンであり、食用である、組成物。
口腔組織を項1〜20のいずれか一項に記載の組成物と接触させること、を含む、方法。
口腔組織を項1〜20のいずれか一項に記載の組成物と接触させること、を含む、方法。
口腔組織を項1〜20のいずれか一項に記載の組成物と接触させること、を含む、方法。
口腔組織を項1〜20のいずれか一項に記載の組成物と接触させること、を含む、方法。
Claims (20)
- 組成物であって、
前記組成物の総重量を基準にして、0.1重量%〜8重量%の、式(I):
前記組成物の総重量を基準にして、5重量%〜95重量%の1つ以上の植物系油と、
前記組成物の総重量を基準にして、5重量%〜80重量%の水と、
前記組成物の総重量を基準にして、0.01重量%〜1重量%の1つ以上の非イオン性芳香族フェノール防腐剤と、
を含み、
前記組成物が、4.5〜9.5のpHを有し、エマルジョンであり、食用である、組成物。 - R1及びR2が、独立して、水素原子、アルキル基、及びC(O)R3からなる群から選択され、R1及びR2のうちの少なくとも1つはC(O)R3であり、R3は、7個の炭素原子を有するアルキル基、8個の炭素原子を有するアルキル基、及び9個の炭素原子を有するアルキル基からなる群から選択される、請求項1に記載の組成物。
- nが4である、請求項1に記載の組成物。
- 1〜2重量%の式Iが存在する、請求項1に記載の組成物。
- R3が、8個の炭素を有するアルキル基である、請求項2に記載の組成物。
- 前記1つ以上の食用植物系油が、ヒマワリ油、ベニバナ油、オリーブ油、ココナッツ油、ヤシ油、ピーナッツ油、大豆油、亜麻仁油、菜種油、アマニ油、麻実油、カカオバター、クルミ油、トウモロコシ油、グレープ種子油、ゴマ油、落花生油、小麦胚芽油、綿実油、魚油、スイカ種子油、レモン油、オレンジ油、アザミ油、トマト種子油、アーモンド油、エゴマ油、キャノーラ油、ピスタチオ油、ヘーゼルナッツ油、ツバキ種子油、シアナッツ油、アンズ核油、オレイン酸、及びアボカド油から選択される、請求項1に記載の組成物。
- 前記1つ以上の食用植物系油が、前記組成物の総重量を基準にして、75重量%〜95重量%である、請求項1に記載の組成物。
- 前記1つ以上の非イオン性芳香族フェノール防腐剤が、プロピルパラベン、チモール、77〜86%のベンジルアルコールと8〜15%のサリチル酸と3〜5%のグリセリンと1〜4%のソルビン酸とを含む別個の防腐剤混合物、又はこれらの組み合わせから選択される、請求項1に記載の組成物。
- 前記1つ以上の非イオン性芳香族フェノール防腐剤が、前記組成物の総重量を基準にして、0.8重量%以下の量で存在する、請求項1に記載の組成物。
- 甘味料、湿潤剤、ミネラル塩、緩衝成分、香味剤、防腐剤、又はこれらの組み合わせを更に含む、請求項1に記載の組成物。
- アロエベラ、葉酸、ヒアルロン酸、オクチルグルコピラノシド、N−アセチル−D−グルコサミン、N−アセチル−D−ガラクトサミン、D−グルコサミン塩酸塩、D−グルコサミン硫酸塩、D−グルカミン、N−メチル−D−グルカミン、N−エチル−D−グルカミン、N−オクチル−D−グルカミン、キシリトール、ソルビトール、エリスリトール、マンニトール、グリシン、ノナン酸、エチルカプリレート、DMSO、セラミド、アルギニン、ベタイン若しくは酸素化グリセロールトリエステル、ビタミンE、ビタミンB12、EDTA、塩化セチルピリジニウム、クロルヘキシジン、他の殺菌剤、又はこれらの組み合わせを更に含む、請求項1項に記載の組成物。
- 前記組成物が、前記組成物の総重量を基準にして、1重量%〜20重量%の甘味料を含む、請求項1に記載の組成物。
- 前記組成物が、前記組成物の総重量を基準にして、2.5重量%〜40重量%の湿潤剤を含む、請求項1に記載の組成物。
- 前記組成物が、いずれの四級アンモニウム抗菌化合物も含まない、請求項1に記載の組成物。
- 前記組成物が、前記組成物と接触する領域におけるバイオフィルムの形成又は維持を防止すること、阻害すること、破壊すること、分散すること、低減すること、制御すること、又はこれらの任意の組み合わせを行うことができる、請求項1に記載の組成物。
- 前記組成物が、前記組成物が接触する領域において、水和状態の喪失に影響を及ぼすことができる、請求項1に記載の組成物。
- 前記組成物が、前記組成物が接触する領域の潤滑性又は潤滑度に影響を及ぼすことができる、請求項1に記載の組成物。
- 口腔組織における水和状態の喪失に影響を及ぼす方法であって、
口腔組織を請求項1に記載の組成物と接触させること、を含む、方法。 - 口腔組織における潤滑性又は潤滑度に影響を及ぼす方法であって、
口腔組織を請求項1に記載の組成物と接触させること、を含む、方法。 - 口腔乾燥症、ドライマウス、又はその両方の影響に働きかける方法であって、
口腔組織を請求項1に記載の組成物と接触させること、を含む、方法。
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JP2012526142A (ja) * | 2009-05-08 | 2012-10-25 | スリーエム イノベイティブ プロパティズ カンパニー | 口腔ケア方法及びキット |
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