JP2020533323A - 水性口腔ケアフッ化物処置組成物、及び方法 - Google Patents
水性口腔ケアフッ化物処置組成物、及び方法 Download PDFInfo
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- 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
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Abstract
Description
本開示の水性口腔ケアフッ化物処置組成物は、水溶性ポリマーを含むが、典型的には、この組成物はゲルではない。一般に、ゲルは、溶媒(例えば、水)によって化学的に架橋及び伸長又は膨潤されるポリマー鎖を含む。したがって、典型的には、本開示の組成物は架橋されていないが、それらは、溶媒(例えば、水)の存在下で伸長される化学的に結合していない結合を有するポリマー鎖を含んでもよい。
及び上記のいずれかの組み合わせ。
本開示の水性口腔ケアフッ化物処置組成物は、活性剤としてフッ化ナトリウムを含む。特定の実施形態では、処置組成物は、水性組成物の総重量に基づいて、少なくとも1.0重量%を含む。特定の実施形態では、処置組成物は、水性組成物の総重量に基づいて、最大2.5重量%を含む。
本開示の水性口腔ケアフッ化物処置組成物はまた、フッ化ナトリウムに加えて、1種以上の活性剤も含有することができる。含まれる場合、1種以上の更なる活性剤としては、常にではないが通常は、歯、歯肉、頬、舌、口蓋などの、障害、疾患、又は状態に対して口腔内で活性な、1種以上の活性剤が挙げられる。
本開示の水性口腔ケアフッ化物処置組成物は、薬学的に許容される緩衝剤を含む。このような緩衝剤の種類及び量は、少なくとも6又は少なくとも6.5のpHを有する処置組成物を提供するように選択される。特定の実施形態では、このような緩衝剤の種類及び量は、最大8、最大7.5、又は最大7のpHを有する処置組成物を提供するように選択される。特定の実施形態では、このような緩衝剤の種類及び量は、6.5〜7.5のpH、又は7.0のpHを有する処置組成物を提供するように選択される。多様な、好適な薬学的に許容される緩衝剤が挙げられる。例としては、酢酸塩(例えば、酢酸ナトリウム)、炭酸ナトリウム、クエン酸塩(例えば、クエン酸ナトリウム)、酒石酸塩、グリシルグリシン、ヒスチジン、グリシン、リジン、アルギニン、リン酸二水素ナトリウム、リン酸水素二ナトリウム、リン酸ナトリウム、トリス(ヒドロキシメチル)−アミノメタン、又はこれらの混合物が挙げられる。
特定の実施形態では、本開示の水性口腔ケアフッ化物処置組成物は、所望の適用方法を可能にする好適な粘度を組成物に提供するために、増粘剤を含む。例えば、反転されたマウスピーストレイアプリケータ内で最大約4分間(専門的に適用されるフッ化物処置のための典型的な時間)組成物を維持するのに適切ではあるが、ただし歯科技師にとって許容される取り扱い特性を有するのに適切な流体である(例えば、歯科用トレイアプリケータ中に分配するとき)ような、溶液粘度を達成するのに十分な量の好適な増粘剤を使用することができる。又は、十分な量にある好適な増粘剤を、歯表面上を塗るのに適切な溶液粘度を達成するために使用してもよい。
特定の実施形態では、本開示の水性口腔ケアフッ化物処置組成物は、香味剤(すなわち、風味剤)及び甘味料を含む1種以上の任意選択の添加剤を含む。所望であれば、このような材料の様々な組み合わせを使用することができる。
実施形態1は、水性口腔ケアフッ化物処置組成物であって、0.5重量%〜4.8重量%の水溶性カチオン性N含有ポリマーと、薬学的に許容される緩衝剤と、1.0重量%〜2.5重量%のフッ化ナトリウムと、少なくとも60重量%の水とを含み、ここで、重量%は水性組成物の総重量に基づくものである、処置組成物である。
から選択される、実施形態6に記載の処置組成物である。
EUDRAGIT E100 polymer
任意の、望ましくない、沈殿、又はポリマー/水相分離の目視試験を実施した。組成物の調製中、液体組成物を、相分離及び/又は白色沈殿について目視検査した。組成物中の2つの異なるポリマー間の相互作用に起因して形成されたポリマー凝集体又はスポンジ様の半固体ゲルが存在した場合、それは、相分離が生じ、不均一な組成物が形成されたことを意味していた。
フッ化物放出を、Mettler Toledo T70滴定器で測定した。Cole Parmerフッ化物電極を、フッ化物放出用の試料を毎日測定する前に、最初に、TISAB IIIを使用してフッ化物基準の百万分率(ppm)で較正した(総イオン強度調整緩衝剤(Total Ionic Strength Adjustment Buffer、TISAB)III濃縮溶液は、フッ化物イオン選択性電極、Sigma Aldrichと共に使用する)。各実施例の組成物を、RINZL Plastic顕微鏡スライド上に薄層でコーティングし、このスライドの両側についてコーティング面積2.54cm2とした。コーティングの総重量は、約0.045gとした。フッ化物測定器滴定カップに、MilliQ DI水45mLと、TISAB III濃縮物5mLとの混合物50mLを充填した。フッ化物イオン選択的電極を、希釈したTISAB III溶液の滴定カップ中に載置し、各試料を分析する前に、30秒間、測定器を平衡化させた。30秒後、クランプした試料を、希釈したTISAB III溶液50mLへと減らした。Mettler Toledo T70滴定器での30分間滴定中の種々の時点で、フッ化物放出(mV)を測定した。フッ化物放出を、フッ化物標準検量線に対して算出した。各実施例につき2つの滴定の平均を報告した。
Fisher Scientific製のAccumet Model 15のpH測定器、及びFisher Scientific製のAccumet pH probe cat#13−620−291、SN 6153081P 15のpHプローブによって、種々の組成物のpHを測定した。測定前に、測定器を標準pH溶液で較正した。pH値は、プローブを溶液中に挿入して、pH値を得るために2分間待機することによって得た。
組成物の粘度を、TA Instruments製の、平行プレート固定具を備えたAR−G2磁気軸受レオメータで室温にて測定した。プレート同士の間に組成物約1.4mLを載置し、プレートの間隙を、室温で測定するために1ミリメートル(mm)に設定した。粘度を、1.0(1/秒)の剪断速度で記録した。各試料について2つの試験を行い、平均を報告した。
カチオン性ポリマー保存溶液の調製
カチオン性ポリマー前駆体をカチオン性ポリマーへと転換するために、以下の手順を用いた。
3.84gの量のクエン酸を、DI水200mLに溶解し、Na2HPO4 14.2gをDI水500mLに溶解した。両方の溶液を作製した後、NA2HPO4溶液465mLをクエン酸溶液150mLに添加した。溶液をよく混合し、最終溶液のpHを測定した。これはpH緩衝剤であり、pHは7.0であった。
塩化カルシウム二水和物を、ガラス瓶内のDI水に溶解した。カチオン性ポリマー保存溶液、フッ化ナトリウム、DI水、キシリトール、及び香味剤を、プラスチックボトル中に添加し、十分に混合して、30分間磁気撹拌しながら溶液を形成した。次に、塩化カルシウム溶液を、撹拌しながら約5分間、ゆっくりとフッ化物溶液中に添加した。更なる混合を、更に30分間実施した。塩化カルシウム溶液をフッ化物含有組成物中に添加する間、任意の白色沈殿を記録した。次に、所望に応じて、リン酸カルシウムなどの他の添加剤を添加し、10分間よく混合した。次に、HEC NATROSOL 250HHX pharm増粘剤を添加し、撹拌を約30分間実施した。次に、試料を、最大回転速度で混合しながらWheatonローラー上に一晩載置し、粘稠な水性コーティング組成物を形成した。組成物中の2つの異なるポリマー間の相互作用に起因する、任意のポリマー凝集体又はスポンジ様の半固体ゲルの形成、水性溶液から分離した、水溶液から分離したポリマー凝集体又はスポンジ様の半固体ゲルについて、試料を目視検査した。
Claims (20)
- 水性口腔ケアフッ化物処置組成物であって
0.5重量%〜4.8重量%の水溶性カチオン性N含有ポリマーと、
薬学的に許容される緩衝剤と、
1.0重量%〜2.5重量%のフッ化ナトリウムと、
少なくとも60重量%の水と
を含み、ここで、前記重量%は前記水性組成物の総重量に基づくものである、処置組成物。 - 前記水溶性カチオン性N含有ポリマーが、0.6重量%〜4.0重量%の量で存在する、請求項1に記載の処置組成物。
- 前記水溶性カチオン性N含有ポリマーが、前記処置組成物中に組み込まれる前はカチオン性ではないポリマー前駆体から誘導される、請求項1又は2に記載の処置組成物。
- 前記水溶性N含有ポリマー又はポリマー前駆体が、ジメチルアミノエチル側基を有する(メタ)アクリレートコポリマー、ポリエチレンイミン、カチオン変性多糖、及びこれらの組み合わせから選択される、請求項1〜3のいずれか一項に記載の処置組成物。
- 増粘剤を更に含む、請求項1〜5のいずれか一項に記載の処置組成物。
- 前記増粘剤が、1.0/秒の剪断速度で0.5〜100パスカル秒の粘度を前記組成物に提供するのに十分な量で存在する、請求項6に記載の処置組成物。
- 前記増粘剤が、2.5重量%未満の量で存在する、請求項6又は7に記載の処置組成物。
- カルシウム塩を更に含む、請求項1〜8のいずれか一項に記載の処置組成物。
- 6〜8のpHを有する、請求項1〜9のいずれか一項に記載の処置組成物。
- 5重量%未満の有機溶媒を含む、請求項1〜10のいずれか一項に記載の処置組成物。
- 5分以内で、フッ化ナトリウムの少なくとも50%を放出する、請求項1〜11のいずれか一項に記載の処置組成物。
- 1分以内で、フッ化ナトリウムの90%以下を放出する、請求項1〜12のいずれか一項に記載の処置組成物。
- 10分以内で、フッ化ナトリウムの100%を放出する、請求項1〜13のいずれか一項に記載の処置組成物。
- 最大96重量%の水を含む、請求項1〜14のいずれか一項に記載の処置組成物。
- フッ化物を患者の歯表面に付与する方法であって、請求項1〜15のいずれか一項に記載の水性口腔ケアフッ化物処置組成物を前記患者の歯表面に適用することを含む、方法。
- 適用することが、前記処置組成物を前記患者の歯表面上に塗ることを含む、請求項16に記載の方法。
- 適用することが、前記処置組成物を歯科用トレイ中に分配することと、その中に前記処置組成物を有する前記トレイを前記患者の歯表面に取り付けることとを含む、請求項16に記載の方法。
- 前記歯科用トレイが、歯科矯正用アライナ処置トレイを含む、請求項18に記載の方法。
- それを必要とする患者におけるう歯の発生率を低減する方法であって、請求項1〜16のいずれか一項に記載の水性口腔ケアフッ化物処置組成物を前記患者の歯表面に適用することを含む、方法。
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