JP2021519310A - リン酸架橋デンプンナノ粒子及び歯科処置 - Google Patents
リン酸架橋デンプンナノ粒子及び歯科処置 Download PDFInfo
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Abstract
Description
この出願は、2018年3月28日に提出された米国仮出願62/648,986及び2018年4月24日に提出された米国仮出願62/661,669の優先権及び/又は利益を主張する。
1Lのプラスチックビーカー中で、30gの天然ワキシーコーンデンプンを16.6gのNaClとともに600gの水に分散させて、顆粒の白色懸濁液を生成した。分散液を、Silverson超高剪断溶解槽攪拌機を使用して6500rpmで混合した。混合しながら7.5gの50%NaOHを加えた。ミキサーの回転を8000rpmまで上げ、混合物の温度を約20〜30分で22〜52℃に上昇させた。41〜42℃で混合物は透明になった。ガラススライド上に置かれた小さな液滴の光学顕微鏡検査は、デンプン粒フラグメントの小さな画分が存続していることを示した(交差偏光子の下で複屈折を伴う)。52℃で、すべての顆粒フラグメントを苛性溶液中で加熱した(NaOHは、デンプンを低温で調理すること、及び後続のSTMPとの架橋反応用の触媒としての役割という二重の目的を果たす)。pH紙はpH約13〜14を示した。顕微鏡検査により、最終デンプン溶液が完全に加熱されていることが示された。
0.3〜0.6MのNaCl又はNaFを含む、pH13、55℃で2時間1Lの4.68重量%デンプン溶液を加熱し、放冷する。NaOHペレットを水に加えて達成されるpHを13に調整する。別法として、60gの熱機械的に加工されたデンプン(又は他の冷水可溶性デンプン)を、10gのNaCl又はモル当量のNaFを含む400mLの脱イオン水に分散させる。いずれの方法でも水相が生成される
水、デンプン、水酸化ナトリウム、界面活性剤(Tween85)、及び油(鉱油又はパラフィン油)を合わせて、混合容器に入れる。高剪断ミキサーで混合を開始し、エマルションが形成されるまで約10分混合する。
カチオン化ナノ粒子の様々な試料を、実施例3の方法に従って製造した。デンプン並びに反応物として添加されたホスファート、カルシウム及びフッ化物のうちの1つ以上の相対量は、表1に示されるとおりである。これらの添加剤の量は、100モルのデンプンAGUに対してモルによるpphで示される。各試料の製造中に添加されるSTMPの量は、各STMP分子の3つのリン酸基の説明となるように、表1に示されている量の3分の1である。フッ化物を、初期水相の作成中に添加されたフッ化ナトリウムによって添加する。カルシウムを、油中水型エマルションに添加される塩化カルシウムによって添加する。ネガティブコントロール(GMB9)は、ホスファート、カルシウム及びフッ化物をいずれも添加せずに作られたナノ粒子によって提供された。ポジティブコントロール(GMB10)は、フッ化ナトリウムを脱イオン水に溶解して116ppmの濃度にすることにより製造したもので、以下で説明するGMB8に関する1時間の放出データと合致する。
アミラーゼを使用すると、試料GMB7は1時間後に1249ppmのフッ化物を放出し、72時間後に21205ppmのフッ化物を放出した。アミラーゼを使用すると、試料GMB8は1時間後に116ppmのフッ化物を放出し、72時間後に7604ppmのフッ化物を放出した。アミラーゼを使用しない場合、試料GMB7は1時間後にフッ化物1161ppmを放出し、72時間後にフッ化物21205ppmを放出した。アミラーゼを使用しない場合、試料GMB8は1時間後に78ppmのフッ化物を放出し、72時間後に8287ppmのフッ化物を放出した。これらの結果は、放出時間に対するアミラーゼの明らかな影響がなかったこと、及び両方の試料が1時間を超えた延長を呈するフッ化物の遅い放出を示すことを示している。フッ化物の放出を遅らせることは、より多くのフッ化物を安全に提供できるため、有益である。在宅処置では、放出の遅延により、プラークに付着し、う蝕病変に入らないナノ粒子をより有効に活用することもできる。急速に放出されたフッ化物は病変の表面で沈殿する傾向があるが、ゆっくり放出されたフッ化物は、沈殿する前に病変の細孔を通って入ることが可能であり得る。
ナノ粒子は、天然のデンプン顆粒を溶解するステップを回避するために、出発材料として熱機械的に加工されたデンプンを使用して、全般的に実施例2記載の要領で調製された。ナノ粒子は20mMのCa2+を有していた。TEM画像に基づくと、ナノ粒子は200〜500nmの範囲のサイズを有しているように見え、DLSで測定されたZ平均サイズは約380nmである。ナノ粒子の1つのバッチ(GM6)をNaClで調製した。ナノ粒子の別のバッチ(GM6 F−)を、NaClの代わりにNaFを使用して調製した。
エナメルスライバーを、Featherstoneら(Featherstone、J.D.B.及びMellberg、J.R.(1981)Relative rates of progress of artificial carious lesions in bovine,ovine and human enamel.Caries Res.15,109−114)記載の乳酸及びカルボキシメチルセルロース(CMC)ゲルプロトコルに従って、各スライバーに脱灰領域を設けて調製した。エナメルスライバーを、不透過性のワニスで部分的に保護し、それに続いて、継続した乳酸とCMCの脱灰に20日間曝露しながら表1に記載の様々なナノ粒子製剤で処理した。ナノ粒子処理は、20日間にわたって、スライバーをナノ粒子試料の1つと1日4回、4分間接触させることで構成された。継続した乳酸とCMCの脱灰プロトコルには、4時間の乳酸とCMCの脱灰溶液中での酸循環と、スライバーが乳酸とCMCの脱灰溶液に浸漬されていない場合のアミラーゼ含有人工唾液溶液中での浸漬が含まれていた。
上記の試料GMB8に従って、ナノ粒子を用いて2つの経口ゲルを製剤化した。ゲルをプロピレングリコールで安定化し、食品用ゼラチンで増粘した。製剤1は25%w/wのナノ粒子を含んでいた。製剤2は5%w/wのナノ粒子を含んでいた。象牙質知覚過敏症に対する、含有する2つのゲル製剤の効果を、製剤を象牙質円板に適用し、水力コンダクタンスの測定によって示されるように象牙質透過性の変化を測定することによって決定した。象牙質知覚過敏症(DH)は象牙細管内の流体の流れによる神経刺激を伴うと考えられているため、水圧コンダクタンスの変化によって示される細管の閉塞は、DHの処置の可能性を示している。
フルオレセインナトリウム及び塩化カルシウムを、約10のpHで水のバイアルに加えた。バイアルの底にカルシウムフルオレセインの沈殿物が形成された。
Claims (24)
- デンプンの水溶液又は水分散液を含む第一相を調製するステップ;
油相などの第二液相中の第一相の分散液又はエマルションを調製するステップ;
(a)1つ以上のアニオン性活性剤、(b)1つ以上の多価カチオン、又は(c)1つ以上のデンプンカチオン化剤のうちの1つ以上を第一相に加えるステップ;及び、
第一相のデンプンをリン酸架橋剤で架橋するステップ
を含む、ナノ粒子を製造する方法。 - アニオン性活性剤が、場合によりフッ化ナトリウムとして添加されてもよく、場合により第二液相中の第一相のエマルション又は分散液を調製する前に第一相に添加されてもよいフッ化物を含む、請求項1に記載の方法。
- アニオン性活性剤が、場合によりフルオレセインナトリウムなどのフルオレセイン塩として添加されてもよく、場合により第二液相中の第一相のエマルション又は分散液を調製する前に第一相に加えられてもよいフルオレセインを含む、請求項1又は2に記載の方法。
- 1つ以上の多価カチオンが、場合によりカルシウム塩として第一相に添加されてもよく、場合により第二液相中の第一相のエマルション又は分散液を調製する間又は後に第一相に添加されてもよいカルシウムを含む、請求項1〜3のいずれかに記載の方法。
- 5.5以下のpHで正のゼータ電位を有するナノ粒子を生成するのに十分な量で1つ以上のデンプンカチオン化剤を添加することを含む、請求項1〜4のいずれかに記載の方法。
- 架橋剤がトリメタリン酸ナトリウムを含む、請求項1〜5のいずれかに記載の方法。
- 油相中の水相のエマルションを十分な剪断力で混合して、動的光散乱(DLS)におけるZ平均サイズによって、又はナノ粒子追跡分析(NTA)での平均サイズによって決定された、100〜700nm、又は100〜500nmの範囲の平均又は平均サイズを有するナノ粒子を生成することを含む、請求項1〜6のいずれかに記載の方法。
- 請求項1〜7のいずれか一項に記載の方法によって生成されたナノ粒子であって、場合によっては水性分散液、ゲル又はペーストに組み込まれていてもよいナノ粒子。
- デンプンとリンを含むナノ粒子であって、リンは必要に応じてデンプン−リン酸化合物及び/又はダングリングホスファートに存在してもよいものとし、pH5.5以下で正のゼータ電位を有し、動的光散乱(DLS)におけるZ平均サイズによって、又はナノ粒子追跡分析(NTA)での平均サイズによって決定された、100〜500nmの範囲の平均又は平均サイズを有するナノ粒子。
- フッ化物、フルオレセイン又はカルシウムのうちの1つ以上を含む、請求項9に記載のナノ粒子。
- フッ化物及びカルシウムを含む、請求項9に記載のナノ粒子。
- 7.0以上のpHで負のゼータ電位を有する、請求項9〜11のいずれかに記載のナノ粒子。
- 水性分散液、ゲル又はペーストに組み込まれた、請求項9〜12のいずれかに記載のナノ粒子。
- う蝕病変の特定、歯の再石灰化、う蝕病変の処置又は予防、又は象牙質知覚過敏症の処置のための、請求項8〜13のいずれかに記載のナノ粒子の使用。
- 必要に応じて1つ以上の歯からプラークを除去した後、請求項8〜13のいずれかに記載のナノ粒子を1つ以上の歯に適用することを含む、歯を処置する方法。
- カルシウム及び/又はフッ化物で強化されたポリリン酸架橋デンプンナノ粒子。
- 詰め物をするか又は歯の再石灰化を支持するためのカルシウム及び/又はフッ化物で強化されたポリリン酸架橋デンプンナノ粒子の使用。
- カルシウム及び/又はフッ化物で強化されたポリリン酸架橋デンプンナノ粒子を歯に投与することを含む、歯に詰め物をするか又は歯の再石灰化を支持する方法。
- 第二相における水のエマルション中にフッ化物及びカルシウム塩の一方又は両方が存在する、リン酸架橋剤を用いた乳化プロセスによってバイオポリマーナノ粒子を製造する方法。
- ナノ粒子が1000nm以下のサイズを有する、請求項16〜19のいずれかに記載の発明。
- ナノ粒子が正味のゼータ電位が正であるカチオン性又は双性イオン性である、請求項16〜20のいずれかに記載の発明。
- ナノ粒子が、液体、ペースト又はゲル担体に分散され、歯に適用される、請求項16〜22のいずれかに記載の発明。
- ナノ粒子が、歯からペリクル及び/又はプラークを洗浄した後又は洗浄中に歯に適用される、請求項22に記載の発明。
- ナノ粒子が、ミネラル、例えばリン酸カルシウム、フルオロアパタイト又はカルシウムヒドロキシアパタイトを含む、請求項16〜23のいずれかに記載の発明。
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