JP2010508346A - 抗菌剤及び宿主反応調節剤の組み合わせを含有する口腔ケア組成物 - Google Patents
抗菌剤及び宿主反応調節剤の組み合わせを含有する口腔ケア組成物 Download PDFInfo
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Abstract
Description
2)動脈の脂肪線条、アテローム斑、斑形成の進行、アテローム斑上の繊維性被膜の菲薄化、アテローム斑の破裂、及びその結果生じる血液凝固症状の発生の軽減;
3)頸動脈(内膜)壁の厚み(例えば超音波技術によって評価した場合の厚み)の縮小;
4)血液循環及び体循環の口腔病原体及び/又はその毒性成分への曝露の軽減(具体的には、口腔細菌、リポ多糖体(LPS)の血中濃度、並びに/又は動脈プラーク、動脈構造、及び/若しくは遠隔臓器(例えば心臓、肝臓、膵臓、腎臓)内に見られる口腔病原体及び/若しくはその成分の発生率の低下をもたらす);
5)下部呼吸器の病原菌吸入への曝露、並びにそれに伴う肺炎の発生及び/又は慢性閉塞性肺疾患の悪化の軽減;
6)循環ヘマトクリット、ヘモグロビン、白血球数、及び/又は血小板数の変化の軽減;
7)炎症性メディエータ/サイトカイン、例えばTNF−α、IL−1、IL−6、及びCD−14の血中/血清及び唾液濃度の調節障害の発生率の低下;
8)C反応性タンパク質、フィブリノゲン、α1−抗トリプシン、及びハプトグロビンなどの急性期反応物質の血流/血清及び唾液レベルの調節障害の発生率の低下;
9)ホモシステイン、グリコシル化ヘモグロビン、8−イソ−PGF−2α、及び尿酸などの代謝調節障害の血中/血清及び唾液マーカーの調節障害の発生率の低下;
10)典型的には耐糖能障害試験によって評価するようなグルコース代謝の調節障害、空腹時に上昇する血糖濃度、及び空腹時インスリン濃度異常の、発生率の低下;並びに
11)血中若しくは血清コレステロール、トリグリセリド、LDL、HDL、VLDL、アポリポタンパク質B、及び/又はアポリポタンパク質A−1などの血中脂質の濃度の調節障害の軽減。
(a)マトリックスメタロプロテイナーゼ(MMP)、シクロオキシゲナーゼ(COX)、PGE2、インターロイキン1(IL−1)、IL−1β変換酵素(ICE)、トランスフォーミング増殖因子β1(TGF−β1)、誘導型一酸化窒素シンターゼ(iNOS)、ヒアルロニダーゼ、カテプシン、核因子κB(NF−κB)、及びIL−1受容体関連キナーゼ(IRAK)から選択される少なくとも1つの宿主炎症促進性因子に対して阻害活性を有する1つ以上の第1の活性剤と;
(b)バイオフィルム形成と、バイオフィルム定着と、ジンジパイン、METアーゼ及びシスタリシン(Cystalysin)から選択される細菌酵素とから選択される細菌性病原因子の少なくとも1つに対して阻害活性を有する1つ以上の第2の活性剤との組み合わせを含む。
2オレオレジン
本発明の組成物は、任意に、最適な効果を得るために追加の治療薬を含んでいてもよい。故に、例えば、本発明の組成物は、抗菌/抗歯垢剤、バイオフィルム阻害剤、抗生物質;鎮痛剤及び局所麻酔剤;象牙質減感剤;悪臭マスキング剤、及び他の宿主反応調節剤などの追加の薬剤を含んでいてもよい。
ヒスタミン−2(H−2又はH2)受容体拮抗化合物(H−2拮抗物質)が、本発明の口腔ケア組成物に使用されてもよい。本明細書で使用するとき、選択的H−2拮抗物質は、H−2受容体を遮断するが、ヒスタミン−1(H−1又はH1)受容体の遮断に関して有意な活性の無い化合物である。選択的H−2拮抗物質は、消化管や気管支などの様々な臓器の平滑筋の収縮を刺激するが、この作用は、典型的な抗ヒスタミン剤である低濃度のメピラミンで抑制することができる。これらメピラミン感受性のヒスタミン応答に関与する薬理学的受容体は、H−1受容体と定義されている(A.S.F.アッシュ(Ash, A.S.F.)及びH.O.シルド(H.O. Schild)、「ブリティッシュ・ジャーナル・オブ・ファーマコロジー・アンド・ケモセラピー(Brit. J. Pharmacol Chemother.)」27巻、1966年、427頁)。ヒスタミンはまた、胃による酸の分泌を刺激し(E.R.ロウ(Loew, E.R.)及びO.チッカーリング(O. Chickerin)、「プロシーディングス・フォー・ザ・エクスペアリメンタル・バイオロジー・アンド・メディシン(Proc. Soc. Exp. Biol. Med.)」48巻、1941年、65頁)、心拍数を上昇させ(U.トレンデレンバーグ(Trendelenburg, U.)、「ジャーナル・オブ・ファーマコロジー(J. Pharmacol)」130巻、1960年、450頁)、ラットの子宮収縮を阻害する(P.B.デュー(Dews, P.B.)及びJ.D.P.グラハム(J.D.P. Graham)、「ブリティッシュ・ジャーナル・オブ・ファーマコロジー・アンド・ケモセラピー(Brit. J. Pharmacol Chemother.)」1巻、1946年、278頁)が、これらの作用はメピルアミン及び関連薬物によっては拮抗できない。口腔ケア組成物又は物質に有用なH−2拮抗物質は、メピラミン非感受性の非H−1(H−2)ヒスタミン応答に関与する受容体を遮断するものであり、メピラミン感受性のヒスタミン応答に関与する受容体を遮断しないものである。
他の抗炎症剤も本発明の口腔組成物に存在してもよい。これらの薬剤には、リポキシゲナーゼ阻害剤、例えばノルジヒドログアイアレチン酸;シクロオキシゲナーゼ阻害物質、例えばフルルビプロフェン;及び非ステロイド性抗炎症剤、例えばアスピリン、ケトロラク、フルルビプロフェン、イブプロフェン、ナプロキセン、インドメタシン、ケトプロフェン、ピロキシカム、メクロフェナム酸、ロフェコキシブ、セレコキシブ、及びこれらの混合物が挙げられるが、これらに限定されない。存在する場合、他の抗炎症剤は一般に、本発明の組成物の約0.001重量%〜約5重量%を構成する。ケトロラクは、米国再発行特許第036,419号(1999年11月30日発行);米国特許第5,785,951号(1998年7月28日発行)及び同第5,464,609号(1995年11月7日発行)に記載されている。
他のマトリックスメタロプロテイナーゼ阻害物質も本発明の口腔組成物に存在してもよい。メタロプロテイナーゼ(MP)は、しばしば細胞間マトリックスに作用する酵素であり、したがって組織の破壊及び再形成に関与する。MPの例には、ヒト皮膚線維芽細胞コラゲナーゼ、ヒト皮膚線維芽細胞ゼラチナーゼ、ヒト喀痰コラゲナーゼ、アグリカナーゼ及びゼラチナーゼ、並びにヒトストロメリシンが挙げられる。コラゲナーゼ、ストロメリシン、アグリカナーゼ及び関連酵素は、歯周病などの多くの症候学的疾患の媒介に重要であると考えられている。MP阻害物質の潜在的な治療上の指標については、リウマチ様関節炎(D.E.ミューリン(Mullins, D. E.)ら(「バイオキミカ・エト・バイオフィジカ・アクタ(Biochim. Biophys. Acta.)」(1983年、695巻:117〜214頁)所収);変形性関節症(B.ヘンダーソン(Henderson, B.)ら(「ドラッグス・アンド・フューチャー(Drugs of the Future)」(1990年、15巻:495〜508頁)所収);腫瘍細胞の転移(前掲論文、M.J.ブロードハースト(Broadhurst, M. J.)ら(欧州特許出願第276,436号(1987年公開))、R.ライヒ(Reich, R.)ら(「キャンサー・リサーチ(Cancer Res.)」(48巻、3307〜3312頁、1988年)所収);及び組織の様々な潰瘍形成又は潰瘍状態の治療を包含する文献中に記載されている。例えば、アルカリ火傷の結果として、又は緑膿菌、アカントアメーバ、単純ヘルペス及びワクシニア・ウイルスによる感染の結果として、角膜に潰瘍状態が起こる可能性がある。望ましくないメタロプロテアーゼ活性を特徴とする状態の他の例とには、歯周病、表皮水疱症、発熱、炎症、及び強膜炎が挙げられる(デチッコ(DeCicco)ら、PCT国際公開特許第95/29892号(1995年11月9日公開))。
細胞の酸化還元状態の調整剤には、酸化防止剤(例えば、N−アセチルシステイン及び没食子酸)、酸化防止酵素誘発因子(例えば、アネトール−ジチオチオン、オルチプラッツ、ピロリジンジチオカルバメート(PDTC)及びインドール−3−カルビノール)、栄養素及びビタミン(例えば、補酵素Q10、ピロロキノリンキノン(PQQ)、ビタミンA、C、及びE、セレン及びこれらの組み合わせ)が挙げられる。
口腔に許容可能なキャリアは、局所的口腔投与に好適な1種以上の混和性のある固体若しくは液体賦形剤、又は希釈剤を含む。本明細書で使用するとき、「混和性のある」とは、組成物の成分が、実質的に組成物の安定性及び/又は効果を低下させるような方法で相互作用することなく混合し得ることを意味する。これらの物質は、当該技術分野において周知であり、組成物が調製されるのに望ましい物理的、審美的及び性能特性に基づいて当業者によって容易に選択される。これらのキャリアは、典型的には、口腔用組成物の約50重量%〜約99重量%、好ましくは約70重量%〜約98重量%、より好ましくは約90重量%〜約95重量%の濃度で含まれてもよい。
本発明の口腔用組成物は、任意に、生物学的に利用可能で有効なフッ化物イオンを提供することができる可溶性フッ化物源を包含する。可溶性フッ化物イオン源には、フッ化ナトリウム、フッ化第一スズ、フッ化インジウム、フッ化アミン及びモノフルオロリン酸ナトリウムが挙げられる。フッ化第一スズは好ましい可溶性フッ化物源である。この成分は、第一スズイオン源及びフッ化物源の両方として作用できる。米国特許第2,946,725号(ノリス(Norris)ら、1960年7月26日発行)及び同第3,678,154号(ウィダー(Widder)ら、1972年7月18日発行)は、このようなフッ化物源、並びにその他の物質を開示している。
本発明は、組成物中に過酸化物源を含んでいてもよい。白化に加えて、過酸化物はまた口腔に他の効果も提供する。過酸化水素及び他の過酸素化合物は、虫歯、歯垢、歯肉炎、歯周炎、口臭、慢性再発性アフター性潰瘍、義歯の炎症、歯列矯正装置の損傷、抜歯後及び歯根膜手術後、外傷性口腔病変、並びに粘膜感染、ヘルペス口内炎などに対する治療的及び/又は予防的処置に有効であると長い間認められてきた。口腔内の過酸化物含有剤は、組織及び唾液酵素との相互作用によって生じる何千もの小さな酸素の泡を生成する化学機械的作用を及ぼす。口内洗浄剤の激しい動き(swishing action)が、この特有の化学機械的作用を増強する。そのような作用は、その他の剤を感染した歯肉のクレバスに送達するために推奨されてきた。故に、過酸化物は、歯周病と関連することが知られている嫌気性細菌のコロニー形成及び増殖を防ぎ、本明細書で使用するのに好ましい抗菌剤の1つである。
本発明はまたアルカリ金属重炭酸塩を包含してもよい。重曹としても知られている重炭酸ナトリウムは、好ましいアルカリ金属重炭酸塩である。上記で示したように、重曹はある程度の抗菌及び抗炎症活性を有し、故に活性成分として使用されてもよい。アルカリ金属重炭酸塩はまた緩衝剤としても機能する。本組成物は、口腔用組成物の約0.5重量%〜約50重量%、好ましくは約0.5重量%〜約30重量%、より好ましくは約2重量%〜約20重量%、最も好ましくは約5重量%〜約18重量%のアルカリ金属重炭酸塩を含有してもよい。
本組成物は、任意に、キレート化活性を有する物質であり、歯石形成に関連する鉱物の沈着を低減するのに有効な抗結石剤を含んでいてもよい。このようなキレート剤は、細菌の細胞壁に見られるカルシウムを錯化でき、更にこのバイオマスをそのまま保持するのに役立つカルシウム架橋からカルシウムを除去することによって歯垢を分解できる。しかしながら、カルシウムに対する親和性が高すぎるキレート剤を用いることは、結果として歯の脱ミネラル化(demineralization)をもたらす可能性があり、これは本発明の目的及び意図に反するために、望ましくない。好適なキレート剤は、通常はカルシウム結合定数が約101〜105であり、洗浄を改善し、歯垢及び結石の形成を減少させる。キレート剤はまた、金属イオンと錯化することができ、故に組成物に存在する場合に第一スズを安定化するために使用することができる。
本発明の組成物の局所口腔キャリアにおいて有用な歯科用研磨剤には、多くの様々な物質が含まれる。選択される物質は、目的の組成物中で混和性があり、象牙質を過度に削らないものでなければならない。好適な研磨剤には、例えば、ゲル及び沈殿物を包含するシリカ、不溶性ポリメタリン酸ナトリウム、水和アルミナ、炭酸カルシウム、オルトリン酸二カルシウム二水和物、ピロリン酸カルシウム、リン酸三カルシウム、ポリメタリン酸カルシウム、及び尿素とホルムアルデヒドとの粒子状縮合生成物のような樹脂性研磨剤物質が挙げられる。
商業的に好適な口腔用組成物の調製に用いる水は、好ましくは、イオン含量が少なく、有機不純物を含まないものであるべきである。口腔用組成物において、水は、本明細書の組成物の0重量%〜約95重量%、好ましくは約5重量%〜約50重量%を占めてもよい。水の量には、添加される遊離水に加えてソルビトール、シリカ、界面活性剤溶液、及び/又は着色剤溶液など他の物質と共に導入される水が包含される。
本組成物は緩衝剤を含有してもよい。本明細書で使用するとき、緩衝剤とは、組成物のpHをpH約3.0〜pH約10の範囲に調整するために用いることができる薬剤を指す。
練り歯磨き又はゲルを調製する際には、組成物の望ましい稠度を提供し、使用に際した望ましい活性剤放出特性を提供し、貯蔵安定性を提供し、組成物などの安定性を提供するために、いくつかの増粘物質を加えることが必要である。好ましい増粘剤は、カルボキシビニルポリマー、カラギーナン、ヒドロキシエチルセルロース、ラポナイト、並びにカルボキシメチルセルロースナトリウム及びカルボキシメチルヒドロキシエチルセルロースナトリウムのようなセルロースエーテルの水溶性塩である。カラヤゴム、キサンタンガム、アラビアゴム、及びトラガカントゴムのような天然ゴムを使用することもできる。更に質感を改善するために、コロイド状ケイ酸アルミニウムマグネシウム又は超微粒子状シリカを増粘剤の一部として使用することができる。
本発明の組成物の局所的な口腔キャリアの別の任意成分は、保湿剤である。保湿剤は、練り歯磨き組成物が空気への曝露時に硬化するのを防ぎ、組成物に口への潤い感を付与し、特定の保湿剤では、練り歯磨き組成物に望ましい甘い香味を付与するのに役立つ。保湿剤は、純保湿剤を基準にすると、一般に本明細書の組成物の約0重量%〜約70重量%、好ましくは約5重量%〜約25重量%を構成する。本発明の組成物における使用に好適な保湿剤には、グリセリン、ソルビトール、キシリトール、ブチレングリコール、ポリエチレングリコール及びプロピレングリコールのような食用多価アルコール、特にソルビトール及びグリセリンが挙げられる。
着香剤もまた、組成物に添加してもよい。好適な着香剤には、ウインターグリーン油、ペパーミント油、スペアミント油、クローブ芽油、メンソール、アネトール、サリチル酸メチル、オイカリプトール、カッシア、1−メンチルアセテート、セージ、オイゲノール、パセリ油、オキサノン(oxanone)、α−イリソン、マジョラム、レモン、オレンジ、プロペニルグエトール、シナモン、バニリン、チモール、リナロール、CGAとして知られるシンナムアルデヒドグリセロールアセタール、及びこれらの混合物が挙げられる。着香剤は、一般に組成物中で、組成物の約0.001重量%〜約5重量%の濃度で用いられる。
本組成物はまた、一般的に起泡剤とも呼ばれる界面活性剤を含んでもよい。好適な界面活性剤は、広いpH範囲にわたって適度に安定かつ発泡性であるものである。界面活性剤は、アニオン性、非イオン性、両性、双性イオン性、カチオン性、又はこれらの混合物であってよい。
本組成物に使用してよい他の乳化剤としては、B.F.グッドリッチ(B.F.Goodrich)から入手可能なペミュレン(Pemulen)(登録商標)シリーズのようなポリマー性乳化剤が挙げられ、これは、主に、疎水性物質用の乳化剤として有用な高分子量のポリアクリル酸ポリマーである。
1つ以上の抗菌剤及び抗炎症剤の組み合わせを含む安全で有効な量の本発明の組成物は、患者の口腔の上述した疾患及び状態の治療又は予防のために、いくつかの従来の方法で、口腔の粘膜組織、口腔の歯肉組織、及び/又は歯の表面に局所適用してもよい。患者は、歯垢、歯肉炎及び歯周炎を包含する口腔状態の治療又は予防の必要なヒト又は動物であってもよい。「動物」とは、特に家庭用ペット若しくは他の家畜、又は捕獲されている動物を包含することを意味する。
調査は、イヌ科動物モデルにてリボフラビン+塩化セチルピリジニウム(CPC)リンスの生体内効果を評価するために行われた。調査の初めに、ビーグル犬披検体は予防処置を受けた。約1週間後、ビーグル犬は基準歯肉炎指数(GI)及び歯垢指数について類別された。歯肉炎指数は、0〜3の等級である(0=炎症なし;1=炎症が存在し、歯肉は赤色である;2=プロービング時に出血;3=自然に出血)。歯垢指数は各歯の歯垢被覆%である。SASランダム化プログラムを用いて基準炎症指数(II)スコアのバランスをとった治療群に犬をランダムに振り分けた。治療は振り分け後の次の日に開始した。動物は、歯/歯肉をスプレーミストボトルを用いて、30日間平日は1日2回、週末には1日1回局所治療された(30mL/治療)。30日の終わりに、動物は最終的な臨床類別を行われた。
Claims (8)
- 局所口腔用組成物であって、口腔に許容可能なキャリア中に、
(a)マトリックスメタロプロテイナーゼ(MMP)、シクロオキシゲナーゼ(COX)、PGE2、インターロイキン1(IL−1)、IL−1β変換酵素(ICE)、トランスフォーミング増殖因子β1(TGF−β1)、誘導型一酸化窒素シンターゼ(iNOS)、ヒアルロニダーゼ、カテプシン、核因子κB(NF−κB)、及びIL−1受容体関連キナーゼ(IRAK)から選択される少なくとも1つの宿主炎症促進性因子に対して阻害活性を有する1つ以上の第1の活性剤と、
(b)バイオフィルム形成と、バイオフィルム定着と、ジンジパイン、METアーゼ及びシスタリシンから選択される酵素とから選択される細菌性病原因子の少なくとも1つに対して阻害活性を有する1つ以上の第2の活性剤と、
の組み合わせを含み、
前記組み合わせが、細菌媒介口腔状態を治療及び予防するための増強された効果を提供するのに有効な量で存在する、局所口腔用組成物。 - 抗炎症活性を有する前記第1の活性剤が、リボフラビン、リボフラビンホスフェート、クルクミン、オイゲノール、ジヒドロオイゲノール、チモール、カルバクロール、シンナムアルデヒド、アントシアニジン、バイカレイン、タンニン酸、ケルセチン、葉酸、ヘキサミジン、エピガロカテキン、エピガロカテキンガレート(EGCG)、ベルベリン、及びこれらの混合物から選択される、請求項1に記載の局所口腔用組成物。
- 抗菌活性を有する前記第2の活性剤が、塩化セチルピリジニウム(CPC)、第一スズイオン剤、亜鉛イオン剤、銅イオン剤、鉄イオン剤、アスコルビルステアレート、オレオイルサルコシン、アルキルサルフェート、ジオクチルスルホスクシネート、及びこれらの混合物から選択される、請求項1に記載の局所口腔用組成物。
- アスピリン、ケトロラク、フルルビプロフェン、イブプロフェン、ナプロキセン、インドメタシン、アスピリン、ケトプロフェン、ピロキシカム、メクロフェナム酸、ノルジヒドログアイアレチン酸、及びこれらの混合物から選択される抗炎症剤を更に含む、請求項2に記載の局所口腔用組成物。
- 前記組成物が、口内洗浄剤、練り歯磨き、歯用ゲル、歯磨き粉、非研磨剤ゲル、ムース、フォーム、チューインガム、口内スプレー、トローチ剤、経口錠剤、歯科用器具、及びペットケア製品から選択される形態である、請求項1に記載の局所口腔用組成物。
- 補酵素Q10、PQQ、ビタミンC、ビタミンE、ビタミンA、アネトール−ジチオチオン、及びこれらの混合物からなる群から選択される細胞酸化還元状態調整剤である宿主反応調節剤を更に含む、請求項1に記載の局所口腔用組成物。
- 前記組成物が、抗菌/抗歯垢剤、バイオフィルム阻害剤、抗生物質、鎮痛剤、局所用麻酔剤、象牙質減感剤、悪臭マスキング剤、及びこれらの混合物から選択される追加の治療活性物質を含む、請求項1に記載の局所口腔用組成物。
- マトリックスメタロプロテイナーゼ(MMP)、シクロオキシゲナーゼ(COX)、PGE2、インターロイキン1(IL−1)、IL−1β変換酵素(ICE)、トランスフォーミング増殖因子β1(TGF−β1)、誘導型一酸化窒素シンターゼ(iNOS)、ヒアルロニダーゼ、カテプシン、核因子κB(NF−κB)、及びIL−1受容体関連キナーゼ(IRAK)から選択される1つ以上の宿主炎症促進因子に対して阻害活性を有する薬剤の、口腔細菌感染の治療及び予防、並びに前記口腔細菌感染及び全身系疾患を有する又は発生する危険性のある患者にて前記口腔細菌感染によって媒介される全身系疾患を阻害するための局所口腔用組成物の製造における使用であって、前記組成物が、バイオフィルム形成と、バイオフィルム定着と、ジンジパイン、METアーゼ及びシスタリシンから選択される酵素とから選択される1つ以上の細菌性病原因子に対して有効な活性剤と、口腔に許容可能なキャリアとを含む組成物を前記患者の口腔に局所投与することを更に含む、使用。
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JP2019142863A (ja) * | 2019-02-28 | 2019-08-29 | ヒルズ・ペット・ニュートリシャン・インコーポレーテッド | 口内炎症を減少または治療するための組成物および方法 |
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Also Published As
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WO2008057136A1 (en) | 2008-05-15 |
JP5280366B2 (ja) | 2013-09-04 |
US8283135B2 (en) | 2012-10-09 |
CN104958187A (zh) | 2015-10-07 |
ES2395854T3 (es) | 2013-02-15 |
EP2079468B1 (en) | 2012-09-19 |
MY157928A (en) | 2016-08-15 |
CA2669019A1 (en) | 2008-05-15 |
RU2009114589A (ru) | 2010-12-20 |
CA2669019C (en) | 2014-01-14 |
EP2079468A1 (en) | 2009-07-22 |
RU2448711C2 (ru) | 2012-04-27 |
US20070053849A1 (en) | 2007-03-08 |
EP2415473A1 (en) | 2012-02-08 |
CN101534823A (zh) | 2009-09-16 |
BRPI0718699A2 (pt) | 2013-01-15 |
AU2007318251B2 (en) | 2013-05-02 |
AU2007318251A1 (en) | 2008-05-15 |
EP2415473B1 (en) | 2014-09-17 |
MX2009004973A (es) | 2009-05-19 |
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