JP7080545B2 - 抗菌剤の迅速な放出のための医療用接着剤 - Google Patents
抗菌剤の迅速な放出のための医療用接着剤 Download PDFInfo
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- A61F2013/0091—Plasters containing means with disinfecting or anaesthetics means, e.g. anti-mycrobic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
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- C09J2301/312—Additional features of adhesives in the form of films or foils characterized by the chemical, physicochemical or physical properties of the adhesive or the carrier parameters being the characterizing feature
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Description
本出願は、2018年6月13日出願の米国仮特許出願第62/684,459号の優先権を主張するものであり、本出願はその全体が参照により本明細書に組み込まれる。
本開示は、概して、医療用包帯およびドレープからの抗菌剤の迅速な放出に特に有用な、抗菌活性の迅速な発現をもたらす接着剤に関するものである。
接着剤組成物
接着剤組成物は、1または複数の相分離された親水性材料を含み得る。相分離された親水性材料は接着剤に溶解せず、代わりに接着剤から相分離されている。相分離された親水性材料は、水性環境においてより小さなフラグメントへの分組成物の解または崩壊を促進し、それによって、利用可能な表面積を増大させ、組成物中に含有される1または複数の親水性の活性剤または活性物質のより迅速な放出を促進するために組成物に添加される物質であり得る。さらに、相分離された親水性材料は、水または他の溶媒または液体がマトリックス内に移動して、1または複数の活性剤をより効率的に抽出することを可能にし得る。多くの実施形態では、相分離された親水性材料は、固体、プラズマ、液体、ゲル、または他の何らかの形態であり得る。特定の態様において、開示された接着剤組成物の相分離された親水性材料は、医療グレードまたは医薬品グレードの材料である。特定の態様において、相分離された親水性材料は、クロスポビドンである。他の態様では、相分離された親水性材料は微結晶セルロースである。特定の態様において、相分離された親水性材料は粘土である。特定の態様において、相分離された親水性材料は二酸化ケイ素である。他の実施形態では、相分離された親水性材料は、二酸化ケイ素、酸化亜鉛、二酸化チタン、炭酸カルシウム、デンプン、結晶セルロース、微結晶セルロース、クロスポビドン、粘土、またはそれらの組み合わせである。
本明細書で使用される場合、「生理活性」という用語は、化合物に曝されていない生体系または生体対象と比較して、生体系または生体対象に対して生理学的効果を有する化合物を指す。本開示の生理活性化合物は、抗菌剤、抗真菌剤、鎮痛剤、組織治癒剤、局所麻酔剤、出血防止剤、酵素、または血管収縮剤であり得る。生理活性化合物は、例えば、抗炎症剤、鎮痛剤、麻酔薬、他の薬学的に許容される化合物、またはそれらの組み合わせなどの薬学的に活性な成分であり得る。生理活性化合物は、薬学的に有効な量で接着剤組成物に含まれ得る。
特定の態様において、接着剤組成物が水と接触してから90分以内に、接着剤組成物は、少なくとも約50μg/cm2、例えば、少なくとも約75μg/cm2、少なくとも約80μg/cm2、少なくとも約96μg/cm2、少なくとも約100μg/cm2、少なくとも約112μg/cm2、少なくとも約128μg/cm2、少なくとも約144μg/cm2、少なくとも約160μg/cm2、少なくとも約176μg/cm2、少なくとも約192μg/cm2、少なくとも約208μg/cm2、または少なくとも約240μg/cm2の水中への生理活性化合物の累積放出速度を有する。接触から90分以内の生理活性化合物の水中への放出速度は、例えば、約約50μg/cm2~約176μg/cm2、約96μg/cm2~約192μg/cm2、約112μg/cm2~約208μg/cm2、約128μg/cm2~約224μg/cm2、または約144μg/cm2~約240μg/cm2の範囲であり得る。
開示された接着剤組成物を使用する接着剤製品も提供される。接着剤製品は、基材層と、基材層の表面の少なくとも一部に配置された接着剤層とを含み、接着剤層は、開示された接着剤組成物を含む。特定の態様において、接着剤製品は、生体皮膚に適合可能な局所適用のために構成される。いくつかの実施形態では、生体皮膚表面は、対象の創傷または手術部位に近接している。本明細書で使用される場合、「対象」という用語は、限定されないが、霊長類、ウシ、ヒツジ、ヤギ、ウマ、イヌ、ネコ、ウサギ、ラット、マウスなどを含む哺乳動物などの動物を指す。特定の実施形態では、対象はヒトである。
接着剤層は、基材層の少なくとも一部に配置され、「配置される(配置された)」という用語は、接着剤層と基材層が互いに直接接触していることを意味するものではない。特定の態様では、1または複数の介在層が、接着剤製品内の接着剤層と基材層との間に配置される。特定の態様では、接着剤層の少なくとも一部は、基材層の少なくとも一部に直接接触する。
基材層の材料および構成は、任意選択で水蒸気を透過することができる薄くて可塑性の層を提供するように選択することができる。いくつかの実施形態では、基材層は、防水性、可撓性、非接着性のフィルムを含む。特定の態様では、基材層は、ポリエチレンフィルム、ポリウレタンフィルム、ポリ塩化ビニルフィルム、ポリエチレンフォーム、ポリウレタンフォーム、ポリ塩化ビニルフォーム、ポリウレタン不織布、エラストマーポリエステル不織布、編布、織布、またはそれらの組み合わせを含む。
いくつかの実施形態では、接着剤製品は、剥離ライナーをさらに含む。剥離ライナーの片面は、接着剤層に直接隣接することができ、または接着剤層と剥離ライナーとの間に1または複数の介在層が存在してもよい。場合によっては、接着剤層の片面が剥離ライナーに直接隣接し、接着剤層の反対側の面が基材層に直接隣接している。
開示された接着剤組成物を使用して対象に生理活性化合物を放出するための方法も提供される。この方法は、開示された接着剤製品を提供すること、および接着剤製品の接着剤層を対象に接触させることを含む。特定の態様において、接着剤層は、対象の生体皮膚表面と接触され、それにより、接着剤製品の生理活性化合物を対象に送達する。いくつかの実施形態では、生体皮膚表面は、対象の創傷または手術部位にあるか、またはそれらに近接している。
開示された接着剤組成物を製造するための方法も提供される。この方法は、1)本明細書に記載のいずれかのタイプおよび量の少なくとも1つの接着剤、2)相分離された親水性材料、および3)生理活性化合物、を提供することを含む。少なくとも1つの接着剤は、アルコール官能化アクリル系接着剤、アルコール官能化シリコーン接着剤、カルボキシル官能化アクリル系接着剤、およびカルボキシル官能化シリコーン接着剤のうちの少なくとも1つの接着剤を含み得る。相分離された親水性材料は、上記のタイプおよび量のいずれかであり得る。少なくとも1つの生理活性化合物は、上記のタイプおよび量のいずれかであり得る。この方法には、1)接着剤、相分離された親水性材料、および生理活性化合物を提供すること、ならびに2)少なくとも1つの接着剤、相分離された親水性材料、および生理活性化合物を組み合わせて、接着剤組成物を生成すること、がさらに含まれる。多くの実施形態では、少なくとも1つの接着剤は、アクリル系接着剤、アルコール官能化アクリル系接着剤、カルボキシル官能化アクリル系接着剤、シリコーン接着剤、アルコール官能化シリコーン接着剤、およびカルボキシル官能化シリコーン接着剤を含み得る。いくつかの実施形態では、この組み合わせは、均一な混合物が得られるまで、アルコール、トルエン、ヘプタンなどの溶媒中で成分をブレンドすることを含む。ブレンド時間は、例えば、約2時間であり得る。当技術分野では様々なブレンド方法が公知であり、均一なブレンドを生成する任意の方法が、接着剤組成物の製造に使用するのに適切であり得る。
以下の実施形態が意図される。機能および実施形態のすべての組み合わせが意図される。
細胞毒性試験方法:
細胞毒性試験のために、剥離ライナーを取り除き、調製物から除外した。120cm’’:20mLのUSP比に基づいて、試験品の60cmの部分を、5%の血清および2%の抗生物質(IX MEM)を添加した10mLの単一強度最小必須培地で覆った。単一の調製物を37℃で24時間、撹拌しながら抽出した。IX MEM抽出法を、極性成分と非極性成分の両方の抽出を最適化するために、血清の存在下で実施した。24時間後の試験抽出物については、比較例Cが0%の溶解を示し、細胞毒性効果(CTE)スコアは非毒性(N)であった。
Claims (26)
- 接着剤組成物であって:
アルコール官能基を有するアクリル系接着剤およびアルコール官能基を有するシリコーン接着剤のうちの少なくとも1つの接着剤を含む少なくとも1つの接着剤と;
二酸化ケイ素と;
クロルヘキシジンジグルコネートと;
を含む接着剤組成物。 - 少なくとも1つの接着剤は感圧接着剤である、請求項1に記載の接着剤組成物。
- 少なくとも1つの接着剤はハイブリッド接着剤である、請求項1または2に記載の接着剤組成物。
- 前記接着剤組成物中の少なくとも1つの接着剤の濃度は、60重量%~95重量%の範囲である、請求項1~3のいずれか一項に記載の接着剤組成物。
- 前記接着剤組成物中の前記二酸化ケイ素の濃度は、2重量%~40重量%の範囲である、請求項1~4のいずれか一項に記載の接着剤組成物。
- 前記接着剤組成物中の前記クロルヘキシジンジグルコネートの濃度は、1重量%~10重量%の範囲である、請求項1~5のいずれか一項に記載の接着剤組成物。
- 前記接着剤組成物中の前記二酸化ケイ素の濃度は、7重量%~15重量%の範囲であり、前記接着剤組成物中の前記接着剤の濃度は、80重量%~90重量%の範囲である、請求項1~6のいずれか一項に記載の接着剤組成物。
- 緑膿菌(Pseudomonas aeruginosa)集団において、前記接着剤組成物が前記集団と接触してから90分以内に少なくとも4の対数減少をもたらす抗菌活性を有する、請求項1~7のいずれか一項に記載の接着剤組成物。
- 大腸菌(Escherichia coli)集団において、前記接着剤組成物が前記集団と接触してから90分以内に少なくとも4の対数減少をもたらす抗菌活性を有する、請求項1~8のいずれか一項に記載の接着剤組成物。
- 黄色ブドウ球菌(Staphylococcus aureus)集団において、前記接着剤組成物が前記集団と接触してから90分以内に少なくとも4の対数減少をもたらす抗菌活性を有する、請求項1~9のいずれか一項に記載の接着剤組成物。
- カンジダ・アルビカンス(Candida albicans)集団において、前記接着剤組成物が前記集団と接触してから90分以内に少なくとも4の対数減少をもたらす抗菌活性を有する、請求項1~10のいずれか一項に記載の接着剤組成物。
- アスペルギルス・ブラジリエンシス(Aspergillus brasiliensis)集団において、前記接着剤組成物が前記集団と接触してから90分以内に少なくとも0.1の対数減少をもたらす抗菌活性を有する、請求項1~11のいずれか一項に記載の接着剤組成物。
- 2以下の細胞毒性グレードを有する、請求項1~12のいずれか一項に記載の接着剤組成物。
- 皮膚一次刺激性指数(Primary Irritation Index)が2以下である、請求項1~13のいずれか一項に記載の接着剤組成物。
- 接着剤製品であって:
基材層と;
前記基材層の表面の少なくとも一部に配置された接着剤層であって、前記接着剤層が、請求項1~14のいずれか一項に記載の接着剤組成物を含む、接着剤層と;
を含む接着剤製品。 - 前記基材層は、ポリエチレンフィルム、ポリウレタンフィルム、ポリ塩化ビニルフィルム、ポリエチレンフォーム、ポリウレタンフォーム、ポリ塩化ビニルフォーム、ポリウレタン不織布、エラストマーポリエステル不織布、編布、織布、またはそれらの組み合わせを含む、請求項15に記載の接着剤製品。
- 前記基材層は、防水性で、可撓性で、且つ非接着性のフィルムを含む、請求項15または16に記載の接着剤製品。
- 前記接着剤製品は、生体皮膚に適合可能な局所適用のために構成される、請求項15~17のいずれか一項に記載の接着剤製品。
- 前記接着剤製品は、感圧絆創膏、創傷被覆材、医療用包帯、外科用包帯、外科用ドレープ、外科用テープ、切開ドレープ、または医療用テープである、請求項15~18のいずれか一項に記載の接着剤製品。
- 前記接着剤層の少なくとも一部は前記基材層の少なくとも一部に直接接触している、請求項15~19のいずれか一項に記載の接着剤製品。
- 剥離ライナーをさらに含む、
請求項15~20のいずれか一項に記載の接着剤製品。 - 生理活性化合物を対象に放出するための方法であって:
請求項15~21のいずれか一項に記載の接着剤製品を提供することと;
前記接着剤製品の接着剤層を対象の生体皮膚表面に接触させ、それによって、前記接着剤製品のクロルヘキシジンジグルコネートを対象に送達することと;
を含む方法。 - 前記生体皮膚表面は、対象の創傷または手術部位に近接している、請求項22に記載の方法。
- 前記対象はヒトである、請求項22または23に記載の方法。
- 接着剤組成物を製造するための方法であって:
1)アルコール官能基を有するアクリル系接着剤およびアルコール官能基を有するシリコーン接着剤のうちの少なくとも1つの接着剤と;2)二酸化ケイ素と;3)クロルヘキシジンジグルコネートと、を提供することと;
前記接着剤、前記二酸化ケイ素、および前記クロルヘキシジンジグルコネートを組み合わせて、接着剤組成物を製造することと;
を含む製造方法。 - 前記接着剤組成物は:
60重量%~95重量%の、アルコール官能基を有するアクリル系接着剤およびアルコール官能基を有するシリコーン接着剤のうちの少なくとも1つの接着剤と;
2重量%~40重量%の二酸化ケイ素と;
1重量%~10重量%のクロルヘキシジンジグルコネートと;
を含む請求項25に記載の製造方法。
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PCT/US2019/036771 WO2019241391A1 (en) | 2018-06-13 | 2019-06-12 | Medical adhesives for quick release of antimicrobials |
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EP4079340A1 (en) * | 2021-04-20 | 2022-10-26 | Mölnlycke Health Care AB | A dressing comprising an antimicrobial coating |
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JP2002272831A (ja) | 2001-03-14 | 2002-09-24 | Fumio Kamiyama | 創傷被覆用粘着性シート |
US20140031734A1 (en) | 2012-01-04 | 2014-01-30 | Momentive Performance Materials Inc. | Silicone adhesive compositions |
US20150367021A1 (en) | 2013-02-07 | 2015-12-24 | Avery Dennison Corporation | Antimicrobial Adhesives Having Improved Properties |
JP2016511310A (ja) | 2013-02-07 | 2016-04-14 | エーブリー デニソン コーポレイション | 改善された性質を有する抗菌性接着剤 |
JP2016539670A (ja) | 2013-10-04 | 2016-12-22 | ロチャル インダストリーズ,エルエルシー | 非自己接着性被覆材 |
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CN112543653A (zh) | 2021-03-23 |
CN115737885A (zh) | 2023-03-07 |
JP2021526578A (ja) | 2021-10-07 |
KR20210018441A (ko) | 2021-02-17 |
US20210259890A1 (en) | 2021-08-26 |
KR102613671B1 (ko) | 2023-12-15 |
CN112543653B (zh) | 2022-12-27 |
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