JP6817472B2 - 医薬組成物および塗膜 - Google Patents
医薬組成物および塗膜 Download PDFInfo
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- JP6817472B2 JP6817472B2 JP2020000231A JP2020000231A JP6817472B2 JP 6817472 B2 JP6817472 B2 JP 6817472B2 JP 2020000231 A JP2020000231 A JP 2020000231A JP 2020000231 A JP2020000231 A JP 2020000231A JP 6817472 B2 JP6817472 B2 JP 6817472B2
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- NQPDZGIKBAWPEJ-UHFFFAOYSA-N valeric acid Chemical compound CCCCC(O)=O NQPDZGIKBAWPEJ-UHFFFAOYSA-N 0.000 description 1
- WKOLLVMJNQIZCI-UHFFFAOYSA-N vanillic acid Chemical compound COC1=CC(C(O)=O)=CC=C1O WKOLLVMJNQIZCI-UHFFFAOYSA-N 0.000 description 1
- TUUBOHWZSQXCSW-UHFFFAOYSA-N vanillic acid Natural products COC1=CC(O)=CC(C(O)=O)=C1 TUUBOHWZSQXCSW-UHFFFAOYSA-N 0.000 description 1
- 235000012141 vanillin Nutrition 0.000 description 1
- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
- FGQOOHJZONJGDT-UHFFFAOYSA-N vanillin Natural products COC1=CC(O)=CC(C=O)=C1 FGQOOHJZONJGDT-UHFFFAOYSA-N 0.000 description 1
- 229940117960 vanillin Drugs 0.000 description 1
- 230000002227 vasoactive effect Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 235000019163 vitamin B12 Nutrition 0.000 description 1
- 239000011715 vitamin B12 Substances 0.000 description 1
- 150000003718 vitamin K5 derivatives Chemical class 0.000 description 1
- 229940041603 vitamin k 3 Drugs 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 239000002759 woven fabric Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052726 zirconium Inorganic materials 0.000 description 1
- CGTADGCBEXYWNE-JUKNQOCSSA-N zotarolimus Chemical compound N1([C@H]2CC[C@@H](C[C@@H](C)[C@H]3OC(=O)[C@@H]4CCCCN4C(=O)C(=O)[C@@]4(O)[C@H](C)CC[C@H](O4)C[C@@H](/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C3)OC)C[C@H]2OC)C=NN=N1 CGTADGCBEXYWNE-JUKNQOCSSA-N 0.000 description 1
- 229950009819 zotarolimus Drugs 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
Images
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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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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Description
(医療機器および材料)
一実施形態では、医療機器の表面はナイロンでできている。
(組成物および塗膜層)
本発明の非限定的な実施形態を図6に示す。
(成分i))
(成分ii))
一実施形態では、成分ii)は式(I)の化合物またはその医薬的に許容される塩である:
R2とR3は−N(R1)C(=O)N(R4)−部分と共に、−OH基で置換されていてもよい5員〜7員の環を形成する)。
一実施形態では、成分ii)は式(I)の化合物またはその医薬的に許容される塩である。
R2とR3は−N(R1)C(=O)N(R4)−部分と共に5員〜7員の環を形成する)。
たとえば、R2とR3は連結され(CH2)2または(CH2)3を表してもよい。
(成分iii))
コハク酸は以下の構造:
カフェインは以下の構造:
一実施形態では、本発明の組成物および塗膜はシクロデキストリンを含まない。
たとえば、一実施形態では本発明の塗膜層(すなわち、成分i)、ii)、およびiii)を含む)は界面活性剤を含まないが、医療機器は、界面活性剤を含む異なる別個の塗膜層を本発明の塗膜層の下または上に有する可能性がある。同様に、一実施形態では本発明の塗膜はタンパク質を含まないが、医療機器は、タンパク質を含むさらなる塗膜層を本発明の塗膜層の下または上に有してもよい。
(治療方法)
(本発明の組成物および塗膜の調製方法)
a)成分i)、ii)、およびiii)を1種以上の溶媒に溶解して1種以上の溶液を調製する工程と、
b)工程a)の前記1種以上の溶液のそれぞれを前記機器の表面に塗布する工程と、
c)前記溶媒を蒸発させる工程とを含み、
成分i)はパクリタキセルである治療薬であり、成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、方法が提供される。
a)成分i)、ii)、およびiii)を溶媒に溶解して溶液を調製する工程と、
b)工程a)の前記溶液を前記機器の表面に塗布する工程と、
c)前記溶媒を蒸発させる工程とを含み、
成分i)はパクリタキセルである治療薬であり、成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、方法が提供される。
a)成分i)、ii)、およびiii)を1種以上の溶媒に溶解して1種以上の溶液を調製する工程と、
b)工程a)の前記1種以上の溶液のそれぞれを前記機器の表面に塗布する工程と、
c)前記溶媒を蒸発させる工程とを含み、
成分i)はパクリタキセルである治療薬であり、成分ii)は尿素またはその誘導体であり、成分iii)はコハク酸、グルタル酸、またはカフェインである、方法が提供される。
a)成分i)、ii)、およびiii)を溶媒に溶解して溶液を調製する工程と、
b)工程a)の前記溶液を前記機器の表面に塗布する工程と、
c)前記溶媒を蒸発させる工程とを含み、
成分i)はパクリタキセルである治療薬であり、成分ii)は尿素またはその誘導体であり、成分iii)はコハク酸、グルタル酸、またはカフェインである、方法が提供される。
(本発明のさらなる実施形態)
・好適なパクリタキセル放出性および組織移行性(たとえば試験方法A−Iまたは試験方法A−IIで測定);
・医療機器への優れた接着性(たとえば試験方法Qで測定);
・塗膜に処方された場合のパクリタキセルの滅菌に対する優れた安定性(たとえば試験方法E(エチレンオキシド滅菌)、試験方法F(電子線滅菌)、試験方法G(過酸化水素蒸気滅菌)または試験方法H(プラズマ過酸化水素滅菌)で測定);
・ヘパリンなどの追加の治療薬との適合性;ならびに
・医療機器の製造に従来使用されている様々な基材材料との適合性。
本明細書に示すパーセント値は、特に示さない限りは重量を基準とする。
(定義および略語)
DEB:薬物溶出性バルーン
DES:薬物溶出性ステント
DSC:示差走査熱量測定
ePTFE:延伸ポリテトラフルオロエチレン
h:時間
HPLC:高速液体クロマトグラフィー
ND:確認されず
N/T:未試験
PEG:ポリエチレングリコール
PBS:リン酸緩衝生理食塩水
Ptx:パクリタキセル
SEM:走査型電子顕微鏡
SSG:ステントまたはステントグラフト
UPLC:超高速液体クロマトグラフィー
(化学薬品)
(溶媒)
(材料)
(評価方法)
各方法で評価されるパラメータを括弧に示す。
(超高速液体クロマトグラフ(UPLC)分析)
(パクリタキセル濃度)
(パクリタキセルの分解産物(実施例13))
(深さ分析を含むX線光電子分光法(XPS)(塗膜厚))
(試験方法)
(試験方法A:パクリタキセルの組織移行および取り込みの生体外試験)
(試験方法A−I:バルーン)
(試験方法A−II:ステントおよびステントグラフト)
(試験方法B:操作後のパクリタキセル含有量の決定)
(試験方法B−I:重量)
(試験方法B−II:抽出)
(試験方法C:パクリタキセル溶出特性の生体外評価)
(試験方法D:パクリタキセル移行の生体内評価―バルーン)
(試験方法E:エチレンオキシドに対する安定性)
(試験方法F:電子線滅菌に対する安定性)
(試験方法G:過酸化水素蒸気滅菌に対する安定性)
(試験方法H:プラズマ過酸化水素滅菌に対する安定性)
(試験方法I−I、I−II、J−I、J−II:バルーン、ステント、およびステントグラフトの操作)
(試験方法I−I:バルーンの圧縮と拘束)
(試験方法I−II:バルーンの展開)
(試験方法J−I:ステントおよびステントグラフトの圧縮と拘束)
(試験方法J−II:ステントまたはステントグラフトの配備)
(試験方法K:血液接触評価(血小板減少))
(試験方法L:HCII結合活性によるヘパリン生物活性の評価(定量的ヘパリン機能))
(試験方法M:ATIII結合活性によるヘパリン生物活性の評価(定量的ヘパリン機能))
(試験方法N:ヘパリン密度の評価(定量的ヘパリン結合))
(試験方法O:染色法)
(試験方法P:表面生体適合性)
(試験方法Q:振盪試験(塗膜の接着性))
(実施例1:本発明の塗膜の調製方法―ステントグラフト)
(実施例1b:パクリタキセル(添加量100μg)、コハク酸、およびエチル尿素を含む本発明の塗膜―ステントグラフト)
(実施例1c:パクリタキセル(添加量100μg)、グルタル酸、およびエチル尿素を含む本発明の塗膜―ステントグラフト)
(実施例1d:パクリタキセル(添加量100μg)および尿素を含む対照塗膜―ステントグラフト)
(実施例2:塗布済みステントグラフトのパクリタキセル含有量の分析)
(実施例3:塗布済みステントグラフトのブタの組織(生体外)へのパクリタキセル取り込みの分析)
(実施例4:試験方法Aの後の塗布済みステントグラフトのパクリタキセル含有量の分析)
(実施例5:本発明の塗膜と共に使用するためのePTFE被覆バルーンの構成)
(実施例6:本発明の塗膜の調製方法―バルーン)
ナイロンバルーンの塗布済み領域の最終パクリタキセル添加量は約4.0μg/mm2であった。
ePTFEバルーンの塗布済み領域の最終パクリタキセル添加量は約3.2μg/mm2であった。
(実施例6b:パクリタキセル(添加量2.0mgまたは2.5mg)、コハク酸、およびエチル尿素を含む本発明の塗膜―バルーン)
(実施例6c:パクリタキセル(添加量2.0mgまたは2.5mg)、グルタル酸、およびエチル尿素を含む本発明の塗膜―バルーン
(実施例6d:パクリタキセル(添加量2.5mg)および尿素を含む対照塗膜―バルーン)
パクリタキセル80mgおよび尿素20mgをガラス製バイアルに加えた。アセトン(4mL)と水(1mL)の混合物を添加して溶液を調製し、これを室温で撹拌しながら溶解させた。一般的な手順の項で先に述べたように、得られた塗膜液(パクリタキセル16mg/mL)を、ピペットで156μLをバルーンに分注することによってバルーンに塗布した。その後、塗布済みバルーンを室温で一晩乾燥させた。
(実施例7:塗布済みバルーンのパクリタキセル含有量の分析)
(実施例8:塗布済みバルーンのブタの組織(生体外)へのパクリタキセル取り込みの分析)
(ナイロンバルーン)
(ePTFEバルーン)
(実施例9:試験方法Aの後の塗布済みバルーンのパクリタキセル含有量の分析)
(実施例10:ブタの組織(生体内)への塗布済みバルーンのパクリタキセル取り込みの1日分析)
(実施例11:ブタの組織(生体内)への塗布済みバルーンのパクリタキセル取り込みの29日分析)
(実施例12:実施例6に従って作製したバルーンの塗膜の接着性試験分析)
(実施例13:滅菌後の塗布済みバルーンのパクリタキセル分解生成物の分析)
(実施例14:医療機器に固定化ヘパリン塗膜を調製する方法)
(実施例15:固定化ヘパリン塗膜層をさらに含む本発明のステントグラフト―ヘパリン生物活性の分析)
(態様)
(態様1)
表面に塗布された以下の成分i)、ii)、およびiii)を含む塗膜層を有する、治療薬を組織に送達する医療機器であって、
成分i)はパクリタキセルである治療薬であり、
成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、
成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、
医療機器。
(態様2)
前記塗膜層は成分i)、ii)、およびiii)の混合物を含む、態様1に記載の医療機器。
(態様3)
成分iii)はコハク酸である、態様1または2に記載の医療機器。
(態様4)
成分iii)はグルタル酸である、態様1または2に記載の医療機器。
(態様5)
成分iii)はカフェインである、態様1または2に記載の医療機器。
(態様6)
成分ii)は以下の式(I)の化合物またはその医薬的に許容される塩である、態様1〜5のいずれか一項に記載の医療機器:
R2とR3は−N(R1)C(=O)N(R4)−部分と共に、1個以上の−OH基で置換されていてもよい5員〜7員の環を形成する)。
(態様7)
R1およびR2はHである、態様6に記載の医療機器。
(態様8)
R3およびR4はHではない、態様6または7に記載の医療機器。
(態様9)
R1、R2、およびR3はHである、態様6または7に記載の医療機器。
(態様10)
成分ii)はメチル尿素、エチル尿素、プロピル尿素、ブチル尿素、ペンチル尿素、またはオクチル尿素である、態様9に記載の医療機器。
(態様11)
成分ii)はエチル尿素である、態様10に記載の医療機器。
(態様12)
前記塗膜層に含まれる成分i)の割合は、10〜95重量%、たとえば40〜90重量%、50〜90重量%、60〜90重量%、70〜90重量%、または75〜85重量%である、態様1〜11のいずれか一項に記載の医療機器。
(態様13)
前記塗膜層に含まれる成分ii)の割合は、1〜95重量%、たとえば5〜80重量%、5〜50重量%、5〜30重量%、5〜20重量%、または5〜15重量%である、態様1〜12のいずれか一項に記載の医療機器。
(態様14)
前記塗膜層に含まれる成分iii)の割合は、1〜95重量%、たとえば5〜80重量%、5〜50重量%、5〜30重量%、5〜20重量%、または5〜15重量%である、態様1〜13のいずれか一項に記載の医療機器。
(態様15)
前記塗膜層は成分i)および/または成分ii)および/または成分iii)を含む1種以上の溶液の蒸発によって形成される、態様1〜14のいずれか一項に記載の機器。
(態様16)
前記塗膜層は
成分i)、ii)、およびiii)の溶液の蒸発によって形成される、態様15に記載の機器。
(態様17)
前記1種以上の溶液は独立して、水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、およびイソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される溶媒の溶液である、態様15に記載の医療機器。
(態様18)
前記1種以上の溶液は独立して、水、アセトン、およびそれらの混合物から選択される溶媒の溶液である、態様17に記載の医療機器。
(態様19)
前記成分i)、ii)、およびiii)の溶液は、
水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、およびイソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される溶媒の溶液である、態様16に記載の医療機器。
(態様20)
前記成分i)、ii)、およびiii)の溶液は、水、アセトン、およびそれらの混合物から選択される溶媒の溶液である、態様19に記載の医療機器。
(態様21)
前記塗膜層は、粉末形態の成分i)、ii)、およびiii)を調製し、次いでこれらの粉末形態を機器に塗布し、必要に応じてその後熱処理工程を行うことによって形成される、態様1〜14のいずれか一項に記載の医療機器。
(態様22)
前記塗膜層は、成分i)、ii)、およびiii)を一緒にして粉末形態にし、次いでその粉末を機器に塗布し、必要に応じてその後に熱処理工程を行うことによって形成される、態様1〜14のいずれか一項に記載の医療機器。
(態様23)
塗布される前記機器の表面の少なくとも一部は多孔質である、態様1〜22のいずれか一項に記載の医療機器。
(態様24)
前記塗膜層はナイロンからなる前記機器の表面に塗布される、態様1〜22のいずれか一項に記載の医療機器。
(態様25)
前記塗膜層は1種以上のフッ素重合体でできた前記機器の表面に塗布される、態様1〜23のいずれか一項に記載の医療機器。
(態様26)
前記フッ素重合体はePTFEである、態様25に記載の医療機器。
(態様27)
成分i)、ii)、およびiii)を含む前記塗膜層と前記機器の表面の材料との間に接着層が介在する、態様1〜26のいずれか一項に記載の医療機器。
(態様28)
成分i)、ii)、およびiii)を含む前記塗膜層に塗布された保護膜層を含む、態様1〜27のいずれか一項に記載の医療機器。
(態様29)
バルーンカテーテルである、態様1〜28のいずれか一項に記載の医療機器。
(態様30)
ステントである、態様1〜28のいずれか一項に記載の医療機器。
(態様31)
ステントグラフトである、態様1〜28のいずれか一項に記載の医療機器。
(態様32)
移植片である、態様1〜28のいずれか一項に記載の医療機器。
(態様33)
成分i)、ii)、およびiii)を含む前記塗膜層は、試験方法Qによる振盪時に消失する成分i)が40%未満(たとえば、30%未満、25%未満、20%未満、15%未満、10%未満、または5%未満)であるような好適な接着性を有する、態様1〜32のいずれか一項に記載の医療機器。
(態様34)
試験方法A−IまたはA−IIを適切に用いた場合に所与の時点の組織内のパクリタキセル濃度の測定値が組織(g)あたり少なくとも1μgの薬物量(μg/g)(たとえば少なくとも2.5μg/g、少なくとも5μg/g、少なくとも10μg/g、少なくとも50μg/g、または少なくとも100μg/g)となるパクリタキセル放出性と組織移行性を有する、態様1〜33のいずれか一項に記載の医療機器。
(態様35)
成分i)は前記塗膜層に処方された場合、エチレンオキシド滅菌に対して安定である、態様1〜34のいずれか一項に記載の医療機器。
(態様36)
成分i)の少なくとも80重量%(たとえば少なくとも85%、90%、または95%)は試験方法Eによる滅菌後も保持される、態様1〜35のいずれか一項に記載の医療機器。
(態様37)
前記パクリタキセル含有塗膜層を上から塗布される固定化ヘパリンの塗膜層をさらに含む、態様1〜36のいずれか一項に記載の医療機器。
(態様38)
試験方法Lによれば埋め込み前に表面積(cm2)あたり1pmolを超える(たとえば少なくとも5pmol/cm2)ヘパリン補因子(HCII)結合活性を有する、態様37に記載の医療機器。
(態様39)
試験方法Mによれば埋め込み前に表面積(cm2)あたり少なくとも1pmol(たとえば少なくとも5pmol/cm2)のアンチトロンビンIII(ATIII)結合活性を有する、態様37または38に記載の医療機器。
(態様40)
試験方法Lによればパクリタキセルの溶出後に表面積(cm2)あたり1pmolを超える(たとえば少なくとも5pmol/cm2)HCII結合活性を有する、態様37〜39のいずれか一項に記載の医療機器。
(態様41)
試験方法Mによればパクリタキセルの溶出後に表面積(cm2)あたり少なくとも1pmol(たとえば少なくとも5pmol/cm2)のATIII結合活性を有する、態様37〜40のいずれか一項に記載の医療機器。
(態様42)
態様1〜41のいずれか一項に記載の医療機器をヒトの体内の血管に一時的または永
久に挿入することを含む、狭窄または再狭窄を予防する方法。
(態様43)
ヒトの体内の血管の狭窄または再狭窄の予防または治療に用いるための態様1〜41のいずれか一項に記載の医療機器。
(態様44)
態様1〜14のいずれか一項に記載の医療機器の作製方法であって、成分i)、ii)、およびiii)を1種以上の溶媒に溶解して1種以上の溶液を調製する工程と、前記1種以上の溶液のそれぞれを前記機器に塗布する工程と、前記1種以上の溶液の溶媒を蒸発させる工程とを含む、方法。
(態様45)
成分i)、ii)、およびiii)を溶媒に溶解して溶液を調製する工程と、前記溶液を前記機器に塗布する工程と、前記溶媒を蒸発させる工程とを含む、態様44に記載の医療機器作製方法。
(態様46)
前記1種以上の溶液は独立して、水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、およびイソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される溶媒の溶液である、態様44に記載の方法。
(態様47)
前記1種以上の溶液は独立して、水、アセトン、およびそれらの混合物から選択される溶媒の溶液である、態様46に記載の方法。
(態様48)
前記溶媒は、水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、イソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される、態様45に記載の方法。
(態様49)
前記溶媒は水、アセトン、およびそれらの混合物から選択される、態様48に記載の方法。
(態様50)
粉末形態の成分i)、ii)、およびiii)を調製する工程と、次いで前記粉末形態を機器に塗布する工程と、必要に応じてその後熱処理工程を行う工程とを含む、態様1〜14のいずれか一項に記載の医療機器の作製方法。
(態様51)
成分i)、ii)、およびiii)を一緒にして粉末形態にする工程と、次いでその粉末を機器に塗布する工程と、必要に応じてその後熱処理工程を行う工程とを含む、態様1〜14のいずれか一項に記載の医療機器の作製方法。
(態様52)
以下の成分i)、ii)、およびiii)の混合物を含む組成物であって、
成分i)はパクリタキセルであり、
成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、
成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、
組成物。
(態様53)
表面に塗布された塗膜の形態である、態様52に記載の組成物。
(態様54)
成分iii)はコハク酸である、態様52または53に記載の組成物。
(態様55)
成分iii)はグルタル酸である、態様52または53に記載の組成物。
(態様56)
成分iii)はカフェインである、態様52または53に記載の組成物。
(態様57)
成分ii)は以下の式(I)の化合物またはその医薬的に許容される塩である、態様52〜56のいずれか一項に記載の組成物:
R2とR3は−N(R1)C(=O)N(R4)−部分と共に、1個以上の−OH基で置換されていてもよい5員〜7員の環を形成する)。
(態様58)
R1およびR2はHである、態様57に記載の組成物。
(態様59)
R3およびR4はHではない、態様57または58に記載の組成物。
(態様60)
R1、R2、およびR3はHである、態様57または58に記載の組成物。
(態様61)
成分ii)はメチル尿素、エチル尿素、プロピル尿素、ブチル尿素、ペンチル尿素、またはオクチル尿素である、態様60に記載の組成物。
(態様62)
成分ii)はエチル尿素である、態様61に記載の組成物。
(態様63)
前記成分i)、ii)、およびiii)の混合物に含まれる成分i)の割合は、10〜95重量%、たとえば40〜90重量%、50〜90重量%、60〜90重量%、70〜90重量%、または75〜85重量%である、態様52〜62のいずれか一項に記載の組成物。
(態様64)
前記成分i)、ii)、およびiii)の混合物に含まれる成分ii)の割合は、1〜95重量%、たとえば5〜80重量%、5〜50重量%、5〜30重量%、5〜20重量%、または5〜15重量%である、態様52〜63のいずれか一項に記載の組成物。
(態様65)
前記成分i)、ii)、およびiii)の混合物に含まれる成分iii)の割合は、1〜95重量%、たとえば5〜80重量%、5〜50重量%、5〜30重量%、5〜20重量%、または5〜15重量%である、態様52〜64のいずれか一項に記載の組成物。
(態様66)
前記塗膜層は成分i)、ii)、およびiii)の溶液の蒸発によって形成される、態様52〜65のいずれか一項に記載の組成物。
(態様67)
前記成分i)、ii)、およびiii)の溶液は、水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、およびイソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される溶媒の溶液である、態様66に記載の組成物。
(態様68)
前記成分i)、ii)、およびiii)の溶液は、水、アセトン、およびそれらの混合物から選択される溶媒の溶液である、態様67に記載の組成物。
(態様69)
態様1〜68のいずれか一項に記載の滅菌済み医療機器または組成物。
(態様70)
エチレンオキシド滅菌された、態様69に記載の滅菌済み医療機器または組成物。
(態様71)
また、医療機器の表面に塗膜層を調製する方法であって、
a)成分i)、ii)、およびiii)を1種以上の溶媒に溶解して1種以上の溶液を調製する工程と、
b)工程a)の前記1種以上の溶液のそれぞれを前記機器の表面に塗布する工程と、
c)前記溶媒を蒸発させる工程とを含み、
成分i)はパクリタキセルである治療薬であり、
成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、
成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、方法。
(態様72)
医療機器の表面に塗膜層を調製する方法であって、
a)成分i)、ii)、およびiii)を溶媒に溶解して溶液を調製する工程と、
b)工程a)の前記溶液を前記機器の表面に塗布する工程と、
c)前記溶媒を蒸発させる工程とを含み、
成分i)はパクリタキセルである治療薬であり、
成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、
成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、方法。
(態様73)
前記1種以上の溶液は独立して、水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、およびイソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される溶媒の溶液である、態様71に記載の方法。
(態様74)
前記1種以上の溶液は独立して、水、アセトン、およびそれらの混合物から選択される溶媒の溶液である、態様73に記載の方法。
(態様75)
前記溶媒は水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、およびイソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される、態様72に記載の方法。
(態様76)
前記溶媒は水、アセトン、およびそれらの混合物から選択される、態様75に記載の方法。
(態様77)
医療機器の表面に塗膜層を調製する方法であって、
A)粉末形態の成分i)、ii)、およびiii)を調製する工程と、
B)工程A)の前記粉末形態を前記機器に塗布する工程と、
C)必要に応じてその後熱処理工程を行う工程とを含み、
成分i)はパクリタキセルである治療薬であり、
成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、
成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、方法。
(態様78)
医療機器の表面に塗膜層を調製する方法であって、
A)成分i)、ii)、およびiii)を一緒にし粉末形態にする工程と、
B)工程A)の前記粉末を前記機器に塗布する工程と、
C)必要に応じてその後熱処理工程を行う工程とを含み、
成分i)はパクリタキセルである治療薬であり、
成分ii)は尿素またはその医薬的に許容される塩、あるいは尿素誘導体またはその医薬的に許容される塩であり、
成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、方法。
Claims (14)
- 以下の成分i)、ii)、およびiii)の混合物を含む医療機器の表面に塗布するための組成物であって、
成分i)はパクリタキセルであり、
成分ii)はメチル尿素、エチル尿素、プロピル尿素、ブチル尿素、ペンチル尿素、もしくはオクチル尿素またはその医薬的に許容される塩であり、
成分iii)はコハク酸、グルタル酸、またはカフェイン、あるいはそのいずれかの医薬的に許容される塩である、
組成物。 - 表面に塗布された塗膜の形態である、請求項1に記載の組成物。
- 成分iii)はコハク酸である、請求項1または2に記載の組成物。
- 成分iii)はグルタル酸である、請求項1または2に記載の組成物。
- 成分iii)はカフェインである、請求項1または2に記載の組成物。
- 成分ii)はエチル尿素である、請求項1〜5のいずれか一項に記載の組成物。
- 前記成分i)、ii)、およびiii)の混合物に含まれる成分i)の割合は、10〜95重量%、たとえば40〜90重量%、50〜90重量%、60〜90重量%、70〜90重量%、または75〜85重量%である、請求項1〜6のいずれか一項に記載の組成物。
- 前記成分i)、ii)、およびiii)の混合物に含まれる成分ii)の割合は、1〜95重量%、たとえば5〜80重量%、5〜50重量%、5〜30重量%、5〜20重量%、または5〜15重量%である、請求項1〜7のいずれか一項に記載の組成物。
- 前記成分i)、ii)、およびiii)の混合物に含まれる成分iii)の割合は、1〜95重量%、たとえば5〜80重量%、5〜50重量%、5〜30重量%、5〜20重量%、または5〜15重量%である、請求項1〜8のいずれか一項に記載の組成物。
- 塗膜層は成分i)、ii)、およびiii)の溶液の蒸発によって形成される、請求項1〜9のいずれか一項に記載の組成物。
- 前記成分i)、ii)、およびiii)の溶液は、水、アセトン、アルコール類(たとえばメタノール、エタノール、プロパノール、およびイソプロピルアルコール)、テトラヒドロフラン、DMF、DMSO、EtOAc、ジオキサン、およびそれらの混合物から選択される溶媒の溶液である、請求項10に記載の組成物。
- 前記成分i)、ii)、およびiii)の溶液は、水、アセトン、およびそれらの混合物から選択される溶媒の溶液である、請求項11に記載の組成物。
- 請求項1〜12のいずれか一項に記載の滅菌済みの組成物。
- エチレンオキシド滅菌された、請求項1〜12のいずれか一項に記載の滅菌済みの組成物。
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