JP6453841B2 - 被覆包装 - Google Patents
被覆包装 Download PDFInfo
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- JP6453841B2 JP6453841B2 JP2016501350A JP2016501350A JP6453841B2 JP 6453841 B2 JP6453841 B2 JP 6453841B2 JP 2016501350 A JP2016501350 A JP 2016501350A JP 2016501350 A JP2016501350 A JP 2016501350A JP 6453841 B2 JP6453841 B2 JP 6453841B2
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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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M2005/3131—Syringe barrels specially adapted for improving sealing or sliding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/62—Insulins
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/04—Endocrine or metabolic disorders
- G01N2800/042—Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
Description
・ポリオレフィン、
・ポリビニルアルコール、
・ポリメタクリレートエーテル
・ポリアクリル酸
・ポリアミド
・ポリイミド
・ポリスルホン
・ポリ乳酸
・環状オレフィン重合体又は共重合体
・ポリエステル
・ポリオレフィンとポリエステルとの組合せ、又は
・これらのいずれか1つの組合せ
を含む又はそれからなる。
・0.5〜10標準体積の有機ケイ素化合物前駆体と;
・0.1〜10標準体積の酸素と;
・1〜100標準体積のキャリアガスと
を含む又はそれからなる。
・約1000〜1040cm−1におけるSi−O−Si対称伸縮ピークの最大振幅と、
・約1060〜約1100cm−1におけるSi−O−Si非対称伸縮ピークの最大振幅と、
の比率が0.75より大きくてもよい。
・0.5〜10標準体積の有機ケイ素化合物前駆体と;
・0.1〜10標準体積の酸素と;
・1〜120標準体積のキャリアガスと
を含む又はそれらからなる。
図1及び図2を参照すると、接着皮膜又は層と称されることもある、タイコート皮膜又は層289が設けられている。タイコート皮膜又は層289は任意選択的に、基板、特に熱可塑性基板へのバリア皮膜又は層288の接着を改善する機能を果たすが、タイコート層はガラス基板又は別の皮膜若しくは層への接着を改善するのに使用することもできる。
Si 100:O 50〜150:C 90〜200(即ち、x=0.5〜1.5、y=0.9〜2);
Si 100:O 70〜130:C 90〜200(即ち、x=0.7〜1.3、y=0.9〜2)
Si 100:O 80〜120:C 90〜150(即ち、x=0.8〜1.2、y=0.9〜1.5)
Si 100:O 90〜120:C 90〜140(即ち、x=0.9〜1.2、y=0.9〜1.4)、又は
Si 100:O 92〜107:C 116〜133(即ち、x=0.92〜1.07、y=1.16〜1.33)、
であってもよい。
図1及び図2を参照すると、バリア皮膜又は層288を任意選択的に、薬剤パッケージ、例えば、熱可塑性パッケージの容器上にプラズマ化学気相成長法(PECVD)又は他の化学気相成長法により堆積させて、酸素、二酸化炭素、又は他のガスが容器に入ることを防止することができ、バリア皮膜288は任意選択的に、非被覆容器210と比較して内腔210内への大気ガスの侵入を低減する、及び/又はパッケージ壁内への若しくはパッケージ壁を通した医薬物質の浸出を防止するのに有効である。
本明細書で定義されるSiOxなどの特定のバリア皮膜又は層286は、本明細書の他の箇所に記載されている被覆容器、特にバリア皮膜又は層が内容物に直接接触する被覆容器の特定の比較的高いpHの内容物により攻撃されると、6ヶ月未満でバリア改善率が測定可能な程度低下するという特徴を有することが判明した。本発明者らは、SiOxのバリア層又は皮膜が一部の流体、例えば、5より高いpHを有する水性組成物により浸食又は溶解されることを見い出した。化学気相成長法により塗布される皮膜は非常に薄く−厚さ数十〜数百ナノメートルになり得るため、浸食速度が比較的遅くても製品パッケージの所望の保管寿命よりも短い時間でバリア層の有効性が失われる又は低下するおそれがある。これは、水性流体医薬組成物の多くが血液及びヒト又は動物の他の体液のpHと類似のおよそ7のpH、又はより広く4〜8、あるいは5〜9の範囲のpHを有するため、水性流体医薬組成物では特に問題となる。医薬製剤のpHが高いほどSiOx皮膜の侵食又は溶解が速くなる。任意選択的に、バリア皮膜若しくは層288、又は他のpH感受性材料をpH保護皮膜又は層286で保護することにより、この問題に対処することができる。
Si 100:O 50〜150:C 90〜200(即ち、x=0.5〜1.5、y=0.9〜2);
Si 100:O 70〜130:C 90〜200(即ち、x=0.7〜1.3、y=0.9〜2)
Si 100:O 80〜120:C 90〜150(即ち、x=0.8〜1.2、y=0.9〜1.5)
Si 100:O 90〜120:C 90〜140(即ち、x=0.9〜1.2、y=0.9〜1.4)、又は
Si 100:O 92〜107:C 116〜133(即ち、x=0.92〜1.07、y=1.16〜1.33)、又は
Si 100:O 80〜130:C 90〜150、
であってもよい。
SiOxの隣接層及びpH保護皮膜又は層に関してここで考えられる別の方法は、任意の2つ以上の隣接PECVD層の段階的複合体、例えば、バリア皮膜又は層288及びpH保護皮膜又は層286及び/又は滑性皮膜又は層281の段階的複合体である。段階的複合物は、それらの間に中間組成物の遷移又は界面を有する別個の保護及び/又はバリア層又は皮膜、又は、それらの間に中間組成物の中間にある明確な(intermediate distinct)pH保護皮膜又は層を有する別個の保護及び/又は疎水性層及びSiOx、又は、保護及び/又は疎水性層の組成物から、よりSiOxのような組成物に、プライマー皮膜又は層を法線方向に連続的に又は段階的に変化させる1つの皮膜又は層とされうる。
PECVD皮膜又は層を形成するためのPECVD装置
特にタイコート皮膜若しくは層289、バリア皮膜若しくは層288、又はpH保護皮膜若しくは層286を含む、本明細書に記載のPECVD皮膜又は層のいずれかを塗布するのに適したPECVD装置、システム、及び前駆体物質は、米国特許第7,985,188号明細書に記載されており、この特許は参照により援用される。
・0.5〜10の標準体積、任意選択的に1〜6の標準体積、任意選択的に2〜4の標準体積、任意選択的に6以下の標準体積、任意選択的に2.5以下の標準体積、任意選択的に1.5以下の標準体積、任意選択的に1.25以下の標準体積の前駆体、例えば、OMCTS又は任意の実施形態の他の前駆体の1種;
・0〜100の標準体積、任意選択的に1〜200の標準体積、任意選択的に1〜80の標準体積、任意選択的に5〜100の標準体積、任意選択的に10〜70の標準体積の任意の実施形態のキャリアガス、例えば、アルゴン。
・0.1〜10の標準体積、任意選択的に0.1〜2の標準体積、任意選択的に0.2〜1.5の標準体積、任意選択的に0.2〜1の標準体積、任意選択的に0.5〜1.5の標準体積、任意選択的に0.8〜1.2の標準体積の酸化剤。
電力レベルは、例えば、0.1〜500ワットとすることができる。
考えられる特定の流量及び電力レベルとしては以下のものが挙げられる。
OMCTS:2.0sccm
酸素:0.7sccm
アルゴン:7.0sccm
電力:3.5ワット
PECVD三層プロセス一般パラメータ表(1mLシリンジ及び5mLバイアル)に、1mLシリンジバレルでの三層皮膜に関する他の一般被覆パラメータ範囲を示し、括弧内に好ましい範囲を示す。
本明細書に記載の及び/又は本明細書に記載の方法に従って作成されたプライマー皮膜又は層を有する容器は、化合物又は組成物の収容、及び/又は保管、及び/又は送達に使用することができる。化合物又は組成物は、感受性、例えば、空気感受性、酸素感受性、感湿性、及び/又は機械的作用(influences)感受性の場合がある。それは、生物活性化合物又は組成物、例えば、インスリンのような医薬製剤若しくは薬剤、又はインスリンを含む組成物であってもよい。別の態様において、それは生物学的流体、任意選択的に体液、例えば血液又は血液分画であってもよい。本発明の特定の態様においては、化合物又は組成物は、それを必要とする対象に投与される製品、例えば、血液(ドナーからレシピエントへの血液の輸血、又は患者から患者自身に戻される血液の再導入におけるような)又はインスリンのような注射される製品であってもよい。
図1及び図2により最も広く示される容器210は、薬剤パッケージとして使用することが考えられている。
テリドール注射薬溶液(プロハンス);カドベルセタミド注射薬(OptiMARK);ガドキセト酸二ナトリウム注射薬(エオビスト);ガニレリクス(ガニレリクス酢酸塩注射薬);ガーダシル;GC1008;GDFD;注射用ゲムツズマブオゾガマイシン(マイロターグ);ジェノトロピン;ゲンタマイシン注射薬;GENZ−112638;ゴリムマブ注射薬(シンポニー注射薬);ゴナールエフRFF(フォリトロピンアルファ注射薬);グラニセトロン塩酸塩(カイトリル注射薬);ゲンタマイシン硫酸塩;グラチラマー酢酸塩;Glucagen;グルカゴン;HAE1;Haldol(ハロペリドール注射薬);Havrix;Hectorol注射薬(ドキセルカルシフェロール注射薬);ヘッジホッグ経路阻害薬;へパリン;ハーセプチン;hG−CSF;ヒューマログ;ヒト成長ホルモン;ヒューマトロープ;HuMax;ヒュメゴン;ヒュミラ;ヒューマリン;イバンドロネートナトリウム注射薬(ボニバ注射薬);イブプロフェンリシン注射薬(NeoProfen);フマル酸イブチリド注射薬(コルベルト);イダマイシンPFS(イダルビシン塩酸注射薬);イダルビシン塩酸注射薬(イダマイシンPFS);イラリス(カナキヌマブ注射薬);注射用イミペネム及びシラスタチン(プリマキシンI.V.);イミトレックス;インコボツリナムトキシンA注射用(Xeomin);Increlex(メカセルミン[rDNA由来]注射薬);インダシンIV(インドメタシン注射薬);インドメタシン注射薬(インダシンIV);Infanrix;イノヘップ;インスリン;インスリンアスパルト[rDNA由来]注射薬(NovoLog);インスリングラルギン[rDNA由来]注射薬(ランタス);インスリングルリシン[rDNA由来]注射薬(アピドラ);インターフェロンアルファ−2b、遺伝子組換え注射用(イントロンA);イントロンA(インターフェロンアルファ−2b、遺伝子組換え注射用);Invanz(エルタペネム注射薬);Invega Sustenna(パリペリドンパルミチン酸エステル持効性懸濁注射液);インビラーゼ(サキナビルメシル酸塩);ヨーベングアンI123静脈内用注射薬(AdreView);イオプロミド注射薬(Ultravist);イオベルソール注射薬(オプチレイ注射薬);Iplex(メカセルミンリンファバート[rDNA由来]注射薬);Iprivask;イリノテカン塩酸(Camptosar注射薬);含糖酸化鉄注射薬(ヴェノファー);Istodax(ロミデプシン注射用);イトラコナゾール注射薬(スポラノックス注射薬);ジェブタナ(カバジタキセル注射薬);Jonexa;Kalbitor(エカランチド注射薬);KCL in D5NS(5%ブドウ糖及び塩化ナトリウム中塩化カリウム(Potassium Chloride in 5% Dextrose and Sodium Chloride)注射薬);KCL in D5W;KCL in NS;ケナログ10注射薬(トリアムシノロンアセトニド懸濁注射液);ケピバンス(パリフェルミン);ケプラ注射薬(レベチラセタム);ケラチノサイト;KFG;キナーゼ阻害薬;Kineret(アナキンラ);Kinlytic(ウロキナーゼ注射薬);Kinrix;クロノピン(クロナゼパム);カイトリル注射薬(グラニセトロン塩酸塩);ラコサミド錠及び注射薬(ビンパット);乳酸リンゲル液;ラノキシン注射薬(ジゴキシン注射薬);ランソプラゾール注射用(プレバシドI.V.);ランタス;ロイコボリンカルシウム(ロイコボリンカルシウム注射薬);レンテ(L);レプチン;レベミル;リューカインサルグラモスチム;ロイプロリド酢酸塩;レボチロキシン;レベチラセタム(ケプラ注射薬);ラブノックス;レボカルニチン注射薬(Carnitor注射薬);レキスキャン(レガデノソン注射薬);リオレサール髄注(バクロフェン注射薬);リラグルチド[rDNA]注射薬(ビクトーザ);ラブノックス(エノキサパリンナトリウム注射薬);ルセンティス(ラニビズマブ注射薬);Lumizyme;ルプロン(ロイプロリド酢酸塩注射薬);Lusedra(ホスプロポフォール二ナトリウム注射薬);Maci;マグネシウム硫酸塩(マグネシウム硫酸塩注射薬);マンニトール注射薬(マンニトールIV);マーカイン(ブピバカイン塩酸及びエピネフリン注射薬);マキシピーム(セフェピム塩酸塩注射用);テクネチウム注射薬のMDP多用量(Multidose)キット(テクネチウムTc99mメドロナート注射薬);メカセルミン[rDNA由来]注射薬(Increlex);メカセルミンリンファバート[rDNA由来]注射薬(Iplex);メルファランHcl注射薬(アルケラン注射薬);メトトレキサート;メナクトラ;Menopur(メノトロピンス注射薬);メノトロピンス注射用(Repronex);メトヘキシタールナトリウム注射用(ブレビタールナトリウム);メチルドーパート塩酸塩注射薬、溶液(メチルドーパートHcl);メチレンブルー(メチレンブルー注射薬);酢酸メチルプレドニゾロン懸濁注射液(デポメロドール);MetMab;メトクロプラミド注射薬(Reglan注射薬);Metrodin(ウロホリトロピン注射用);メトロニダゾール注射薬(フラジール注射薬);Miacalcin;ミダゾラム(ミダゾラム注射薬);ミンパラ(シナカレト(Cinacalet));ミノシン注射薬(ミノサイクリン注射薬);ミノサイクリン注射薬(ミノシン注射薬);ミポメルセン;ミトキサントロン注射用濃縮液(ノバントロン);モルヒネ注射薬(Duramorph);モルヒネ硫酸塩XRリポソーム注射薬(デポデュール);モルイン酸ナトリウム(モルイン酸ナトリウム注射薬);モテサニブ;モゾビル(プレリキサフォル注射薬);Multihance(ガドベン酸メグルミン注射薬);多電解質及びブドウ糖注射薬;多電解質注射薬;マイロターグ(注射用ゲムツズマブオゾガマイシン);マイオザイム(アルグルコシダーゼアルファ);ナフシリン注射薬(ナフシリンナトリウム);ナフシリンナトリウム(ナフシリン注射薬);ナルトレキソンXR注射薬(ビビトロル;ナプロシン(ナプロキセン);NeoProfen(イブプロフェンリシン注射薬);ナンドロルデカン酸エステル(Nandrol Decanoate);ネオスチグミンメチル硫酸塩(ネオスチグミンメチル硫酸塩注射薬);NEO−GAA;NeoTect(テクネチウムTc99mデプレオチド注射薬);Nephramine(必須アミノ酸注射薬);Neulasta(ペグフィルグラスチム);Neupogen(フィルグラスチム);ノボリン;Novolog;NeoRecormon;Neutrexin(グルコン酸トリメトレキサート注射薬);NPH(N);Nexterone(アミオダロンHCl注射薬);ノルディトロピン(ソマトロピン注射薬);生理食塩水(塩化ナトリウム注射薬);ノバントロン(ミトキサントロン注射用濃縮液);ノボリン70/30イノレット(70%NPH、ヒトインスリンイソフェン懸濁液及び30%レギュラー、ヒトインスリン注射薬);NovoLog(インスリンアスパルト[rDNA由来]注射薬);Nplate(ロミプロスチム);ニュートロピン(ソマトロピン(rDNA由来)注射用);ニュートロピンAQ;ニュートロピンデポ(Depot)(ソマトロピン(rDNA由来)注射用);オクトレオチド酢酸塩注射薬(サンドスタチンLAR);オクレリズマブ;オファツムマブ注射薬(アーゼラ);徐放性オランザピン懸濁注射液(Zyprexa Relprevv);Omnitarg;Omnitrope(ソマトロピン[rDNA由来]注射薬);オンダンセトロン塩酸注射薬(ゾフラン注射薬);OptiMARK(カドベルセタミド注射薬);オプチレイ注射薬(イオベルソール注射薬);オレンシア;Osmitrol注射薬、Aviva(マンニトール注射薬、Avivaプラスチック薬剤);Osmitrol注射薬、Viaflex(マンニトール注射薬、Viaflexプラスチック薬剤);オステオプロテグリン(Osteoprotegrin);Ovidrel(絨毛性ゴナドトロピンアルファ注射薬);オキサシリン(オキサシリン注射用);オキサリプラチン注射薬(エロキサチン);オキシトシン注射薬(ピトシン);パリペリドンパルミチン酸エステル持効性懸濁注射液(Invega Sustenna);パミドロン酸二ナトリウム注射薬(パミドロン酸二ナトリウム注射薬);パニツムマブ静注用(ベクティビックス);パパベリン塩酸塩注射薬(パパベリン注射薬);パパベリン注射薬(パパベリン塩酸塩注射薬);副甲状腺ホルモン;パリカルシトール注射薬フリップトップ型バイアル(Zemplar注射薬);PARP阻害薬;Pediarix;ペグイントロン;ペグインターフェロン;ペグフィルグラスチム;ペニシリンGベンザチン及びペニシリンGプロカイン;ペンテト酸カルシウム三ナトリウム注射薬(Ca−ジエチレントリアミン五酢酸);ペンテト酸亜鉛三ナトリウム注射薬(Zn−ジエチレントリアミン五酢酸);ペプシド注射薬(ファモチジン注射薬);Pergonal;ペルツズマブ;フェントラミンメシル酸塩(フェントラミンメシル酸塩注射用);サリチル酸フィゾスチグミン(サリチル酸フィゾスチグミン(注射薬));サリチル酸フィゾスチグミン(注射薬)(サリチル酸フィゾスチグミン);ピペラシリン及びタゾバクタム注射薬(ゾシン);ピトシン(オキシトシン注射薬);Plasma−Lyte148(多電解質注射薬);Plasma−Lyte56及びブドウ糖(多電解質及びブドウ糖注射薬、Viaflexプラスチック薬剤パッケージ210);PlasmaLyte;プレリキサフォル注射薬(モゾビル);ポリドカノール注射薬(Asclera);塩化カリウム;プララトレキサート溶液静注用(フォロチン);酢酸プラムリンタイド注射薬(Symlin);プレマリン注射薬(注射用結合型エストロゲン);注射用テクネチウムTc99セスタミビ用調製キット(Prep kit)(カーディオライト);プレバシドI.V.(ランソプラゾール注射用);プリマキシンI.V.(注射用イミペネム及びシラスタチン);Prochymal;プロクリット;黄体ホルモン;プロハンス(ガドテリドール注射薬溶液);プロリア(デノスマブ注射薬);プロメタジンHCl注射薬(プロメタジン塩酸注射薬);プロプラノロール塩酸塩注射薬(プロプラノロール塩酸塩注射薬);グルコン酸キニジン注射薬(キニジン注射薬);キニジン注射薬(グルコン酸キニジン注射薬);R−Gene10(塩酸アルギニン注射薬);ラニビズマブ注射薬(ルセンティス);ラニチジン塩酸塩注射薬(ザンタック注射薬);ラプティバ;リクラスト(ゾレドロン酸注射薬);Recombivarix HB;レガデノソン注射薬(レキスキャン);Reglan注射薬(メトクロプラミド注射薬);レミケード;レナジェル;Renvela(炭酸セベラマー);Repronex(メノトロピンス注射用);レトロビルIV(ジドブジン注射薬);rhApo2L/TRAIL;リンゲル及び5%ブドウ糖注射薬(ブドウ糖加リンガー液(Ringers));リンゲル液(リンガー(Ringers)液);リツキサン;リツキシマブ;ロセフィン(セフトリアキソン);ロクロニウム臭化物注射薬(Zemuron);Roferon−A(インターフェロンアルファ−2a);Romazicon(フルマゼニル);ロミデプシン注射用(Istodax);サイゼン(ソマトロピン注射薬);サンドスタチンLAR(オクトレオチド酢酸塩注射薬);スクレロスチンAb;Sensipar(シナカルセト);Sensorcaine(ブピバカインHCI注射薬);Septocaine(アルチケーンHCI(Articane HCl)及びエピネフリン注射薬);Serostim LQ(ソマトロピン(rDNA由来)注射薬);シンポニー注射薬(ゴリムマブ注射薬);ナトリウム酢酸塩(ナトリウム酢酸塩注
射薬;炭酸水素ナトリウム(炭酸水素ナトリウム5%注射薬);乳酸ナトリウム(乳酸ナトリウム注射薬、AVIVA);フェニル酢酸ナトリウム及び安息香酸ナトリウム注射薬(Ammonul);ソマトロピン(rDNA由来)注射用(ニュートロピン);スポラノックス注射薬(イトラコナゾール注射薬);ステラーラ注射薬(ウステキヌマブ);Stemgen;Sufenta(クエン酸スフェンタニル注射薬);クエン酸スフェンタニル注射薬(Sufenta);Sumavel;スマトリプタン注射薬(Alsuma);Symlin;Symlin Pen;全身用ヘッジホッグ(Systemic Hedgehog)拮抗薬;Synvisc−One(ヒラン(Hylan)G−F20単回関節内注射薬);タルセバ;タキソテール(ドセタクセル注射用);テクネチウムTc99m;テラバンシン注射用(ヴィバティブ);テムシロリムス注射薬(トーリセル);テノーミンI.V.注射薬(アテノロール注射薬);テリパラチド(rDNA由来)注射薬(フォルテオ);テストステロンシピオネート;テストステロンエナント酸エステル;テストステロンプロピオン酸エステル;Tev−Tropin(ソマトロピン、rDNA由来、注射用);tgAAC94;塩化タリウム;テオフィリン;チオテパ(チオテパ注射薬);サイモグロブリン(抗胸腺細胞免疫グロブリン(ウサギ);タイロゲン(チロトロピンアルファ注射用);チカルシリンナトリウム及びクラブラン酸カリウムギャラクシー(Galaxy)(チメンチン注射薬);Tigan注射薬(塩酸トリメトベンズアミド注射可能物質(injectable);チメンチン注射薬(チカルシリンナトリウム及びクラブラン酸カリウムギャラクシー(Galaxy);TNKase;トブラマイシン注射薬(トブラマイシン注射薬);トシリズマブ注射薬(アクテムラ);トーリセル(テムシロリムス注射薬);Totect(注射用デキスラゾキサン、静注のみ);トラスツズマブ−DM1;Travasol(アミノ酸(注射薬));トレアンダ(塩酸ベンダムスチン注射薬);トレルスター(トリプトレリンパモエート懸濁注射液用);トリアムシノロンアセトニ;酢酸トリアムシノロン;トリアムシノロンヘキサアセトニド懸濁注射液(アリストスパン注射薬20mg);Triesence(トリアムシノロンアセトニド懸濁注射液);塩酸トリメトベンズアミド注射可能物質(injectable)(Tigan注射薬);グルコン酸トリメトレキサート注射薬(Neutrexin);トリプトレリンパモエート懸濁注射液用(トレルスター);Twinject;Trivaris(トリアムシノロンアセトニド懸濁注射液);トリセノックス(三酸化ヒ素注射薬);Twinrix;腸チフスVi;Ultravist(イオプロミド注射薬);ウロホリトロピン注射用(Metrodin);ウロキナーゼ注射薬(Kinlytic);ウステキヌマブ(ステラーラ注射薬);ウルトラレンテ(U);バリウム(ジアゼパム);バルプロ酸ナトリウム注射薬(Depacon);Valtropin(ソマトロピン注射薬);バルプロ酸ナトリウム(バルプロ酸ナトリウム注射薬);バルプロ酸ナトリウム注射薬(バルプロ酸ナトリウム);バプリゾール(コニバプタンHcl注射薬);VAQTA;バソビスト(ガドホスベセット三ナトリウム静注用);ベクティビックス(パニツムマブ静注用);ヴェノファー(含糖酸化鉄注射薬);ベルテポルフィン注射薬(ビスダイン);ヴィバティブ(テラバンシン注射用);ビクトーザ(リラグルチド[rDNA]注射薬);ビンパット(ラコサミド錠及び注射薬);ビンブラスチン硫酸塩(ビンブラスチン硫酸塩注射薬);Vincasar PFS(ビンクリスチン硫酸塩注射薬);ビクトーザ;ビンクリスチン硫酸塩(ビンクリスチン硫酸塩注射薬);ビスダイン(ベルテポルフィン注射薬);ビタミンB−12;ビビトロル(ナルトレキソンXR注射薬);ボルベン(塩化ナトリウム中ヒドロキシエチルデンプン(Hydroxyethyl Starch in Sodium Chloride)注射薬);ゼローダ;ゼニカル(オルリスタット);Xeomin(インコボツリナムトキシンA注射用);ゾレア;ザンタック注射薬(ラニチジン塩酸塩注射薬);Zemplar注射薬(パリカルシトール注射薬フリップトップ型バイアル);Zemuron(ロクロニウム臭化物注射薬);ゼナパックス(ダクリズマブ);ゼバリン;ジドブジン注射薬(レトロビルIV);ジスロマック注射薬(アジスロマイシン);Zn−ジエチレントリアミン五酢酸(ペンテト酸亜鉛三ナトリウム注射薬);ゾフラン注射薬(オンダンセトロン塩酸注射薬);Zingo;ゾレドロン酸注射用(ゾメタ);ゾレドロン酸注射薬(リクラスト);ゾメタ(ゾレドロン酸注射用);ゾシン(ピペラシリン及びタゾバクタム注射薬);Zyprexa Relprevv(徐放性オランザピン懸濁注射液)が挙げられる。
塩酸塩点眼液);Tyvaso(トレプロスチニル吸入液);ベントリン;ブイフェンド;ビブラマイシン経口用(ドキシサイクリンカルシウム経口懸濁液);ヴァイデックス(ジダノシン小児用散経口液用);ビガバトリン経口液(サブリル);Viokase;ビラセプト;ビラミューン;ビタミンK1(ビタミンK1の流体コロイド溶液);ボルタレン眼科用薬(ジクロフェナクナトリウム点眼液);ザロンチン経口液(エトスクシミド経口液);ザイアジェン;ザイボックス;Zymar(ガチフロキサシン点眼液);Zymaxid(ガチフロキサシン点眼液)が挙げられる。
更に別の実施形態は血液収容容器である。このような容器の幾つかの非限定的な例には、輸血バッグ、試料を採取した血液試料採取容器、人工心肺のチューブ類、可撓壁採血バッグ、又は手術中に患者の血液を採取し、その血液を患者自身の血管系に再導入するために使用されるチューブ類がある。容器が血液を圧送するためのポンプ含む場合、特に好適なポンプは遠心ポンプ又は蠕動ポンプである。容器は壁を有し;壁は内腔を画定する内面又は内部表面を有する。壁の内面又は内部表面は、任意選択的に疎水性表面も呈する、保護層の少なくとも部分的なプライマー皮膜又は層を有する。プライマー皮膜又は層は単分子の厚さほどの薄さであっても、又は約1000nmの厚さであってもよい。容器は、内腔内に疎水性層と接触して配置された、患者の血管系に戻される生血液を収容する。
別の実施形態は壁を有する容器である。壁は、内腔を画定する内面又は内部表面を有し、疎水性表面も呈する少なくとも部分的なプライマー皮膜又は層を有し、式中、任意選択的にx及びyは前記に定義する通りである。内面又は内部表面で、プライマー皮膜又は層の厚さは単分子の厚さから約1000nmの厚さの範囲内である。プライマー皮膜又は層は、疎水性層で被覆されていない同じ種類の壁と比較して、内面又は内部表面に曝露された血液の凝固又は血小板活性化を低減するのに有効である。
別の実施形態は内腔を画定する内面又は内部表面を有する壁を有する、血液収容容器である。内面又は内部表面は、III族の1種以上の元素、IV族の1種以上の元素、又はこれらの2種以上の組合せを含む組成物の少なくとも部分的なプライマー皮膜又は層を有する。内面又は内部表面で、プライマー皮膜又は層の厚さは単分子の厚さから約1000nmの厚さ(両端値を含む)までである。容器は、内腔内にプライマー皮膜又は層と接触して配置された、患者の血管系に戻される生血液を収容する。
任意選択的に、前段落の容器内で、III族元素又はIV族元素のプライマー皮膜又は層は、容器壁の内面又は内部表面に曝露される血液の凝固又は血小板活性化を低減するのに有効である。
1つの選択肢として、化合物又は組成物の成分はインスリンであり、インスリンの沈殿が防止又は低減される。別の選択肢として、化合物又は組成物の成分は血液又は血液分画であり、血液凝固又は血小板活性化が防止又は低減される。更に別の選択肢として、プライマー皮膜又は層を有する容器は採血管である。任意選択的に、採血管は血液凝固又は血小板活性化を防止する薬剤、例えば、エチレンジアミン四酢酸(EDTA)、そのナトリウム塩、又はヘパリンを含み得る。
原子組成
タイコート皮膜又は層、バリア皮膜又は層、及びpH保護皮膜又は層の原子組成は、ケイ素、酸素、及び炭素の測定にはX線光電子分光法(XPS)、並びに水素の測定にはラザフォード後方散乱(RBS)又は水素前方散乱(HFS)分光法のいずれかを用いてキャラクタリゼーションを行う。XPSは水素を検出しないため、水素含有量を求めるには別の分析方法を使用する。特記しない限り、以下の方法を使用する。
XPSデータは、比感度係数及び均質な層を前提とするモデルを用いて定量化される。分析体積は、分析面積(スポットサイズ又は開口サイズ)と情報深さとの積である。光電子はX線侵入深さ(通常、何ミクロン(マイクロメートル)もの深さ)内で発生するが、上部の3つの光電子脱出深さ内の光電子だけが検出される。脱出深さは約15〜35Åであり、これにより分析深さは約50〜100Åとなる。通常、信号の95%はこの深さから発生する。
・機器:PHI Quantum 2000
・X線源:Monochromated Alka 1486.6eV
・取り込み角 ±23°
・取り出し角 45°
・分析面積 600μm
・電荷補正 C1s 284.8eV
・イオン銃条件 Ar+、1keV、2×2mmラスター
・スパッタ速度 15.6Å/分(SiO2当量)
RBSスペクトルは、後方散乱角160°及び適切なグレージング角(grazing angle)で(試料を入射イオンビームに垂直な向きに配置して)取得する。入射ビームに対してランダムな配置(geometry)を呈するように、試料を小さい角度で回転又は傾斜させる。これは、フィルムと基板の両方でのチャネリングを回避する。2つの検出角度を使用することにより、薄い表面層を分析する必要がある場合、組成の測定精度を著しく改善することができる。
分析パラメータ:RBS
・He++イオンビームエネルギー 2.275MeV
・法線(Normal)検出角度 160°
・グレージング検出角度 約100°
・分析モード CC RR
HFS実験では、検出器を入射He++イオンビームの前方軌道から30°で配置し、入射ビームが法線から75°で表面に当たるように試料を回転させる。この配置では、プロービングHe++イオンビームとの衝突後に試料から前方に散乱された軽原子、即ち、水素を捕集することが可能である。同様に試料から前方に散乱されるHe++イオンを除去するために、検出器上に薄い吸収箔を配置する。
分析パラメータ:HFS
・He++イオンビームエネルギー 2.275MeV
・法線検出角度 160°
・グレージング検出角度 約30°
・試料法線に対するイオンビーム 75°
このプロトコルは、容器壁全体に存在するケイ素皮膜の総量を決定するために使用される。溶液又は成分とガラスとの間の接触を回避するよう留意し、ある供給量の0.1N水酸化カリウム(KOH)水溶液を用意する。使用される水は精製水で、18MΩ品質である。特に定めのない限りは測定にPerkin Elmer Optima Model 7300DV ICP−OES機器が使用される。
実施例のいくつかにおいては、例えば、試験溶液の溶解速度を評価するために、試験溶液によって容器の壁から溶解したケイ素の量が10億分率(ppb)で決定される。この溶解したケイ素の決定は、試験条件下でSiOx及び/又はSiOxCy皮膜又は層が提供された容器内に試験溶液を保管し、その後、溶液のサンプルを容器から除去し、サンプルのSi濃度を試験することによって実施される。試験は、総ケイ素測定のためのプロトコルと同じ手法で実施されるが、そのプロトコルの温浸ステップの代わりにこのプロトコルに記載されるような容器内における試験溶液の保管が使用される。総Si濃度は試験溶液中のSiの10億分率として報告される。
実施例から分かるように、ケイ素溶解速度は、容器からその内容物中に浸出される総ケイ素を求めることにより測定され、pH保護皮膜若しくは層286、滑性層281、バリア皮膜若しくは層288、又は存在する他の物質に由来するケイ素を区別するものではない。
以下の実施例において報告される計算保管寿命値は、総ケイ素測定のためのプロトコル及び平均溶解速度を決定するためのプロトコルにそれぞれ記載したように決定された総ケイ素測定値及び平均溶解速度の外挿によって決定される。示された保管条件下において、SiOxCy pH保護皮膜又は層は皮膜が完全に除去されるまで平均溶解速度で除去されると想定される。したがって、容器の総ケイ素測定値を溶解速度によって除算すると、試験溶液がSiOxCy皮膜を完全に溶解するのに要する時間が得られる。この期間は計算保管寿命として報告される。市販保管寿命の計算とは異なり、安全率は計算されない。その代わり、計算保管寿命は計算破損時間である。
pH保護皮膜又は層、バリア皮膜又は層、滑性皮膜又は層、及び/又はこれら層のいずれか2つ以上の複合体などのPECVD皮膜又は層の厚さは、例えば、透過電子顕微鏡法(TEM)により測定することができる。pH保護皮膜又は層の例示的なTEM画像を図17に示す。SiO2バリア皮膜又は層の例示的なTEM画像を図18に示す。
機器 走査透過電子顕微鏡
製造業者/型式 Hitachi HD2300
加速電圧 200kV
対物絞り 2
コンデンサレンズ1設定 1.672
コンデンサレンズ2設定 1.747
おおよその対物レンズ設定 5.86
ZCモード投影レンズ 1.149
TEモード投影レンズ 0.7
画像取得
画素分解能 1280×960
取得時間 20秒(×4
機器 透過電子顕微鏡
製造業者/型式 Hitachi HF2000
加速電圧 200kV
コンデンサレンズ1 0.78
コンデンサレンズ2 0
対物レンズ 6.34
コンデンサレンズ絞り 1
撮影(imaging)用対物レンズ絞り 3
SAD用選択領域絞り N/A
SEMサンプルの調製:各シリンジサンプルをその長さに沿って半分に切断した(内側又は内部表面を露出させるため)。サンプルを小さくするためにシリンジ(ルアー端部)の上部を切り取った。
AFM画像は、NanoScope III Dimension 3000マシン(Digital Instruments,Santa Barbara,California,USA)を使用して収集した。機器はNISTにトレース可能な標準に照らして校正した。エッチングされたシリコン製の走査型プローブ顕微鏡(SPM)チップを使用した。自動平坦化(auto−flattening)、平面フィッティング又は畳み込みを含む画像処理手順を用いた。1つの10μmx10μm面積を画像化した。粗さ分析を実施し、以下において表した。(1)二乗平均粗さ(Root−Mean−Square Roughness)、RMS、2 平均粗さ、Ra、及び(3)最大高さ(山対谷)、Rmax。これらは全てnmで測定した(表5)。粗さ分析のため、各サンプルを10μmx10μm面積上において画像化し、続いて、10μmx10μm画像においてフィーチャを切断する3つの断面を分析者が選択した。フィーチャの垂直深さは断面ツール(cross section tool)を使用して測定した。各断面について、二乗平均粗さ(RMS)をナンメートルで報告した。これらRMS値を各サンプルの3つの断面の平均値とともに表5に示す。
Z範囲(Rр):画像の最高点と最低点との間の差。この値は画像の平面内の傾きに関して補正されない。したがって、平面フィッティング又はデータの平坦化により値は変化する。
Rq={Σ(Z1−Zavg)2/N}
式中、Zavgは画像内の平均Z値であり、Z1はZの現在値であり、Nは画像内における点の数である。この値は画像の平面内の傾きに関して補正されない。したがって、平面フィッティング又はデータの平坦化によりこの値は変化する。
表面積差=100[(表面積/S12−1]
式中、S1は走査された面積から阻止域によって除外された任意の面積を差し引いた長さ(及び幅)である。
pH保護層の作製に使用される幾つかの条件を表1に示す。
シリンジサンプルは以下のように作製した。COCシリンジバレルを形成するためのプロトコルに従い、COC 8007延伸バレルシリンジを作製した。COCシリンジバレル内部をSiOxで被覆するためのプロトコルに従い、SiOxバリア皮膜又は層をシリンジバレルに塗布した。COCシリンジバレル内部をOMCTSで被覆するためのプロトコルに従い、pH保護皮膜又は層をSiOxで被覆されたシリンジに塗布し、以下のように変更を加えた。表2に示すアルゴンキャリアガス及び酸素を使用した。プロセス条件は以下のように又は表2に示すように設定した。
OMCTS − 3sccm(使用する場合)
アルゴンガス − 7.8sccm(使用する場合)
酸素 0.38sccm(使用する場合)
電力 − 3ワット
電源オン時間 − 10秒
実施例5,6、及び7のシリンジを、容器中の溶解したケイ素を測定するためのプロトコルを使用して試験し、総抽出可能レベル(有機ケイ素化合物ベースPECVD pH保護皮膜又は層の抽出を示す)を決定し、この例に示すように変更を加えるとともに補足した。
噴霧器:Quartz Meinhardt
噴霧室:Cyclonic
RF(高周波)電力:1550ワット
アルゴン(Ar)流:15.0L/分
補助Ar流:1.2L/分
噴霧器ガス流:0.88L/分
積分時間:80秒
走査モード:ピークホッピング(peak hopping)
CeO(m/z156:<2%としてのセリウムのRPq(RPqは除去パラメータ(rejection parameter))
3つの異なるpH保護皮膜又は層を使用するシリンジ実施例9、10、及び11は、以下以外、即ち、表3に示すもの以外、実施例5〜8と同様に製造した。
・OMCTS − 2.5sccm
・アルゴンガス − 7.6sccm(使用する場合)
・酸素 0.38sccm(使用する場合)
・電力 − 3ワット
・電源投入時間 − 10秒
表3:OMCTSpH保護皮膜又は層
・OMCTS − 2.5sccm
・アルゴンガス − 7.6sccm(使用する場合)
・酸素 0.38sccm(使用する場合)
・電力 − 3ワット
・電源投入時間 − 10秒
実施例12〜14ではHMDSOを前駆体として使用したこと以外、実施例12〜14ではOMCTS前駆体ガスを用いた実施例9〜11を繰り返した。結果を表4に示す。これらの実施例に従って作製される皮膜は、バリア皮膜又は層が設けられているがpH保護皮膜又は層は設けられていない類似の容器と比較して容器の保管寿命を延長するためのpH保護皮膜又は層として、また保護皮膜又は層としても機能すると考えられている。
[表8は、上記OMCTS皮膜又は層の概要を示す。
ここで変更を加えるもの以外の、容器中の溶解したケイ素を測定するためのプロトコルは以下の通りである。試験溶液、pH3、6、7、8、9及び12の50mM緩衝溶液を用意する。研究されるpH値を提供するのに適切なpKa値を有する緩衝液を選択する。pH3、7、8及び12についてはリン酸カリウム緩衝液を選択し、pH6についてはクエン酸ナトリウム緩衝液を利用し、pH9についてはトリス緩衝液を選択する。3mlの各試験溶液をホウケイ酸ガラス5ml薬剤バイアル及びSiOxで被覆された5ml熱可塑性プラスチック薬剤バイアル内に配置する。バイアルは全て、標準的な、被覆されたストッパで閉じられ、圧着される。バイアルをストレージ内に20〜25℃で配置し、誘導結合プラズマ分光計(ICP)により、異なる保管時間の、バイアル内に収容された溶液中のSi含有量を10億分率(ppb)重量において分析するため、種々の時点において引き出す。
pH保護皮膜又は層をその保護皮膜又は層としての機能性について試験するために、SiOx皮膜+OMCTS pH保護皮膜又は層で被覆された容器について実験を実施した。容器は、環式オレフィンコポリマー(COC、Topas(登録商標)6013M−07)を含む5mLバイアル(バイアルには、通常、5mLまでの製品が充填され、キャップが嵌められている場合の、ヘッドスペースなしのそれら容量は約7.5mLである)である。
HMDSO流量:0.47sccm
酸素流量:7.5sccm
RF電力:70ワット
被覆時間:12秒(2秒のRF電力ランプアップ時間を含む)
OMCTS流量:2.5sccm
アルゴン流量:10sccm
酸素流量:0.7sccm
RF電力:3.4ワット
被覆時間:5秒
上記の比較実施例26の結果と実施例27の結果が以下のように比較されうる。ここで、「pH保護被膜又は層」とは、実施例BBにおいて言及したSiOxCyの皮膜である。
同様の加速させた溶解条件下で実施したいくつかの異なる実験の以下のデータによって別の比較を示す。そのうちの1日のデータを同様に図10に示す。
表9に列挙したサンプル1〜6を実施例AAに記載したように調製した。更なる詳細は以下の通りである。
この例及び表10(結果が表にされている)に示すように変更を加え、実施例27と同様の実験を実施した。100本の5mLCOPバイアルを作製し、サンプルPC194では不活性化層又はpH保護皮膜のみを塗布したこと以外は、上に記載したようにSiOxバリア層及びOMCTSベースのpH保護皮膜又は層で被覆した。表10に報告されるように、バイアルの表面から抽出され、全pH保護皮膜又は層を除去する皮膜量を10億分率において再度測定した。
RF電力レベルの継続的な増加の、pH保護皮膜又は層のFTIR吸光度スペクトルに対する影響を示す、実施例31のものに類似する更なる一連の実験を実施した。結果は表11に示す。表11では、いずれの場合においても、通常、約1000〜1040cm−1に位置するSi−O−Si対称伸縮ピークの最大振幅と、通常、約1060〜約1100cm−1に位置するSi−O−Si非対称伸縮ピークの最大振幅との間において0.75を超える対称/非対称比率を示す。したがって、特に定めのない限り比較可能な条件下における対称/非対称比率は、20Wの電力レベルにおいては0.79、40W、60W又は80Wの電力レベルにおいては1.21又は1.22、100ワットにおいては1.26である。
この実施例の目的は、ガラス、COP及び被覆バイアルからの、僅かに粘性の水溶液の回収性(recoverability)又は排出を評価することである。
シリンジ試料は以下のように作製した。COCシリンジバレルを形成するためのプロトコルに従って、COC8007延伸バレルシリンジを作製した。COCシリンジバレル内部をSiOxで被覆するためのプロトコルに従って、SiOx皮膜又は層をシリンジの幾つかに塗布した。以下のように変更を加えた、COCシリンジバレル内部をOMCTS滑性皮膜で被覆するためのプロトコルに従い、pH保護皮膜又は層をSiOx被覆シリンジに塗布した。OMCTSは揮発性が低いため、気化器から供給した。アルゴンキャリアガスを使用した。プロセス条件は以下のように設定した。
・OMCTS − 3sccm
・アルゴンガス − 65sccm
・電力 − 6ワット
・時間 − 10秒
本明細書に記載のPECVD三層皮膜を、例えば、次のように1mL容器〜5mL容器に関して塗布することができる。2つの特定の実施例は、1mL熱可塑性樹脂シリンジ及び5mL熱可塑性樹脂薬物バイアルである。それより大きい又は小さい容器はパラメータの調節を必要とし、当業者はそれを本明細書の開示に鑑みて実施することができる。
1mLシリンジ及び5mLバイアルに使用した特定被覆パラメータの実施例をPECVD三層プロセス特定のパラメータ表(1mLシリンジ及び5mLバイアル)に示す。
図18及び表、実施例36を参照すると、固定(staked)針(PECVD堆積中に存在する)及び表示する三層皮膜(平均厚さ:接着又はタイコート皮膜又は層38nm;バリア皮膜又は層55nm、pH保護皮膜又は層273nm)を有する1mLシリンジの長さに沿った4つの点における厚さの均一性が示されている。表は、印を付けた4つの点における個々の層の厚さを示し、高プロファイルシリンジバレルに沿った各点で各層が十分な厚さを有することを示す。
図21及び図22は、内径に対してずっと短い、従って均一に被覆し易い5mLバイアルの三層皮膜分布を示し、皮膜厚さのばらつきがほとんどなく、被覆された表面の大部分は三層の厚さ150〜250nmであり、容器を被覆した三層が50〜250nmであったのはごく一部だけであった。
図23は、バイアル位置による皮膜厚さ(nm)の内訳を示す。バイアル皮膜分布表は、皮膜の均一性を示す。
図24は、前述の三層バイアル皮膜の完全性を示す目視検査結果である。図24及び図24Aの3本の5mL環状オレフィン重合体(COC)バイアルは、それぞれ:
・非被覆(左側のバイアル)、
・本明細書に記載の二層皮膜(バリア皮膜又は層+pH保護皮膜又は層−三層皮膜の第2の成分と第3の成分)を被覆したもの(中央のバイアル);及び
・本明細書に記載の三層皮膜を被覆したもの(右側のバイアル)、
であった。
Claims (14)
- ・内腔の少なくとも一部を囲む内部表面を有する熱可塑性の壁と;
・SiOxCyHz又はSiNxCyHz(式中、xは、X線光電子分光法(XPS)により測定した場合、0.5〜2.4であり、yは、XPSにより測定した場合、0.6〜3であり、zは、ラザフォード後方散乱分光法(RBS)又は水素前方散乱法(HFS)の少なくとも一方により測定した場合、2〜9である)を含み又はそれからなり、壁面に面する外面と、内部表面とを有するタイコート皮膜又は層と;
・前記タイコート皮膜又は層の内部表面と前記内腔との間に配置される、SiOx(式中、xは、XPSにより測定した場合、1.5〜2.9である)のバリア皮膜又は層と;
・前記バリア皮膜又は層と前記内腔との間に配置される、SiOxCyHz(式中、xは、XPSにより測定した場合、0.5〜2.4であり、yは、XPSにより測定した場合、0.6〜3であり、zは、RBS又はHFSの少なくとも一方により測定した場合、2〜9である)のpH保護皮膜又は層と
を含む、又はそれらからなる容器であって、
前記pH保護皮膜又は層が、
・1000〜1040cm -1 におけるSi−O−Si対称伸縮ピークの最大振幅と、
・1060〜1100cm -1 におけるSi−O−Si非対称伸縮ピークの最大振幅と、
の比率が0.75より大きいFTIR吸光度スペクトルを示し、
併用して有効な前記pH保護皮膜又は層とタイコート皮膜又は層とは、少なくとも6か月間、前記内腔に収容された5より高いpHを有する流体に攻撃されても前記バリア皮膜又は層を少なくとも実質的に非溶解状態に保つものであり、注射用水で希釈され、濃縮硝酸でpH8に調整され、0.2wt.%ポリソルベート80界面活性剤を含有する50mMリン酸カリウム緩衝液による前記容器からのケイ素溶解速度が、170ppb/日未満である、前記容器。 - 前記タイコート皮膜又は層、前記バリア皮膜又は層、あるいは前記pH保護被膜又は層の少なくとも1つが、プラズマ化学気相成長法(PECVD)により塗布される、請求項1に記載の容器。
- シリンジバレル、バイアル、カートリッジ、又はブリスターパッケージを含む又はそれからなる、請求項1〜2のいずれか一項に記載の容器。
- 前記熱可塑性の壁の少なくとも一部が、
・ポリオレフィン、
・ポリビニルアルコール、
・ポリメタクリレートエーテル
・ポリアクリル酸
・ポリアミド
・ポリイミド
・ポリスルホン
・ポリ乳酸
・環状オレフィン重合体又は共重合体
・ポリエステル
・ポリオレフィンとポリエステルとの組合せ、又は
・これらのいずれか1つの組合せ
を含む又はそれからなる、請求項1〜3のいずれか一項に記載の容器。 - 前記pH保護皮膜又は層あるいはタイコート皮膜又は層の少なくとも一方に関して、xが、XPSにより測定した場合、1〜2であり、yが、XPSにより測定した場合、0.6〜1.5であり、zが、RBS又はHFSにより測定した場合、2〜5である、請求項1〜4のいずれか一項に記載の容器。
- 前記pH保護皮膜又は層が、厚さ10〜1000nmである、請求項1〜5のいずれか一項に記載の容器。
- 前記内腔に収容された5より高いpHを有する流体が直接接触した場合の前記pH保護皮膜又は層の浸食速度が、前記同じ条件下で前記同じ流体が直接接触した場合の前記バリア皮膜又は層の浸食速度の20%未満である、請求項1〜6のいずれか一項に記載の容器。
- 前記内腔に収容された5より高いpHを有する流体が直接接触する時、元来は20℃の前記流体を収容する前記容器の保管に基づき、あるいは40℃の前記流体を収容する前記容器の保管に基づき、保管寿命が少なくとも2年である、請求項1〜7のいずれか一項に記載の容器。
- 前記内腔に収容された5より高いpHを有する流体が、前記流体と88時間接触する毎にpH保護皮膜又は層厚さ1nm以下の割合で、前記pH保護皮膜又は層を除去する、請求項1〜8のいずれか一項に記載の容器。
- 前記pH保護皮膜又は層は、
- 前記タイコート皮膜又は層が平均して厚さ5〜200nmである、請求項1〜10のいずれか一項に記載の容器。
- 内壁に前記タイコート皮膜又は層、バリア皮膜又は層、及びpH保護皮膜又は層が被覆されているシリンジバレルを有し、前記バレル内に着座するプランジャを更に有し、前記内腔に収容された5より高いpHを有する医薬組成物を収容するプレフィルドシリンジであって、少なくとも6ヶ月の保管寿命を有するプレフィルドシリンジである、請求項1〜11のいずれか一項に記載の容器。
- 5より高いpHを有する流体を保管するための、請求項1〜12のいずれか一項に記載の容器の使用。
- 請求項1〜12のいずれか一項に記載の容器の製造方法であって、
・タイコート皮膜又は層を形成する工程と;
・バリア皮膜又は層を形成する工程と;
・前記バリア皮膜又は層と前記内腔との間に配置されるpH保護皮膜又は層を形成する工程と;
を含み、
前記pH保護皮膜又は層とタイコート皮膜又は層とを併用すると、少なくとも6か月間、前記内腔に収容された5より高いpHを有する流体に攻撃されても前記バリア皮膜又は層を少なくとも実質的に非溶解状態に保つのに有効である、前記方法。
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