JP7391779B2 - 耐層剥離性ガラス製容器の形成方法 - Google Patents
耐層剥離性ガラス製容器の形成方法 Download PDFInfo
- Publication number
- JP7391779B2 JP7391779B2 JP2020105942A JP2020105942A JP7391779B2 JP 7391779 B2 JP7391779 B2 JP 7391779B2 JP 2020105942 A JP2020105942 A JP 2020105942A JP 2020105942 A JP2020105942 A JP 2020105942A JP 7391779 B2 JP7391779 B2 JP 7391779B2
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- glass
- glass container
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- sidewall
- container
- Prior art date
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Images
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- C03C17/00—Surface treatment of glass, not in the form of fibres or filaments, by coating
- C03C17/28—Surface treatment of glass, not in the form of fibres or filaments, by coating with organic material
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- C03C17/00—Surface treatment of glass, not in the form of fibres or filaments, by coating
- C03C17/34—Surface treatment of glass, not in the form of fibres or filaments, by coating with at least two coatings having different compositions
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- C03C17/00—Surface treatment of glass, not in the form of fibres or filaments, by coating
- C03C17/34—Surface treatment of glass, not in the form of fibres or filaments, by coating with at least two coatings having different compositions
- C03C17/42—Surface treatment of glass, not in the form of fibres or filaments, by coating with at least two coatings having different compositions at least one coating of an organic material and at least one non-metal coating
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- C03C21/00—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface
- C03C21/001—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface in liquid phase, e.g. molten salts, solutions
- C03C21/002—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface in liquid phase, e.g. molten salts, solutions to perform ion-exchange between alkali ions
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- C08G73/00—Macromolecular compounds obtained by reactions forming a linkage containing nitrogen with or without oxygen or carbon in the main chain of the macromolecule, not provided for in groups C08G12/00 - C08G71/00
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- C08G73/10—Polyimides; Polyester-imides; Polyamide-imides; Polyamide acids or similar polyimide precursors
- C08G73/1046—Polyimides containing oxygen in the form of ether bonds in the main chain
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- C08G73/1067—Wholly aromatic polyimides, i.e. having both tetracarboxylic and diamino moieties aromatically bound
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- C09D179/00—Coating compositions based on macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing nitrogen, with or without oxygen, or carbon only, not provided for in groups C09D161/00 - C09D177/00
- C09D179/04—Polycondensates having nitrogen-containing heterocyclic rings in the main chain; Polyhydrazides; Polyamide acids or similar polyimide precursors
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- C03C2217/00—Coatings on glass
- C03C2217/70—Properties of coatings
- C03C2217/78—Coatings specially designed to be durable, e.g. scratch-resistant
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- C03C2218/00—Methods for coating glass
- C03C2218/10—Deposition methods
- C03C2218/11—Deposition methods from solutions or suspensions
- C03C2218/111—Deposition methods from solutions or suspensions by dipping, immersion
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- Y10T428/131—Glass, ceramic, or sintered, fused, fired, or calcined metal oxide or metal carbide containing [e.g., porcelain, brick, cement, etc.]
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Description
Type IB医薬品ホウケイ酸ガラスから形成されたガラス製容器のエッチング速度を測定した。各々がGerresheimerから市販されているType IB医薬品ホウケイ酸ガラスから形成された5本のガラス製容器2組(組G1およびG2)をテストした。具体的には、容器は、Gerresheimer GX-51 Flintガラス製の3mlガラスバイアルであった。各々がType IB医薬品ホウケイ酸ガラスから形成されており、Schott Glassから市販されている5本のガラス製容器2組(組S1およびS2)もまたテストした。具体的には、容器は、Schott Fiolax(登録商標)ガラス製の3mlガラスバイアルであった。容器の各々を最初に計量し、重量を記録した。組G1およびS1を、0.5モル濃度のフッ化水素酸および0.9モル濃度の塩酸の溶液で満たした。この溶液を、1分間~12分間(すなわち、1分間、2分間、4分間、8分間および12分間)の範囲内の異なる時間の間、容器の各々において保持した。時間が経過した後、溶液を各容器から出し、容器をすすぎ、乾燥させ、計量して重量損失を測定した。次いで、重量損失を推定表面積に正規化した。
2組の容器をテストして、容器の内部からの永続的層不均質性を有する内部表面層の除去におけるエッチング剤の効力を評価した。これらの容器は、Type IB医薬品ホウケイ酸ガラス製であった。テストしたガラス製容器は、Gerresheimer GX-51 Flintガラス製3mlガラスバイアル(「G」サンプル)およびSchott Fiolax(登録商標)ガラス製3mlガラスバイアル(「S」サンプル)であった。5本の容器(GおよびSサンプルの混合)の第1の組をテストして、永続的層不均質性を有する内部表面層の存在を判定した。具体的には、メチレンブルー染料の1%水溶液を、その組の各容器の内部空間に1分間入れた。次いで、容器を空にし、水ですすいだ。この組における各容器を青色の染色について視覚的に検査した。各容器は、容器の内部表面において認識可能な程度の青色の着色を有するもので、特に富ホウ素領域といった永続的層不均質性を有する内部表面層の存在を示しており、これは、各バイアルの底付近において青色の着色が灰色の領域として現れている図6Aに示されているとおりである。
ガラス製容器をテストして、永続的層不均質性を有する内部表面層を除去することによる、ガラス製容器の加水分解耐性に対する効果を判定した。容器は、Type IB医薬品ホウケイ酸ガラス製であった。具体的には、「G」容器は、Gerresheimer GX-51 Flintガラス製の3mlガラスバイアルであった。「S」容器は、Schott Fiolax(登録商標)ガラス製の3mlガラスバイアルであった。サンプルを、「Glass Containers For Pharmaceutical Use」と題されたヨーロッパ薬局方7.0の第3.2.1節に準拠してテストした(本明細書において以降、欧州特許第3.2.1テスト)。サンプルG1、S1~S3、Gエッチングしていない、S4、S5、G6およびG7を、成形されたままの状態でテストした。Gエッチングしたは、1.5モル濃度のフッ化水素酸および3モル濃度の塩酸を含むエッチング剤で処理した後にテストした。エッチング剤を12分間の間容器の中に入れたままにした。次いで、容器を空にし、すすぎ、乾燥させ、テストした。
Claims (7)
- ガラス製容器の形成方法であって、
内部空間を少なくとも部分的に内包するサイドウォールを備えるガラス製容器を形成する工程であって、前記サイドウォールの内部表面の少なくとも一部分が前記サイドウォールの中間点に比して永続性のある層不均質性を有する内部表面層を有し、前記内部表面層が前記サイドウォールの前記中間点と比較して貧シリカ性でありかつ富ホウ素領域を含む工程、および
前記サイドウォールの被改質内部表面が、前記被改質内部表面の下方10nmから前記サイドウォールの肉厚部中に延在する内部領域を有するよう、前記サイドウォールの前記内部表面から前記内部表面層を、フッ化水素酸と鉱酸と、キレート化剤および界面活性剤の少なくとも一つを含むエッチング剤により除去する工程であって、前記内部領域が、前記被改質内部表面が層剥離に対して耐性であるよう、前記サイドウォールの前記中間点に比して永続性のある層均質性を有する工程、
を含み、
前記内部表面層が除去された後において、前記内部領域における各構成成分の層濃度の極値が、前記サイドウォールの前記肉厚部の中間点における同一の構成成分のバルク濃度の92%以上、かつ、108%以下である、
ことを特徴とする方法。 - 前記ガラス製容器が成形されたままの状態である場合、前記内部表面層における各構成成分の層濃度の極値が、前記サイドウォールの中間点における同一の構成成分のバルク濃度の80%未満または120%超であることを特徴とする、請求項1に記載の方法。
- 前記サイドウォールの前記被改質内部表面が、前記ガラス製容器の前記被改質内部表面の全体にわたって、前記ガラス製容器の前記被改質内部表面から10nmから50nmの深度まで延在する表面領域を備え、
前記永続的層不均質性が除去された後において、前記ガラス製容器の前記被改質内部表面上の独立した点について、前記独立した点における前記表面領域中の前記ガラスの構成成分の各々の表面濃度の極値が、前記ガラス製容器の前記被改質内部表面上の任意の第2の独立した点における前記表面領域中の同一の構成成分の70%以上、かつ、130%以下であることを特徴とする、請求項1又は2に記載の方法。 - 外表面層を前記サイドウォールの外表面から除去する工程をさらに含むことを特徴とする、請求項1から3のいずれか一項に記載の方法。
- 前記内部表面層が除去された後、前記ガラス製容器が10以下の層剥離係数を有することを特徴とする、請求項1から4のいずれか一項に記載の方法。
- 前記ガラス製容器が、ASTM規格E438-92に準拠したType I、クラスAまたはType I、クラスBガラスから形成されていることを特徴とする、請求項1から5のいずれか一項に記載の方法。
- 前記被改質内部表面の表面積10,000μm2当たりの平均山対谷粗さが1μm未満であることを特徴とする、請求項1から6のいずれか一項に記載の方法。
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