TW201433311A - 形成抗分層玻璃容器的方法 - Google Patents
形成抗分層玻璃容器的方法 Download PDFInfo
- Publication number
- TW201433311A TW201433311A TW102143273A TW102143273A TW201433311A TW 201433311 A TW201433311 A TW 201433311A TW 102143273 A TW102143273 A TW 102143273A TW 102143273 A TW102143273 A TW 102143273A TW 201433311 A TW201433311 A TW 201433311A
- Authority
- TW
- Taiwan
- Prior art keywords
- glass
- glass container
- sidewall
- layer
- container
- Prior art date
Links
- 239000011521 glass Substances 0.000 title claims abstract description 502
- 238000000034 method Methods 0.000 title claims abstract description 77
- 230000032798 delamination Effects 0.000 title claims abstract description 51
- 239000002344 surface layer Substances 0.000 claims abstract description 123
- 239000010410 layer Substances 0.000 claims abstract description 109
- 239000000470 constituent Substances 0.000 claims description 78
- 239000000203 mixture Substances 0.000 claims description 74
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 34
- KRHYYFGTRYWZRS-UHFFFAOYSA-N Fluorane Chemical compound F KRHYYFGTRYWZRS-UHFFFAOYSA-N 0.000 claims description 25
- 239000000463 material Substances 0.000 claims description 25
- 238000005530 etching Methods 0.000 claims description 20
- 230000002688 persistence Effects 0.000 claims description 20
- 229910000420 cerium oxide Inorganic materials 0.000 claims description 13
- BMMGVYCKOGBVEV-UHFFFAOYSA-N oxo(oxoceriooxy)cerium Chemical compound [Ce]=O.O=[Ce]=O BMMGVYCKOGBVEV-UHFFFAOYSA-N 0.000 claims description 13
- 239000005388 borosilicate glass Substances 0.000 claims description 11
- 239000002253 acid Substances 0.000 claims description 9
- 230000007547 defect Effects 0.000 claims description 9
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 3
- 239000011707 mineral Substances 0.000 claims description 3
- 229910021538 borax Inorganic materials 0.000 claims description 2
- 235000010339 sodium tetraborate Nutrition 0.000 claims description 2
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 claims description 2
- 230000002085 persistent effect Effects 0.000 abstract description 30
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- 229940079593 drug Drugs 0.000 description 9
- 230000015556 catabolic process Effects 0.000 description 7
- 238000006731 degradation reaction Methods 0.000 description 7
- CXKWCBBOMKCUKX-UHFFFAOYSA-M methylene blue Chemical compound [Cl-].C1=CC(N(C)C)=CC2=[S+]C3=CC(N(C)C)=CC=C3N=C21 CXKWCBBOMKCUKX-UHFFFAOYSA-M 0.000 description 7
- 229960000907 methylthioninium chloride Drugs 0.000 description 7
- 230000008569 process Effects 0.000 description 7
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 description 6
- 239000007864 aqueous solution Substances 0.000 description 6
- 239000002585 base Substances 0.000 description 6
- 230000008859 change Effects 0.000 description 6
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- 229910052796 boron Inorganic materials 0.000 description 5
- CETPSERCERDGAM-UHFFFAOYSA-N ceric oxide Chemical compound O=[Ce]=O CETPSERCERDGAM-UHFFFAOYSA-N 0.000 description 5
- 229910000422 cerium(IV) oxide Inorganic materials 0.000 description 5
- 238000005342 ion exchange Methods 0.000 description 5
- 238000002386 leaching Methods 0.000 description 5
- ZOXJGFHDIHLPTG-UHFFFAOYSA-N Boron Chemical compound [B] ZOXJGFHDIHLPTG-UHFFFAOYSA-N 0.000 description 4
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 4
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- 239000010751 BS 2869 Class A2 Substances 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000003929 acidic solution Substances 0.000 description 3
- 239000002738 chelating agent Substances 0.000 description 3
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- 238000010438 heat treatment Methods 0.000 description 3
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- 238000000386 microscopy Methods 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- QPJSUIGXIBEQAC-UHFFFAOYSA-N n-(2,4-dichloro-5-propan-2-yloxyphenyl)acetamide Chemical compound CC(C)OC1=CC(NC(C)=O)=C(Cl)C=C1Cl QPJSUIGXIBEQAC-UHFFFAOYSA-N 0.000 description 3
- 239000008194 pharmaceutical composition Substances 0.000 description 3
- 150000003839 salts Chemical class 0.000 description 3
- 238000004544 sputter deposition Methods 0.000 description 3
- 238000010186 staining Methods 0.000 description 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 150000007513 acids Chemical class 0.000 description 2
- 239000003513 alkali Substances 0.000 description 2
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- BMYNFMYTOJXKLE-UHFFFAOYSA-N 3-azaniumyl-2-hydroxypropanoate Chemical compound NCC(O)C(O)=O BMYNFMYTOJXKLE-UHFFFAOYSA-N 0.000 description 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
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- 125000000707 boryl group Chemical group B* 0.000 description 1
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- 150000001875 compounds Chemical class 0.000 description 1
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C17/00—Surface treatment of glass, not in the form of fibres or filaments, by coating
- C03C17/001—General methods for coating; Devices therefor
- C03C17/003—General methods for coating; Devices therefor for hollow ware, e.g. containers
- C03C17/005—Coating the outside
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
- B65D1/0207—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1468—Containers characterised by specific material properties
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B17/00—Layered products essentially comprising sheet glass, or glass, slag, or like fibres
- B32B17/06—Layered products essentially comprising sheet glass, or glass, slag, or like fibres comprising glass as the main or only constituent of a layer, next to another layer of a specific material
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
- B65D1/0207—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features
- B65D1/0215—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features multilayered
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/40—Details of walls
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/40—Details of walls
- B65D1/42—Reinforcing or strengthening parts or members
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D23/00—Details of bottles or jars not otherwise provided for
- B65D23/02—Linings or internal coatings
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D23/00—Details of bottles or jars not otherwise provided for
- B65D23/08—Coverings or external coatings
- B65D23/0807—Coatings
- B65D23/0814—Coatings characterised by the composition of the material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D23/00—Details of bottles or jars not otherwise provided for
- B65D23/08—Coverings or external coatings
- B65D23/0807—Coatings
- B65D23/0814—Coatings characterised by the composition of the material
- B65D23/0821—Coatings characterised by the composition of the material consisting mainly of polymeric materials
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/14—Linings or internal coatings
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/34—Coverings or external coatings
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
- B65D65/38—Packaging materials of special type or form
- B65D65/42—Applications of coated or impregnated materials
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03B—MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
- C03B23/00—Re-forming shaped glass
- C03B23/04—Re-forming tubes or rods
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C15/00—Surface treatment of glass, not in the form of fibres or filaments, by etching
- C03C15/02—Surface treatment of glass, not in the form of fibres or filaments, by etching for making a smooth surface
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C17/00—Surface treatment of glass, not in the form of fibres or filaments, by coating
- C03C17/22—Surface treatment of glass, not in the form of fibres or filaments, by coating with other inorganic material
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- 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
- C03C17/30—Surface treatment of glass, not in the form of fibres or filaments, by coating with organic material with silicon-containing compounds
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C17/00—Surface treatment of glass, not in the form of fibres or filaments, by coating
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Abstract
在一個實施例中,一種形成玻璃容器之方法可包括形成包含至少部分封閉內部容積之側壁的玻璃容器。該側壁之內表面之至少一部分可具有相對於該側壁之中點具有持久性層異質性的內表面層。該玻璃容器之內表面層可自該側壁之該內表面移除,使得該側壁之經修飾內表面具有自該經修飾內表面下方約10nm處延伸進入該側壁之一定厚度處的內部區域。該內部區域可相對於該側壁之該中點具有持久性層均質性,使得該經修飾內表面具有抗分層性。
Description
本申請案主張2012年11月30日申請且標題為「Glass Containers With Improved Attributes」之美國專利申請案第61/731,767號及2013年11月25日申請且標題為「Methods For Forming Delamination Resistant Glass Containers」之美國專利申請案第14/088,556號之優先權,兩個專利申請案均以引用之方式併入本文中。
本說明書大體上關於形成玻璃容器之方法,且更確切言之係關於以使得玻璃容器具有抗分層性之方式形成玻璃容器之方法。
歷史上將玻璃用作用於封裝藥物之較佳材料,因為相對於其他材料玻璃具有密封性、光學透明度及極佳化學耐久性。確切言之,用於藥物封裝之玻璃必須具有足夠化學耐久性以便不會影響其中所含醫藥組合物的穩定性。具有合適化學耐久性之玻璃包括在ASTM標準E438.92「IA型」及「IB
型」玻璃組合物(該等玻璃組合物具有經證實之化學耐久性歷史)範圍內的彼等玻璃組合物。一般而言,化學耐久性玻璃為在玻璃暴露於溶液很長一段時間時構成組分不會自玻璃中溶解出來的玻璃。
儘管IA型及IB型玻璃組合物由於具有化學耐久性而常用於藥物封裝中,但它們具有若干缺陷,包括藥物封裝之內表面使玻璃微粒脫落或在暴露於藥物溶液之後發生「分層」的趨勢。
因此,對展現出降低之分層傾向之替代性玻璃容器存在需要。
根據一個實施例,一種形成玻璃容器之方法可包括形成包含至少部分封閉內部容積之側壁的玻璃容器。該側壁之內表面之至少一部分可具有相對於該側壁之中點具有持久性層異質性的內表面層。該玻璃容器之內表面層可自該側壁之該內表面移除,使得該側壁之經修飾內表面具有自該經修飾內表面下方約10nm處延伸進入該側壁之一定厚度處的內部區域。該內部區域可相對於該側壁之該中點具有持久性層均質性,使得該經修飾內表面具有抗分層性。
在另一實施例中,一種形成玻璃容器之方法可包括形成包含至少部分封閉內部容積之側壁的玻璃容器。該側壁之內表面之至少一部分可具有相對於該側壁之中點具有持久性層異質性的內表面層。蝕刻該側壁之該內表面以移除該內表面層,使得該側壁之經修飾內表面具有自該經修飾內表面
下方約10nm處延伸進入該側壁之一定厚度處的內部區域。該內部區域可相對於該側壁之該中點具有持久性層均質性,使得該經修飾內表面具有抗分層性。
在另一實施例中,一種形成玻璃容器之方法包括形成包含至少部分封閉內部容積之側壁的玻璃容器,使得該側壁之內表面之至少一部分具有內表面層。當該玻璃容器處於成形時狀態時,該內表面層中各構成組分之層濃度的極值小於約80%或大於約120%的該側壁之中點處相同構成組分的體積濃度。將該內表面層自該側壁之該內表面移除,使得該側壁之經修飾內表面具有延伸進入該側壁之一定厚度處的內部區域。在已移除該內表面層之後,該內部區域中各構成組分之層濃度的極值大於或等於約92%且小於或等於約108%的該側壁之厚度之中點處相同構成組分的體積濃度。
本文中所描述之玻璃容器之其他特徵及優勢將闡述於以下實施方式中,且在某種程度上對於熟習此項技術者而言將容易地根據該實施方式而顯而易知,或藉由實踐本文中所描述之實施例(包括以下實施方式、申請專利範圍以及隨附圖式)而被認識到。
應瞭解,前面之概述及以下實施方式均描述各種實施例且意欲提供概觀或架構以便理解所主張之標的之性質及特徵。包括隨附圖式以便進一步理解各種實施例,且將隨附圖式併入本說明書中且構成本說明書之一部分。圖式說明本文所描述之各種實施例,且連同該實施方式一起用來解釋所主張之標的之原理及操作。
100‧‧‧玻璃容器
102‧‧‧玻璃主體
104‧‧‧內表面
104"‧‧‧經修飾內表面
105‧‧‧內表面層
106‧‧‧外表面
108‧‧‧內部容積
110‧‧‧壁部分
112‧‧‧底部分
114‧‧‧跟部分
120‧‧‧內部區域
130‧‧‧表面區域
第1圖示意性地展示根據本文所描述之一或多個實施例之玻璃容器,確切言之玻璃小瓶的截面;第2圖示意性地展示在移除具有持久性層異質性之內表面層之前第1圖之玻璃容器的側壁的一部分;第3圖示意性地展示在移除具有持久性層異質性之內表面層之後第1圖之玻璃容器的側壁的一部分;第4圖示意性地展示在移除具有持久性層異質性之內表面層之後第1圖之玻璃容器的側壁的部分;第5圖以圖形方式展示由不同IB型玻璃形成且經不同蝕刻劑蝕刻之玻璃容器隨蝕刻時間(x軸)而變化的重量損失(y軸);第6A圖為具有染色之玻璃小瓶之相片,該染色指示具有持久性層異質性之內表面層的存在;且第6B圖為在蝕刻處理及亞甲基藍染色之後的玻璃小瓶之相片。
現將詳細參考形成具有改良之抗分層性之玻璃容器的方法之各種實施例,該等玻璃容器之實例說明於隨附圖式中。在任何可能的時候,將貫穿圖式使用相同元件符號來表示相同或相似部分。在一個實施例中,一種形成玻璃容器之方法可包括形成包含至少部分封閉內部容積之側壁的玻璃容器。該側壁之內表面之至少一部分可具有相對於該側壁之中點具有持久性層異質性的內表面層。該玻璃容器之內表面層
可自該側壁之該內表面移除,使得該側壁之經修飾內表面具有自該經修飾內表面下方約10nm處延伸進入該側壁之一定厚度處的內部區域。該內部區域可相對於該側壁之該中點具有持久性層均質性,使得該經修飾內表面具有抗分層性。形成抗分層玻璃容器之方法及該等玻璃容器之特性將伴隨對隨附圖式之特定參考而於本文中更詳細地加以描述。
如本文所使用之術語「化學耐久性」係指玻璃組合物在暴露於指定化學條件時抗降解之能力。確切言之,根據3個既定材料測試標準評估本文所描述之玻璃組合物之化學耐久性:日期為2001年3月且標題為「Testing of glass-Resistance to attack by a boiling aqueous solution of hydrochloric acid-Method of test and classification」之DIN 12116;標題為「Glass--Resistance to attack by a boiling aqueous solution of mixed alkali--Method of test and classification」之ISO 695:1991:標題為「Glass--Hydrolytic resistance of glass grains at 121 degrees C--Method of test and classification」之ISO 720:1985;及ISO 719:1985「Glass--Hydrolytic resistance of glass grains at 98 degrees C--Method of test and classification」。各標準及各標準內之分類進一步詳細地描述於本文中。或者,可根據評估玻璃表面之耐久性的標題為「Surface Glass Test」的USP<660>及/或標題為「Glass Containers For Pharmaceutical Use」的歐洲藥典3.2.1(European Pharmacopeia 3.2.1)評估玻璃組合物之化學耐久性。
用於容納醫藥組合物之習知玻璃容器或玻璃封裝大體由已知展現化學耐久性及低熱膨脹度的玻璃組合物(諸如IB型鹼性硼矽酸鹽玻璃)形成。儘管鹼性硼矽酸鹽玻璃展現良好的化學耐久性,但容器製造商已觀察到分散於玻璃容器中所含溶液中的富含二氧化矽的玻璃薄片。此現象稱為分層。分層尤其出現於已將溶液以與玻璃表面直接接觸之形式存儲了較長時間(數月至數年)時。因此,展現良好化學耐久性之玻璃可能不一定具有抗分層性。
分層係指在一系列瀝濾、腐蝕及/或風化反應之後玻璃粒子自玻璃表面釋放的一種現象。一般而言,玻璃粒子為富含二氧化矽之玻璃薄片,該等玻璃薄片由於將改質劑離子瀝濾至封裝內所含溶液而源自於封裝之內表面。此等薄片大體可為約1nm至約2μm厚,且寬度大於約50μm。因為此等薄片主要由二氧化矽組成,所以該等薄片大體不會在自玻璃表面釋放之後進一步降解。
迄今為止,已假設分層係因在將玻璃暴露於用於使玻璃重新形成容器形狀之高溫時出現於鹼性硼矽酸鹽玻璃中的相分離所致。
然而,目前咸信富含二氧化矽之玻璃薄片自玻璃容器之內表面發生分層係因呈成形時狀態之玻璃容器的組成特徵所致。確切言之,鹼性硼矽酸鹽玻璃之高二氧化矽含量導致玻璃具有相對較高的熔融及成形溫度。然而,玻璃組合物中之鹼性及硼酸鹽組分在低得多的溫度下熔融及/或汽化。特定言之,玻璃中之硼酸鹽物質具有高度揮發性且在形成及重
新形成玻璃所必需之高溫下自玻璃表面蒸發。
確切言之,在高溫下且在直接火焰中使玻璃原料(諸如玻璃管或其類似物)重新形成玻璃容器。在較高設備速度下所需要之高溫導致更易揮發之硼酸鹽物質自玻璃表面之部分蒸發。當此蒸發出現在玻璃容器之內部容積內時,所揮發之硼酸鹽物質再沈積於玻璃容器表面之其他區域中,造成玻璃容器表面中之組成異質性,尤其相對於玻璃容器內部之近表面區域(亦即在或直接鄰近於玻璃容器之內表面處之彼等區域)而言。
舉例而言,參看第1圖,示意性地展示一種玻璃容器,諸如用於存儲醫藥組合物之玻璃容器的截面。玻璃容器100大體包含具有玻璃主體102之玻璃物品。玻璃主體102延伸於內表面104與外表面106之間且大體封閉內部容積108。在第1圖中所示之玻璃容器100之實施例中,玻璃主體102大體包含壁部分110及底部分112。壁部分110及底部分112大體可具有在約0.5mm至約3.0mm範圍內之厚度。壁部分110經由跟部分114過渡至底部分112。內表面104及底部分112為未經塗佈的(亦即其不含任何無機塗層或有機塗層),且因此玻璃容器100之內部容積108中所存儲之內容物與形成玻璃容器100之玻璃直接接觸。儘管在第1圖中將玻璃容器100展示為具有特定形狀形式(亦即小瓶),但應瞭解,玻璃容器100可具有其他形狀形式,包括但不限於真空採集器(vacutainer)、筒(cartridge)、注射器、注射器桶、安瓿、瓶子、燒瓶、管形瓶、管、燒杯或其類似物。
如本文中所指出,玻璃容器100可藉由將玻璃管轉化成容器形狀而形成。舉例而言,當加熱玻璃管之一端以使該玻璃管閉合且形成容器100之底部或底部分112時,具有更高揮發性之物質,諸如硼酸鹽物質及/或鹼性物質或其類似物,會自該管之底部部分蒸發且再沈積於該管中之其他地方。材料自容器之跟及底部分發生的蒸發尤其顯著,因為容器之此等區域經歷最廣泛之重新形成且因此暴露於最高溫度。因此,暴露於較高溫度之容器區域,諸如底部分112,可具有富含二氧化矽之表面。容器之內表面104的便於揮發物質沈積之其他區域,諸如壁部分110,可具有由揮發物質之冷凝所形成的內表面層105(示意性地展示於第2圖中),且因此該表面缺乏二氧化矽。舉例而言,在硼酸鹽物質之情況下,處於大於玻璃組合物之退火點但小於重新形成期間玻璃所經歷之最熱溫度之溫度下的便於硼沈積之區域會導致玻璃表面上的硼併入。
現參看第1圖及第2圖,第2圖示意性地展示玻璃容器100之一部分之內表面104,包括內表面層105,該內表面層105包括經沈積之揮發物質。內表面層105之組成與壁部分中更深處(諸如壁部分110之中點MP處)之玻璃的組成不同。確切言之,第2圖示意性地展示第1圖之玻璃容器100之壁部分110的部分截面。玻璃容器100之玻璃主體102包括內表面層105,該內表面層105自玻璃容器100之內表面104延伸進入壁部分110之一定厚度處,達至距玻璃容器之內表面104深度DSL處。內表面層105內之玻璃組合物相對於
壁部分之中點MP處之玻璃具有持久性層異質性,且因此應瞭解,內表面層105中玻璃之組成與壁部分110之中點MP處之玻璃不同。在一些實施例中,內表面層之厚度TSL為至少約30nm。在一些實施例中,內表面層之厚度TSL為至少約50nm。在一些實施例中,內表面層之厚度TSL為至少約100nm。在一些實施例中,內表面層之厚度TSL為至少約150nm。在一些其他實施例中,內表面層之厚度TSL為至少約200nm或甚至約250nm。在一些其他實施例中,內表面層之厚度TSL為至少約300nm或甚至約350nm。在其他實施例中,內表面層之厚度TSL為至少約500nm。在一些實施例中,內表面層可延伸至至少約1μm或甚至至少約2μm之厚度TSL。
在本文所描述之實施例中,短語「持久性層異質性」意指內表面層105中玻璃組合物之構成組分(例如SiO2、Al2O3、Na2O等)之濃度與玻璃主體之厚度之中點處(亦即沿均分內表面104與外表面106之間的玻璃主體的中點線MP的一點處)相同構成組分的濃度相差當長期暴露於玻璃容器內所含溶液時將會導致玻璃主體分層的量。在本文所描述之實施例中,玻璃主體之內表面層中之持久性層異質性使得當玻璃容器100處於成形時狀態時,內表面層105中玻璃組合物之各構成組分之層濃度的極值(亦即最小值或最大值)小於約92%或大於約108%的玻璃主體之厚度之中點處相同構成組分之值。在其他實施例中,玻璃主體之內表面層105中之持久性層異質性使得當玻璃容器100處於成形時狀態時,內表面層105中玻璃組合物之各構成組分之層濃度的極值小於
約90%或大於約110%的玻璃主體之厚度之中點處的相同構成組分之值。在其他實施例中,玻璃主體之內表面層105中之持久性層異質性使得當玻璃容器100處於成形時狀態時,內表面層105中玻璃組合物之各構成組分之層濃度的極值小於約80%或大於約120%的玻璃主體之厚度之中點處的相同構成組分之值。在一些實施例中,持久性層異質性不包括以小於約2mol.%之量存在之玻璃組合物的構成組分。持久性層異質性亦不包括可存在於玻璃組合物中的任何水。
如本文所使用之術語「成形時狀態(as-formed condition)」係指在玻璃容器已由玻璃原料形成之後但在容器暴露於任何其他處理步驟(諸如離子交換增強、塗佈、硫酸銨處理、酸蝕刻及/或任何其他表面改質)之前的玻璃容器100的組成。在本文所描述之實施例中,玻璃組合物中構成組分之層濃度藉由使用動態次級離子質譜(「D-sims」)穿過所關注之區域中玻璃主體的厚度收集組合物樣品來測定。在本文所描述之實施例中,自玻璃主體102之內表面104之區域對組成型態進行取樣。所取樣區域具有1mm2之最大面積。此技術對所取樣區域而言產生隨距玻璃主體之內表面之深度而變化的玻璃中之物質的組成型態。
當玻璃容器由硼矽酸鹽玻璃組合物(諸如IB型玻璃組合物)形成時,亦可定性確定含有經沈積揮發性物質之內表面層105之存在。確切言之,可用亞甲基藍染料溶液填充玻璃容器100。亞甲基藍染料與玻璃表面之富含硼之區域反應且化學鍵結至該等區域,使該等區域染上可觀察到的藍色。
合適的亞甲基藍染料溶液可包括但不限於1%亞甲基藍水溶液。
若經沈積揮發物質之此內表面層105保持於內表面104上,則容器中所含溶液可自內表面層105瀝濾經沈積揮發物質。當自玻璃瀝濾此等揮發物質時,高二氧化矽玻璃網狀物(凝膠)保持於內表面104上,該內表面104在水合作用期間產生膨脹及應變且最終自表面剝落(亦即玻璃容器100之內表面104分層),有可能將微粒物質引入玻璃容器內所含溶液中。
一種針對分層之習知解決方案為用無機塗料(諸如SiO2)塗佈玻璃容器之主體之內表面。此塗層可具有約100nm至200nm之厚度,且防止容器之內容物接觸主體之內表面且造成分層。然而,此類塗層之塗覆可能有困難且需要其他製造及/或檢查步驟,由此增加容器製造之總成本。此外,若容器之內容物滲透塗層且與主體之內表面接觸,諸如穿過塗層中之不連續性,則所產生之玻璃主體之分層會導致部分塗層自主體之內表面上分離。
在本文所描述之實施例中,玻璃容器分層之傾向藉由如下方法來減輕:將內表面層105自玻璃容器移除,使得經修飾內表面(亦即移除內表面層之後的玻璃容器的內表面)相對於玻璃容器之壁部分110之中點MP具有更均勻的組成。玻璃容器100在移除內表面層105之後展現出改良之抗分層性。
在一些實施例中,藉由蝕刻將內表面層105自玻璃
容器之壁部分110移除。舉例而言,可將蝕刻劑引入內部容積108中,且使該蝕刻劑保持在內部容積中一段足以移除內表面層105的時間。合適的蝕刻劑將均一地溶解內表面層105。確切言之,玻璃容器100大體由包括二氧化矽(SiO2)(作為主要網狀物形成劑)及存在於二氧化矽網狀物中之其他構成組分(例如B2O3、鹼金屬氧化物、鹼土金屬氧化物及其類似物)的玻璃組合物形成。然而,二氧化矽及構成組分不一定可溶於相同溶液中或以相同速率溶解於溶液中。因此,蝕刻劑溶液可含有一或多種酸以有助於內表面層105中所含玻璃網狀物及其他構成組分的均一溶解。
舉例而言,可利用氫氟酸(HF)溶解二氧化矽網狀物,因為氟化學物質(fluorine chemistry)攻擊二氧化矽之Si-O-Si鍵。其餘構成組分(亦即除二氧化矽外的成分)可能不易於溶於HF中,且因此會保留為玻璃容器之內部上之沈積物。此等沈積物在微觀檢查下會呈現為表面特徵,且因為沈積物周圍之網狀物已溶解,所以沈積物可僅微弱地黏著於玻璃容器內部,且因此造成污染風險。為了將此等其餘構成組分自內表面上移除,蝕刻劑可進一步包括一或多種無機酸,該一或多種無機酸溶解其餘構成組分,從而有助於玻璃網狀物及其他構成組分之均一溶解,且在玻璃容器內部上留下光滑無特徵的經修飾內表面。
一般而言,蝕刻劑包括至少0.1莫耳HF用於溶解二氧化矽網狀物,且包括至少一種無機酸用於溶解存在於玻璃網狀物中之其他構成組分。合適蝕刻劑之一個實例包括但不
限於1.5莫耳氫氟酸及3莫耳鹽酸(HCl)。此類蝕刻劑可以約每四分鐘1μm(亦即0.25μm/min)之速率溶解典型的IB型藥物玻璃。一微米深度大體與約0.24mg/cm2溶解玻璃相對應。玻璃在蝕刻劑中之溶解速率大致與時間呈線性關係(亦即諧溶(congruent dissolution)),此允許精確控制用蝕刻劑移除之層的深度。舉例而言,在前述HF-HCl溶液中處理12分鐘將使約3μm厚度之玻璃層移除。在本文所描述之實施例中,允許蝕刻劑在容器之內部中保持一段足以移除內表面層105及持久性層異質性的時間,由此改良玻璃容器對分層之抗性。在一些實施例中,蝕刻劑在玻璃容器之內部容積中保持一段足以移除至少1μm厚度或甚至至少1.5μm厚度之玻璃層(大體足以移除持久性層異質性)的時間。在一些實施例中,蝕刻劑在玻璃容器之內部容積中保持一段足以移除至少3μm厚之玻璃層的時間。
在本文所描述之實施例中,應瞭解,處理條件會影響玻璃在蝕刻劑中之蝕刻速率,且可經調節以控制玻璃之溶解速率。舉例而言,可升高蝕刻劑及/或玻璃小瓶之溫度以提高玻璃在蝕刻劑中之蝕刻速率,由此減少處理時間。或者,可升高蝕刻劑之濃度以提高玻璃在蝕刻劑中之蝕刻速率,由此減少處理時間。
儘管本文已描述一種特定蝕刻劑溶液,但應瞭解,涵蓋其他蝕刻劑,用於將持久性層異質性自玻璃容器之內部移除。舉例而言,蝕刻劑可包括其他無機酸,諸如硫酸、硝酸、鹽酸、氫氟酸、氫溴酸及磷酸及/或其各種組合。在一個
實施例中,酸性溶液可包括1.5M氫氟酸與0.9M硫酸之混合物。此等酸溶液有效移除經揮發及再沈積之有機溶液的薄表層而不在玻璃容器之內表面上留下耗盡的「瀝濾層」。其他合適蝕刻劑可包括但不限於揭示於美國專利第2,106,744號、美國專利公開案第2011/0165393號、美國專利公開案第2013/0122306號中之蝕刻處理,且亦可使用美國專利公開案第2012/0282449號來蝕刻至少玻璃容器之內表面。
在某些狀況下,蝕刻劑可含有已知促進螯合之化合物。添加螯合劑以有助於降低溶解於溶液中之金屬之活性。術語「金屬」係指由蝕刻劑溶解之玻璃態組分(Si、Al、B、Na、K、Mg、Ca、Sr、Ba、Fe、Ti、Zr等)。藉由降低蝕刻劑中金屬之活性/濃度,蝕刻劑更均一地溶解玻璃表面且促進形成均一的玻璃表面化學物質(surface chemistry)。換言之,可添加螯合劑以限制由於優先蝕刻而在深度方面產生組成異質性的非諧溶。
類似地,亦可使用勒夏忒列原理(LeChatelier’s principle)使金屬物質自蝕刻劑中沈澱。不同於螯合劑,可向蝕刻劑中添加反應性陰離子(或官能基)以迫使金屬物質自蝕刻劑中沈澱且維持蝕刻劑中之低金屬濃度。當金屬濃度足夠低時,蝕刻溶液促進形成均一的玻璃表面化學物質。
表面組合物中之一些異質性與有機及無機微粒物質之表面沈積有關。可向蝕刻劑溶液中添加界面活性劑以促進將此等粒子及異質性自玻璃表面上沖洗/移除,作為蝕刻處理之一部分。在恰當選擇界面活性劑之情況下,異質性及粒子
濃度可被降低且有助於形成均一的表面化學反應。
在蝕刻處理已將持久性層異質性自玻璃容器之內表面上移除之後,洗滌且乾燥容器,在此之後不存在蝕刻處理之明顯可覺跡象。此外,在蝕刻處理之後,玻璃容器之經修飾內表面為光滑的且無表面形狀變化,諸如凹點及/或峰點,包括由未溶解之玻璃組分的沈積物之存在造成的彼等表面形狀變化。如本文所使用,當每10,000μm2表面積之平均峰至谷粗糙度小於1μm時,將玻璃容器之經修飾內表面視為「無表面形狀變化」。在一些實施例中,當每10,000μm2表面積之平均峰至谷粗糙度小於100nm時,將玻璃容器之經修飾內表面視為「無表面形狀變化」。在一些實施例中,當每10,000μm2表面積之平均峰至谷粗糙度小於50nm時,將玻璃容器之經修飾內表面視為「無表面形狀變化」。移除具有持久性層異質性之內表面層之後來自玻璃容器之表面形狀變化的缺乏可隨後有助於定性評估暴露於溶液之後分層之存在(或缺乏)。舉例而言,評估分層之一種定性技術為檢查暴露於溶液之後玻璃容器之表面拓撲。若內表面最初為光滑的且其後在暴露於溶液之後呈現有凹點,則可能已發生分層。然而,可能難以進行此類定性評估,除非玻璃容器最初實質上無表面形狀變化。
儘管上文將蝕刻劑描述為引入玻璃容器之內部容積中,但應瞭解,其他實施例為可能的。舉例而言,可將玻璃容器完全浸漬於蝕刻劑中,使得蝕刻劑與玻璃容器之內表面及玻璃容器之外表面均直接接觸。此允許玻璃層同時自玻璃
容器之外表面上移除,此可改良玻璃容器之機械特性。確切言之,可使缺陷(諸如刮痕、碎裂或其類似缺陷)引入呈成形時狀態之玻璃容器之外部。此類缺陷可為藉由處理設備或其類似物以機械方式處理容器之結果。此等缺陷可充當「應力冒口(stress riser)」且充當裂痕起始位點,從而實際上降低玻璃容器之強度。在此實施例中,將玻璃容器之外表面蝕刻至比存在於玻璃容器之壁部分之外表面中的表面缺陷之深度大的深度。蝕刻玻璃容器之外表面允許藉由移除含有缺陷之玻璃層來移除此等缺陷,從而降低玻璃容器因存在之缺陷而失效的敏感性。此外,蝕刻玻璃容器之外表面可改良隨後塗覆至外表面之塗層(包括但不限於有機及無機塗層)對外表面的黏著性。
現參看第1圖及第3圖,在將內表面層105自玻璃容器移除之後,玻璃容器在壁部分、跟部分及底部分中之每一者中貫穿玻璃主體102之整個厚度均具有均質組成。確切言之,第3圖示意性地展示玻璃容器100之壁部分110之部分截面。玻璃容器100之玻璃主體102具有自玻璃容器100之經修飾內表面104"下方約10nm處(在第3圖中示為DLR1)延伸進入壁部分110之一定厚度處,達至距玻璃容器之經修飾內表面104"深度DLR2處的內部區域120。自經修飾內表面104"下方約10nm處延伸之內部區域由於實驗性偽訊(experimental artifact)而區別於表面下方初始5至10nm處之組成。在DSIMS分析開始時,初始5至10nm因為三個問題而未包括於分析中:由於外源碳而造成之離子自表面之可
變濺射速率、部分因可變濺射速率所致之穩態電荷的建立、及在建立穩態濺射條件之同時物質的混合。因此,應瞭解,內部區域120具有等於DLR2-DLR1之厚度TLR。內部區域內之玻璃組合物具有持久性層均質性,該持久性層均質性與內部區域之厚度TLR一起足以防止在長期暴露於玻璃容器100之內部容積108中所含溶液之後玻璃主體的分層。在一些實施例中,厚度TLR為至少約100nm。在一些實施例中,厚度TLR為至少約150nm。在一些其他實施例中,厚度TLR為至少約200nm或甚至約250nm。在一些其他實施例中,厚度TLR為至少約300nm或甚至約350nm。在其他實施例中,厚度TLR為至少約500nm。在一些實施例中,內部區域120可延伸至至少約1μm或甚至至少約2μm之厚度TLR。
儘管上文中將內部區域120描述為自玻璃容器100之經修飾內表面104"下方10nm處延伸進入壁部分110之一定厚度處,達至距玻璃容器100之經修飾內表面104"深度DLR2處,但應瞭解,其他實施例為可能的。舉例而言,假設儘管有上文指出之實驗性偽訊,但具有持久性層均質性之內部區域可實際上自玻璃容器100之經修飾內表面104"延伸進入壁部分之一定厚度處。因此,在一些實施例中,厚度TLR可自內表面延伸至深度DLR2。在此等實施例中,厚度TLR可為至少約100nm。在一些實施例中,厚度TLR為至少約150nm。在一些其他實施例中,厚度TLR為至少約200nm或甚至約250nm。在一些其他實施例中,厚度TLR為至少約300nm或甚至約350nm。在其他實施例中,厚度TLR為至少約500nm。在
一些實施例中,內部區域120可延伸至至少約1μm或甚至至少約2μm之厚度TLR。
在本文所描述之實施例中,短語「持久性層均質性」意指內部區域中玻璃組合物之構成組分(例如SiO2、Al2O3、Na2O等)之濃度與玻璃主體之厚度之中點處(亦即沿均分經修飾內表面104"與外表面106之間的玻璃主體的中點線MP的一點處)相同構成組分的濃度不相差當長期暴露於玻璃容器內所含溶液時將會導致玻璃主體分層的量。在本文所描述之實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,玻璃主體之內部區域中之持久性層均質性使得內部區域120中玻璃組合物之各構成組分之層濃度的極值(亦即最小值或最大值)大於或等於約80%且小於或等於約120%的玻璃主體之厚度之中點處的相同構成組分之值。在其他實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,玻璃主體之內部區域中之持久性層均質性使得內部區域120中玻璃組合物之各構成組分之層濃度的極值大於或等於約90%且小於或等於約110%的玻璃主體之厚度之中點處的相同構成組分之值。在其他實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,玻璃主體之內部區域中之持久性層均質性使得內部區域120中玻璃組合物之各構成組分之層濃度的極值大於或等於約92%且小於或等於約108%的玻璃主體之厚度之中點處的相同構成組分之值。在一些實施例中,持久性層均質性不包括以小於約2mol.%之量存在的玻璃組合物之構成組分。持久性層均質性亦不包括可存
在於玻璃組合物中之任何水。
移除具有持久性層異質性之內表面層使得玻璃容器之經修飾內表面具有持久性層均質性,如上文所述,大體上改良玻璃容器對分層之抗性。確切言之,向玻璃容器提供在組成方面為均質的內部區域(亦即內部區域中構成組分之濃度的極值在+/- 20%的玻璃主體之厚度之中點處的相同構成組分之值內)可移除會對瀝濾敏感之玻璃組合物的構成組分的局部濃度,此轉而在自玻璃表面瀝濾此等構成組分之情況下緩解玻璃粒子自玻璃容器之內表面發生的損失。
在移除具有持久性層異質性之內表面層後,玻璃容器包括自主體之內表面延伸至至少250nm或甚至至少300nm之深度的實質性單獨組合物。術語「單獨組合物(unitary composition)」係指如下事實:自經修飾內表面延伸進入主體之一定厚度處而達至至少250nm或甚至至少300nm之深度的主體的部分所來自的玻璃與塗覆至具有相同或不同組成之另一材料的塗層材料相比為材料的單一組合物(single composition)。舉例而言,在一些實施例中,容器之主體可由單一玻璃組合物建構。在另一實施例中,容器之主體可由層合玻璃建構,使得主體之內表面具有自內表面延伸至至少250nm或甚至至少300nm之深度的單獨組合物。玻璃容器可包括自經修飾內表面或自經修飾內表面下方10nm處延伸至至少100nm之深度的內部區域,如上文所指出。此內部區域可具有持久性層均質性。
現參看第1圖及第4圖,在移除具有持久性表面異
質性之內表面層後,本文所描述之玻璃容器亦可具有遍及玻璃主體102之經修飾內表面104"均質的表面組合物,包括於壁部分、跟部分及底部分中。第4圖示意性地展示玻璃容器100之壁部分110之部分截面。玻璃容器100具有遍及玻璃容器之整個內表面延伸的表面區域130。表面區域130具有自玻璃容器100之經修飾內表面104"朝向外表面106延伸進入玻璃主體之一定厚度處的深度DSR。因此,應瞭解,表面區域130具有等於深度DSR的厚度TSR。在一些實施例中,表面區域自玻璃容器100之經修飾內表面104"延伸至至少約10nm之深度DSR。在一些其他實施例中,表面區域130可延伸至至少約50nm之深度DSR。在一些其他實施例中,表面區域130可延伸至約10nm至約50nm之深度DSR。因此,應瞭解,表面區域130延伸至比內部區域120淺的深度。表面區域之玻璃組合物具有持久性表面均質性,該持久性表面均質性與內部區域之深度DSR一起足以防止在長期暴露於玻璃容器之內部容積中所含溶液之後玻璃主體的分層。
在本文所描述之實施例中,短語「持久性表面均質性」意指表面區域中離散點處之玻璃組合物之構成組分(例如SiO2、Al2O3、Na2O等)的濃度與表面區域中任何第二離散點處相同構成組分的濃度不相差當長期暴露於玻璃容器內所含溶液時將會導致玻璃主體分層的量。在本文所描述之實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,表面區域中之持久性表面均質性使得對於玻璃容器之經修飾內表面104"上之離散點而言,一離散點處之表面區
域130中各構成組分之表面濃度的極值(亦即最小值或最大值)大於或等於約70%且小於或等於約130%的玻璃容器100之經修飾內表面104"上任何第二離散點處之表面區域130中的相同構成組分之值。舉例而言,第3圖展示壁部分110之經修飾內表面104"上之三個離散點(A、B及C)。各點與相鄰點相隔至少約3mm。點「A」處之表面區域130中各構成組分之表面濃度的極值大於或等於約70%且小於或等於約130%的點「B」及「C」處之表面區域130中的相同構成組分之值。當提及容器之跟部分時,離散點可大致以跟部分之頂點為中心,且相鄰點位於沿容器之底部分及沿容器之壁部分距跟部分之頂點至少3mm處,各點之間的距離受小瓶之半徑及側壁之高度(亦即側壁過渡至小瓶肩部的點)限制。
在一些實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,表面區域中之持久性表面均質性使得對於玻璃容器100之經修飾內表面104"上之任何離散點而言,表面區域130中玻璃組合物之各構成組分之表面濃度的極值均大於或等於約75%且小於或等於約125%的玻璃容器100之經修飾內表面104"上之任何第二離散點處之表面區域130中的相同構成組分之值。在一些其他實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,表面區域中之持久性表面均質性使得對於玻璃容器100之經修飾內表面104"上之任何離散點而言,表面區域130中玻璃組合物之各構成組分之表面濃度的極值均大於或等於約80%且小於或等於約120%的玻璃容器100之經修飾內表面104"上之任何第
二離散點處之表面區域130中的相同構成組分之值。在其他實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,表面區域中之持久性表面均質性使得對於玻璃容器100之經修飾內表面104"上之任何離散點而言,表面區域130中玻璃組合物之各構成組分之表面濃度的極值均大於或等於約85%且小於或等於約115%的玻璃容器100之內表面104上之任何第二離散點處之表面區域130中的相同構成組分之值。在本文所描述之實施例中,表面區域中玻璃組合物之構成組分之表面濃度藉由光電子光譜法來量測。在一些實施例中,表面區域中之持久性表面均質性不包括以小於約2mol.%之量存在之玻璃組合物的構成組分。持久性表面均質性亦不包括可存在於玻璃組合物中之任何水。
在已將具有持久性層異質性之內表面層自玻璃容器移除後,表面區域130中玻璃構成組分之表面濃度之均質性大體能指示玻璃組合物分層且使玻璃粒子自玻璃容器100之經修飾內表面104"上脫落的傾向性。當玻璃組合物在表面區域130中具有持久性表面均質性時(亦即當內表面104上一離散點處之表面區域130中玻璃構成組分的表面濃度之極值在+/- 30%的內表面104上任何第二離散點處表面區域130中的相同構成組分時),玻璃組合物具有改良之抗分層性。
現應瞭解,本文所描述之玻璃容器具有持久性層均質性及/或持久性表面均質性,在已將具有持久性層異質性之內表面層自玻璃容器移除後,各均質性均改良玻璃容器之抗分層性。持久性層均質性及/或持久性表面均質性不僅存在於
玻璃容器之側壁部分中,而且存在於玻璃容器之跟部分及底部分中,使得界定內部容積之玻璃容器表面具有抗分層性。
如上所指出,在長期暴露於溶液後,分層會導致富含二氧化矽之玻璃薄片釋放進入玻璃容器內所含溶液中。因此,抗分層性可以特定條件下暴露於溶液後玻璃容器內所含溶液中存在的玻璃微粒數目來表徵。為了評估玻璃容器之長期抗分層性,採用加速分層測試。針對離子交換及非離子交換玻璃容器兩者進行測試。測試由以下組成:在室溫下洗滌玻璃容器1分鐘,且使容器在約320℃下去熱原1小時。其後將pH值為10之20mM甘胺酸水溶液置放於玻璃容器中至80%至90%填充,封閉玻璃容器,且將玻璃容器快速加熱至100℃,且隨後在2個大氣壓之壓力下以1度/分鐘之升溫速率自100℃加熱至121℃。使玻璃容器及溶液在此溫度下保持60分鐘,以0.5度/分鐘之速率冷卻至室溫,且重複加熱循環及保持。隨後將玻璃容器加熱至50℃,且保持10天或更多天,以便進行高溫調節。加熱之後,自至少18"之距離處使玻璃容器降落至牢固表面(諸如層合瓷磚地面)上,以使微弱黏著於玻璃容器之內表面上的任何薄片或粒子移位。降落之距離可適當按比例增減以防止較大尺寸之小瓶在衝擊下破裂。
其後,分析玻璃容器中所含溶液以確定每公升溶液中存在之玻璃粒子的數目。確切言之,將來自玻璃容器之溶液直接倒至附接至真空抽吸器之Millipore Isopore膜過濾器(固持於具有部件#AP1002500及#M000025A0之組合件中的Millipore #ATTP02500)的中心上,以在10至15秒內經由過
濾器抽取溶液5mL。其後,使用另外5mL水沖洗以將緩衝液殘留物自過濾器介質中移除。隨後藉由差分干涉對比顯微法(DIC)以反射模式對微粒薄片進行計數,如來自Fundamentals of light microscopy and digital imaging.New York:Wiley-Liss第153-168頁之「Differential interference contrast(DIC)microscopy and modulation contrast microscopy」中所描述之反射模式。將視場設定為約1.5mm×1.5mm,且以手動方式對大於50μm之粒子進行計數。在影像之間無重疊之情況下以3×3模式在各過濾薄膜之中心中進行9次此類量測。若對過濾器介質之較大面積進行分析,則可將結果針對等效面積(亦即20.25mm2)進行歸一化。用影像分析程式(Media Cybernetic之ImagePro Plus第6.1版)檢查自光學顯微鏡收集之影像以量測且計數所存在之玻璃薄片的數目。此如下實現:突出顯示藉由簡單灰度級分段獲得之呈現比背景 暗 的影像內的所有特徵;隨後量測長度大於25微米之所有突出顯示之特徵的長度、寬度、面積及周長;隨後將任何明顯非玻璃粒子自資料中移除;隨後將量測資料輸出至試算表中。隨後,提取長度大於25微米且比背景 亮 的所有特徵且量測該等特徵;量測長度大於25微米之所有突出顯示之特徵的長度、寬度、面積、周長及X-Y縱橫比;將任何明顯非玻璃粒子自資料中移除;且將量測資料附加至試算表中先前輸出之資料。隨後根據特徵長度將試算表內之資料排序,且根據大小分至各組中。報告結果係針對長度大於50微米之特徵。隨後對此等組中之每一者進行計數,且針對樣品
中之每一者報告計數。
測試最少為100mL之溶液。因此,可將來自複數個小容器之溶液合併以使溶液總量達至100mL。對於容積大於10mL之容器而言,在相同處理條件下針對10個由相同玻璃組合物形成之容器之試驗進行重複測試,且對10個容器之粒子計數之結果取平均值以確定平均粒子計數。或者,在小容器之情況下,針對10個小瓶之試驗進行重複測試,歷經多次試驗對10個小瓶中之每一者進行分析且對粒子計數取平均值以確定平均每試驗粒子計數。歷經多個容器對粒子計數取平均值可對個別容器之分層行為之潛在變化作出解釋。表1概括用於測試之樣品體積及容器數目的一些非限制性實例:
應瞭解,前述測試用於鑑別由於分層而自玻璃容器之內壁脫落之粒子且不會使由成形過程形成之容器中存在之粒子或由於溶液與玻璃之間的反應而自玻璃容器中所裝之溶液沈澱析出的粒子浮起。確切言之,分層粒子可基於粒子之縱橫比(亦即粒子最大長度與粒子厚度之比,或最大與最小尺寸之比)而區別於浮起玻璃粒子。分層產生形狀不規則且
典型具有大於約50μm,但通常大於約200μm之最大長度的微粒薄片或薄層。薄片之厚度通常大於約100nm且可為約1μm一般大。因此,薄片之最小縱橫比通常大於約50。縱橫比可大於約100且有時大於約1000。相反,浮起玻璃粒子將大體具有小於約3之低縱橫比。因此,在使用顯微鏡觀測期間,由分層產生之粒子可基於縱橫比而區別於浮起粒子。其他常見非玻璃粒子包括毛髮、纖維、金屬粒子、塑膠粒子及其他污染物且因此在檢查期間排除在外。結果之驗證可藉由評價所測試容器之內部區域來實現。觀測時應注意表皮腐蝕/凹點/薄片移除之跡象,如來自Journal of Pharmaceutical Sciences 101(4),2012,第1378-1384頁之「Nondestructive Detection of Glass Vial Inner Surface Morphology with Differential Interference Contrast Microscopy」中所描述。
在本文所描述之實施例中,可採用加速分層測試之後存在之粒子數目為所測試之一組小瓶建立分層因子。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於10個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子10。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於9個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子9。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於8個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子8。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於7個最小長度
約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子7。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於6個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子6。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於5個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子5。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於4個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子4。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於3個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子3。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於2個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子2。在本文所描述之實施例中,將加速分層測試之後平均每試驗少於1個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子1。在本文所描述之實施例中,將加速分層測試之後每試驗具有0個最小長度約50μm且縱橫比大於約50之玻璃粒子的玻璃容器試驗視為具有分層因子0。因此,應瞭解,分層因子越小,玻璃容器之抗分層性越佳。在本文所描述之實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,玻璃容器具有10或低於10之分層因子(亦即3、2、1或0之分層因子)。
具有上文所描述之特徵(亦即遍及內表面且貫穿厚
度均質之組成以及抗分層性)之玻璃容器藉由將具有持久性層異質性之內表面層自玻璃容器移除來獲得,如本文所描述。確切言之,容器最初由IB型玻璃組合物形成,使得玻璃容器具有在玻璃容器之內表面中延伸的具有持久性層異質性之內表面層(亦即內表面層之組成與壁部分之中點處之玻璃的組成不同)。容器最初由提供玻璃原料材料而形成,該玻璃原料材料諸如玻璃管、玻璃片或其類似物,且使用習知成形技術使玻璃原料材料成形成玻璃容器,使得至少玻璃容器之內表面有具有持久性異質性之內表面層。其後,將具有持久性層異質性之內表面層自玻璃容器之內表面上移除,如本文所描述,使得玻璃容器具有遍及內表面且貫穿壁部分之厚度均質的組合物。
在本文所描述之實施例中,玻璃容器可由依據標題為「Standard Specification for Glasses in Laboratory Apparatus」之ASTM標準E438-92(2011)符合I型A類(IA型)或I型B類(IB型)玻璃之準則的玻璃組合物形成。硼矽酸鹽玻璃符合I型(A或B)準則且常規用於藥物封裝。硼矽酸鹽玻璃之實例包括但不限於Corning® Pyrex® 7740、7800、Wheaton 180、200及400、Schott Duran®、Schott Fiolax®、KIMAX® N-51A、Gerresheimer GX-51 Flint及其他者。
在本文所描述之一些實施例中,在已將具有持久性層異質性之內表面層自玻璃容器移除後,諸如藉由離子交換增強或其類似方法增強玻璃主體102。在實施例中,玻璃主體
102可在玻璃表面處具有大於或等於約250MPa、300MPa或甚至大於或等於約350MPa之壓縮應力。在實施例中,壓縮應力可在玻璃表面處大於或等於約400MPa或在玻璃表面處甚至大於或等於約450MPa。在一些實施例中,壓縮應力可在玻璃表面處大於或等於約500MPa或在玻璃表面處甚至大於或等於約550MPa。在其他實施例中,壓縮應力可在玻璃表面處大於或等於約650MPa或在玻璃表面處甚至大於或等於約750MPa。玻璃主體102中之壓縮應力大體延伸至至少約10μm之層深度(DOL)。在一些實施例中,玻璃主體102可具有大於約25μm或甚至大於約50μm之層深度。在一些其他實施例中,層深度可達至約75μm或甚至約100μm。離子交換增強可在維持在約350℃至約600℃之溫度的熔融鹽浴液中進行。為達成所需壓縮應力,可使處於成形時狀態之玻璃容器在鹽浴液中浸漬少於約30小時或甚至少於約20小時。在實施例中,可使容器浸漬少於約15小時或甚至少於約12小時。在其他實施例中,可使容器浸漬少於約10小時。舉例而言,在一個實施例中,使玻璃容器在約450℃下之100% KNO3鹽浴液中浸漬約5小時至約8小時,以便在維持玻璃組合物之化學耐久性之同時達成所需層深度及壓縮應力。
在已將具有持久性層異質性之內表面層自玻璃容器移除後,形成玻璃容器所用之玻璃組合物具有化學耐久性且對降解具有抗性,如藉由ISO 720標準所確定。ISO 720標準為蒸餾水中玻璃之降解抗性(亦即玻璃之水解抗性)之量度。簡言之,ISO 720標準方案利用碾碎玻璃顆粒,使該等玻璃顆
粒在高壓釜條件(121℃,2atm)下與18MΩ水接觸,持續30分鐘。隨後用稀HCl以比色方式將溶液滴定至中性pH。隨後將滴定至中性溶液所需之HCl量換算成提取自玻璃之Na2O之等效量,且以μg玻璃為單位來報告,較小值指示較大耐久性。將ISO 720標準分成個別類型。HGA1型指示至多62μg之Na2O之提取等效量;HGA2型指示超過62μg且至多527μg之Na2O之提取等效量;且HGA3型指示超過527μg且至多930μg之Na2O之提取等效量。在已將具有持久性層異質性之內表面層自玻璃容器移除後,本文所描述之玻璃容器具有ISO 720型HGA1水解抗性。
在已將具有持久性層異質性之內表面層自玻璃容器移除後,形成玻璃容器所用之玻璃組合物亦具有化學耐久性且對降解具有抗性,如藉由ISO 719標準所確定。ISO 719標準為蒸餾水中玻璃之降解抗性(亦即玻璃之水解抗性)之量度。簡言之,ISO 719標準方案利用碾碎玻璃顆粒,使該等玻璃顆粒在2atm壓力及98℃溫度下與18MΩ水接觸,持續60分鐘。隨後用稀HCl以比色方式將溶液滴定至中性pH。隨後將滴定至中性溶液所需之HCl之量換算成提取自玻璃之Na2O之等效量,且以μg玻璃為單位來報告,較小值指示較大耐久性。將ISO 719標準分成個別類型。HGB1型指示至多31μg之Na2O之提取等效量;HGB2型指示超過31μg且至多62μg之Na2O之提取等效量;HGB3型指示超過62μg且至多264μg之Na2O之提取等效量;HGB4型指示超過264μg且至多620μg之Na2O之提取等效量;且HGB5
型指示超過620μg且至多1085μg之Na2O之提取等效量。在已將具有持久性層異質性之內表面層自玻璃容器移除後,本文所描述之玻璃容器具有ISO 719 HGB1型水解抗性。
就USP<660>測試及/或歐洲藥典3.2.1測試而言,在已將具有持久性層異質性之內表面層自玻璃容器移除後,本文所描述之玻璃容器具有1型化學耐久性。如上所指出,USP<660>及歐洲藥典3.2.1測試係針對完好玻璃容器而非碾碎玻璃顆粒進行,且因此USP<660>及歐洲藥典3.2.1測試可用於直接評估玻璃容器之內表面的化學耐久性。
在已將具有持久性層異質性之內表面層自玻璃容器移除後,形成玻璃容器所用之玻璃組合物亦在酸性溶液中具有化學耐久性且對降解具有抗性,如藉由DIN 12116標準所確定。簡言之,DIN 12116標準利用具有已知表面積之拋光玻璃樣品,將該玻璃樣品稱重且隨後加以安置,使其與成比例之量的沸騰的6M鹽酸接觸6小時。隨後將樣品自溶液中移除,乾燥且再次稱重。在暴露於酸性溶液期間所損失之玻璃質量為樣品之酸耐久性之量度,較小數值指示較大耐久性。以每表面積之半質量(確切言之,mg/dm2)為單位報告測試結果。將DIN 12116標準分成個別類別。S1類表示至多0.7mg/dm2之重量損失;S2類表示0.7mg/dm2至至多1.5mg/dm2之重量損失;S3類表示1.5mg/dm2至至多15mg/dm2之重量損失;且S4類表示超過15mg/dm2之重量損失。在已將具有持久性層異質性之內表面層自玻璃容器移除後,本文所描述之玻璃容器具有DIN 12116 S2類酸抗性或更佳。
在已將具有持久性層異質性之內表面層自玻璃容器移除後,形成玻璃容器所用之玻璃組合物亦在鹼性溶液中具有化學耐久性且對降解具有抗性,如藉由ISO 695標準所確定。簡言之,ISO 695標準利用拋光玻璃樣品,將該玻璃樣品稱重且隨後在沸騰的1M NaOH+0.5M Na2CO3溶液中置放3小時。隨後將樣品自溶液中移除,乾燥且再次稱重。在暴露於鹼性溶液期間所損失之玻璃質量為樣品之鹼耐久性之量度,且較小數值指示較大耐久性。與DIN 12116標準一樣,以每表面積之質量(確切言之,mg/dm2)為單位報告ISO 695標準之結果。將ISO 695標準分成個別類別。A1類表示至多75mg/dm2之重量損失;A2類表示75mg/dm2至至多175mg/dm2之重量損失;且A3類表示超過175mg/dm2之重量損失。在已將具有持久性層異質性之內表面層自玻璃容器移除後,本文所描述之玻璃容器具有A2類之ISO 695鹼抗性或更佳。
應瞭解,當提及上文所參考之根據ISO 695、ISO 719、ISO 720或DIN 12116之分類時,具有指定分類「或更佳」之玻璃組合物或玻璃物品意指玻璃組合物之效能與指定分類一樣好或比指定分類更佳。舉例而言,具有「A2類」之ISO 695鹼抗性或更佳之玻璃物品可具有A2類或A1類之ISO 695分類。
本文所描述之具有改良之抗分層性的玻璃容器之實施例將藉由以下實例進一步闡明。
測定由IB型藥物硼矽酸鹽玻璃容器形成之玻璃容器的蝕刻速率。對各組(G1及G2組)均由可自Gerresheimer商購之IB型藥物硼矽酸鹽玻璃形成的兩組各五個玻璃容器進行測試。確切言之,容器為由Gerresheimer GX-51 Flint玻璃形成之3ml玻璃小瓶。亦測試各組(S1及S2組)均由可自Schott Glass商購之IB型藥物硼矽酸鹽玻璃形成的兩組五個玻璃容器。確切言之,容器為由Schott Fiolax®玻璃形成之3ml玻璃小瓶。初始時將各容器稱重且記錄重量。用0.5莫耳氫氟酸與0.9莫耳鹽酸的溶液填充G1及S1組。使溶液在各容器中保持在1分鐘至12分鐘範圍內之不同時間量(亦即1分鐘、2分鐘、4分鐘、8分鐘及12分鐘)。時間期滿時,將溶液自各容器中倒空,且將容器沖洗、乾燥及稱重以確定重量損失。隨後將重量損失針對估算表面積進行歸一化。
用1.5莫耳氫氟酸與3.0莫耳鹽酸的溶液填充G2及S2組。使溶液在各容器中保持在1分鐘至12分鐘範圍內之不同時間量(亦即1分鐘、2分鐘、4分鐘、8分鐘及12分鐘)。時間期滿時,將溶液自各容器中倒空,且將容器沖洗、乾燥及稱重以確定重量損失。隨後將重量損失針對估算表面積進行歸一化。
隨蝕刻時間(分鐘)變化之重量損失(mg/cm2)以圖形方式展示在第5圖中。如第5圖中所示,隨著暴露於蝕刻劑之時間增加,重量損失變得更負(亦即損失更多重量)。第5圖亦顯示,當蝕刻劑濃度增大時,重量損失之速率增加,
表明可經由暴露時間及/或蝕刻劑濃度控制自玻璃內表面移除之材料的量。
測試兩組容器以評估蝕刻劑在將具有持久性層異質性之內表面層自容器之內部移除方面的功效。容器由IB型藥物硼矽酸鹽玻璃形成。所測試之玻璃容器為由Gerresheimer GX-51 Flint玻璃形成之3ml玻璃小瓶(「G」樣品)及由Schott Fiolax®玻璃形成之3ml玻璃小瓶(「S」樣品)。測試第一組之五個容器(G與S樣品之混合)以確定具有持久性層異質性之內表面層的存在。確切言之,將1%亞甲基藍染料水溶液引入該組之各容器的內部容積中,保持1分鐘。隨後將容器倒空且用水沖洗容器。目測該組中之各容器的藍色染色狀況。各容器在容器之內表面上具有可覺藍色染色,表明存在具有持久性層異質性之內表面層,確切言之,富含硼之區域,如第6A圖中所示,其中藍色染色呈現為接近各小瓶之底部的灰色區域。
用包含1.5莫耳氫氟酸與3莫耳鹽酸之蝕刻劑處理與第一組相同之第二組的五個容器。使蝕刻劑在容器中保持十二分鐘。隨後將容器倒空、沖洗及乾燥。隨後將1%亞甲基藍染料水溶液引入該組之各容器的內部容積中,保持1分鐘。隨後將容器倒空且用水沖洗容器。測試之後的容器顯示於第6B圖中。目測該組中之各容器的藍色染色狀況。容器中無一者展現染色,表明蝕刻劑處理將具有持久性層異質性之內表面層完全移除。
測試玻璃容器以確定移除具有持久性層異質性之內表面層對玻璃容器之水解抗性的影響。容器由IB型藥物硼矽酸鹽玻璃製得。確切言之,「G」容器為由Gerresheimer GX-51 Flint玻璃形成之3ml玻璃小瓶。「S」容器為由Schott Fiolax®玻璃形成之3ml玻璃小瓶。根據標題為「Glass Containers For Pharmaceutical Use」之歐洲藥典7.0之3.2.1章節對樣品進行測試(下文中EP 3.2.1測試)。以成形時狀態測試樣品G1、S1-S3、G未經蝕刻、S4、S5、G6及G7。在用包含1.5莫耳氫氟酸與3莫耳鹽酸之蝕刻劑處理之後對G經蝕刻進行測試。使蝕刻劑在容器中保持十二分鐘。隨後將容器倒空、沖洗、乾燥及測試。
表2報告EP 3.2.1測試之結果。確切言之,用每毫升溶液為中和在測試期間提取自容器之鹼而使用之0.01M HCl的容積報告測試結果。因此,所使用之HCl之較低值表示較佳水解抗性。如表2中所示,未經蝕刻之容器需要約0.4ml至約1.14ml HCl來中和所提取之鹼。然而,經蝕刻之容器(G經蝕刻)僅需要0.1ml HCl來中和所提取之鹼,表明相對於未經蝕刻之容器而言,蝕刻後溶液中存在之鹼的量低得多,且水解抗性得到顯著改良。
可根據多個態樣理解形成玻璃容器之前述方法。
第一態樣包括:一種形成玻璃容器之方法可包括形成包含至少部分封閉內部容積之側壁的玻璃容器。該側壁之內表面之至少一部分可具有相對於該側壁之中點具有持久性層異質性的內表面層。該玻璃容器之內表面層可自該側壁之該內表面移除,使得該側壁之經修飾內表面具有自該經修飾內表面下方約10nm處延伸進入該側壁之一定厚度處的內部區域。該內部區域可相對於該側壁之該中點具有持久性層均質性,使得該經修飾內表面具有抗分層性。
第二態樣包括:一種形成玻璃容器之方法可包括形成包含至少部分封閉內部容積之側壁的玻璃容器。該側壁之內表面之至少一部分可具有相對於該側壁之中點具有持久性層異質性的內表面層。蝕刻該側壁之該內表面以移除該內表面層,使得該側壁之經修飾內表面具有自該經修飾內表面下方約10nm處延伸進入該側壁之一定厚度處的內部區域。該內部區域可相對於該側壁之該中點具有持久性層均質性,使得該經修飾內表面具有抗分層性。
第三態樣包括:一種形成玻璃容器之方法包括形成包含至少部分封閉內部容積之側壁的玻璃容器,使得側壁之內表面之至少一部分具有內表面層。當該玻璃容器處於成形時狀態時,該內表面層中各構成組分之層濃度的極值小於約
80%或大於約120%的該側壁之中點處相同構成組分的體積濃度。將該內表面層自該側壁之該內表面移除,使得該側壁之經修飾內表面具有延伸進入該側壁之一定厚度處的內部區域。在已移除該內表面層之後,該內部區域中各構成組分之層濃度的極值大於或等於約92%且小於或等於約108%的該側壁之該厚度之中點處相同構成組分的體積濃度。
第四態樣包括第一至第三態樣中之任一者之方法,進一步包含將外表面層自側壁之外表面上移除。可將外表面蝕刻至比存在於側壁之外表面中的表面缺陷的深度大的深度。
第五態樣包括第一至第四態樣中之任一者之方法,其中在移除內表面層後,至少玻璃容器之內表面具有小於或等於10之分層因子。
第六態樣包括第一至第五態樣中之任一者之方法,其中用蝕刻劑將內表面層自側壁之內表面上移除。
第七態樣包括第六態樣之方法,其中蝕刻劑包含氫氟酸及/或至少一種無機酸。
第八態樣包括第一至第七態樣中之任一者之方法,其中內表面層具有大於或等於10nm或甚至大於或等於30nm之厚度。
第九態樣包括第一與第二態樣及第四至第八態樣中之任一者之方法,其中當玻璃容器處於成形時狀態時,內表面層中各構成組分之層濃度的極值小於約80%或大於約120%的側壁之中點處相同構成組分的體積濃度。
第十態樣包括第一至第九態樣中之任一者方法,其中玻璃容器由符合ASTM標準E438-92之I型A類或I型B類玻璃形成。
第十一態樣包括第一至第十態樣中之任一者之方法,其中玻璃容器由硼矽酸鹽玻璃形成。
第十二態樣包括第一至第十一態樣中之任一者之方法,其中內表面層缺乏二氧化矽。
第十三態樣包括第一與第二態樣及第四至第十二態樣中之任一者之方法,其中在已移除內表面層後,內部區域中各構成組分之層濃度的極值大於或等於約92%且小於或等於約108%的側壁之厚度之中點處相同構成組分的體積濃度。
第十四態樣包括第一至第十三態樣中之任一者之方法,其中側壁之經修飾內表面包含遍及玻璃容器之經修內部表面延伸至距玻璃容器之內表面約10nm至約50nm之深度的表面區域;且對於玻璃容器之經修飾內表面上之離散點而言,在已移除持久性層異質性後,該離散點處之表面區域中玻璃之各構成組分之表面濃度的極值大於或等於約70%且小於或等於約130%的玻璃容器之經修飾內表面上任何第二離散點處之表面區域中的相同構成組分之值。
第十五態樣包括第一至第十四態樣中之任一者之方法,其中玻璃容器之經修飾內表面實質上無表面形狀變化。
第十六態樣包括第一至第十五態樣中之任一者之方法,其中內表面層包含富含硼酸鈉之玻璃材料。
第十七態樣包括第一至第十六態樣中之任一者之方
法,其中經修飾內表面之每10,000μm2表面積的平均峰至谷粗糙度小於1μm。
熟習此項技術者將顯而易知,在不脫離所主張之標的之精神及範疇的情況下可對本文所描述之實施例作出各種修改及變化。因此希望本說明書涵蓋本文所描述之各種實施例之修改及變化,限制條件為該等修改及變化在隨附申請專利範圍及其等效形式之範疇內。
104"‧‧‧經修飾內表面
106‧‧‧外表面
110‧‧‧壁部分
120‧‧‧內部區域
Claims (32)
- 一種形成一玻璃容器之方法,該方法包含以下步驟:形成包含至少部分封閉一內部容積之一側壁的一玻璃容器,該側壁之一內表面之至少一部分具有相對於該側壁之一中點具有一持久性層異質性的一內表面層;且將該內表面層自該側壁之該內表面移除,使得該側壁之一經修飾內表面具有自該經修飾內表面下方約10nm處延伸進入該側壁之一定厚度處的一內部區域,該內部區域相對於該側壁之該中點具有一持久性層均質性,使得該經修飾內表面具有抗分層性。
- 如請求項1所述之方法,進一步包含將一外表面層自該側壁之一外表面上移除。
- 如請求項1所述之方法,其中在移除該內表面層之後該玻璃容器具有小於或等於10之一分層因子。
- 如請求項1所述之方法,其中用一蝕刻劑將該內表面層自該側壁之該內表面移除。
- 如請求項4所述之方法,其中該蝕刻劑包含氫氟酸。
- 如請求項4所述之方法,其中該蝕刻劑包含至少一種無機酸。
- 如請求項1所述之方法,其中該內表面層具有大於或等於30nm之一厚度。
- 如請求項1所述之方法,其中當該玻璃容器處於成形時狀態(as-formed condition)時,該內表面層中各構成組分之一層濃度的一極值小於約80%或大於約120%的該側壁之一中點處一相同構成組分的一體積濃度。
- 如請求項1所述之方法,其中該玻璃容器由符合ASTM標準E438-92之I型A類或I型B類玻璃形成。
- 如請求項1所述之方法,其中該玻璃容器由硼矽酸鹽玻璃形成。
- 如請求項1所述之方法,其中該內表面層缺乏二氧化矽。
- 如請求項1所述之方法,其中在已移除該內表面層之後,該內部區域中各構成組分之一層濃度的一極值大於或等於約92%且小於或等於約108%的該側壁之該厚度的一中點處一相同構成組分的一體積濃度。
- 如請求項1所述之方法,其中該側壁之該經修飾內表面包含遍及該玻璃容器之經修飾內表面延伸至距該玻璃容器之 該內表面約10nm至約50nm之一深度的一表面區域;且對於該玻璃容器之該經修飾內表面上的一離散點而言,在已移除該持久性層異質性之後,該離散點處之該表面區域中該玻璃的各構成組分的一表面濃度的一極值大於或等於約70%且小於或等於約130%的該玻璃容器之該經修飾內表面上任何第二離散點處之該表面區域中的一相同構成組分之值。
- 如請求項1所述之方法,其中該玻璃容器之該經修飾內表面實質上無表面形狀變化。
- 一種形成一玻璃容器之方法,該方法包含以下步驟:形成包含至少部分封閉一內部容積之一側壁的一玻璃容器,該側壁之一內表面之至少一部分具有相對於該側壁之一中點具有一持久性層異質性的一內表面層;且用一蝕刻劑蝕刻該側壁之該內表面以移除該內表面層,使得該側壁之一經修飾內表面具有自該經修飾內表面下方約10nm處延伸進入該側壁之一定厚度處的一內部區域,該內部區域相對於該側壁之該中點具有一持久性層均質性,使得該經修飾內表面具有抗分層性。
- 如請求項15所述之方法,進一步包含蝕刻該側壁之一外表面。
- 如請求項16所述之方法,其中將該外表面蝕刻至大於存 在於該側壁之該外表面中之表面缺陷的一深度的一深度。
- 如請求項15所述之方法,其中在移除該內表面層之後,該玻璃容器具有小於或等於10之一分層因子。
- 如請求項15所述之方法,其中該蝕刻劑包含氫氟酸。
- 如請求項15所述之方法,其中該蝕刻劑包含鹽酸。
- 如請求項15所述之方法,其中該內表面層具有大於或等於10nm之一厚度。
- 如請求項15所述之方法,其中該玻璃容器由符合ASTM標準E438-92之I型A類或I型B類玻璃形成。
- 如請求項15所述之方法,其中該內表面層包含一富含硼酸鈉之玻璃材料。
- 如請求項15所述之方法,其中當該玻璃容器處於成形時狀態時,該內表面層中各構成組分之一層濃度的一極值小於約80%或大於約120%的該側壁之一中點處一相同構成組分的一體積濃度。
- 如請求項15所述之方法,其中在已移除該內表面層之 後,該內部區域中各構成組分之一層濃度的一極值大於或等於約92%且小於或等於約108%的該側壁之該厚度之一中點處一相同構成組分的一體積濃度。
- 如請求項15所述之方法,其中該側壁之該經修飾內表面包含遍及該玻璃容器之該經修飾內表面延伸至距該玻璃容器之該內表面約10nm至約50nm之一深度的一表面區域;且對於該玻璃容器之該經修飾內表面上的一離散點而言,在已移除該持久性層異質性之後,該離散點處之該表面區域中該玻璃的各構成組分的一表面濃度之一極值大於或等於約70%且小於或等於約130%的該玻璃容器之該經修飾內表面上任何第二離散點處之該表面區域中的一相同構成組分之值。
- 如請求項15所述之方法,其中該經修飾內表面之每10,000μm2表面積的一平均峰至谷粗糙度小於1μm。
- 一種形成一玻璃容器之方法,該方法包含以下步驟:形成包含至少部分封閉一內部容積之一側壁的一玻璃容器,使得該側壁之一內表面之至少一部分具有一內表面層,其中當該玻璃容器處於一成形時狀態時,該內表面層中各構成組分之一層濃度的一極值小於約80%或大於約120%的該側壁之一中點處一相同構成組分之一體積濃度;及將該內表面層自該側壁之該內表面移除,使得該側壁之一經修飾內表面具有延伸進入該側壁之一定厚度處的一內部 區域,其中在已移除該內表面層之後,該內部區域中各構成組分之一層濃度的一極值大於或等於約92%且小於或等於約108%的該側壁之該厚度之一中點處一相同構成組分的一體積濃度。
- 如請求項28所述之方法,其中在移除該內表面層之後,至少該玻璃容器之該經修飾內表面具有小於或等於10之一分層因子。
- 如請求項28所述之方法,其中該玻璃容器由符合ASTM標準E438-92之I型A類或I型B類玻璃形成。
- 如請求項28所述之方法,其中該經修飾內表面之每10,000μm2表面積的一平均峰至谷粗糙度小於1μm。
- 如請求項28所述之方法,其中該側壁之該經修飾內表面包含遍及該玻璃容器之該經修飾內表面延伸至距該玻璃容器之該內表面約10nm至約50nm之一深度的一表面區域;且對於該玻璃容器之該經修飾內表面上的一離散點而言,在已移除該內表面層之後,該離散點處之該表面區域中該玻璃的各構成組分之一表面濃度的一極值大於或等於約70%且小於或等於約130%的該玻璃容器之該經修飾內表面上任何第二離散點處之該表面區域中的一相同構成組分之值。
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TWI705946B (zh) * | 2014-09-05 | 2020-10-01 | 美商康寧公司 | 玻璃物品及改善玻璃物品可靠性的方法 |
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