JP2017200874A - 耐化学薬品性を有する医薬品包装材 - Google Patents
耐化学薬品性を有する医薬品包装材 Download PDFInfo
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- 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
- C03C3/00—Glass compositions
- C03C3/04—Glass compositions containing silica
- C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
- C03C3/083—Glass compositions containing silica with 40% to 90% silica, by weight containing aluminium oxide or an iron compound
- C03C3/085—Glass compositions containing silica with 40% to 90% silica, by weight containing aluminium oxide or an iron compound containing an oxide of a divalent metal
- C03C3/087—Glass compositions containing silica with 40% to 90% silica, by weight containing aluminium oxide or an iron compound containing an oxide of a divalent metal containing calcium oxide, e.g. common sheet or container glass
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- 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
-
- 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
- A61J1/062—Carpules
-
- 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
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- 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
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
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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
- 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
-
- 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
- C03C3/00—Glass compositions
- C03C3/04—Glass compositions containing silica
- C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
- C03C3/089—Glass compositions containing silica with 40% to 90% silica, by weight containing boron
- C03C3/091—Glass compositions containing silica with 40% to 90% silica, by weight containing boron containing aluminium
- C03C3/093—Glass compositions containing silica with 40% to 90% silica, by weight containing boron containing aluminium containing zinc or zirconium
-
- 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
- C03C4/00—Compositions for glass with special properties
- C03C4/20—Compositions for glass with special properties for chemical resistant glass
-
- 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
- C03C2204/00—Glasses, glazes or enamels with special properties
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- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Materials Engineering (AREA)
- Geochemistry & Mineralogy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Ceramic Engineering (AREA)
- Mechanical Engineering (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Glass Compositions (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
SiO2 59〜84
Al2O3 7〜18.5
CaO 1〜25
SrO 0〜6.5
BaO 0〜5
ZrO2 0〜3
TiO2 0〜5
B2O3 0〜1
(CaO+SrO+BaO)/Al2O3比は2.8未満であり、
(CaO+SrO+BaO)/SiO2比は0.39以下であり、
DIN ISO 720に従った耐加水分解性はクラス HGA 1であり、
かつ、前記ガラスは、不可避的不純物以外にアルカリ金属酸化物及び酸化マグネシウムを含んでいない。
第1表には、本発明による医薬品包装材用のガラスと並んでそれらの最も重要な特性をまとめている。
Claims (19)
- 医薬品包装材、特にガラス容器、とりわけボトル、シリンジ、カートリッジ又はアンプルの形態の医薬品包装材であって、少なくとも以下の成分(酸化物を基準としてモル%で):
SiO2 59〜84
Al2O3 7〜18.5
CaO 1〜25
SrO 0〜6.5
BaO 0〜5
ZrO2 0〜3
TiO2 0〜5
B2O3 0〜1
を含有するガラスを有し、
(CaO+SrO+BaO)/Al2O3比は2.8未満であり、
(CaO+SrO+BaO)/SiO2比は0.39以下であり、
DIN ISO 720に従った耐加水分解性はクラス HGA 1であり、
かつガラスは、不可避的不純物を除き、アルカリ金属酸化物及び酸化マグネシウムを含まない、医薬品包装材。 - (CaO+SrO+BaO)/Al2O3比が2.3未満であり、かつ、好ましくは1.9超である、請求項1に記載の医薬品包装材。
- (CaO+SrO+BaO)/SiO2比が0.25より大きい、請求項1又は2に記載の医薬品包装材。
- BaOの含有率が3モル%以下、好ましくは1.5モル%以下である、請求項1から3までのいずれか1項に記載の医薬品包装材。
- Al2O3の含有率が12モル%未満である、請求項1から4までのいずれか1項に記載の医薬品包装材。
- Al2O3の含有率が9モル%超である、請求項1から5までのいずれか1項に記載の医薬品包装材。
- CaOの含有率が15モル%超であり、かつ、好ましくは24.5モル%未満である、請求項1から6までのいずれか1項に記載の医薬品包装材。
- SrOの含有率が4モル%未満であり、好ましくは3モル%未満である、請求項1から7までのいずれか1項に記載の医薬品包装材。
- TiO2+ZrO2の合計含有率が少なくとも0.5モル%であり、好ましくは少なくとも0.8モル%である、請求項1から8までのいずれか1項に記載の医薬品包装材。
- TiO2+ZrO2の合計含有率が最大でも6モル%であり、好ましくは最大でも4モル%であり、さらに有利には最大でも3モル%であり、とりわけ有利には最大でも2.5モル%である、請求項1から9までのいずれか1項に記載の医薬品包装材。
- SiO2の含有率が60モル%超である、請求項1から10までのいずれか1項に記載の医薬品包装材。
- SiO2の含有率が70モル%未満である、請求項1から11までのいずれか1項に記載の医薬品包装材。
- B2O3を少なくとも0.05モル%、又は少なくとも0.1モル%、かつ最大で1.0モル%まで、好ましくは0.5モル%まで含有する、請求項1から12までのいずれか1項に記載の医薬品包装材。
- 最大でも1350℃、好ましくは最大でも1320℃の加工温度T4を有する、請求項1から13までのいずれか1項に記載の医薬品包装材。
- DIN ISO 720に従った質量損失が、グラム当たりNa2O 50μg未満、好ましくはグラム当たりNa2O 46μg未満、とりわけ有利にはグラム当たりNa2O 40μg未満である、請求項1から14までのいずれか1項に記載の医薬品包装材。
- DIN ISO 720に従った耐加水分解性がHGA 1である、請求項1から15までのいずれか1項に記載の医薬品包装材。
- さらに0.01〜2モル%、好ましくは0.1〜1.5モル%の清澄剤、好ましくは、As2O3、Sb2O3、SnO2、CeO2、Cl−、F−及びSO4 2−からなる群から選択される少なくとも1種の清澄剤を含有する、請求項1から16までのいずれか1項に記載の医薬品包装材。
- As2O3、Sb2O3、Cl−、F−及びSO4 2−の含有率が、それぞれ最大1.5モル%であり、ここで、SnO2及びCeO2の含有率が、好ましくはそれぞれ最大1モル%であり、好ましくはそれぞれ0.01モル%未満である、請求項1から17までのいずれか1項に記載の医薬品包装材。
- pH範囲1〜11の有効成分及び/若しくは緩衝溶液を収容するための、又はpH範囲5〜7の有効成分及び/若しくは緩衝溶液を収容するための、又は注射用水を収容するための、請求項1から18までのいずれか1項に記載の医薬品包装材。
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102016108301 | 2016-05-04 | ||
DE102016108301.1 | 2016-05-04 | ||
DE102017102900.1A DE102017102900A1 (de) | 2016-05-04 | 2017-02-14 | Pharmapackmittel mit einem chemisch beständigen Glas |
DE102017102900.1 | 2017-02-14 |
Publications (2)
Publication Number | Publication Date |
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JP2017200874A true JP2017200874A (ja) | 2017-11-09 |
JP6938203B2 JP6938203B2 (ja) | 2021-09-22 |
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Application Number | Title | Priority Date | Filing Date |
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JP2017091148A Active JP6938203B2 (ja) | 2016-05-04 | 2017-05-01 | 耐化学薬品性を有する医薬品包装材 |
Country Status (4)
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US (1) | US10315948B2 (ja) |
JP (1) | JP6938203B2 (ja) |
CN (1) | CN107344813B (ja) |
DE (1) | DE102017102900A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2019155108A (ja) * | 2018-03-16 | 2019-09-19 | ショット アクチエンゲゼルシャフトSchott AG | ガラス層と、水による濡れに関する接触角を有する表面領域とを有する中空体、特に医薬組成物を包装するための中空体 |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102018133413A1 (de) * | 2018-12-21 | 2020-06-25 | Schott Ag | Chemisch beständige, Bor- und Alkali-freie Gläser |
WO2020190504A1 (en) * | 2019-03-15 | 2020-09-24 | Corning Incorporated | Chemically durable aluminosilicate glass compositions and glass articles formed therefrom |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5688843A (en) * | 1979-10-11 | 1981-07-18 | Jenaer Glaswerk Schott & Gen | Alkaliifree sealing glass for molybdenum |
JPS63176332A (ja) * | 1987-01-16 | 1988-07-20 | Nippon Sheet Glass Co Ltd | 電子機器の基板用ガラス |
JP2001122637A (ja) * | 1999-10-26 | 2001-05-08 | Nippon Electric Glass Co Ltd | ディスプレイ用ガラス基板 |
JP2002537206A (ja) * | 1999-02-15 | 2002-11-05 | カール−ツアイス−スチフツング | 高酸化ジルコニウム含有ガラス及びその使用 |
JP2015013793A (ja) * | 2013-06-06 | 2015-01-22 | 日本電気硝子株式会社 | 医薬品容器用ガラス |
US20160107918A1 (en) * | 2013-05-30 | 2016-04-21 | Dalwick Continental Corp | Method for manufacturing glass containers for pharmaceutical use |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BR6804453D0 (pt) | 1967-12-26 | 1973-01-30 | Gen Electric | Vidros de alta temperatura |
US4012263A (en) | 1975-02-10 | 1977-03-15 | Owens-Illinois, Inc. | Alkali-free glasses |
US4302250A (en) | 1980-09-08 | 1981-11-24 | Corning Glasss Works | Glass envelopes for tungsten-halogen lamps |
JP3083586B2 (ja) | 1991-04-26 | 2000-09-04 | 旭硝子株式会社 | 無アルカリガラス |
JPH05155638A (ja) | 1991-12-06 | 1993-06-22 | Nippon Electric Glass Co Ltd | ガラス組成物 |
DE10035801B4 (de) * | 2000-07-22 | 2008-04-03 | Schott Ag | Borosilicatglas hoher chemischer Beständigkeit und dessen Verwendungen |
US8152020B2 (en) * | 2008-07-09 | 2012-04-10 | Flowers Mary E | Dosage dispensing and tracking container |
EP2639205B1 (en) | 2010-11-08 | 2019-03-06 | Nippon Electric Glass Co., Ltd. | Alkali-free glass |
WO2012077609A1 (ja) | 2010-12-07 | 2012-06-14 | 旭硝子株式会社 | 無アルカリガラスおよび無アルカリガラスの製造方法 |
EP2771300B1 (en) | 2011-10-25 | 2017-12-20 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
KR101833805B1 (ko) | 2011-12-29 | 2018-03-02 | 니폰 덴키 가라스 가부시키가이샤 | 무알칼리 유리 |
JP2015061808A (ja) * | 2012-12-21 | 2015-04-02 | 日本電気硝子株式会社 | 強化ガラス、強化ガラス板、強化ガラス容器及び強化用ガラス |
US9839579B2 (en) | 2013-04-24 | 2017-12-12 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
JP6256744B2 (ja) * | 2013-10-17 | 2018-01-10 | 日本電気硝子株式会社 | 無アルカリガラス板 |
-
2017
- 2017-02-14 DE DE102017102900.1A patent/DE102017102900A1/de not_active Ceased
- 2017-05-01 JP JP2017091148A patent/JP6938203B2/ja active Active
- 2017-05-03 CN CN201710304178.9A patent/CN107344813B/zh active Active
- 2017-05-04 US US15/586,345 patent/US10315948B2/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5688843A (en) * | 1979-10-11 | 1981-07-18 | Jenaer Glaswerk Schott & Gen | Alkaliifree sealing glass for molybdenum |
JPS63176332A (ja) * | 1987-01-16 | 1988-07-20 | Nippon Sheet Glass Co Ltd | 電子機器の基板用ガラス |
JP2002537206A (ja) * | 1999-02-15 | 2002-11-05 | カール−ツアイス−スチフツング | 高酸化ジルコニウム含有ガラス及びその使用 |
JP2001122637A (ja) * | 1999-10-26 | 2001-05-08 | Nippon Electric Glass Co Ltd | ディスプレイ用ガラス基板 |
US20160107918A1 (en) * | 2013-05-30 | 2016-04-21 | Dalwick Continental Corp | Method for manufacturing glass containers for pharmaceutical use |
JP2015013793A (ja) * | 2013-06-06 | 2015-01-22 | 日本電気硝子株式会社 | 医薬品容器用ガラス |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2019155108A (ja) * | 2018-03-16 | 2019-09-19 | ショット アクチエンゲゼルシャフトSchott AG | ガラス層と、水による濡れに関する接触角を有する表面領域とを有する中空体、特に医薬組成物を包装するための中空体 |
Also Published As
Publication number | Publication date |
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CN107344813A (zh) | 2017-11-14 |
JP6938203B2 (ja) | 2021-09-22 |
US10315948B2 (en) | 2019-06-11 |
US20170320770A1 (en) | 2017-11-09 |
CN107344813B (zh) | 2022-07-22 |
DE102017102900A1 (de) | 2017-11-09 |
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