JP2001506888A - 液体薬剤を貯蔵するための線状オレフィンのポリマーからなる薬剤容器 - Google Patents
液体薬剤を貯蔵するための線状オレフィンのポリマーからなる薬剤容器Info
- Publication number
- JP2001506888A JP2001506888A JP52825498A JP52825498A JP2001506888A JP 2001506888 A JP2001506888 A JP 2001506888A JP 52825498 A JP52825498 A JP 52825498A JP 52825498 A JP52825498 A JP 52825498A JP 2001506888 A JP2001506888 A JP 2001506888A
- Authority
- JP
- Japan
- Prior art keywords
- container
- weight
- polymer
- drug
- cresol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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- 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
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- A61J1/06—Ampoules or carpules
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61J1/10—Bag-type containers
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/04—Homopolymers or copolymers of ethene
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/10—Homopolymers or copolymers of propene
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
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- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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Landscapes
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- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
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- Physical Or Chemical Processes And Apparatus (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Packages (AREA)
- Packging For Living Organisms, Food Or Medicinal Products That Are Sensitive To Environmental Conditiond (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.1またはそれ以上の活性薬剤、水、並びにm−クレゾールおよび/またはフ ェノールおよび/またはベンジルアルコールを含む液体薬剤を貯蔵するための薬 剤容器であって、先端部および基端部、並びに壁を備え、壁の少なくとも2つの 対向部分はポリマー材料で構成され、該ポリマー壁部分は、0.3mmないし3 mmの厚さを有し、該容器に水を入れ、標準分光光度計を用い、空気を参照とし て該対向する容器壁部分の両方を通して測定して400nmの透光率25%以上 、好ましくは30%以上を有し、該ポリマー壁部分は、線状で場合に応じて分枝 しているポリオレフィン材料を少なくとも70重量%含む材料で構成され、その オレフィンモノマーは、エチレン、プロピレン、ブチレンまたはその混合物から 選ばれ、該材料は、該容器壁から片を切り出し、アルミニウムパン中で走査速度 10℃/分で10℃から270℃まで加熱することにより溶融吸熱を記録し、積 分し、参照として100%結晶性ポリプロピレンについての値209J/gを用 い、差動走査型熱量測定法で測定して35重量%を超える結晶度を有する薬剤容 器。 2.ポリマー壁材料がポリオレフィン材料を少なくとも75重量%、好ましくは 95重量%を超えて、より好ましくは98重量%を超えて含有する請求項1に記 載の容器。 3.ポリオレフィン材料が線状もしくは分枝ポリプロピレンまたは線状もしくは 分枝ポリエチレンであり、より好ましくはポリプロピレンホモポリマーである請 求項1または2に記載の容器。 4.ポリオレフィン材料が、730cm-1でのFTIR分光光度計を用い、かつ 内部標準として460cm-1でのプロピレン吸収を用いて測定して、総ポリマー 壁材料の1.8重量%までの、好ましくは0.5ないし1.8重量%、より好ま しくは1ないし1.8重量%のエチレン含有率を有するプロピレンエチレンコポ リマーである請求項1または2に記載の容器。 5.ポリマー壁材料が、請求項1に規定した通りに測定して、50重量%までの 、好ましくは45重量%までの、より好ましくは42重量%までの結晶度を有す る請求項1ないし4のいずれか1項に記載の容器。 6.ポリマー壁部分が、請求項1に規定した通りに測定して、400nmにおい て30%の透光率を有する請求項1ないし5のいずれか1項に記載の容器。 7.ポリマー壁材料が、少なくとも−15℃、より好ましくは−10℃を超える ガラス転移温度を有する請求項1ないし6のいずれか1項に記載の容器。 8.ポリマー壁材料が、添加剤、好ましくは抗酸化剤、潤滑剤、界面活性剤、核 形成剤および透明化剤から選ばれる添加剤を5重量%まで、並びに不活性フィラ ー、好ましくはポリマー材料の屈折率とほぼ等しい屈折率を有するガラス粒子を 30重量%まで含有し、添加剤とフィラーの合計量が30重量%までである請求 項1ないし7のいずれか1項に記載の容器。 9.容器壁が、内表面と外表面を有し、該内表面が実質的に円筒形状を有する請 求項1ないし8のいずれか1項に記載の容器。 10.容器壁が、内表面と外表面を有し、該外表面が実質的に円筒形状を有する 請求項1ないし9のいずれか1項に記載の容器。 11.容器がカートリッジであり、その先端部が刺通可能なシールを備え、基端 部がプランジャーを備える請求項1ないし10のいずれが1項に記載の容器。 12.ポリマー壁部分が、壁の面積の少なくとも30%を構成し、好ましくは5 0%を超えて構成し、より好ましくは80%を超えて構成する請求項1ないし1 1のいずれか1項に記載の容器。 13.ポリマー壁部分が、ポリマー壁を3mg/mlのm−クレゾール水溶液と 接触させることにより37℃および12%RHで3ヵ月の貯蔵期間後に測定して 、0.0072g/m2/24時間未満のm−クレゾール透過率を有し、37℃ 、12%RHで3ヵ月の貯蔵期間後に測定して、0.4g/m2/24時間未満 の水透過率を有する請求項1ないし12のいずれか1項に記載の容器。 14.ポリマー壁部分が、ポリマー壁を3mg/mlのm−クレゾール水溶液と 接触させることにより37℃および12%RHで3ヵ月の貯蔵期間後に測定して 、0.0070g/m2/24時間未満の、より好ましくは0.0055g/m2 /24時間未満の、さらに好ましくは0.0045g/m2/24時間未満のm −クレゾール透過率を有する請求項13に記載の容器。 15.ポリマー壁部分が、37℃、12%RHで3ヵ月の貯蔵期間後に測定して 、 0.35g/m2/24時間未満の、好ましくは0.30g/m2/24時間未満 の水透過率を有する請求項13または14に記載の容器。 16.ポリマー壁部分が、8℃、13%RHで36ヶ月の貯蔵期間後に測定して 0.0025g/m2/24時間未満の未満の、好ましくは0.021g/m2/ 24時間未満の水透過率を有する請求項1ないし15のいずれか1項に記載の容 器。 17.請求項1ないし16のいずれか1項に記載の薬剤容器の、1またはそれ以 上の防腐剤を含む薬剤を貯蔵するための使用。 18.薬剤が、好ましくは薬剤のml当り25ないし600IUのインスリン、 0.1ないし5mgのフェノールおよび/またはベンジルアルコール、並びに0 .5ないし5mgのm−クレゾールを含むところの、インスリン水性溶液もしく は懸濁液である請求項17に記載の使用。 19.薬剤がヒト成長ホルモンの水性溶液もしくは懸濁液である請求項17に記 載の使用。 20.1またはそれ以上の活性薬剤、水、並びにm−クレゾールおよび/または フェノールおよび/またはベンジルアルコールを含む液体薬剤で部分的に満たさ れた請求項1ないし16のいずれが1項に記載の薬剤容器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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DK1498/96 | 1996-12-23 | ||
DK149896 | 1996-12-23 | ||
PCT/DK1997/000570 WO1998027926A1 (en) | 1996-12-23 | 1997-12-16 | A medicament container of polymer of linear olefin for storing a liquid medicament |
Publications (2)
Publication Number | Publication Date |
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JP2001506888A true JP2001506888A (ja) | 2001-05-29 |
JP4672818B2 JP4672818B2 (ja) | 2011-04-20 |
Family
ID=8105469
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP52825398A Pending JP2001506887A (ja) | 1996-12-23 | 1997-12-16 | 液体薬剤を貯蔵するための環状炭化水素のポリマーからなる薬剤容器 |
JP52825498A Expired - Fee Related JP4672818B2 (ja) | 1996-12-23 | 1997-12-16 | 液体薬剤を貯蔵するための線状オレフィンのポリマーからなる薬剤容器 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP52825398A Pending JP2001506887A (ja) | 1996-12-23 | 1997-12-16 | 液体薬剤を貯蔵するための環状炭化水素のポリマーからなる薬剤容器 |
Country Status (22)
Country | Link |
---|---|
US (2) | US5945187A (ja) |
EP (2) | EP0954273A1 (ja) |
JP (2) | JP2001506887A (ja) |
KR (2) | KR20000069681A (ja) |
CN (2) | CN1244109A (ja) |
AT (1) | ATE215348T1 (ja) |
AU (3) | AU728503B2 (ja) |
BR (2) | BR9713627A (ja) |
CA (2) | CA2275894A1 (ja) |
CZ (2) | CZ221199A3 (ja) |
DE (1) | DE69711703T3 (ja) |
DK (1) | DK0954272T3 (ja) |
ES (1) | ES2174314T3 (ja) |
HU (2) | HUP9904598A3 (ja) |
IL (2) | IL130432A0 (ja) |
IN (1) | IN186895B (ja) |
NO (2) | NO314123B1 (ja) |
PL (2) | PL334251A1 (ja) |
PT (1) | PT954272E (ja) |
RU (2) | RU2183110C2 (ja) |
WO (2) | WO1998027925A1 (ja) |
ZA (2) | ZA9711380B (ja) |
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1997
- 1997-12-16 EP EP97949989A patent/EP0954273A1/en not_active Withdrawn
- 1997-12-16 PT PT97949988T patent/PT954272E/pt unknown
- 1997-12-16 CA CA002275894A patent/CA2275894A1/en not_active Abandoned
- 1997-12-16 HU HU9904598A patent/HUP9904598A3/hu unknown
- 1997-12-16 AU AU53099/98A patent/AU728503B2/en not_active Ceased
- 1997-12-16 ES ES97949988T patent/ES2174314T3/es not_active Expired - Lifetime
- 1997-12-16 BR BR9713627-1A patent/BR9713627A/pt active Search and Examination
- 1997-12-16 RU RU99116251/14A patent/RU2183110C2/ru not_active IP Right Cessation
- 1997-12-16 US US08/991,518 patent/US5945187A/en not_active Expired - Lifetime
- 1997-12-16 HU HU0000081A patent/HUP0000081A3/hu unknown
- 1997-12-16 CN CN97181308A patent/CN1244109A/zh active Pending
- 1997-12-16 AU AU5309998D patent/AU719221B2/xx not_active Expired - Lifetime
- 1997-12-16 JP JP52825398A patent/JP2001506887A/ja active Pending
- 1997-12-16 CZ CZ992211A patent/CZ221199A3/cs unknown
- 1997-12-16 CN CN97181309A patent/CN1244110A/zh active Pending
- 1997-12-16 AT AT97949988T patent/ATE215348T1/de not_active IP Right Cessation
- 1997-12-16 WO PCT/DK1997/000569 patent/WO1998027925A1/en not_active Application Discontinuation
- 1997-12-16 PL PL97334251A patent/PL334251A1/xx unknown
- 1997-12-16 RU RU99116323/14A patent/RU2183111C2/ru not_active IP Right Cessation
- 1997-12-16 BR BR9714078-3A patent/BR9714078A/pt not_active Application Discontinuation
- 1997-12-16 WO PCT/DK1997/000570 patent/WO1998027926A1/en not_active Application Discontinuation
- 1997-12-16 EP EP97949988A patent/EP0954272B2/en not_active Expired - Lifetime
- 1997-12-16 PL PL97334252A patent/PL334252A1/xx unknown
- 1997-12-16 AU AU53100/98A patent/AU741689B2/en not_active Ceased
- 1997-12-16 IL IL13043297A patent/IL130432A0/xx unknown
- 1997-12-16 DE DE69711703T patent/DE69711703T3/de not_active Expired - Lifetime
- 1997-12-16 US US08/991,519 patent/US6680091B2/en not_active Expired - Lifetime
- 1997-12-16 JP JP52825498A patent/JP4672818B2/ja not_active Expired - Fee Related
- 1997-12-16 DK DK97949988T patent/DK0954272T3/da active
- 1997-12-16 KR KR1019997005728A patent/KR20000069681A/ko not_active Application Discontinuation
- 1997-12-16 KR KR1019997005727A patent/KR20000069680A/ko not_active Application Discontinuation
- 1997-12-16 CA CA002275903A patent/CA2275903A1/en not_active Abandoned
- 1997-12-16 IL IL13043397A patent/IL130433A0/xx unknown
- 1997-12-16 CZ CZ992212A patent/CZ221299A3/cs unknown
- 1997-12-18 ZA ZA9711380A patent/ZA9711380B/xx unknown
- 1997-12-18 ZA ZA9711387A patent/ZA9711387B/xx unknown
- 1997-12-23 IN IN3755DE1997 patent/IN186895B/en unknown
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1999
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JP2015517328A (ja) * | 2012-05-03 | 2015-06-22 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 医薬品を保管するための容器および方法 |
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