JP2015517328A - 医薬品を保管するための容器および方法 - Google Patents
医薬品を保管するための容器および方法 Download PDFInfo
- Publication number
- JP2015517328A JP2015517328A JP2015510384A JP2015510384A JP2015517328A JP 2015517328 A JP2015517328 A JP 2015517328A JP 2015510384 A JP2015510384 A JP 2015510384A JP 2015510384 A JP2015510384 A JP 2015510384A JP 2015517328 A JP2015517328 A JP 2015517328A
- Authority
- JP
- Japan
- Prior art keywords
- polyolefin
- insulin
- fatty acid
- acid amide
- stabilizer
- 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
- 239000003814 drug Substances 0.000 title claims abstract description 87
- 238000000034 method Methods 0.000 title claims abstract description 42
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims abstract description 172
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- 108090001061 Insulin Proteins 0.000 claims abstract description 84
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- 229920000098 polyolefin Polymers 0.000 claims abstract description 48
- 239000003381 stabilizer Substances 0.000 claims abstract description 47
- 235000014113 dietary fatty acids Nutrition 0.000 claims abstract description 39
- 239000000194 fatty acid Substances 0.000 claims abstract description 39
- 229930195729 fatty acid Natural products 0.000 claims abstract description 39
- 150000004665 fatty acids Chemical class 0.000 claims abstract description 39
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims abstract description 35
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- UAUDZVJPLUQNMU-KTKRTIGZSA-N erucamide Chemical class CCCCCCCC\C=C/CCCCCCCCCCCC(N)=O UAUDZVJPLUQNMU-KTKRTIGZSA-N 0.000 claims abstract description 12
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- -1 polypropylene Polymers 0.000 claims description 27
- 239000000203 mixture Substances 0.000 claims description 19
- LYRFLYHAGKPMFH-UHFFFAOYSA-N octadecanamide Chemical compound CCCCCCCCCCCCCCCCCC(N)=O LYRFLYHAGKPMFH-UHFFFAOYSA-N 0.000 claims description 16
- HSEMFIZWXHQJAE-UHFFFAOYSA-N hexadecanamide Chemical compound CCCCCCCCCCCCCCCC(N)=O HSEMFIZWXHQJAE-UHFFFAOYSA-N 0.000 claims description 14
- 239000004743 Polypropylene Substances 0.000 claims description 11
- 229920001155 polypropylene Polymers 0.000 claims description 11
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 10
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- ILRSCQWREDREME-UHFFFAOYSA-N dodecanamide Chemical compound CCCCCCCCCCCC(N)=O ILRSCQWREDREME-UHFFFAOYSA-N 0.000 claims description 10
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- FUSNPOOETKRESL-ZPHPHTNESA-N (z)-n-octadecyldocos-13-enamide Chemical compound CCCCCCCCCCCCCCCCCCNC(=O)CCCCCCCCCCC\C=C/CCCCCCCC FUSNPOOETKRESL-ZPHPHTNESA-N 0.000 claims description 5
- ORAWFNKFUWGRJG-UHFFFAOYSA-N Docosanamide Chemical compound CCCCCCCCCCCCCCCCCCCCCC(N)=O ORAWFNKFUWGRJG-UHFFFAOYSA-N 0.000 claims description 5
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- 125000003717 m-cresyl group Chemical group [H]C1=C([H])C(O*)=C([H])C(=C1[H])C([H])([H])[H] 0.000 claims description 5
- FTQWRYSLUYAIRQ-UHFFFAOYSA-N n-[(octadecanoylamino)methyl]octadecanamide Chemical compound CCCCCCCCCCCCCCCCCC(=O)NCNC(=O)CCCCCCCCCCCCCCCCC FTQWRYSLUYAIRQ-UHFFFAOYSA-N 0.000 claims description 5
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- 125000001117 oleyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])/C([H])=C([H])\C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 3
- VMRGZRVLZQSNHC-ZCXUNETKSA-N n-[(z)-octadec-9-enyl]hexadecanamide Chemical compound CCCCCCCCCCCCCCCC(=O)NCCCCCCCC\C=C/CCCCCCCC VMRGZRVLZQSNHC-ZCXUNETKSA-N 0.000 claims description 2
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- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 2
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- QTWJRLJHJPIABL-UHFFFAOYSA-N 2-methylphenol;3-methylphenol;4-methylphenol Chemical compound CC1=CC=C(O)C=C1.CC1=CC=CC(O)=C1.CC1=CC=CC=C1O QTWJRLJHJPIABL-UHFFFAOYSA-N 0.000 description 1
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Images
Classifications
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- 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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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
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Abstract
Description
この実施例は、インスリンからの保存剤の喪失を確定するために、また貯蔵時のインスリン安定性を確定するために実施した。
Becton,Dickinson and Companyの環状オレフィンコポリマーおよびエルカ酸アミドから作られた商標DISCARDIT IIのシリンジを、m−クレゾールとフェノールの混合物を含むインスリンで充填し、25℃および37℃で保管した。インスリン、m−クレゾールおよびフェノールを収容するガラス製バイアルを同じ条件下でコントロールとして保管した。m−クレゾールの喪失はHPLCによって決定し、インスリンの喪失はImmulite分析によって決定した。結果は図6のグラフに示される。図6に示されるように、環状オレフィンコポリマーは、25℃および37℃においてm−クレゾールの喪失を15日の期間にわたり実質的に示さなかった。25℃と37℃におけるインスリンの喪失は、15日の期間にわたりほぼ同じであった。
Claims (25)
- 医薬品の貯蔵装置であって、
ポリオレフィン中に分散させた脂肪酸アミドを含み、前記ポリオレフィンから形成された貯蔵容器と、
前記貯蔵容器内にあり、前記医薬品を安定化するのに有効な量のフェノール安定剤を含有する医薬品とを備え、
前記脂肪酸アミドは、前記医薬品から前記ポリオレフィン中への前記安定剤の移行速度を低減させるのに有効な量が、前記ポリオレフィン中に含まれることを特徴とする貯蔵装置。 - 前記貯蔵容器は、充填済みシリンジであることを特徴とする請求項1に記載の貯蔵装置。
- 前記貯蔵容器は、電気機械式注入ポンプアセンブリの貯蔵器であることを特徴とする請求項1に記載の貯蔵装置。
- 前記貯蔵容器は、外層および内層を含み、前記内層は、前記脂肪酸アミドを含有する前記ポリオレフィンから形成されることを特徴とする請求項1に記載の貯蔵装置。
- 前記容器は、可撓性管であることを特徴とする請求項4に記載の貯蔵装置。
- 前記容器はインスリン注入デバイスの一次インスリン貯蔵器であり、前記医薬品はインスリンであることを特徴とする請求項4に記載の貯蔵装置。
- 前記ポリオレフィンはポリプロピレンであり、前記脂肪酸アミドはエルカ酸アミドであることを特徴とする請求項1に記載の貯蔵装置。
- 前記ポリオレフィンは、ポリプロピレン、ポリエチレン、およびポリプロピレン/ポリエチレン混合物からなる群から選択されることを特徴とする請求項1に記載の貯蔵装置。
- 前記ポリオレフィンは環状オレフィンコポリマーであることを特徴とする請求項1に記載の貯蔵装置。
- 前記脂肪酸アミドは、ラウラミド、ミリスタミド、パルミタミド、ステアラミド、ベヘナミド、エルカ酸アミド、モンタンアミド、ステアリルエルカアミド、オレイルパルミトアミド、メチレンビス(ステアラミド)、エチレンビス(ミリスタミド)、エチレンビス(パルミタミド)およびエチレンビス(ステアラミド)からなる群から選択され、
前記安定剤は、m−クレゾール、フェノール、またはそれらの混合物であることを特徴とする請求項1に記載の貯蔵装置。 - 医薬品を保存する方法であって、
脂肪酸アミドを含むポリオレフィンから形成された収納器内に前記医薬品を収納および保管するステップを含み、前記医薬品は、前記医薬品を長期貯蔵のために安定化するのに有効な量のフェノール安定剤を含み、前記ポリオレフィンは、前記医薬品から前記ポリオレフィン中への前記安定剤の移行速度を低減させるのに有効な量の前記脂肪酸アミドを含むことを特徴とする方法。 - 前記医薬品はインスリンであり、前記安定剤は、m−クレゾール、フェノール、およびそれらの混合物からなる群から選択されることを特徴とする請求項11に記載の方法。
- 前記脂肪酸アミドは、ラウラミド、ミリスタミド、パルミタミド、ステアラミド、ベヘナミド、エルカ酸アミド、モンタンアミド、ステアリルエルカアミド、オレイルパルミトアミド、メチレンビス(ステアラミド)、エチレンビス(ミリスタミド)、エチレンビス(パルミタミド)およびエチレンビス(ステアラミド)からなる群から選択されることを特徴とする請求項11に記載の方法。
- 前記収納器は電気機械式注入ポンプの貯蔵器であることを特徴とする請求項11に記載の方法。
- 前記電気機械式注入ポンプは、前記ポリオレフィンおよび脂肪酸アミドから作られた可撓性管を含むことを特徴とする請求項14に記載の方法。
- 前記収納器は、インスリンを収容する充填済みシリンジであることを特徴とする請求項11に記載の方法。
- 前記ポリオレフィンは、ポリプロピレン、エチレン、およびポリプロピレン/ポリエチレン混合物からなる群から選択されることを特徴とする請求項11に記載の方法。
- 前記ポリオレフィンは、環状オレフィンコポリマーであることを特徴とする請求項11に記載の方法。
- 貯蔵時の医薬品からの安定剤の喪失を抑制する方法であって、
脂肪酸アミドを含有するポリオレフィンから形成された貯蔵チャンバの中に前記医薬品を導入するステップと、前記医薬品を保管するステップとを含み、前記医薬品は、前記医薬品を安定化するのに有効な量のフェノール安定剤を含み、前記脂肪酸アミドは、前記医薬品から前記ポリオレフィン中への前記安定剤の移行速度を低減させるのに有効な量が、前記ポリオレフィンに混合されることを特徴とする方法。 - 前記医薬品はインスリンであり、前記安定剤は、m−クレゾール、フェノール、およびそれらの混合物からなる群から選択されることを特徴とする請求項19に記載の方法。
- 前記脂肪酸アミドは、ラウラミド、ミリスタミド、パルミタミド、ステアラミド、ベヘナミド、エルカ酸アミド、モンタンアミド、ステアリルエルカアミド、オレイルパルミトアミド、メチレンビス(ステアラミド)、エチレンビス(ミリスタミド)、エチレンビス(パルミタミド)およびエチレンビス(ステアラミド)からなる群から選択されることを特徴とする請求項20に記載の方法。
- 前記貯蔵チャンバは、電気機械式注入デバイスであることを特徴とする請求項19に記載の方法。
- 前記貯蔵チャンバは、前記電気機械式注入デバイスの可撓性管類であることを特徴とする請求項22に記載の方法。
- 前記可撓性管類は外層と、前記医薬品と接触する内側バリア層とを有し、前記内側バリア層は前記ポリオレフィンおよび脂肪酸アミドから形成されることを特徴とする請求項23に記載の方法。
- 前記医薬品はインスリンであり、前記安定剤は、m−クレゾール、フェノール、およびそれらの混合物からなる群から選択され、前記脂肪酸アミドはエルカ酸アミドであることを特徴とする請求項19に記載の方法。
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- 2013-04-30 WO PCT/US2013/038864 patent/WO2013166014A1/en active Application Filing
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- 2013-05-03 CN CN201320447362.6U patent/CN204219374U/zh not_active Expired - Lifetime
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JP2020516695A (ja) * | 2017-04-12 | 2020-06-11 | ウリゲン ファーマシューティカルズ、インコーポレイテッド | 改善された安定性を備えた注射器中に局所麻酔薬、緩衝液、およびグルコサミノグリカンを含む製品 |
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CA2872413A1 (en) | 2013-11-07 |
US20130296235A1 (en) | 2013-11-07 |
WO2013166014A1 (en) | 2013-11-07 |
CN204219374U (zh) | 2015-03-25 |
US9068565B2 (en) | 2015-06-30 |
EP2844212A4 (en) | 2015-05-27 |
WO2013166014A4 (en) | 2014-01-03 |
EP2844212B1 (en) | 2021-07-07 |
CN103417371B (zh) | 2018-04-10 |
CA2872413C (en) | 2020-08-11 |
CN103417371A (zh) | 2013-12-04 |
JP6141413B2 (ja) | 2017-06-07 |
EP2844212A1 (en) | 2015-03-11 |
ES2883928T3 (es) | 2021-12-09 |
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