JP5493115B2 - 液体収納容器 - Google Patents
液体収納容器 Download PDFInfo
- Publication number
- JP5493115B2 JP5493115B2 JP2007167162A JP2007167162A JP5493115B2 JP 5493115 B2 JP5493115 B2 JP 5493115B2 JP 2007167162 A JP2007167162 A JP 2007167162A JP 2007167162 A JP2007167162 A JP 2007167162A JP 5493115 B2 JP5493115 B2 JP 5493115B2
- Authority
- JP
- Japan
- Prior art keywords
- resin
- drug
- cyclic polyolefin
- container
- pharmaceutical preparation
- 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.)
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- 238000003860 storage Methods 0.000 title description 40
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- 239000011347 resin Substances 0.000 claims description 41
- 238000002844 melting Methods 0.000 claims description 31
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- SNIOPGDIGTZGOP-UHFFFAOYSA-N Nitroglycerin Chemical compound [O-][N+](=O)OCC(O[N+]([O-])=O)CO[N+]([O-])=O SNIOPGDIGTZGOP-UHFFFAOYSA-N 0.000 claims description 23
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 10
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- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 description 3
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- 125000000094 2-phenylethyl group Chemical group [H]C1=C([H])C([H])=C(C([H])=C1[H])C([H])([H])C([H])([H])* 0.000 description 2
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
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- RLAWWYSOJDYHDC-BZSNNMDCSA-N lisinopril Chemical compound C([C@H](N[C@@H](CCCCN)C(=O)N1[C@@H](CCC1)C(O)=O)C(O)=O)CC1=CC=CC=C1 RLAWWYSOJDYHDC-BZSNNMDCSA-N 0.000 description 2
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Classifications
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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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
- B65D31/00—Bags or like containers made of paper and having structural provision for thickness of contents
- B65D31/02—Bags or like containers made of paper and having structural provision for thickness of contents with laminated walls
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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
- A61J1/10—Bag-type containers
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
- B32B27/325—Layered products comprising a layer of synthetic resin comprising polyolefins comprising polycycloolefins
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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
- B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
- B65D65/38—Packaging materials of special type or form
- B65D65/40—Applications of laminates for particular packaging purposes
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- 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
- B32B2439/00—Containers; Receptacles
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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
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
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Landscapes
- Health & Medical Sciences (AREA)
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
また、本発明は、ガラス転移温度が容器の熱処理または高圧蒸気滅菌処理の温度より5℃以上高い環状ポリオレフィン系樹脂を主成分として含有するバリア層とポリエチレン系樹脂またはポリプロピレン系樹脂を主成分として含有するシール層を含む多層フィルムおよび/またはシートからなり、当該バリア層と当該シール層が隣接していることを特徴とする液体収納容器に、樹脂吸着性の薬液を充填してなる医薬製剤を提供するものである。
また、バリア層には環状ポリオレフィン系樹脂以外を混合すると、薬剤の吸着または透過を防御する効果が低下し、保存安定性への効果が低下することを見出した。
表1に示す構成材料にて基材層、バリア層およびシール層を有する3層以上のフィルムを共押出し法およびドライラミネート法を組み合わせて作成した。また、表1に示す構成材料にてポート部を射出成形により作成すると共に、これらの3層以上のフィルムおよびポート部を用いて内容量100mLとなる液体収納容器を作成した。
a:融点120℃の直鎖状低密度ポリエチレン(プライムポリマー製、モアテック)と融点105℃の直鎖状低密度ポリエチレン(日本ポリエチレン製、ハーモレックス)を80:20の割合で混合したもの
b:融点120℃の直鎖状低密度ポリエチレン(プライムポリマー製、モアテック)と融点105℃の直鎖状低密度ポリエチレン(日本ポリエチレン製、ハーモレックス)を85:15の割合で混合したもの
c:融点120℃の直鎖状低密度ポリエチレン(東ソー製、ペトロセン)
d:融点120℃の直鎖状低密度ポリエチレン(プライムポリマー製、モアテック)
e:融点135℃の高密度ポリエチレン(日本ポリエチレン製)
f:アルミナ蒸着PETフィルム(凸版印刷製、GL)
g:融点136℃の高密度ポリエチレン(東ソー製、ニポロンハード)と融点120℃の直鎖状低密度ポリエチレン(プライムポリマー製、モアテック)を80:20の割合で混合したもの
h:融点111℃の直鎖状低密度ポリエチレン(宇部丸善ポリエチレン製、ユメリット)
i:融点108℃の直鎖状低密度ポリエチレン(日本ポリエチレン製、ハーモレックス)
j:融点165℃のポリプロピレン系エラストマー(三菱化学製、ゼラス)
k:接着性樹脂(三菱化学製 モディック)
l:融点160℃のポリプロピレン(日本ポリプロピレン製、ノバテック)
0R)
II:ガラス転移温度が163℃の環状ポリオレフィン(日本ゼオン製、1600R)
III:ガラス転移温度が135℃の環状ポリオレフィン(三井化学製、アペルAPL50
14DP)
IV:ガラス転移温度が105℃の環状ポリオレフィン(日本ゼオン製、ゼオノア1020R)
V:ガラス転移温度が75℃の環状ポリオレフィン(日本ゼオン製、ゼオノア750R)
VI:ガラス転移温度が145℃の環状ポリオレフィン(三井化学製、アペルAPL6015T)と直鎖状低密度ポリエチレン(プライムポリマー製エボリュー)を8:2の割合で混合したもの
実施例および比較例で得られた液体収納容器に0.05%ニトログリセリン注射液100mLを充填し、110℃、0.106MPaの条件で40分間高圧蒸気滅菌を施した。滅菌後、容器の外観を観察し、スティッキングの発生について評価した後、40℃で保存試験を実施した。保存開始から1ヶ月および3ヶ月の時点における各製剤中のニトログリセリン濃度を高速液体クロマトグラフィ(HPLC)で測定し、初期濃度に対する割合を残存率として求めた。結果を表2に示す。
本発明の液体収納容器について耐衝撃性を評価するため、落下試験を実施した。上記実施例および比較例の各液体収納容器について、試験例1と同様に薬剤を充填し、高圧蒸気滅菌処理を施した後、5℃で48時間保存した。その後、各容器を1.80mの高さより10回連続で落下させて外観を確認した後、さらに異物のない鉄板面に置いて手で押圧し、容器の割れや液漏れがないか確認した。各実施例についてそれぞれ100個の容器について試験を実施した。結果を表2に示す。
薬剤を20%アルブミン注射液とし、高圧蒸気滅菌処理に代えて、60℃で10時間の熱処理を施した以外は、試験例1および2と同様に試験した。結果を表3に示す。なお、実施例1の構成の容器にはヒト血漿由来のアルブミンを使用し、その他の実施例および比較例の構成の容器には遺伝子組み換え由来のアルブミンを使用した。
薬剤をビタミンD3含有製剤とし、高圧蒸気滅菌処理の条件を105℃、0.106MPaで30分間に変更した以外は試験例1および2と同様にして試験した。結果を表4に示す。
薬剤をラジカル捕捉剤含有製剤であるエダラボンとし、高圧蒸気滅菌処理の条件を105℃、0.106MPaで30分間に変更した以外は試験例1および2と同様にして試験した。結果を表5に示す。
また基材層とシール層を融点120℃以下のポリエチレンを使用した比較例5ではスティッキングにより容器内部の部分的貼りつきが発生し、この他容器外面でも滅菌後のべたつき感が強く、他の容器に貼りつく問題が発生した。
Claims (9)
- ガラス転移温度が容器の熱処理または高圧蒸気滅菌処理の温度より5℃以上高い環状ポリオレフィン系樹脂からなるバリア層と、ポリエチレン系樹脂またはポリプロピレン系樹脂を主成分として含有する、容器の最内層となって当該容器に収容される薬剤と直接に接触するシール層とを含む多層フィルムおよび/またはシートからなり、当該バリア層と当該シール層が隣接している液体収納容器に、樹脂吸着性および/または樹脂透過性の薬剤の溶液を充填してなる注射用医薬製剤であって、
前記環状ポリオレフィン系樹脂が次の一般式(1)で示されることを特徴とする注射用医薬製剤。
- 環状ポリオレフィン系樹脂が、ガラス転移温度が130℃以上の環状ポリオレフィン系樹脂である請求項1記載の注射用医薬製剤。
- 前記ポリエチレン系樹脂が、融点110〜130℃の直鎖状低密度ポリエチレンおよび/または融点が120〜145℃の高密度ポリエチレンであることを特徴とする請求項1又は2記載の注射用医薬製剤。
- 前記多層フィルムおよび/またはシートが、前記バリア層の前記シール層と逆側に、融点110〜130℃の直鎖状低密度ポリエチレンおよび/または融点120〜145℃の高密度ポリエチレンを主成分として含有してなる基材層を備えるものである請求項1〜3のいずれか1項記載の注射用医薬製剤。
- ポート部がポリエチレン系樹脂またはポリプロピレン系樹脂で形成されている請求項1〜4のいずれか1項記載の注射用医薬製剤。
- 前記液体収納容器が60℃以上の温度で熱処理または105℃以上の温度で高圧蒸気滅菌処理されることを特徴とする請求項1〜5のいずれか1項記載の注射用医薬製剤。
- 前記樹脂吸着性および/または樹脂透過性の薬剤がニトログリセリン含有薬剤である請求項1〜6のいずれか1項記載の注射用医薬製剤。
- 前記樹脂吸着性および/または樹脂透過性の薬剤が蛋白質含有薬剤、ヒアルロン酸含有薬剤、ビタミン類含有薬剤、または微量元素含有薬剤、ラジカル捕捉剤含有薬剤である請求項1〜6のいずれか1項記載の注射用医薬製剤。
- 前記蛋白質含有薬剤がヒト血漿由来アルブミン、遺伝子組み換え由来アルブミン、またはホルモンを含有する薬剤である請求項8記載の注射用医薬製剤。
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US20090310890A1 (en) * | 2005-06-15 | 2009-12-17 | Fujimori Kogyo Co., Ltd. | Duplex-Chamber Package |
KR101493833B1 (ko) * | 2007-11-22 | 2015-02-16 | 미쓰비시 타나베 파마 코퍼레이션 | 환상 폴리올레핀층을 포함하는 플라스틱 용기 |
JP5262407B2 (ja) | 2008-08-05 | 2013-08-14 | 藤森工業株式会社 | 多層液体容器 |
JP5314972B2 (ja) * | 2008-09-12 | 2013-10-16 | シーアイ化成株式会社 | 多層フィルム及び多層フィルムを用いた薬剤容器 |
FR2949195B1 (fr) | 2009-08-24 | 2011-10-14 | Lfb Biomedicaments | Poche de stockage de solution therapeutique |
JP5632226B2 (ja) | 2010-07-30 | 2014-11-26 | 株式会社細川洋行 | 医療用多層チューブ、および医療用輸液バッグ |
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- 2007-06-26 ES ES07790212.0T patent/ES2627032T3/es active Active
- 2007-06-26 KR KR1020087030787A patent/KR101430772B1/ko active IP Right Grant
- 2007-06-26 US US12/303,759 patent/US20100163446A1/en not_active Abandoned
- 2007-06-26 WO PCT/JP2007/000689 patent/WO2008001496A1/ja active Application Filing
- 2007-06-26 CN CN2007800235823A patent/CN101478945B/zh active Active
- 2007-06-26 EP EP07790212.0A patent/EP2033615B1/en active Active
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EP2033615A4 (en) | 2012-09-05 |
KR20090021350A (ko) | 2009-03-03 |
EP2033615A1 (en) | 2009-03-11 |
CN101478945A (zh) | 2009-07-08 |
KR101430772B1 (ko) | 2014-08-18 |
US20100163446A1 (en) | 2010-07-01 |
EP2033615B1 (en) | 2017-05-10 |
WO2008001496A1 (en) | 2008-01-03 |
ES2627032T3 (es) | 2017-07-26 |
CN101478945B (zh) | 2013-07-31 |
JP2008029829A (ja) | 2008-02-14 |
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