JP5518855B2 - 薬品のための容器及びこの容器の製造方法 - Google Patents
薬品のための容器及びこの容器の製造方法 Download PDFInfo
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- JP5518855B2 JP5518855B2 JP2011513948A JP2011513948A JP5518855B2 JP 5518855 B2 JP5518855 B2 JP 5518855B2 JP 2011513948 A JP2011513948 A JP 2011513948A JP 2011513948 A JP2011513948 A JP 2011513948A JP 5518855 B2 JP5518855 B2 JP 5518855B2
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- 239000000126 substance Substances 0.000 title claims description 77
- 238000004519 manufacturing process Methods 0.000 title claims description 5
- 239000002904 solvent Substances 0.000 claims description 73
- 239000013543 active substance Substances 0.000 claims description 40
- 230000007935 neutral effect Effects 0.000 claims description 35
- 239000003814 drug Substances 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 16
- 238000007710 freezing Methods 0.000 claims description 10
- 230000008014 freezing Effects 0.000 claims description 10
- 230000009977 dual effect Effects 0.000 claims description 7
- 238000001802 infusion Methods 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 6
- 238000004090 dissolution Methods 0.000 claims description 4
- 238000005415 bioluminescence Methods 0.000 claims description 3
- 230000029918 bioluminescence Effects 0.000 claims description 3
- 238000006243 chemical reaction Methods 0.000 description 13
- 229940079593 drug Drugs 0.000 description 7
- 230000014759 maintenance of location Effects 0.000 description 6
- 239000000243 solution Substances 0.000 description 5
- 239000000463 material Substances 0.000 description 4
- 238000004108 freeze drying Methods 0.000 description 3
- 238000002844 melting Methods 0.000 description 3
- 230000008018 melting Effects 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 238000005842 biochemical reaction Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 241000792859 Enema Species 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 239000007920 enema Substances 0.000 description 1
- 229940095399 enema Drugs 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004020 luminiscence type Methods 0.000 description 1
- 238000010309 melting process Methods 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
Images
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
- F26B5/065—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing the product to be freeze-dried being sprayed, dispersed or pulverised
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines Containing Plant Substances (AREA)
Description
この課題は、請求項1の特徴を備えた容器によって、果たされる。薬品のための容器は、少なくとも1つのチャンバを有しており、少なくとも2つの凍結乾燥された活性物質及び/もしくは補助物質が少なくとも1つのチャンバに一緒に収容されることを特徴としている。前記活性物質及び/もしくは補助物質が凍結乾燥された状態で収容されていることによって、分子の構成要素が、固定され、従って、不活性である。このことは、前記凍結乾燥された物質が互いに完全混和された状態(innig miteinander vermischt)であっても、前記活性物質及び/もしくは補助物質が非常にゆっくりと互いに反応することを、意味する。不利な保存状態、即ち、完全混和の状態であっても、前記物質は、溶液の状態で一緒に収容されている場合よりも、ずっと長く保存可能である。
Claims (6)
- 少なくとも1つのチャンバ(3)を有する薬品のための容器であって、凍結乾燥された活性物質及び/もしくは補助物質(W1、W3、W5、W7)の少なくとも2つの層が、少なくとも1つのチャンバ(3)中に一緒に収容される容器において、
複数の要素が、少なくとも2つの層を成して一体化され、これら要素は、溶剤(17)による溶解及び混合の際に、互いに反応することができ、かくして、化学ルミネセンスもしくは生物ルミネセンスを生じさせることができ、
前記容器(1)は、注射器、カープル、デュアルもしくマルチチャンバシステム、フラスコ、注入袋、注入瓶のいずれかであることを特徴とする、容器。 - 前記少なくとも2つの活性物質及び/もしくは補助物質(W1、W3、W5、W7)は、少なくとも1つの凍結乾燥された中性物質(N1、N3、N5)によって互いに離間されていることを特徴とする請求項1に記載の容器。
- 前記少なくとも2つの活性物質及び/もしくは補助物質(W1、W3、W5、W7)は、凍結乾燥された中性物質(N1、N3、N5)の少なくとも1つの層によって、互いに離間されていることを特徴とする請求項1又は2に記載の容器。
- 順序が変更され得る以下の工程、即ち、
a)少なくとも1つのチャンバ(3)を有する薬品のための容器(1)を準備する工程と、
b)第1の活性物質及び/もしくは補助物質の溶剤を、前記少なくとも1つのチャンバ(3)中に充填する工程であって、前記溶剤は第1の発光要素を含む、溶剤を充填する工程と、
c)前記第1の溶剤を急速冷凍する工程と、
d)活性物質及び/もしくは補助物質の更なる溶剤を、前記少なくとも1つのチャンバ(3)中に充填する工程であって、前記更なる溶剤は更なる発光要素を含む、更なる溶剤を充填する工程と、
e前記更なる溶剤を急速冷凍する工程と、
f)必要ならば、所望の数の活性物質及び/もしくは補助物質(W1、W3、W5、W7)が前記少なくとも1つのチャンバ(3)に収容されるまで、前記工程d),e)を繰り返す工程と、
g)前記容器(1)の凍結された溶剤を凍結乾燥する工程と、
によって特徴付けられ、
h)前記凍結された溶剤は、前記容器内で複数の層を形成し、
i)複数の構成要素は、分離している凍結された複数の層内で一体化され、溶剤による溶解及び混合の際に、互いに反応することができ、また、化学ルミネセンスもしくは生物ルミネセンス現象が生じる、
請求項1乃至3のいずれか1に記載の容器(1)の製造方法。 - 活性物質及び/もしくは補助物質(W1、W3、W5、W7)の溶剤の急速冷凍の後、及び、活性物質及び/もしくは補助物質(W1、W3、W5、W7)の更なる溶剤の充填の前に、中性物質(N1、N3、N5)が、前記少なくとも1つのチャンバ(3)中に充填され、前記中性物質(N1、N3、N5)は、前記充填の後に、急速冷凍されることを特徴とする、請求項4に記載の方法。
- 前記中性物質(N1、N3、N5)は、中性物質(N1、N3、N5)の溶剤であることを特徴とする、請求項5に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102008030273.2 | 2008-06-19 | ||
DE102008030273 | 2008-06-19 | ||
PCT/EP2009/004385 WO2009153039A1 (de) | 2008-06-19 | 2009-06-18 | Behälter für medizinische produkte und verfahren zu dessen herstellung |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2011524226A JP2011524226A (ja) | 2011-09-01 |
JP5518855B2 true JP5518855B2 (ja) | 2014-06-11 |
Family
ID=41055123
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011513948A Active JP5518855B2 (ja) | 2008-06-19 | 2009-06-18 | 薬品のための容器及びこの容器の製造方法 |
Country Status (10)
Country | Link |
---|---|
US (1) | US8813955B2 (ja) |
EP (1) | EP2291163B1 (ja) |
JP (1) | JP5518855B2 (ja) |
BR (1) | BRPI0914170B8 (ja) |
CA (1) | CA2728117C (ja) |
ES (1) | ES2400664T3 (ja) |
MX (1) | MX2010013044A (ja) |
PT (1) | PT2291163E (ja) |
RU (1) | RU2532363C2 (ja) |
WO (1) | WO2009153039A1 (ja) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AT509703B1 (de) * | 2010-09-22 | 2011-11-15 | Murray & Pool Entpr Ltd | Verfahren zur lagerung und zum transport eines gefriergetrockneten physiologisch wirksamen wirkstoffes sowie einer flüssigkeit |
JP6465796B2 (ja) | 2012-06-26 | 2019-02-06 | バイオニア・アクティーゼルスカブBioneer A/S | 中空プランジャーを備えるシリンジ |
EP3009354A1 (en) * | 2014-10-15 | 2016-04-20 | F. Hoffmann-La Roche AG | Method for providing in a primary packaging container a dried solid product containing an active pharmaceutical ingredient |
US9333289B1 (en) | 2015-01-16 | 2016-05-10 | Plas-Tech Engineering, Inc. | Tamper evident closure container |
AU2017376593A1 (en) * | 2016-12-16 | 2019-06-13 | Boehringer Ingelheim Vetmedica Gmbh | Container system and method |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US337041A (en) * | 1886-03-02 | Foree baix | ||
US3269905A (en) * | 1955-03-02 | 1966-08-30 | Charles W Damaskus | Dry stratiform products and methods of producing same |
GB798147A (en) | 1955-09-22 | 1958-07-16 | Upjohn Co | Improvements in or relating to therapeutic compositions and the manufacture thereof |
GB1057440A (en) * | 1962-11-26 | 1967-02-01 | Ghimas S A R L | A method of keeping mutually incompatible substances within the same container |
US3337041A (en) * | 1965-10-23 | 1967-08-22 | Charles W Damaskus | Layered lyophilized product in a disposable syringe |
FR2086919A5 (ja) * | 1970-04-14 | 1971-12-31 | Commissariat Energie Atomique | |
US4254768A (en) * | 1979-09-14 | 1981-03-10 | Ty Perla J | Hypodermic syringe |
US4722733A (en) * | 1986-02-26 | 1988-02-02 | Intelligent Medicine, Inc. | Drug handling apparatus and method |
ES2052098T3 (es) * | 1989-07-07 | 1994-07-01 | Omniglow Corp | Elemento de alumbrado quimioluminiscente. |
DE69111333T2 (de) * | 1990-08-30 | 1996-04-04 | Omniglow Corp | Chemilumineszentes Lichtelement. |
SE9201246D0 (sv) | 1992-04-21 | 1992-04-21 | Kabi Pharmacia Ab | Injection cartridge arrangement |
DE10140704A1 (de) | 2001-08-18 | 2003-03-06 | Vetter & Co Apotheker | Verfahren zur Durchmischung einer schwer löslichen pharmazeutischen Substanz mit einem Lösungsmittel und Spritze zur Anwendung des Verfahrens |
JP3768892B2 (ja) * | 2002-02-04 | 2006-04-19 | 株式会社ルミカ | 光る容器 |
MX2008008280A (es) * | 2005-12-21 | 2008-11-06 | Meso Scale Technologies Llc | Modulos de ensayo que tienen reactivos de ensayo y metodos para hacer y utilizar los mismos. |
-
2009
- 2009-06-18 JP JP2011513948A patent/JP5518855B2/ja active Active
- 2009-06-18 EP EP09765619A patent/EP2291163B1/de active Active
- 2009-06-18 WO PCT/EP2009/004385 patent/WO2009153039A1/de active Application Filing
- 2009-06-18 MX MX2010013044A patent/MX2010013044A/es active IP Right Grant
- 2009-06-18 PT PT97656193T patent/PT2291163E/pt unknown
- 2009-06-18 RU RU2011101688/15A patent/RU2532363C2/ru active
- 2009-06-18 ES ES09765619T patent/ES2400664T3/es active Active
- 2009-06-18 BR BRPI0914170A patent/BRPI0914170B8/pt active IP Right Grant
- 2009-06-18 CA CA2728117A patent/CA2728117C/en active Active
- 2009-06-18 US US12/999,241 patent/US8813955B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
EP2291163B1 (de) | 2012-12-05 |
WO2009153039A1 (de) | 2009-12-23 |
JP2011524226A (ja) | 2011-09-01 |
RU2011101688A (ru) | 2012-07-27 |
BRPI0914170A8 (pt) | 2019-09-03 |
BRPI0914170A2 (pt) | 2015-10-20 |
US20110089065A1 (en) | 2011-04-21 |
BRPI0914170B1 (pt) | 2019-10-15 |
RU2532363C2 (ru) | 2014-11-10 |
US8813955B2 (en) | 2014-08-26 |
CA2728117C (en) | 2016-01-05 |
ES2400664T3 (es) | 2013-04-11 |
MX2010013044A (es) | 2011-04-04 |
EP2291163A1 (de) | 2011-03-09 |
CA2728117A1 (en) | 2009-12-23 |
BRPI0914170B8 (pt) | 2021-06-22 |
PT2291163E (pt) | 2013-03-06 |
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