JPH10500990A - 各種物質の再水和または融解時の凝集を防止する方法及び該方法により得られる組成物 - Google Patents
各種物質の再水和または融解時の凝集を防止する方法及び該方法により得られる組成物Info
- Publication number
- JPH10500990A JPH10500990A JP8500542A JP50054296A JPH10500990A JP H10500990 A JPH10500990 A JP H10500990A JP 8500542 A JP8500542 A JP 8500542A JP 50054296 A JP50054296 A JP 50054296A JP H10500990 A JPH10500990 A JP H10500990A
- Authority
- JP
- Japan
- Prior art keywords
- substance
- trehalose
- suspension
- solution
- composition
- 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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- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 9
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- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 description 8
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- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/61—Growth hormone [GH], i.e. somatotropin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/18—Erythrocytes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
-
- 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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Molecular Biology (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Zoology (AREA)
- Endocrinology (AREA)
- Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Hematology (AREA)
- Developmental Biology & Embryology (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Toxicology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- General Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Virology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1. 物質の水和/再水和中の凝集を低減又は防止する方法であって、物質の溶 液又は懸濁液に再水和時の凝集を防止又は低減させるのに十分な量のトレハロー スを添加し、前記溶液又は懸濁液を脱水することを特徴とする方法。 2. 更に、物質を再水和して実質的に非凝集形態の物質の溶液又は懸濁液を得 ることを特徴とする請求の範囲第1項に記載の方法。 3. 溶液又は懸濁液中の物質の凍結中の凝集を軽減又は防止する方法であって 、物質の溶液又は懸濁液に凍結中の凝集を防止又は低減させるのに十分な量のト レハロースを添加し、前記溶液又は懸濁液を凍結することを特徴とする方法。 4. 更に、溶液又は懸濁液を融解して実質的に非凝集形態の物質の溶液又は懸 濁液を得ることを特徴とする請求の範囲第3項に記載の方法。 5. 物質が治療、予防又は診断用物質であることを特徴とする請求の範囲第1 項〜第4項のいずれかに記載の方法。 6. 物質が治療用物質であり、生体応答調節剤であるこ とを特徴とする請求の範囲第5項に記載の方法。 7. 生体応答調節剤がタンパク質、ペプチド、ステロイドホルモン、オリゴサ ッカライド、核酸、ポリヌクレオチド又は小型分子であることを特徴とする請求 の範囲第6項に記載の方法。 8. タンパク質が成長ホルモン、成長因子、インシュリン、モノクローナル抗 体、インターロイキン又はインターフェロンであることを特徴とする請求の範囲 第7項に記載の方法。 9. 物質がヒト成長ホルモンであることを特徴とする請求の範囲第8項に記載 の方法。 10. ステロイドホルモンがエストロゲン、プロゲステロン又はテストステロン であることを特徴とする請求の範囲第7項に記載の方法。 11. 物質が予防用物質であり、アルミニウムを主成分とするアジュバントであ ることを特徴とする請求の範囲第5項に記載の方法。 12. 更に、アジュバントをワクチンに配合することを特徴とする請求の範囲第 11項に記載の方法。 13. ワクチンがジフテリア/破傷風/百日咳(DTP) 又はジフテリア/破傷風/百日咳/不活化ポリオワクチン(DTP/IPV)で あることを特徴とする請求の範囲第12項に記載の方法。 14. ワクチンがDTP又はIPVであることを特徴とする請求の範囲第13項 に記載の方法。 15. 物質が診断用物質であり、金コロイド、ポリスチレンラテックス、固定赤 血球又はモノクローナル抗体であることを特徴とする請求の範囲第1項〜第14 項のいずれかに記載の方法。 16. トレハロースを1〜50%(w/v)の最終濃度が得られるような量添加 することを特徴とする請求の範囲第1項〜第15項のいずれかに記載の方法。 17. トレハロースを5〜25%(w/v)の最終濃度が得られるような量添加 することを特徴とする請求の範囲第1項〜第16項のいずれかに記載の方法。 18. 物質が赤血球であり、更にトレハロースを添加する前に赤血球を固定する ことを特徴とする請求の範囲第15項〜第17項のいずれかに記載の方法。 19. グルタルアルデヒドにより固定することを特徴とする請求の範囲第18項 に記載の方法。 20. 脱水が凍結乾燥、周囲条件での乾燥又は低下した蒸気圧での乾燥により起 こることを特徴とする請求の範囲第1項、第2項及び第5項〜第19項のいずれ かに記載の方法。 21. 低下した蒸気圧での乾燥が室温又は室温より高いが物質の分解又は化学的 変化が生ずる温度よりも低い温度で起こることを特徴とする請求の範囲第20項 に記載の方法。 22. 請求の範囲第1項〜第21項のいずれかに記載の方法により得られる組成 物。 23. 物質及び、凍結/融解又は水和/再水和時の物質の実質的な凝集を低減又 は防止するのに十分な量のトレハロースを含む水性組成物。 24. 物質及び、融解時の物質の実質的な凝集を低減又は防止するのに十分な量 のトレハロースを含む凍結組成物。 25. 物質及び、再水和時の物質の凝集を低減又は防止するのに十分な量のトレ ハロースを含む脱水組成物。 26. 治療、予防又は診断用組成物である請求の範囲第23項〜第25項のいず れかに記載の組成物。 27. トレハロースを使用して、物質の溶液又は懸濁液中 での凍結・融解又は水和・再水和時の物質の凝集を低減又は防止する方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US25296794A | 1994-06-02 | 1994-06-02 | |
US08/252,967 | 1994-06-02 | ||
PCT/GB1995/001277 WO1995033488A1 (en) | 1994-06-02 | 1995-06-02 | Method of preventing aggregation of various substances upon rehydration or thawing and compositions obtained thereby |
Related Child Applications (1)
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JP2008010077A Division JP2008179636A (ja) | 1994-06-02 | 2008-01-21 | 各種物質の再水和または融解時の凝集を防止する方法及び該方法により得られる組成物 |
Publications (2)
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JPH10500990A true JPH10500990A (ja) | 1998-01-27 |
JP4142095B2 JP4142095B2 (ja) | 2008-08-27 |
Family
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JP50054296A Expired - Fee Related JP4142095B2 (ja) | 1994-06-02 | 1995-06-02 | 各種物質の再水和または融解時の凝集を防止する方法及び該方法により得られる組成物 |
JP2008010077A Withdrawn JP2008179636A (ja) | 1994-06-02 | 2008-01-21 | 各種物質の再水和または融解時の凝集を防止する方法及び該方法により得られる組成物 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2008010077A Withdrawn JP2008179636A (ja) | 1994-06-02 | 2008-01-21 | 各種物質の再水和または融解時の凝集を防止する方法及び該方法により得られる組成物 |
Country Status (10)
Country | Link |
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US (2) | US6890512B2 (ja) |
EP (1) | EP0762897B1 (ja) |
JP (2) | JP4142095B2 (ja) |
CN (1) | CN1188171C (ja) |
AT (1) | ATE235919T1 (ja) |
DE (1) | DE69530196T2 (ja) |
DK (1) | DK0762897T3 (ja) |
ES (1) | ES2194911T3 (ja) |
PT (1) | PT762897E (ja) |
WO (1) | WO1995033488A1 (ja) |
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1995
- 1995-06-02 WO PCT/GB1995/001277 patent/WO1995033488A1/en active IP Right Grant
- 1995-06-02 DK DK95921031T patent/DK0762897T3/da active
- 1995-06-02 EP EP95921031A patent/EP0762897B1/en not_active Revoked
- 1995-06-02 CN CNB951944339A patent/CN1188171C/zh not_active Expired - Fee Related
- 1995-06-02 PT PT95921031T patent/PT762897E/pt unknown
- 1995-06-02 DE DE69530196T patent/DE69530196T2/de not_active Revoked
- 1995-06-02 JP JP50054296A patent/JP4142095B2/ja not_active Expired - Fee Related
- 1995-06-02 ES ES95921031T patent/ES2194911T3/es not_active Expired - Lifetime
- 1995-06-02 AT AT95921031T patent/ATE235919T1/de not_active IP Right Cessation
-
2001
- 2001-04-16 US US09/836,625 patent/US6890512B2/en not_active Expired - Fee Related
-
2005
- 2005-03-18 US US11/084,223 patent/US20050163750A1/en not_active Abandoned
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2008
- 2008-01-21 JP JP2008010077A patent/JP2008179636A/ja not_active Withdrawn
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2002540079A (ja) * | 1999-03-23 | 2002-11-26 | アヴァンティ・パストゥール | 液体ワクチンを安定化するためのトレハロースの使用 |
JP2012503652A (ja) * | 2008-09-26 | 2012-02-09 | サルーブリアス ファーマスーティカルズ エルエルシー | リウマチ性関節炎、震え・パーキンソン病、多発性硬化症及び非ウィルス性の癌の治療方法 |
WO2013168403A1 (ja) * | 2012-05-08 | 2013-11-14 | 株式会社大塚製薬工場 | トレハロース含有肺塞栓形成予防用哺乳動物細胞懸濁液 |
US10265346B2 (en) | 2012-05-08 | 2019-04-23 | Otsuka Pharmaceutical Factory, Inc. | Trehalose-containing mammalian cell suspension for prevention of pulmonary embolism formation |
JP2021501144A (ja) * | 2017-10-25 | 2021-01-14 | メルク・シャープ・アンド・ドーム・コーポレーションMerck Sharp & Dohme Corp. | アジュバントワクチン |
Also Published As
Publication number | Publication date |
---|---|
US20050163750A1 (en) | 2005-07-28 |
DE69530196D1 (de) | 2003-05-08 |
CN1188171C (zh) | 2005-02-09 |
PT762897E (pt) | 2003-07-31 |
US20010055583A1 (en) | 2001-12-27 |
EP0762897A1 (en) | 1997-03-19 |
CN1156967A (zh) | 1997-08-13 |
ES2194911T3 (es) | 2003-12-01 |
DE69530196T2 (de) | 2003-11-20 |
ATE235919T1 (de) | 2003-04-15 |
US6890512B2 (en) | 2005-05-10 |
EP0762897B1 (en) | 2003-04-02 |
JP4142095B2 (ja) | 2008-08-27 |
DK0762897T3 (da) | 2003-07-21 |
WO1995033488A1 (en) | 1995-12-14 |
JP2008179636A (ja) | 2008-08-07 |
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