JP2009544636A - メトトレキセート濃厚溶液 - Google Patents
メトトレキセート濃厚溶液 Download PDFInfo
- Publication number
- JP2009544636A JP2009544636A JP2009521153A JP2009521153A JP2009544636A JP 2009544636 A JP2009544636 A JP 2009544636A JP 2009521153 A JP2009521153 A JP 2009521153A JP 2009521153 A JP2009521153 A JP 2009521153A JP 2009544636 A JP2009544636 A JP 2009544636A
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- Prior art keywords
- methotrexate
- use according
- ready
- present
- dose
- 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
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- FBOZXECLQNJBKD-ZDUSSCGKSA-N L-methotrexate Chemical compound C=1N=C2N=C(N)N=C(N)C2=NC=1CN(C)C1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 FBOZXECLQNJBKD-ZDUSSCGKSA-N 0.000 title claims abstract description 77
- 229960000485 methotrexate Drugs 0.000 title claims abstract description 69
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- 238000009472 formulation Methods 0.000 claims abstract description 26
- 239000002904 solvent Substances 0.000 claims abstract description 26
- 208000023275 Autoimmune disease Diseases 0.000 claims abstract description 11
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 25
- 229940090048 pen injector Drugs 0.000 claims description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 20
- 238000003860 storage Methods 0.000 claims description 18
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Classifications
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
Abstract
Description
を具有させることによって達成することができる活性成分の皮下投与に適するように設計される。さらに、好ましくは、本発明によるペンインジェクター及び該ペンインジェクター内へ挿入されたカルプルは、単一投与量の薬剤の多重投与が可能になるように設計させる。この目的のためには、好ましくは、本発明によるペンインジェクターは、投与されるべき一定投与量のメトトレキセートが医者、医療スタッフ又は患者自身(自己投与の場合)によって調整される(即ち、薬学的溶液状配合物中のメトトレキセート活性成分の既知の濃度と一定の投与体積が明確に選定される)ようにするための構造部品(例えば、調整ダイアル)を具備する。従って、この実施態様においては、本発明は、所望により、市販されていない貯蔵容器又は注射器具(特に、注射用ボトル又は既製シリンジ)に関連する中間投与量の選択も可能にする。このようなタイプの構造を有するペンインジェクターは当該分野、特に、インシュリンのインジェクターの分野においては周知である。
配合成分 配合量(g)
メトトレキセート 1500
塩化ナトリウム 120
水酸化ナトリウム 300
注射用水 28764
全量 30684
(30リットル)
配合成分 配合量(g)
メトトレキセート二ナトリウム 1645
塩化ナトリウム 120
注射用水 30684
全量 30684
(30リットル)
Claims (35)
- 炎症性自己免疫疾患を治療するための非経口投与薬剤の製造におけるメトトレキセートの使用であって、メトトレキセートを、薬学的に許容される溶剤中に25mg/mlよりも高い濃度で存在させる該使用。
- メトトレキセートを、25mg/mlよりも高い濃度から150mg/mlまでの濃度で存在させる請求項1記載の使用。
- メトトレキセートを、約50mg/mlの濃度で存在させる請求項2記載の使用。
- 薬学的に許容される溶剤が、水、注射用水、等張性添加剤含有水及び塩化ナトリウム溶液から選択される溶剤、特に塩化ナトリウム溶液である請求項1から3いずれかに記載の使用。
- 炎症性自己免疫性疾患が、リウマトイド関節炎、若年性関節炎、脈管炎、膠原病、クローン病、潰瘍性大腸炎、気管支喘息、アルツハイマー疾患、多発性硬化症、ベクテレフ疾患、関節症及び乾癬から選択される疾患である請求項1から4いずれかに記載の使用。
- 炎症性自己免疫疾患がリウマトイド関節炎、特に若年性関節リウマチである請求項5記載の使用。
- 薬剤を、皮下投与に適した形態で存在させる請求項1から6いずれかに記載の使用。
- 薬剤を、患者本人が自己投与するために適した形態で存在させる請求項7記載の使用。
- 薬剤を、一回投与用の注射器具内へ保有させる請求項1から8いずれかに記載の使用。
- 注射器具が、メトトレキセートを5〜40mgの投与量、特に、5.0mg、7.5mg、10.0mg、12.5mg、15.0mg、17.5mg、20.0mg、22.5mg、25.0mg、27.5mg、30.0mg、32.5mg、35.0mg、37.5mg又は40.0mgの投与量で保有する請求項9記載の使用。
- 注射器具が既製シリンジである請求項9又は10記載の使用。
- 薬剤が貯蔵容器内に保有される請求項1から8いずれかに記載の使用。
- 薬剤が防腐剤をさらに含有する請求項12記載の使用。
- 貯蔵容器が、全投与量として5〜5000mgのメトトレキセートを保有する請求項12又は13記載の使用。
- 貯蔵容器が注射用のボトル、バイアル、バッグ、ガラス製アンプル又はカルプルである請求項12から14いずれかに記載の使用。
- 貯蔵容器がカルプルであり、該カルプルが、注射器具、特にペンインジェクターによって薬剤を投与するために適している請求項15記載の使用。
- カルプルとペンインジェクターが、単一投与量の薬剤が複数回投与されるように装備される請求項16記載の使用。
- メトトレキセートの一回投与当たりの単一投与量が5〜40mg、特に、5.0mg、7.5mg、10.0mg、12.5mg、15.0mg、17.5mg、20.0mg、22.5mg、25.0mg、27.5mg、30.0mg、32.5mg、35.0mg、37.5mg又は40.0mgに調整可能である請求項17記載の使用。
- 薬学的に許容される溶剤中に25mg/mlよりも高濃度のメトトレキセートを含有する薬剤溶液配合物を保有する既製シリンジ。
- メトトレキセートを25mg/mlより高濃度であって、150mg/mlまでの濃度で存在させる請求項19記載の既製シリンジ。
- メトトレキセートを約50mg/mlまでの濃度で存在させる請求項20記載の既製シリンジ。
- メトトレキセートを5〜40mgの投与量、特に、5.0mg、7.5mg、10.0mg、12.5mg、15.0mg、17.5mg、20.0mg、22.5mg、25.0mg、27.5mg、30.0mg、32.5mg、35.0mg、37.5mg又は40.0mgの投与量で保有する請求項19から21いずれかに記載の既製シリンジ。
- 薬学的に許容される溶剤が、水、注射用水、等張性添加剤含有水及び塩化ナトリウム溶液から選択される溶剤、特に塩化ナトリウム溶液である請求項19から22いずれかに記載の既製シリンジ。
- 皮下投与用の請求項19から23いずれかに記載の既製シリンジ。
- 既製シリンジが、精密モーターの操作技能に欠ける患者による自己投与を可能にするように構成される請求項24記載の既製シリンジ。
- メトトレキセートを、薬学的に許容される溶剤中に25mg/mlよりも高濃度で含有する薬学的溶液配合物を保有するカルプル。
- メトトレキセートを25mg/mlより高濃度であって、150mg/mlまでの濃度で存在させる請求項26記載のカルプル。
- メトトレキセートを約50mg/mlまでの濃度で存在させる請求項27記載のカルプル。
- 薬学的溶液配合物が防腐剤をさらに含有する請求項26から28いずれかに記載のカルプル。
- カルプルが、全投与量として5〜5000mg、特に7.5〜300mgのメトトレキセートを保有する請求項26から29いずれかに記載のカルプル。
- 薬学的に許容される溶剤が、水、注射用水、等張性添加剤含有水及び塩化ナトリウム溶液から選択される溶剤、特に塩化ナトリウム溶液である請求項26から30いずれかに記載のカルプル。
- 請求項26から31いずれかに記載のカルプルを具有する請求項26から31いずれかに記載のペンインジェクター。
- 皮下投与用の請求項32記載のペンインジェクター
- カルプルとペンインジェクターが、単一投与量の薬剤が複数回投与されるように装備される請求項32又は33記載のペンインジェクター。
- メトトレキセートの一回投与当たりの単一投与量が5〜40mg、特に、5.0mg、7.5mg、10.0mg、12.5mg、15.0mg、17.5mg、20.0mg、22.5mg、25.0mg、27.5mg、30.0mg、32.5mg、35.0mg、37.5mg又は40.0mgに調整可能である請求項34記載のペンインジェクター。
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DE102006033837A DE102006033837A1 (de) | 2006-07-21 | 2006-07-21 | Konzentrierte Methotrexat-Lösungen |
DE102006033837.5 | 2006-07-21 | ||
PCT/EP2007/006491 WO2008009476A2 (de) | 2006-07-21 | 2007-07-20 | Konzentrierte methotrexat-lösungen |
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EP (2) | EP2046332B1 (ja) |
JP (1) | JP5683810B2 (ja) |
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CA (2) | CA2869671A1 (ja) |
CY (1) | CY1111159T1 (ja) |
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RU (1) | RU2403044C1 (ja) |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2015147018A1 (ja) * | 2014-03-28 | 2015-10-01 | テルモ株式会社 | 炎症性自己免疫疾患治療用の注射用水性製剤 |
JP2017066073A (ja) * | 2015-09-29 | 2017-04-06 | テルモ株式会社 | 炎症性自己免疫疾患治療用の注射用水性製剤およびその保存方法 |
JP2019058744A (ja) * | 2012-04-06 | 2019-04-18 | アンタレス・ファーマ・インコーポレーテッド | テストステロン組成物の針支援式ジェット注入投与 |
Families Citing this family (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20040103930A (ko) | 2002-02-11 | 2004-12-09 | 앤태어스 파머, 인코퍼레이티드 | 피내 주사기 |
BRPI0614025A2 (pt) | 2005-01-24 | 2012-12-25 | Antares Pharma Inc | injetores de jato |
US8251947B2 (en) | 2006-05-03 | 2012-08-28 | Antares Pharma, Inc. | Two-stage reconstituting injector |
US9144648B2 (en) | 2006-05-03 | 2015-09-29 | Antares Pharma, Inc. | Injector with adjustable dosing |
DE102006033837A1 (de) * | 2006-07-21 | 2008-01-31 | Medac Gesellschaft für klinische Spezialpräparate m.b.H | Konzentrierte Methotrexat-Lösungen |
BRPI0719109A2 (pt) * | 2006-11-21 | 2013-12-10 | Kalobios Pharmaceuticals Inc | Métodos para tratar doenças inflamatórias crônicas usando um antagonista de gm-csf |
EP2268342B1 (en) | 2008-03-10 | 2015-09-16 | Antares Pharma, Inc. | Injector safety device |
JP5611208B2 (ja) | 2008-08-05 | 2014-10-22 | アンタレス・ファーマ・インコーポレーテッド | 多数回服用量の注射装置 |
AU2010226442A1 (en) | 2009-03-20 | 2011-10-13 | Antares Pharma, Inc. | Hazardous agent injection system |
US9770414B2 (en) | 2010-05-13 | 2017-09-26 | Pacira Pharmaceuticals, Inc. | Sustained release formulation of methotrexate as a disease-modifying antirheumatic drug (DMARD) and an anti-cancer agent |
US8496619B2 (en) | 2011-07-15 | 2013-07-30 | Antares Pharma, Inc. | Injection device with cammed ram assembly |
US9220660B2 (en) | 2011-07-15 | 2015-12-29 | Antares Pharma, Inc. | Liquid-transfer adapter beveled spike |
GB201200192D0 (en) | 2012-01-06 | 2012-02-22 | Rosemont Pharmaceuticals Ltd | Methotrexate composition |
JP6165786B2 (ja) | 2012-03-06 | 2017-07-19 | アンタレス・ファーマ・インコーポレーテッド | 離脱力特徴を備える充填シリンジ |
WO2013169800A1 (en) | 2012-05-07 | 2013-11-14 | Antares Pharma, Inc. | Injection device with cammed ram assembly |
US10086141B2 (en) * | 2013-01-29 | 2018-10-02 | Sanofi-Aventis Deutschland Gmbh | Electronic module and drug delivery device |
EP2953667B1 (en) | 2013-02-11 | 2019-10-23 | Antares Pharma, Inc. | Needle assisted jet injection device having reduced trigger force |
WO2014164786A1 (en) | 2013-03-11 | 2014-10-09 | Madsen Patrick | Dosage injector with pinion system |
WO2014165136A1 (en) * | 2013-03-12 | 2014-10-09 | Antares Pharma, Inc. | Constant volume prefilled syringes and kits thereof |
US20150297600A1 (en) * | 2014-04-16 | 2015-10-22 | Antares Pharma, Inc. | Method Of Achieving Increased Systemic Availability of Methotrexate |
WO2015183213A1 (en) | 2014-05-28 | 2015-12-03 | Onko İlaç Sanayi̇ Ve Ti̇caret A. Ş. | Pharmaceutical dosage forms containing n-[4-[[(2,4-diamino-6-pteridinyl)methyl] methylamino] benzoyl]-l- glutamic acid and n-[4-[[(2-amino-3,4- dihydro -4-oxo-6- pteridinyl) methyl] methyl amino] benzoyl]-l-glutamic acid |
KR102095284B1 (ko) | 2017-05-11 | 2020-04-01 | (주)케어젠 | 메토트렉세이트와 펩타이드의 결합체 |
GB2591681A (en) * | 2018-08-29 | 2021-08-04 | Ftf Pharma Private Ltd | Methotrexate pharmaceutical composition |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4357971A (en) * | 1980-09-19 | 1982-11-09 | Cyberon Corporation | Syringe gauging, loading and injection apparatus |
US5279585A (en) * | 1992-02-04 | 1994-01-18 | Becton, Dickinson And Company | Medication delivery pen having improved dose delivery features |
US5681291A (en) * | 1992-11-19 | 1997-10-28 | Tebro S.A. | Disposable auto-injector for prefilled syringes |
US5593671A (en) | 1994-07-01 | 1997-01-14 | American Cyanamid Company | Method of attenuating lung capillary leak in a mammal |
US5542934A (en) * | 1995-06-02 | 1996-08-06 | Silver; Richard M. | Multiple carpule hypodermic syringe |
US6544504B1 (en) | 1999-07-28 | 2003-04-08 | Schering Corporation | Combined use of interleukin 10 and methotrexate for immuno-modulatory therapy |
NZ528076A (en) * | 2001-03-02 | 2005-09-30 | Medimmune Inc | Methods of preventing or treating inflammatory or autoimmune disorders by administering integrin alphav beta3 antagonists with an immunomodulatory agents, anti-inflammatory agents, TNF-alpha antagonists or CD2 binding molecules |
US20040176381A1 (en) * | 2003-03-06 | 2004-09-09 | Walsh Michael J. | Methotrexate compliance packaging |
US20050153969A1 (en) * | 2004-01-13 | 2005-07-14 | Iomed, Inc. | Methods for treating neoplastic, angiogenic, fibroblastic, and/or immunosuppressive ocular irregularities via administration of methotrexate based medicaments, and ocular iontophoretic devices for delivering methotrexate based medicament |
DE102006033837A1 (de) | 2006-07-21 | 2008-01-31 | Medac Gesellschaft für klinische Spezialpräparate m.b.H | Konzentrierte Methotrexat-Lösungen |
-
2006
- 2006-07-21 DE DE102006033837A patent/DE102006033837A1/de active Pending
-
2007
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- 2007-07-20 RU RU2009106053/15A patent/RU2403044C1/ru active
- 2007-07-20 MX MX2009000812A patent/MX2009000812A/es active IP Right Grant
- 2007-07-20 KR KR1020097003655A patent/KR101260554B1/ko active IP Right Grant
- 2007-07-20 UA UAA200901346A patent/UA95488C2/ru unknown
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- 2007-07-20 PT PT07786239T patent/PT2046332E/pt unknown
- 2007-07-20 RS RS20110010A patent/RS51688B/en unknown
- 2007-07-20 DE DE502007005972T patent/DE502007005972D1/de active Active
- 2007-07-20 BR BRPI0715433-0A patent/BRPI0715433A2/pt not_active Application Discontinuation
- 2007-07-20 AT AT07786239T patent/ATE491455T1/de active
- 2007-07-20 EP EP07786239A patent/EP2046332B1/de active Active
- 2007-07-20 US US12/374,528 patent/US8664231B2/en active Active
- 2007-07-20 CA CA2659662A patent/CA2659662C/en active Active
- 2007-07-20 ES ES07786239T patent/ES2355399T3/es active Active
- 2007-07-20 SI SI200730475T patent/SI2046332T1/sl unknown
- 2007-07-20 WO PCT/EP2007/006491 patent/WO2008009476A2/de active Application Filing
- 2007-07-20 EP EP10194145A patent/EP2292235A3/de not_active Withdrawn
- 2007-07-20 ME MEP-2011-207A patent/ME01940B/me unknown
-
2011
- 2011-02-03 CY CY20111100118T patent/CY1111159T1/el unknown
- 2011-02-28 HR HR20110148T patent/HRP20110148T1/hr unknown
-
2014
- 2014-02-07 US US14/175,357 patent/US20140155405A1/en not_active Abandoned
- 2014-03-03 US US14/195,117 patent/US20140179703A1/en not_active Abandoned
-
2015
- 2015-03-02 US US14/635,542 patent/US20150164902A1/en not_active Abandoned
-
2017
- 2017-05-11 US US15/592,882 patent/US20170246172A1/en not_active Abandoned
-
2018
- 2018-10-05 US US16/152,463 patent/US10610531B2/en active Active
-
2020
- 2020-02-25 US US16/800,584 patent/US11944629B2/en active Active
Non-Patent Citations (4)
Title |
---|
JPN5010013616; JANSEN M M P M: PHARMACEUTISCH WEEKBLAD V134 N46, 19991119, P1592-1596 * |
JPN5010013618; KURNIK D: ALIMENTARY PHARMACOLOGY & THERAPEUTICS V18 N1, 20030701, P57-63, BLACKWELL SCIENTIFIC PUBLICATIONS LTD. * |
JPN5010013619; HOEKSTRA MONIQUE: THE JOURNAL OF RHEUMATOLOGY V31 N4, 20040401, P645-648 * |
JPN5010013620; ZACKHEIM H S: JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY V26 N6, 19920101, P1008, C.V. MOSBY * |
Cited By (4)
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WO2015147018A1 (ja) * | 2014-03-28 | 2015-10-01 | テルモ株式会社 | 炎症性自己免疫疾患治療用の注射用水性製剤 |
JPWO2015147018A1 (ja) * | 2014-03-28 | 2017-04-13 | テルモ株式会社 | 炎症性自己免疫疾患治療用の注射用水性製剤 |
JP2017066073A (ja) * | 2015-09-29 | 2017-04-06 | テルモ株式会社 | 炎症性自己免疫疾患治療用の注射用水性製剤およびその保存方法 |
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