CY1122526T1 - Φαρμακευτικες συνθεσεις και μεθοδοι για τη σταθεροποιηση αυτων - Google Patents
Φαρμακευτικες συνθεσεις και μεθοδοι για τη σταθεροποιηση αυτωνInfo
- Publication number
- CY1122526T1 CY1122526T1 CY20191101341T CY191101341T CY1122526T1 CY 1122526 T1 CY1122526 T1 CY 1122526T1 CY 20191101341 T CY20191101341 T CY 20191101341T CY 191101341 T CY191101341 T CY 191101341T CY 1122526 T1 CY1122526 T1 CY 1122526T1
- Authority
- CY
- Cyprus
- Prior art keywords
- pharmaceutical compositions
- light
- clevidipine
- h324ns
- oxygen
- Prior art date
Links
Classifications
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic 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
- A61P9/06—Antiarrhythmics
-
- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- 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
- A61P9/12—Antihypertensives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Dispersion Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Neurology (AREA)
- Urology & Nephrology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Hydrogenated Pyridines (AREA)
Abstract
Περιγράφονται φαρμακευτικές συνθέσεις και μία μέθοδος σταθεροποίησης φαρμακευτικών συνθέσεων που έχουν κλεβιδιπίνη ή οποιοδήποτε φαρμακευτικά αποδεκτό άλας αυτής ως δραστικό συστατικό. Η μέθοδος συμπεριλαμβάνει την επιβράδυνση ή την αναστολή του μονοπατιού οξείδωσης της κλεβιδιπίνης. Αυτό μπορεί να επιτευχθεί δια μείωσης της ποσότητας έκθεσης της φαρμακευτικής σύνθεσης στο οξυγόνο και/ή το φως κατά τη διάρκεια των διεργασιών παραγωγής και αποθήκευσης. Συνεπώς, στη μέθοδο αυτή, το οξυγόνο πρέπει να απομακρυνθεί ή να αντικατασταθεί, ή το φως πρέπει να αποκλεισθεί επαρκώς έτσι ώστε η ενέργεια φωτός να μην μπορεί να φθάσει στο δραστικό συστατικό της σύνθεσης ή να έχει μειωθεί σε ένα επίπεδο στο οποίο η αντίδραση οξείδωσης η οποία επάγεται από το φως μετατροπής της κλεβιδιπίνης σε H324nS έχει ελαχιστοποιηθεί έτσι ώστε το συνολικό ανιχνεύσιμο επίπεδο H324nS σε ένα δεδομένο δείγμα σύνθεσης να μην υπερβαίνει περίπου 0.2% σε βάση βάρους-προς-βάρος.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US8559408P | 2008-08-01 | 2008-08-01 | |
| US9381008P | 2008-09-03 | 2008-09-03 | |
| PCT/US2009/004399 WO2010014234A1 (en) | 2008-08-01 | 2009-07-30 | Pharmaceutical compositions and methods for stabilizing the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CY1122526T1 true CY1122526T1 (el) | 2021-01-27 |
Family
ID=41610652
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CY20191101341T CY1122526T1 (el) | 2008-08-01 | 2019-12-20 | Φαρμακευτικες συνθεσεις και μεθοδοι για τη σταθεροποιηση αυτων |
Country Status (21)
| Country | Link |
|---|---|
| US (4) | US20100105743A1 (el) |
| EP (1) | EP2320739B1 (el) |
| JP (4) | JP2011529879A (el) |
| KR (4) | KR20110059843A (el) |
| CN (2) | CN106377501A (el) |
| AU (1) | AU2009277100B2 (el) |
| BR (1) | BRPI0917562B8 (el) |
| CA (1) | CA2732692C (el) |
| CY (1) | CY1122526T1 (el) |
| DK (1) | DK2320739T3 (el) |
| EA (1) | EA201170287A1 (el) |
| ES (1) | ES2770178T3 (el) |
| HR (1) | HRP20200136T1 (el) |
| HU (1) | HUE047692T2 (el) |
| LT (1) | LT2320739T (el) |
| MX (1) | MX2011001241A (el) |
| NZ (1) | NZ591204A (el) |
| PL (1) | PL2320739T3 (el) |
| PT (1) | PT2320739T (el) |
| SI (1) | SI2320739T1 (el) |
| WO (1) | WO2010014234A1 (el) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2543470T3 (es) * | 2009-09-30 | 2015-08-19 | Microdose Therapeutx, Inc. | Métodos y composiciones para el tratamiento del fenómeno de Raynaud |
| US8658676B2 (en) | 2010-10-12 | 2014-02-25 | The Medicines Company | Clevidipine emulsion formulations containing antimicrobial agents |
| MX2013004151A (es) * | 2010-10-12 | 2013-05-20 | Medicines Co | Formulaciones de emulsion de clevidipina que contienen agentes antimicrobianos. |
| JP2014509654A (ja) * | 2011-04-01 | 2014-04-21 | ザ メディシンズ カンパニー | 脳卒中損傷の低減に使用するための短時間作用型ジヒドロピリジン（クレビジピン） |
| CN103134891A (zh) * | 2011-11-30 | 2013-06-05 | 天津金耀集团有限公司 | 一种丁酸氯维地平含量和有关物质的测定方法 |
| CN110840890A (zh) | 2012-10-26 | 2020-02-28 | 凯西制药公司 | 用于在心力衰竭中控制血压和减轻呼吸困难的方法 |
| CN103520104B (zh) * | 2013-10-25 | 2015-08-26 | 北京蓝丹医药科技有限公司 | 丁酸氯维地平脂肪乳注射液及其制备方法 |
| CN109776405A (zh) * | 2019-03-07 | 2019-05-21 | 重庆安格龙翔医药科技有限公司 | 一种丁酸氯维地平杂质的制备方法 |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BE756779A (fr) * | 1969-09-30 | 1971-03-01 | Warner Lambert Pharmaceutical | Solutions stables de cardenolides sensibles a l'oxydation |
| US4150744A (en) * | 1976-02-27 | 1979-04-24 | Smith & Nephew Pharmaceuticals Ltd. | Packaging |
| DE3532129A1 (de) * | 1985-09-10 | 1987-03-12 | Bayer Ag | Ss-carotin enthaltende gelatine |
| US5651991A (en) * | 1987-10-28 | 1997-07-29 | Nippon Shinyaku Co. Ltd. | Drug carriers |
| AU614465B2 (en) * | 1989-04-05 | 1991-08-29 | Yissum Research Development Company Of The Hebrew University Of Jerusalem | Medicinal emulsions |
| SE9303744D0 (sv) * | 1993-11-12 | 1993-11-12 | Astra Ab | Pharmaceutical emulsion |
| SE9804002D0 (sv) | 1998-11-23 | 1998-11-23 | Astra Ab | New manufacturing process |
| JP2000247883A (ja) * | 1999-02-23 | 2000-09-12 | Fujisawa Pharmaceut Co Ltd | ジヒドロピリジン系化合物を含有する内服用液剤 |
| US20030102246A1 (en) * | 1999-03-20 | 2003-06-05 | Lts Lohmann Therapie-Systeme Ag | Method for improving the stability of stored and/or used light-sensitive therapeutic systems or components thereof |
| US6956048B2 (en) * | 1999-03-31 | 2005-10-18 | Pharmacia & Upjohn Company | Pharmaceutical emulsions for retroviral protease inhibitors |
| US6680334B2 (en) * | 2001-08-28 | 2004-01-20 | Pfizer Inc | Crystalline material |
| JP2003104888A (ja) * | 2001-09-28 | 2003-04-09 | Taiyo Yakuhin Kogyo Kk | ジヒドロピリジン誘導体の錠剤 |
| DE10224612A1 (de) * | 2002-06-04 | 2003-12-24 | Lohmann Therapie Syst Lts | Wirkstoffhaltige filmförmige Zubereitungen mit verbesserter chemischer Stabilität, und Verfahren zu deren Herstellung |
| JP4667867B2 (ja) * | 2002-08-02 | 2011-04-13 | メルク・シャープ・エンド・ドーム・コーポレイション | 置換フロ［２，３−ｂ］ピリジン誘導体 |
| EP1635773A2 (en) * | 2003-06-06 | 2006-03-22 | Merck & Co., Inc. (a New Jersey corp.) | Combination therapy for the treatment of hypertension |
| TW200613275A (en) * | 2004-08-24 | 2006-05-01 | Recordati Ireland Ltd | Lercanidipine salts |
| JP4509118B2 (ja) * | 2004-10-06 | 2010-07-21 | エルメッド エーザイ株式会社 | 医薬組成物及びその製造方法、並びに医薬組成物におけるジヒドロピリジン系化合物の安定化方法 |
| US7737155B2 (en) * | 2005-05-17 | 2010-06-15 | Schering Corporation | Nitrogen-containing heterocyclic compounds and methods of use thereof |
| BRPI0614417A2 (pt) * | 2005-07-28 | 2011-03-29 | Reliant Pharmaceuticals Inc | composições farmacêuticas compreendendo bloqueadores de canais de cálcio de dihidropiridina e ácidos graxos de Èmega-3 e métodos de tratamento utilizando as mesmas |
| WO2007121483A2 (en) * | 2006-04-18 | 2007-10-25 | Ekr Therapeutics, Inc. | Pre-mixed, ready-to-use iv bolus compositions and methods of use |
-
2009
- 2009-07-30 ES ES09803270T patent/ES2770178T3/es active Active
- 2009-07-30 SI SI200932033T patent/SI2320739T1/sl unknown
- 2009-07-30 BR BRPI0917562A patent/BRPI0917562B8/pt active IP Right Grant
- 2009-07-30 KR KR1020117004355A patent/KR20110059843A/ko active Application Filing
- 2009-07-30 WO PCT/US2009/004399 patent/WO2010014234A1/en active Application Filing
- 2009-07-30 DK DK09803270.9T patent/DK2320739T3/da active
- 2009-07-30 HU HUE09803270A patent/HUE047692T2/hu unknown
- 2009-07-30 KR KR1020187014941A patent/KR101946977B1/ko active IP Right Grant
- 2009-07-30 EA EA201170287A patent/EA201170287A1/ru unknown
- 2009-07-30 CN CN201610773076.7A patent/CN106377501A/zh active Pending
- 2009-07-30 CA CA2732692A patent/CA2732692C/en active Active
- 2009-07-30 AU AU2009277100A patent/AU2009277100B2/en active Active
- 2009-07-30 MX MX2011001241A patent/MX2011001241A/es unknown
- 2009-07-30 PT PT98032709T patent/PT2320739T/pt unknown
- 2009-07-30 JP JP2011521123A patent/JP2011529879A/ja active Pending
- 2009-07-30 LT LTEP09803270.9T patent/LT2320739T/lt unknown
- 2009-07-30 EP EP09803270.9A patent/EP2320739B1/en active Active
- 2009-07-30 NZ NZ591204A patent/NZ591204A/xx unknown
- 2009-07-30 PL PL09803270T patent/PL2320739T3/pl unknown
- 2009-07-30 CN CN2009801389616A patent/CN102186351A/zh active Pending
- 2009-07-30 US US12/462,147 patent/US20100105743A1/en not_active Abandoned
- 2009-07-30 KR KR1020177012094A patent/KR20170051542A/ko active Application Filing
- 2009-07-30 KR KR1020167021112A patent/KR20160095206A/ko active Application Filing
-
2012
- 2012-08-30 US US13/600,083 patent/US20120322836A1/en not_active Abandoned
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2015
- 2015-01-23 JP JP2015010907A patent/JP2015098472A/ja not_active Withdrawn
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2016
- 2016-08-29 JP JP2016166426A patent/JP2016216501A/ja active Pending
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2017
- 2017-01-11 JP JP2017002785A patent/JP6537538B2/ja active Active
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2018
- 2018-12-21 US US16/229,654 patent/US20190117660A1/en not_active Abandoned
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2019
- 2019-12-20 CY CY20191101341T patent/CY1122526T1/el unknown
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2020
- 2020-01-29 HR HRP20200136TT patent/HRP20200136T1/hr unknown
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2023
- 2023-05-30 US US18/203,381 patent/US20230302002A1/en active Pending
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