JP7337060B2 - 安定なグルココルチコイド製剤 - Google Patents
安定なグルココルチコイド製剤 Download PDFInfo
- Publication number
- JP7337060B2 JP7337060B2 JP2020529561A JP2020529561A JP7337060B2 JP 7337060 B2 JP7337060 B2 JP 7337060B2 JP 2020529561 A JP2020529561 A JP 2020529561A JP 2020529561 A JP2020529561 A JP 2020529561A JP 7337060 B2 JP7337060 B2 JP 7337060B2
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- JP
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- Prior art keywords
- formulation
- less
- months
- dexamethasone
- headspace
- 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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Classifications
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2023084640A JP2023116498A (ja) | 2018-11-14 | 2023-05-23 | 安定なグルココルチコイド製剤 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862767448P | 2018-11-14 | 2018-11-14 | |
| US62/767,448 | 2018-11-14 | ||
| PCT/US2019/061363 WO2020102474A1 (en) | 2018-11-14 | 2019-11-14 | Stable glucocorticoid formulation |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023084640A Division JP2023116498A (ja) | 2018-11-14 | 2023-05-23 | 安定なグルココルチコイド製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2021514934A JP2021514934A (ja) | 2021-06-17 |
| JP7337060B2 true JP7337060B2 (ja) | 2023-09-01 |
Family
ID=68808595
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020529561A Active JP7337060B2 (ja) | 2018-11-14 | 2019-11-14 | 安定なグルココルチコイド製剤 |
| JP2023084640A Pending JP2023116498A (ja) | 2018-11-14 | 2023-05-23 | 安定なグルココルチコイド製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023084640A Pending JP2023116498A (ja) | 2018-11-14 | 2023-05-23 | 安定なグルココルチコイド製剤 |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US20200289650A1 (enExample) |
| EP (1) | EP3706721A1 (enExample) |
| JP (2) | JP7337060B2 (enExample) |
| KR (2) | KR102444113B1 (enExample) |
| CN (1) | CN111918645A (enExample) |
| AU (1) | AU2019378874B2 (enExample) |
| BR (1) | BR112021009365A2 (enExample) |
| CA (1) | CA3118505A1 (enExample) |
| EA (1) | EA202191345A1 (enExample) |
| IL (1) | IL283199A (enExample) |
| MX (1) | MX2021005665A (enExample) |
| SG (1) | SG11202104702VA (enExample) |
| WO (1) | WO2020102474A1 (enExample) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116789728A (zh) * | 2023-06-16 | 2023-09-22 | 山东斯瑞药业有限公司 | 一种降低糖皮质激素原料药重金属元素杂质含量的工艺 |
| CN116807970A (zh) * | 2023-07-26 | 2023-09-29 | 遂成药业股份有限公司 | 一种地塞米松磷酸钠注射液及其制备方法 |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002502975A (ja) | 1998-02-03 | 2002-01-29 | バイエル コーポレイション | ゼロヘッドスペース容器での安定pO2を有する多分析物参照溶液 |
| JP2006136490A (ja) | 2004-11-11 | 2006-06-01 | Terumo Corp | 塩酸リトドリン注射液製剤 |
| JP2011136973A (ja) | 2009-12-28 | 2011-07-14 | Keiki Imoto | 安定なエダラボン含有水性製剤 |
| JP2014207983A (ja) | 2013-03-28 | 2014-11-06 | テルモ株式会社 | アセトアミノフェン注射液製剤 |
| JP2015042638A (ja) | 2008-02-07 | 2015-03-05 | アムジエン・インコーポレーテツド | 安定化されたタンパク質組成物 |
| JP2016518404A (ja) | 2013-05-08 | 2016-06-23 | シージェイ ヘルスケア コーポレイションCj Healthcare Corporation | 安定化したペメトレキセド製剤 |
| WO2018183927A1 (en) | 2017-04-01 | 2018-10-04 | Avm Biotechnology, Llc | Replacement of cytotoxic preconditioning before cellular immunotherapy |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040197333A1 (en) * | 2000-02-10 | 2004-10-07 | Cornell Research Foundation, Inc. | Use of TGF-beta antagonists to inhibit tumor cell formation or progression |
| US9694103B2 (en) * | 2003-04-16 | 2017-07-04 | The Children's Hospital Of Philadelphia | Photochemical activation of surfaces for attaching biomaterial |
| WO2005110374A1 (en) * | 2004-04-30 | 2005-11-24 | Allergan, Inc. | Intraocular drug delivery systems containing a therapeutic component, a cyclodextrin, and a polymeric component |
| US20080038316A1 (en) * | 2004-10-01 | 2008-02-14 | Wong Vernon G | Conveniently implantable sustained release drug compositions |
| CN101340916A (zh) * | 2005-12-22 | 2009-01-07 | 兴和株式会社 | 类固醇的经时稳定性得到改善的外用制剂 |
| AU2013200089B2 (en) * | 2006-02-09 | 2016-03-03 | Santen Pharmaceutical Co., Ltd | Stable formulations, and methods of their preparation and use |
| CN101623291B (zh) | 2008-07-07 | 2011-12-07 | 天津金耀集团有限公司 | 一种地塞米松磷酸钠注射液 |
| EP2365812A4 (en) * | 2008-11-10 | 2012-05-16 | Nitric Biotherapeutics Inc | PHARMACEUTICAL FORMULATIONS FOR THE IONTOPHORETIC DELIVERY OF A CORTICOSTEROID |
| GB2477545B (en) * | 2010-02-05 | 2011-12-21 | Special Products Ltd | A liquid morphine composition for buccal administration |
| CA2844109C (en) | 2010-08-18 | 2018-11-06 | Theresa Deisher | Compositions and methods to inhibit stem cell binding to active germinal centers in lymphatic tissues |
| ITMI20122002A1 (it) | 2012-11-26 | 2014-05-27 | Farmacologico Milanese Srl Lab | Preparazioni farmaceutiche liquide stabilizzate |
| GR1008921B (el) | 2015-12-10 | 2017-01-12 | Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων | Φαρμακευτικο σκευασμα ελευθερο συντηρητικου για οφθαλμικη χορηγηση περιεχον δεξαμεθαζονη |
| CN107375200A (zh) | 2017-06-16 | 2017-11-24 | 北京立时达药业有限公司 | 一种地塞米松磷酸钠注射液及其制备方法 |
| EP3488851A1 (en) * | 2018-10-03 | 2019-05-29 | AVM Biotechnology, LLC | Immunoablative therapies |
-
2019
- 2019-11-14 CN CN201980007393.XA patent/CN111918645A/zh active Pending
- 2019-11-14 KR KR1020207017795A patent/KR102444113B1/ko active Active
- 2019-11-14 AU AU2019378874A patent/AU2019378874B2/en active Active
- 2019-11-14 SG SG11202104702VA patent/SG11202104702VA/en unknown
- 2019-11-14 BR BR112021009365-6A patent/BR112021009365A2/pt unknown
- 2019-11-14 EP EP19817060.7A patent/EP3706721A1/en active Pending
- 2019-11-14 EA EA202191345A patent/EA202191345A1/ru unknown
- 2019-11-14 KR KR1020227031562A patent/KR20220130253A/ko not_active Ceased
- 2019-11-14 MX MX2021005665A patent/MX2021005665A/es unknown
- 2019-11-14 JP JP2020529561A patent/JP7337060B2/ja active Active
- 2019-11-14 CA CA3118505A patent/CA3118505A1/en active Pending
- 2019-11-14 WO PCT/US2019/061363 patent/WO2020102474A1/en not_active Ceased
-
2020
- 2020-05-28 US US16/885,815 patent/US20200289650A1/en active Pending
-
2021
- 2021-05-13 IL IL283199A patent/IL283199A/en unknown
-
2023
- 2023-05-23 JP JP2023084640A patent/JP2023116498A/ja active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002502975A (ja) | 1998-02-03 | 2002-01-29 | バイエル コーポレイション | ゼロヘッドスペース容器での安定pO2を有する多分析物参照溶液 |
| JP2006136490A (ja) | 2004-11-11 | 2006-06-01 | Terumo Corp | 塩酸リトドリン注射液製剤 |
| JP2015042638A (ja) | 2008-02-07 | 2015-03-05 | アムジエン・インコーポレーテツド | 安定化されたタンパク質組成物 |
| JP2011136973A (ja) | 2009-12-28 | 2011-07-14 | Keiki Imoto | 安定なエダラボン含有水性製剤 |
| JP2014207983A (ja) | 2013-03-28 | 2014-11-06 | テルモ株式会社 | アセトアミノフェン注射液製剤 |
| JP2016518404A (ja) | 2013-05-08 | 2016-06-23 | シージェイ ヘルスケア コーポレイションCj Healthcare Corporation | 安定化したペメトレキセド製剤 |
| WO2018183927A1 (en) | 2017-04-01 | 2018-10-04 | Avm Biotechnology, Llc | Replacement of cytotoxic preconditioning before cellular immunotherapy |
Non-Patent Citations (3)
| Title |
|---|
| Otol Nerrol,2015年,36,1321-1327 |
| Tetrahedron Letters,2009年,50(32),4575-4581 |
| 医薬品インタビューフォーム ソルコート静注液100mg,2011年 |
Also Published As
| Publication number | Publication date |
|---|---|
| BR112021009365A2 (pt) | 2021-08-10 |
| AU2019378874A1 (en) | 2021-06-17 |
| US20200289650A1 (en) | 2020-09-17 |
| EA202191345A1 (ru) | 2021-10-08 |
| IL283199A (en) | 2021-06-30 |
| JP2023116498A (ja) | 2023-08-22 |
| JP2021514934A (ja) | 2021-06-17 |
| CN111918645A (zh) | 2020-11-10 |
| MX2021005665A (es) | 2021-09-23 |
| CA3118505A1 (en) | 2020-05-22 |
| KR20220130253A (ko) | 2022-09-26 |
| AU2019378874B2 (en) | 2025-05-29 |
| KR20200111675A (ko) | 2020-09-29 |
| WO2020102474A1 (en) | 2020-05-22 |
| KR102444113B1 (ko) | 2022-09-19 |
| SG11202104702VA (en) | 2021-06-29 |
| EP3706721A1 (en) | 2020-09-16 |
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