CN111918645A - 稳定的糖皮质激素制剂 - Google Patents

稳定的糖皮质激素制剂 Download PDF

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Publication number
CN111918645A
CN111918645A CN201980007393.XA CN201980007393A CN111918645A CN 111918645 A CN111918645 A CN 111918645A CN 201980007393 A CN201980007393 A CN 201980007393A CN 111918645 A CN111918645 A CN 111918645A
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CN
China
Prior art keywords
formulation
less
months
aqueous pharmaceutical
dexamethasone
Prior art date
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Pending
Application number
CN201980007393.XA
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English (en)
Chinese (zh)
Inventor
T·迭舍尔
A·贾森
I·邓肯
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AVM Biotechnology LLC
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AVM Biotechnology LLC
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Application filed by AVM Biotechnology LLC filed Critical AVM Biotechnology LLC
Publication of CN111918645A publication Critical patent/CN111918645A/zh
Pending legal-status Critical Current

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    • 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
    • A61K47/02—Inorganic compounds
    • 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

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  • 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)
CN201980007393.XA 2018-11-14 2019-11-14 稳定的糖皮质激素制剂 Pending CN111918645A (zh)

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

Publications (1)

Publication Number Publication Date
CN111918645A true CN111918645A (zh) 2020-11-10

Family

ID=68808595

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980007393.XA Pending CN111918645A (zh) 2018-11-14 2019-11-14 稳定的糖皮质激素制剂

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)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018183927A1 (en) * 2017-04-01 2018-10-04 Avm Biotechnology, Llc Replacement of cytotoxic preconditioning before cellular immunotherapy

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US6136607A (en) 1995-11-02 2000-10-24 Bayer Corporation Multi-analyte reference solutions with stable pO2 in zero headspace containers
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
JP4598484B2 (ja) 2004-11-11 2010-12-15 テルモ株式会社 塩酸リトドリン注射液製剤
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
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EP2365812A4 (en) * 2008-11-10 2012-05-16 Nitric Biotherapeutics Inc PHARMACEUTICAL FORMULATIONS FOR THE IONTOPHORETIC DELIVERY OF A CORTICOSTEROID
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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
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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

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2018183927A1 (en) * 2017-04-01 2018-10-04 Avm Biotechnology, Llc Replacement of cytotoxic preconditioning before cellular immunotherapy

Non-Patent Citations (2)

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吴正红等: "《执业药师考试用书药师考试 复习精要 药学专业知识 1 11讲 第2版 2017版》", 28 February 2017 *
曹筱琛: "地塞米松磷酸钠注射液的杂质研究和制剂影响因素探讨", 《中国优秀博硕士学位论文全文数据库(硕士)医药卫生科技辑》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

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
MX2021005665A (es) 2021-09-23
CA3118505A1 (en) 2020-05-22
KR20220130253A (ko) 2022-09-26
JP7337060B2 (ja) 2023-09-01
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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