AU2019378874B2 - Stable glucocorticoid formulation - Google Patents

Stable glucocorticoid formulation Download PDF

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Publication number
AU2019378874B2
AU2019378874B2 AU2019378874A AU2019378874A AU2019378874B2 AU 2019378874 B2 AU2019378874 B2 AU 2019378874B2 AU 2019378874 A AU2019378874 A AU 2019378874A AU 2019378874 A AU2019378874 A AU 2019378874A AU 2019378874 B2 AU2019378874 B2 AU 2019378874B2
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AU
Australia
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months
formulation
edta
impurity
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AU2019378874A
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AU2019378874A1 (en
Inventor
Theresa Deisher
Iain Duncan
Adalbert JARZYNA
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AVM Biotechnology LLC
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AVM Biotechnology LLC
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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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2019378874A 2018-11-14 2019-11-14 Stable glucocorticoid formulation Active AU2019378874B2 (en)

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 (2)

Publication Number Publication Date
AU2019378874A1 AU2019378874A1 (en) 2021-06-17
AU2019378874B2 true AU2019378874B2 (en) 2025-05-29

Family

ID=68808595

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019378874A Active AU2019378874B2 (en) 2018-11-14 2019-11-14 Stable glucocorticoid formulation

Country Status (13)

Country Link
US (1) US20200289650A1 (https=)
EP (1) EP3706721A1 (https=)
JP (2) JP7337060B2 (https=)
KR (2) KR20220130253A (https=)
CN (1) CN111918645A (https=)
AU (1) AU2019378874B2 (https=)
BR (1) BR112021009365A2 (https=)
CA (1) CA3118505A1 (https=)
EA (1) EA202191345A1 (https=)
IL (1) IL283199A (https=)
MX (1) MX2021005665A (https=)
SG (1) SG11202104702VA (https=)
WO (1) WO2020102474A1 (https=)

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US12609718B2 (en) 2023-06-14 2026-04-21 Hewlett Packard Enterprise Development Lp WiFi-7 optimized split band architecture and method of operation
CN116789728B (zh) * 2023-06-16 2026-02-06 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

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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
KR101121529B1 (ko) * 2005-12-22 2012-02-28 코와 가부시키가이샤 스테로이드의 경시적 안정성이 개선된 외용 제제
AU2013200089B2 (en) * 2006-02-09 2016-03-03 Santen Pharmaceutical Co., Ltd Stable formulations, and methods of their preparation and use
EP2249801A2 (en) * 2008-02-07 2010-11-17 Amgen Inc. Stabilized protein compositions
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HAYNES, D.S. et al., ‘lntratympanic dexamethasone for sudden sensorineural hearing loss after failure of systemic therapy’, Laryngoscope. 2007, Vol. 117, No. 1, pp. 3-15 *
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Also Published As

Publication number Publication date
AU2019378874A1 (en) 2021-06-17
BR112021009365A2 (pt) 2021-08-10
JP2023116498A (ja) 2023-08-22
CN111918645A (zh) 2020-11-10
US20200289650A1 (en) 2020-09-17
WO2020102474A1 (en) 2020-05-22
CA3118505A1 (en) 2020-05-22
JP2021514934A (ja) 2021-06-17
KR102444113B1 (ko) 2022-09-19
EP3706721A1 (en) 2020-09-16
EA202191345A1 (ru) 2021-10-08
JP7337060B2 (ja) 2023-09-01
KR20200111675A (ko) 2020-09-29
IL283199A (en) 2021-06-30
KR20220130253A (ko) 2022-09-26
SG11202104702VA (en) 2021-06-29
MX2021005665A (es) 2021-09-23

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