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
Prior art keywords
months
formulation
edta
impurity
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AU2019378874A
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English (en)
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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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Publication of AU2019378874A1 publication Critical patent/AU2019378874A1/en
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Publication of AU2019378874B2 publication Critical patent/AU2019378874B2/en
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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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (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 (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)

* 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
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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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
WO2007072923A1 (ja) * 2005-12-22 2007-06-28 Kowa Company, Ltd. ステロイドの経時的安定性が改善された外用製剤
AU2013200089B2 (en) * 2006-02-09 2016-03-03 Santen Pharmaceutical Co., Ltd Stable formulations, and methods of their preparation and use
CN102202643A (zh) 2008-02-07 2011-09-28 安姆根有限公司 稳定化的蛋白组合物
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
US20110281834A1 (en) * 2008-11-10 2011-11-17 Friden Phillip M Pharmaceutical Formulations for 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
US20120045435A1 (en) 2010-08-18 2012-02-23 Theresa Deisher Compositions and methods to inhibit stem cell and progenitor cell binding to lymphoid tissue and for regenerating germinal centers in lymphatic tissues
ITMI20122002A1 (it) 2012-11-26 2014-05-27 Farmacologico Milanese Srl Lab Preparazioni farmaceutiche liquide stabilizzate
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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
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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 *
LAWRASON HUGHES, A. et al., ‘Dexamethasone Otoprotection in a Multidose Cisplatin Ototoxicity Mouse Model’, Otolaryngology–Head and Neck Surgery. 2014, Vol. 150, No. 1, pp. 115-20 *

Also Published As

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

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