EP3806827A4 - Epinephrinsprühformulierungen - Google Patents

Epinephrinsprühformulierungen Download PDF

Info

Publication number
EP3806827A4
EP3806827A4 EP19819360.9A EP19819360A EP3806827A4 EP 3806827 A4 EP3806827 A4 EP 3806827A4 EP 19819360 A EP19819360 A EP 19819360A EP 3806827 A4 EP3806827 A4 EP 3806827A4
Authority
EP
European Patent Office
Prior art keywords
spray formulations
epinephrine spray
epinephrine
formulations
spray
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.)
Pending
Application number
EP19819360.9A
Other languages
English (en)
French (fr)
Other versions
EP3806827A1 (de
Inventor
Thrimoorthy Potta
Craig Bastian
Ningxin YAN
Venkat GOSKONDA
Chandeshwari Chilampalli
Rachana Inavolu
Eshwaran Narayanan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hikma Pharmaceuticals USA Inc
Original Assignee
Hikma Pharmaceuticals USA Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US16/007,999 external-priority patent/US11571384B2/en
Priority claimed from US16/007,998 external-priority patent/US11517525B2/en
Priority claimed from US16/290,853 external-priority patent/US10973781B2/en
Application filed by Hikma Pharmaceuticals USA Inc filed Critical Hikma Pharmaceuticals USA Inc
Publication of EP3806827A1 publication Critical patent/EP3806827A1/de
Publication of EP3806827A4 publication Critical patent/EP3806827A4/de
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
EP19819360.9A 2018-06-13 2019-06-12 Epinephrinsprühformulierungen Pending EP3806827A4 (de)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US16/007,999 US11571384B2 (en) 2015-09-18 2018-06-13 Epinephrine spray formulations
US16/007,998 US11517525B2 (en) 2015-09-18 2018-06-13 Epinephrine spray formulations
US16/023,313 US10617637B2 (en) 2015-09-18 2018-06-29 Epinephrine spray formulations
US16/240,632 US10966925B2 (en) 2015-09-18 2019-01-04 Epinephrine spray formulations
US16/290,853 US10973781B2 (en) 2015-09-18 2019-03-01 Epinephrine spray formulations
PCT/US2019/036788 WO2019241401A1 (en) 2018-06-13 2019-06-12 Epinephrine spray formulations

Publications (2)

Publication Number Publication Date
EP3806827A1 EP3806827A1 (de) 2021-04-21
EP3806827A4 true EP3806827A4 (de) 2022-03-23

Family

ID=68842158

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19819360.9A Pending EP3806827A4 (de) 2018-06-13 2019-06-12 Epinephrinsprühformulierungen

Country Status (5)

Country Link
EP (1) EP3806827A4 (de)
JP (1) JP7443258B2 (de)
CN (1) CN112512506A (de)
CA (1) CA3102815A1 (de)
WO (1) WO2019241401A1 (de)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115666513A (zh) 2020-05-18 2023-01-31 奥瑞克索股份公司 用于药物递送的新颖药物组合物
EP4236921A1 (de) 2021-11-25 2023-09-06 Orexo AB Adrenalin enthaltende pharmazeutische zusammensetzung

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170079907A1 (en) * 2015-09-18 2017-03-23 Insys Development Company, Inc. Sublingual Epinephrine Spray

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4603687B2 (ja) * 1998-01-30 2010-12-22 ノバルテイス・コンシユーマー・ヘルス・エス・アー 点鼻用液剤
US9119876B1 (en) * 2015-03-13 2015-09-01 Par Pharmaceutical, Inc. Epinephrine formulations
US11517525B2 (en) * 2015-09-18 2022-12-06 Hikma Pharmaceuticals Usa Inc. Epinephrine spray formulations
US10039710B2 (en) * 2015-09-18 2018-08-07 Insys Development Company, Inc. Epinephrine spray formulations

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170079907A1 (en) * 2015-09-18 2017-03-23 Insys Development Company, Inc. Sublingual Epinephrine Spray

Also Published As

Publication number Publication date
EP3806827A1 (de) 2021-04-21
CA3102815A1 (en) 2019-12-19
CN112512506A (zh) 2021-03-16
JP2021527091A (ja) 2021-10-11
JP7443258B2 (ja) 2024-03-05
WO2019241401A1 (en) 2019-12-19

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RIN1 Information on inventor provided before grant (corrected)

Inventor name: NARAYANAN, ESHWARAN

Inventor name: INAVOLU, RACHANA

Inventor name: CHILAMPALLI, CHANDESHWARI

Inventor name: GOSKONDA, VENKAT

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