CA3076816A1 - Enhanced delivery epinephrine and prodrug compositions - Google Patents

Enhanced delivery epinephrine and prodrug compositions Download PDF

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Publication number
CA3076816A1
CA3076816A1 CA3076816A CA3076816A CA3076816A1 CA 3076816 A1 CA3076816 A1 CA 3076816A1 CA 3076816 A CA3076816 A CA 3076816A CA 3076816 A CA3076816 A CA 3076816A CA 3076816 A1 CA3076816 A1 CA 3076816A1
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
composition according
epinephrine
polymeric matrix
film
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
CA3076816A
Other languages
English (en)
French (fr)
Inventor
Alexander Mark Schobel
Stephanie Marie Varjan
Stephen Paul Wargacki
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.)
Aquestive Therapeutics Inc
Original Assignee
Aquestive Therapeutics 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 US15/717,859 external-priority patent/US20180125977A1/en
Priority claimed from US15/791,249 external-priority patent/US12427121B2/en
Application filed by Aquestive Therapeutics Inc filed Critical Aquestive Therapeutics Inc
Publication of CA3076816A1 publication Critical patent/CA3076816A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives 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
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/49—Cinchonan derivatives, e.g. quinine

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Botany (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Plant Substances (AREA)
CA3076816A 2017-09-27 2018-09-27 Enhanced delivery epinephrine and prodrug compositions Pending CA3076816A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US15/717,859 US20180125977A1 (en) 2016-05-05 2017-09-27 Enhanced delivery epinephrine compositions
US15/717,859 2017-09-27
US15/791,249 US12427121B2 (en) 2016-05-05 2017-10-23 Enhanced delivery epinephrine compositions
US15/791,249 2017-10-23
PCT/US2018/053042 WO2019067670A1 (en) 2017-09-27 2018-09-27 EPINEPHRINE AND ENHANCED DELIVERY COMPOSITIONS

Publications (1)

Publication Number Publication Date
CA3076816A1 true CA3076816A1 (en) 2019-04-04

Family

ID=63858169

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3076816A Pending CA3076816A1 (en) 2017-09-27 2018-09-27 Enhanced delivery epinephrine and prodrug compositions

Country Status (8)

Country Link
EP (1) EP3687510A1 (enExample)
JP (2) JP2020535162A (enExample)
KR (1) KR20200060748A (enExample)
CN (1) CN111465391A (enExample)
BR (1) BR112020005948A2 (enExample)
CA (1) CA3076816A1 (enExample)
IL (2) IL273485B2 (enExample)
WO (1) WO2019067670A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11273131B2 (en) 2016-05-05 2022-03-15 Aquestive Therapeutics, Inc. Pharmaceutical compositions with enhanced permeation
US12433850B2 (en) 2016-05-05 2025-10-07 Aquestive Therapeutics, Inc. Enhanced delivery epinephrine and prodrug compositions
US12427121B2 (en) 2016-05-05 2025-09-30 Aquestive Therapeutics, Inc. Enhanced delivery epinephrine compositions
KR20230137362A (ko) 2016-05-05 2023-10-04 어퀘스티브 테라퓨틱스, 아이엔씨. 강화된 전달 에프네프린 조성물
AU2020373100A1 (en) * 2019-11-01 2022-05-19 Aquestive Therapeutics, Inc. Prodrug compositions and methods of treatment
US11571468B2 (en) * 2021-02-01 2023-02-07 Matthias W. Rath Micronutrient combination to reduce blood pressure
WO2023076281A1 (en) 2021-10-25 2023-05-04 Aquestive Therapeutics, Inc. Oral and nasal compositions and methods of treatment
US20240016734A1 (en) * 2022-06-14 2024-01-18 Aquestive Therapeutics, Inc. Enhanced delivery epinephrine and prodrug compositions
EP4302751A1 (en) * 2022-07-07 2024-01-10 LTS Lohmann Therapie-Systeme AG Oral thin films with low water activity
CN118121542A (zh) * 2023-03-31 2024-06-04 中国药科大学 鼻用药物组合物、其制备方法及应用

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7357891B2 (en) 2001-10-12 2008-04-15 Monosol Rx, Llc Process for making an ingestible film
US8603514B2 (en) 2002-04-11 2013-12-10 Monosol Rx, Llc Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
US7425292B2 (en) 2001-10-12 2008-09-16 Monosol Rx, Llc Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
US7666337B2 (en) 2002-04-11 2010-02-23 Monosol Rx, Llc Polyethylene oxide-based films and drug delivery systems made therefrom
US8765167B2 (en) 2001-10-12 2014-07-01 Monosol Rx, Llc Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US20030143195A1 (en) * 2002-01-30 2003-07-31 Pinsker Judy Senior Use of histamine as a drug delivery enhancing compound for use in transmucosal or transdermal delivery
US20040096569A1 (en) * 2002-11-15 2004-05-20 Barkalow David G. Edible film products and methods of making same
US20050266085A1 (en) * 2004-05-28 2005-12-01 Warner Kevin S Gelled emulsion and microemulsion formulations for dermal drug delivery
US20070202163A1 (en) * 2005-09-09 2007-08-30 Mutasem Rawas-Qalaji Fast-disintegrating epinephrine tablets for buccal or sublingual administration
IL175338A0 (en) * 2006-05-01 2006-09-05 Biota Ltd Orally administrable films and preparation thereof
TW200815048A (en) * 2006-06-05 2008-04-01 Verus Pharmaceuticals Inc Methods for buccal, lingual or sublingual dosing regimens of epinephrine for the treatment of allergic emergencies
US20070293582A1 (en) * 2006-06-05 2007-12-20 Malcolm Hill Epinephrine dosing regimens comprising buccal, lingual or sublingual and injectable dosage forms
PE20091084A1 (es) * 2007-12-07 2009-07-23 Schering Plough Healthcare Formulaciones farmaceuticas de fenilefrina y composiciones para absorcion transmucosal
WO2010122355A1 (en) * 2009-04-23 2010-10-28 Londonpharma Ltd. Sublingual pharmaceutical composition comprising a neutral oil
EP2552486B1 (en) * 2010-03-30 2020-08-12 Phosphagenics Limited Transdermal delivery patch
WO2013063614A1 (en) * 2011-10-28 2013-05-02 Sung-Yun Kwon Dissolving solid solution perforator patch for migraine treatment
NZ706302A (en) * 2012-10-11 2017-07-28 Ix Biopharma Ltd Sublingual wafer solid dosage form containing amylopectin
US20160051494A1 (en) * 2014-08-21 2016-02-25 Mylan, Inc. Multi-dose medication kit for treating anaphylaxis
KR20230137362A (ko) * 2016-05-05 2023-10-04 어퀘스티브 테라퓨틱스, 아이엔씨. 강화된 전달 에프네프린 조성물
WO2017192923A1 (en) * 2016-05-05 2017-11-09 Monosol Rx, Llc Pharmaceutical compositions with enhanced permeation
CA3076751A1 (en) * 2017-09-26 2019-04-04 Aquestive Therapeutics, Inc. Delivery pharmaceutical compositions including permeation enhancers

Also Published As

Publication number Publication date
IL273485B1 (en) 2024-07-01
IL313551A (en) 2024-08-01
IL273485A (en) 2020-05-31
JP2020535162A (ja) 2020-12-03
WO2019067670A1 (en) 2019-04-04
CN111465391A (zh) 2020-07-28
JP2023159150A (ja) 2023-10-31
BR112020005948A2 (pt) 2020-12-01
IL273485B2 (en) 2024-11-01
KR20200060748A (ko) 2020-06-01
EP3687510A1 (en) 2020-08-05

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220927

EEER Examination request

Effective date: 20220927

EEER Examination request

Effective date: 20220927

EEER Examination request

Effective date: 20220927