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WO2023076477A3 - Comprimé à désintégration orale pour formulations de promédicament d'épinéphrine - Google Patents

Comprimé à désintégration orale pour formulations de promédicament d'épinéphrine Download PDF

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Publication number
WO2023076477A3
WO2023076477A3 PCT/US2022/048024 US2022048024W WO2023076477A3 WO 2023076477 A3 WO2023076477 A3 WO 2023076477A3 US 2022048024 W US2022048024 W US 2022048024W WO 2023076477 A3 WO2023076477 A3 WO 2023076477A3
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WO
WIPO (PCT)
Prior art keywords
epinephrine
orally disintegrating
prodrug
patient
disclosure
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.)
Ceased
Application number
PCT/US2022/048024
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English (en)
Other versions
WO2023076477A2 (fr
Inventor
Mingbao Zhang
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.)
Insignis Therapeutics Inc
Original Assignee
Insignis 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
Application filed by Insignis Therapeutics Inc filed Critical Insignis Therapeutics Inc
Publication of WO2023076477A2 publication Critical patent/WO2023076477A2/fr
Publication of WO2023076477A3 publication Critical patent/WO2023076477A3/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4406—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 3, e.g. zimeldine
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—Proteins, e.g. gelatin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un comprimé de Promédicament d'épinéphrine à désintégration orale (ODT) qui comprend un promédicament d'épinéphrine, un sel pharmaceutiquement acceptable de celui-ci, un liant, un agent de formation de matrice et un agent de masquage de goût. L'ODT de l'invention fournit rapidement de l'épinéphrine à un patient lorsqu'il est administré. L'invention concerne également un procédé de traitement d'un patient qui a un état sensible à l'épinéphrine, tel qu'un événement cardiaque, l'asthme, le croup, le Cancer, une infection microbienne, la maladie d'Addison, ou une réaction allergique, en particulier l'anaphylaxie par l'administration d'un comprimé de promédicament d'épinéphrine à désintégration orale au patient.
PCT/US2022/048024 2021-10-27 2022-10-27 Comprimé à désintégration orale pour formulations de promédicament d'épinéphrine Ceased WO2023076477A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163272520P 2021-10-27 2021-10-27
US63/272,520 2021-10-27

Publications (2)

Publication Number Publication Date
WO2023076477A2 WO2023076477A2 (fr) 2023-05-04
WO2023076477A3 true WO2023076477A3 (fr) 2023-07-13

Family

ID=84364008

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/048024 Ceased WO2023076477A2 (fr) 2021-10-27 2022-10-27 Comprimé à désintégration orale pour formulations de promédicament d'épinéphrine

Country Status (1)

Country Link
WO (1) WO2023076477A2 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170020827A1 (en) * 2005-09-09 2017-01-26 Nova Southeastern University Epinephrine fine particles and methods for use thereof for treatment of conditions responsive to epinephrine
WO2019051387A1 (fr) * 2017-09-08 2019-03-14 Mingbao Zhang Procédés d'utilisation de la dipivéfrine
WO2020081952A1 (fr) * 2018-10-19 2020-04-23 Nova Southeastern University Compositions d'épinéphrine sublinguales comprenant des excipients modifiant le ph et des amplificateurs de la pénétration et leurs méthodes d'utilisation
US20200276114A1 (en) * 2019-03-01 2020-09-03 Insignis Therapeutics, Inc. Dipivefrin orally disintegrating tablet formulations
WO2021087359A1 (fr) * 2019-11-01 2021-05-06 Aquestive Therapeutics, Inc. Compositions de promédicament et procédés de traitement

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5925682A (en) 1995-11-20 1999-07-20 Immunotech Inc. Epinephrine as inhibitor of cancerous tumors
US10039710B2 (en) 2015-09-18 2018-08-07 Insys Development Company, Inc. Epinephrine spray formulations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170020827A1 (en) * 2005-09-09 2017-01-26 Nova Southeastern University Epinephrine fine particles and methods for use thereof for treatment of conditions responsive to epinephrine
WO2019051387A1 (fr) * 2017-09-08 2019-03-14 Mingbao Zhang Procédés d'utilisation de la dipivéfrine
WO2020081952A1 (fr) * 2018-10-19 2020-04-23 Nova Southeastern University Compositions d'épinéphrine sublinguales comprenant des excipients modifiant le ph et des amplificateurs de la pénétration et leurs méthodes d'utilisation
US20200276114A1 (en) * 2019-03-01 2020-09-03 Insignis Therapeutics, Inc. Dipivefrin orally disintegrating tablet formulations
WO2021087359A1 (fr) * 2019-11-01 2021-05-06 Aquestive Therapeutics, Inc. Compositions de promédicament et procédés de traitement

Non-Patent Citations (8)

* Cited by examiner, † Cited by third party
Title
BAROT MEGHA ET AL: "Prodrug Strategies in Ocular Drug Delivery", MEDICINAL CHEMISTRY, vol. 8, no. 4, 1 June 2012 (2012-06-01), NL, pages 753 - 768, XP055944741, ISSN: 1573-4064, Retrieved from the Internet <URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4407659/pdf/nihms-680936.pdf> DOI: 10.2174/157340612801216283 *
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; YUAN, SUN-SHINE ET AL: "Synthesis and activity of (R)-(-)-m-trimethylacetoxy-.alpha.-[(methylamino)methyl]benzyl alcohol hydrochloride: a prodrug from of phenylephrine", XP002809021, retrieved from STN Database accession no. 1976:503761 *
JORDAN A M ET AL: "Melanocyte-Directed enzyme prodrug therapy (MDEPT)", BIOORGANIC & MEDICINAL CHEMISTRY, ELSEVIER, AMSTERDAM, NL, vol. 9, no. 6, 1 June 2001 (2001-06-01), pages 1549 - 1558, XP027414386, ISSN: 0968-0896, [retrieved on 20010601] *
KOUR JAGPREET ET AL: "Ocular prodrugs: Attributes and challenges", ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 16, no. 2, 28 September 2020 (2020-09-28), NL, pages 175 - 191, XP093019299, ISSN: 1818-0876, Retrieved from the Internet <URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8105420/pdf/main.pdf> DOI: 10.1016/j.ajps.2020.08.002 *
NAKAMURA M ET AL: "Characterization of esterases involved in the hydrolysis of dipivefrin hydrochloride", OPHTHALMIC RESEARCH, vol. 25, no. 1, 10 December 2009 (2009-12-10), CH, pages 46, XP093038526, ISSN: 0030-3747, Retrieved from the Internet <URL:https://www.karger.com/Article/Abstract/267220> DOI: 10.1159/000267220 10.1159/000267220 *
RACHID OUSAMA ET AL: "Epinephrine (adrenaline) absorption from new-generation, taste-masked sublingual tablets: a preclinical study", CLINICAL EFFICACY AND IMMUNE REGULATION WITH PEANUT ORAL IMMUNOTHERAPY,, vol. 131, no. 1, 31 December 2012 (2012-12-31), pages 236 - 238, XP009520358, ISSN: 1097-6825, DOI: 10.1016/J.JACI.2012.10.016 *
REDELL M A ET AL: "The role of esterase activity in the ocular disposition of dipivalyl epinephrine in rabbits", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER, NL, vol. 17, no. 2-3, 1 December 1983 (1983-12-01), pages 299 - 312, XP023844454, ISSN: 0378-5173, [retrieved on 19831201], DOI: 10.1016/0378-5173(83)90041-8 *
YUAN, SUN-SHINE ET AL: "Synthesis and activity of (R)-(-)-m-trimethylacetoxy-.alpha.- [(methylamino)methyl]benzyl alcohol hydrochloride: a", JOURNAL OF PHARMACEUTICAL SCIENCES , 65(6), 929-31 CODEN: JPMSAE; ISSN: 0022-3549, 1976, DOI: 10.1002/JPS.2600650637 10.1002/JPS.2600650637 *

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