AU2016342374B2 - Gastric residence systems for sustained release of therapeutic agents and methods of use thereof - Google Patents

Gastric residence systems for sustained release of therapeutic agents and methods of use thereof Download PDF

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Publication number
AU2016342374B2
AU2016342374B2 AU2016342374A AU2016342374A AU2016342374B2 AU 2016342374 B2 AU2016342374 B2 AU 2016342374B2 AU 2016342374 A AU2016342374 A AU 2016342374A AU 2016342374 A AU2016342374 A AU 2016342374A AU 2016342374 B2 AU2016342374 B2 AU 2016342374B2
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Australia
Prior art keywords
release
therapeutic agent
gastric residence
period
gastric
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AU2016342374A1 (en
Inventor
Andrew BELLINGER
Colin Gardner
Tyler GRANT
Rosemary KANASTY
Saumya MOORTHY
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Lyndra Therapeutics Inc
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Lyndra Therapeutics Inc
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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
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K31/365—Lactones
    • 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
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/65—Tetracyclines
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/58—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/593—Polyesters, e.g. PLGA or polylactide-co-glycolide
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2016342374A 2015-10-23 2016-10-21 Gastric residence systems for sustained release of therapeutic agents and methods of use thereof Active AU2016342374B2 (en)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201562245789P 2015-10-23 2015-10-23
US201562245797P 2015-10-23 2015-10-23
US62/245,789 2015-10-23
US62/245,797 2015-10-23
US201562264799P 2015-12-08 2015-12-08
US201562264806P 2015-12-08 2015-12-08
US201562264795P 2015-12-08 2015-12-08
US62/264,806 2015-12-08
US62/264,795 2015-12-08
US62/264,799 2015-12-08
US201662402947P 2016-09-30 2016-09-30
US62/402,947 2016-09-30
PCT/US2016/058309 WO2017070612A1 (en) 2015-10-23 2016-10-21 Gastric residence systems for sustained release of therapeutic agents and methods of use thereof

Publications (2)

Publication Number Publication Date
AU2016342374A1 AU2016342374A1 (en) 2018-06-07
AU2016342374B2 true AU2016342374B2 (en) 2022-08-04

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AU2016342374A Active AU2016342374B2 (en) 2015-10-23 2016-10-21 Gastric residence systems for sustained release of therapeutic agents and methods of use thereof

Country Status (8)

Country Link
US (1) US11576859B2 (enExample)
EP (1) EP3364946A4 (enExample)
JP (2) JP7085473B2 (enExample)
CN (2) CN118975972A (enExample)
AU (1) AU2016342374B2 (enExample)
CA (1) CA3002916C (enExample)
HK (1) HK1258050A1 (enExample)
WO (1) WO2017070612A1 (enExample)

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US20170266112A1 (en) 2014-06-11 2017-09-21 Massachusetts Institute Of Technology Residence structures and related methods
JP6666858B2 (ja) 2014-06-11 2020-03-18 マサチューセッツ インスティテュート オブ テクノロジー 滞留構造体および関連方法
CN118975972A (zh) 2015-10-23 2024-11-19 林德拉治疗公司 用于治疗剂缓释的胃驻留系统及其使用方法
BR112018011636B1 (pt) 2015-12-08 2024-03-12 Lyndra Therapeutics, Inc Sistema de residência gástrico para liberação sustentada de um agente terapêutico
CN119925721A (zh) * 2016-05-27 2025-05-06 林德拉治疗公司 用于胃驻留系统的材料结构
CN110022861B (zh) 2016-09-30 2024-06-28 林德拉治疗公司 用于金刚烷类药物缓释的胃驻留系统
IL301683B2 (en) 2017-05-17 2025-02-01 Massachusetts Inst Technology Self-healing systems and related components and methods
US11541015B2 (en) 2017-05-17 2023-01-03 Massachusetts Institute Of Technology Self-righting systems, methods, and related components
AU2018279853B2 (en) * 2017-06-09 2024-07-04 Lyndra Therapeutics, Inc. Gastric residence systems with release rate-modulating films
KR102046395B1 (ko) * 2017-12-12 2019-11-19 동아에스티 주식회사 베포타스틴 또는 이의 약제학적으로 허용 가능한 염을 포함하는 서방성 제제
AU2019245436B2 (en) * 2018-03-29 2024-12-12 Mati Therapeutics Inc. Ophthalmic drug sustained release formulation and uses for dry eye syndrome treatment
EP3793667A1 (en) 2018-05-17 2021-03-24 Massachusetts Institute of Technology Systems for electrical stimulation
WO2019245925A1 (en) 2018-06-19 2019-12-26 National University Of Singapore Formulations of 5-hydroxy tryptophan (5-htp) for better bioavailability for various indications
US12142158B2 (en) 2018-12-03 2024-11-12 Lyndra Therapeutics, Inc. Stomach simulating device
US11771829B2 (en) 2019-02-01 2023-10-03 Massachusetts Institute Of Technology Systems and methods for liquid injection
EP3941445A4 (en) 2019-03-20 2023-08-02 Lyndra Therapeutics, Inc. CAPSULES AND CAPSULE COATINGS FOR GASOLINE DOSAGE FORMS
AU2020378437A1 (en) * 2019-11-08 2022-06-02 Lyndra Therapeutics, Inc. Formulations for release-rate modulating films for gastric residence systems
EP4054545A4 (en) * 2019-11-08 2024-02-14 Lyndra Therapeutics, Inc. GASTRIC STAY SYSTEMS FOR THE ADMINISTRATION OF ACTIVE AGENTS
WO2021092487A1 (en) * 2019-11-08 2021-05-14 Lyndra, Inc. Polymeric linkers for a gastric residence system
US11541216B2 (en) 2019-11-21 2023-01-03 Massachusetts Institute Of Technology Methods for manufacturing tissue interfacing components
JP2023536456A (ja) 2020-07-29 2023-08-25 ザ・セカント・グループ・エルエルシー 架橋ポリ（セバシン酸グリセロール）を含む構造を含む形状誘導型制御放出および保持
US20240335400A1 (en) * 2021-05-05 2024-10-10 Lyndra Therapeutics, Inc. Gastric residence systems comprising methadone
EP4333823A4 (en) * 2021-05-05 2025-04-09 Lyndra Therapeutics, Inc. Indwelling gastric sytems containing buprenorphine and naloxone
AU2022320730A1 (en) 2021-07-30 2024-03-14 Evecxia Therapeutics, Inc. 5-hydroxytryptophan gastroretentive dosage forms
US12409163B2 (en) 2021-07-30 2025-09-09 Evecxia Therapeutics, Inc. Method of enhancing 5-hydroxytryptophan (5-HTP) exposure
EP4392031A4 (en) 2021-10-14 2025-07-30 Evecxia Therapeutics Inc METHOD FOR OPTIMIZING 5-HYDROXYTRYPTAMINE FUNCTION IN THE BRAIN FOR THERAPEUTIC PURPOSES
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