JP2024505429A - プロドラッグ組成物及び治療の方法 - Google Patents

プロドラッグ組成物及び治療の方法 Download PDF

Info

Publication number
JP2024505429A
JP2024505429A JP2023542915A JP2023542915A JP2024505429A JP 2024505429 A JP2024505429 A JP 2024505429A JP 2023542915 A JP2023542915 A JP 2023542915A JP 2023542915 A JP2023542915 A JP 2023542915A JP 2024505429 A JP2024505429 A JP 2024505429A
Authority
JP
Japan
Prior art keywords
hydrochloride
prodrug
commercially available
composition
epinephrine
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
JP2023542915A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024505429A5 (https=
Inventor
マーク ショベル アレクサンダー
アール. バーバー ダニエル
ポール ワルガクキ ステファン
クマール カインザン ラジェシュ
エム. バージャン ステファニー
デュライ マラールビズヒ
Original Assignee
アクエスティブ セラピューティクス インコーポレイテッド
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 アクエスティブ セラピューティクス インコーポレイテッド filed Critical アクエスティブ セラピューティクス インコーポレイテッド
Publication of JP2024505429A publication Critical patent/JP2024505429A/ja
Publication of JP2024505429A5 publication Critical patent/JP2024505429A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K47/06Organic 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • 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
    • A61K9/141Intimate 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
    • A61K9/143Intimate 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 inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Immunology (AREA)
  • Cardiology (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2023542915A 2021-01-15 2022-01-15 プロドラッグ組成物及び治療の方法 Pending JP2024505429A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163137881P 2021-01-15 2021-01-15
US63/137,881 2021-01-15
PCT/US2022/012633 WO2022155544A1 (en) 2021-01-15 2022-01-15 Prodrug compositions and methods of treatment

Publications (2)

Publication Number Publication Date
JP2024505429A true JP2024505429A (ja) 2024-02-06
JP2024505429A5 JP2024505429A5 (https=) 2025-01-24

Family

ID=80222567

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023542915A Pending JP2024505429A (ja) 2021-01-15 2022-01-15 プロドラッグ組成物及び治療の方法

Country Status (7)

Country Link
US (1) US20220233471A1 (https=)
EP (1) EP4277611A1 (https=)
JP (1) JP2024505429A (https=)
KR (1) KR20230134136A (https=)
CN (1) CN116940351A (https=)
CA (1) CA3208345A1 (https=)
WO (1) WO2022155544A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12440488B2 (en) 2020-12-01 2025-10-14 Reverspah Llc Methods and compositions for treating chronic obstructive pulmonary disease, asthma, pneumonia, bronchitis, cystic fibrosis, pulmonary edema, interstitial lung disease, sarcoidosis, idiopathic pulmonary fibrosis, acute respiratory distress syndrome, and pulmonary arterial hypertension
CN117695279A (zh) * 2023-11-28 2024-03-15 九华华源药业(桂林)有限公司 氯雷他定组合物及氯雷他定药物

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003026631A1 (en) * 2001-05-24 2003-04-03 Alexza Molecular Delivery Corporation Delivery of drug esters through an inhalation route
US6655379B2 (en) * 1998-03-16 2003-12-02 Nektar Therapeutics Aerosolized active agent delivery
WO2004002451A1 (fr) * 2002-06-28 2004-01-08 Fang Chen Suppositoire a liberation controlee utilise dans un canal secreteur de lait
US20040076588A1 (en) * 2002-06-28 2004-04-22 Batycky Richard P. Inhalable epinephrine
US20090017124A1 (en) * 2007-04-17 2009-01-15 Baxter International Inc. Nucleic Acid Microparticles for Pulmonary Delivery
WO2014062621A1 (en) * 2012-10-15 2014-04-24 Stc.Unm Treatment of autophagy-based disorders and related pharmaceutical compositions, diagnostic and screening assays and kits
WO2018089570A1 (en) * 2016-11-13 2018-05-17 Iono Pharma, Llc Pharmaceutical formulation for sublingual or buccal delivery of epinephrine

Family Cites Families (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5429824A (en) 1992-12-15 1995-07-04 Eastman Kodak Company Use of tyloxapole as a nanoparticle stabilizer and dispersant
US5587143A (en) 1994-06-28 1996-12-24 Nanosystems L.L.C. Butylene oxide-ethylene oxide block copolymer surfactants as stabilizer coatings for nanoparticle compositions
US5569448A (en) 1995-01-24 1996-10-29 Nano Systems L.L.C. Sulfated nonionic block copolymer surfactants as stabilizer coatings for nanoparticle compositions
US5622938A (en) 1995-02-09 1997-04-22 Nano Systems L.L.C. Sugar base surfactant for nanocrystals
US5591456A (en) 1995-02-10 1997-01-07 Nanosystems L.L.C. Milled naproxen with hydroxypropyl cellulose as a dispersion stabilizer
US5580579A (en) 1995-02-15 1996-12-03 Nano Systems L.L.C. Site-specific adhesion within the GI tract using nanoparticles stabilized by high molecular weight, linear poly (ethylene oxide) polymers
US5565188A (en) 1995-02-24 1996-10-15 Nanosystems L.L.C. Polyalkylene block copolymers as surface modifiers for nanoparticles
US6153223A (en) 1998-06-05 2000-11-28 Watson Pharmaceuticals, Inc. Stabilized pharmaceutical compositions
US6428814B1 (en) 1999-10-08 2002-08-06 Elan Pharma International Ltd. Bioadhesive nanoparticulate compositions having cationic surface stabilizers
US7071186B2 (en) 1999-06-15 2006-07-04 Bristol-Myers Squibb Pharma Co. Substituted heterocycle fused gamma-carbolines
US6713471B1 (en) 1999-06-15 2004-03-30 Bristol-Myers Squibb Pharma Company Substituted heterocycle fused gamma-carbolines
ATE277048T1 (de) 1999-06-15 2004-10-15 Bristol Myers Squibb Pharma Co Substituierte hetercyclisch kondensierte gamma carboline
US20030051728A1 (en) * 2001-06-05 2003-03-20 Lloyd Peter M. Method and device for delivering a physiologically active compound
US8765167B2 (en) 2001-10-12 2014-07-01 Monosol Rx, Llc Uniform films for rapid-dissolve dosage form incorporating anti-tacking 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
EP1471887B1 (en) 2002-02-04 2010-04-21 Elan Pharma International Ltd. Nanoparticulate compositions having lysozyme as a surface stabilizer
KR20040098023A (ko) 2002-03-26 2004-11-18 테바 파마슈티컬 인더스트리즈 리미티드 약물 미세입자
US7607436B2 (en) 2002-05-06 2009-10-27 The Research Foundation Of State University Of New York Methods, devices and formulations for targeted endobronchial therapy
GB0505420D0 (en) 2005-03-16 2005-04-20 Isogenica Ltd Stable ligand selection method
US20080078382A1 (en) 2006-09-20 2008-04-03 Lemahieu Edward Methods and Systems of Delivering Medication Via Inhalation
KR102107954B1 (ko) 2007-03-12 2020-05-07 인트라-셀룰라 써래피스, 인코퍼레이티드. 치환된 헤테로환 융합 감마-카르볼린 합성
AU2009223701B2 (en) 2008-03-12 2015-04-16 Intra-Cellular Therapies, Inc. Substituted heterocycle fused gamma-carbolines solid
EP3085231A1 (en) 2008-05-27 2016-10-26 Intra-Cellular Therapies, Inc. Method and compositions for sleep disorders and other disorders
ES2929343T3 (es) 2008-06-13 2022-11-28 Mannkind Corp Inhalador de polvo seco accionado por aspiración para la administración de fármacos
CA2796756A1 (en) 2010-04-22 2011-10-27 Intra-Cellular Therapies, Inc. Substituted pyrido(3',4':4,5)pyrrolo(1,2,3-de)quinoxalines for the treatment of central nervous system disorders
KR20140146192A (ko) 2012-04-14 2014-12-24 인트라-셀룰라 써래피스, 인코퍼레이티드. 유기 화합물
EA201590019A1 (ru) * 2012-07-05 2015-09-30 Арвен Айлак Санайи Ве Тиджарет А.С. Ингаляторы сухого порошка, содержащие носитель, отличный от лактозы
US9708322B2 (en) 2013-03-15 2017-07-18 Intra-Cellular Therapies, Inc. Substituted pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalines for inhibiting serotonin reuptake transporter activity
KR102373288B1 (ko) 2013-12-03 2022-03-10 인트라-셀룰라 써래피스, 인코퍼레이티드. 신규한 방법
CA2944755A1 (en) 2014-04-04 2015-10-08 Intra-Cellular Therapies, Inc. Organic compounds
US10077267B2 (en) 2014-04-04 2018-09-18 Intra-Cellular Therapies, Inc. Organic compounds
WO2015191554A1 (en) 2014-06-09 2015-12-17 Intra-Cellular Therapies, Inc. Compounds and methods of use to treat schizophrenia
US12433850B2 (en) * 2016-05-05 2025-10-07 Aquestive Therapeutics, Inc. Enhanced delivery epinephrine and prodrug compositions
KR20220126286A (ko) 2019-11-01 2022-09-15 어퀘스티브 테라퓨틱스, 아이엔씨. 전구약물 조성물 및 치료 방법

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6655379B2 (en) * 1998-03-16 2003-12-02 Nektar Therapeutics Aerosolized active agent delivery
WO2003026631A1 (en) * 2001-05-24 2003-04-03 Alexza Molecular Delivery Corporation Delivery of drug esters through an inhalation route
WO2004002451A1 (fr) * 2002-06-28 2004-01-08 Fang Chen Suppositoire a liberation controlee utilise dans un canal secreteur de lait
US20040076588A1 (en) * 2002-06-28 2004-04-22 Batycky Richard P. Inhalable epinephrine
US20090017124A1 (en) * 2007-04-17 2009-01-15 Baxter International Inc. Nucleic Acid Microparticles for Pulmonary Delivery
WO2014062621A1 (en) * 2012-10-15 2014-04-24 Stc.Unm Treatment of autophagy-based disorders and related pharmaceutical compositions, diagnostic and screening assays and kits
WO2018089570A1 (en) * 2016-11-13 2018-05-17 Iono Pharma, Llc Pharmaceutical formulation for sublingual or buccal delivery of epinephrine

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DOLOVICH, M.B., ET AL.: "Aerosol drug delivery: developments in device design and clinical use", LANCET, vol. 377, JPN6026008626, 2011, pages 1032 - 1045, ISSN: 0005813043 *

Also Published As

Publication number Publication date
KR20230134136A (ko) 2023-09-20
EP4277611A1 (en) 2023-11-22
WO2022155544A1 (en) 2022-07-21
CN116940351A (zh) 2023-10-24
US20220233471A1 (en) 2022-07-28
CA3208345A1 (en) 2022-07-21

Similar Documents

Publication Publication Date Title
JP7637616B2 (ja) 厳密な活性剤溶解プロファイルを有する口腔用フィルム組成物及び剤形
US12310922B2 (en) System and method for making personalized individual unit doses containing pharmaceutical actives
JP2026048683A (ja) プロドラッグ組成物及び治療方法
JP2023539685A (ja) チュアブル製剤
JP2023502069A (ja) マルチモーダルな組成物及び治療方法
JP2024505429A (ja) プロドラッグ組成物及び治療の方法
US20220347117A1 (en) Dosage forms having equivalent biocomparable profiles
US12465564B2 (en) Oral and nasal compositions and methods of treatment

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250114

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20250114

RD13 Notification of appointment of power of sub attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7433

Effective date: 20250828

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20260310