JP7349428B2 - 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤 - Google Patents

改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤 Download PDF

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JP7349428B2
JP7349428B2 JP2020529210A JP2020529210A JP7349428B2 JP 7349428 B2 JP7349428 B2 JP 7349428B2 JP 2020529210 A JP2020529210 A JP 2020529210A JP 2020529210 A JP2020529210 A JP 2020529210A JP 7349428 B2 JP7349428 B2 JP 7349428B2
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gamma
hydroxybutyrate
pharmaceutical composition
acid
formulation
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JP2021506752A (ja
JP2021506752A5 (enExample
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エルヴェ ギヤール，
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フラメル アイルランド リミテッド
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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/36—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
JP2020529210A 2017-12-20 2018-12-18 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤 Active JP7349428B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2023008736A JP7603091B2 (ja) 2017-12-20 2023-01-24 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤
JP2023119142A JP2023126652A (ja) 2017-12-20 2023-07-21 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762607937P 2017-12-20 2017-12-20
US62/607,937 2017-12-20
US201862618832P 2018-01-18 2018-01-18
US62/618,832 2018-01-18
PCT/IB2018/060278 WO2019123269A1 (en) 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability

Related Child Applications (2)

Application Number Title Priority Date Filing Date
JP2023008736A Division JP7603091B2 (ja) 2017-12-20 2023-01-24 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤
JP2023119142A Division JP2023126652A (ja) 2017-12-20 2023-07-21 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤

Publications (3)

Publication Number Publication Date
JP2021506752A JP2021506752A (ja) 2021-02-22
JP2021506752A5 JP2021506752A5 (enExample) 2022-01-06
JP7349428B2 true JP7349428B2 (ja) 2023-09-22

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Application Number Title Priority Date Filing Date
JP2020529210A Active JP7349428B2 (ja) 2017-12-20 2018-12-18 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤
JP2023008736A Active JP7603091B2 (ja) 2017-12-20 2023-01-24 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤
JP2023119142A Pending JP2023126652A (ja) 2017-12-20 2023-07-21 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤

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JP2023008736A Active JP7603091B2 (ja) 2017-12-20 2023-01-24 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤
JP2023119142A Pending JP2023126652A (ja) 2017-12-20 2023-07-21 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤

Country Status (8)

Country Link
US (3) US20190183806A1 (enExample)
EP (1) EP3727348A1 (enExample)
JP (3) JP7349428B2 (enExample)
CN (1) CN111511355A (enExample)
AU (2) AU2018389797B2 (enExample)
BR (1) BR112020012417A2 (enExample)
CA (2) CA3084120C (enExample)
WO (1) WO2019123269A1 (enExample)

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MX391660B (es) 2010-03-24 2025-03-21 Jazz Pharmaceuticals Inc Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas
US10398662B1 (en) 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
UY37341A (es) 2016-07-22 2017-11-30 Flamel Ireland Ltd Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11000498B2 (en) 2016-07-22 2021-05-11 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US20180263936A1 (en) 2017-03-17 2018-09-20 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
BR112021006027A2 (pt) 2018-11-19 2021-06-29 Jazz Pharmaceuticals Ireland Limited formulações de fármaco resistente a álcool
BR112021013766A2 (pt) 2019-03-01 2021-09-21 Flamel Ireland Limited Composições de gama-hidroxibutirato com farmacocinética melhorada no estado alimentado
WO2021127461A1 (en) 2019-12-20 2021-06-24 Xw Laboratories Limited Methods of synthesizing 4-valyloxybutyric acid
TW202139986A (zh) 2020-02-21 2021-11-01 愛爾蘭商爵士製藥愛爾蘭有限責任公司 治療原發性嗜睡症之方法
KR102982616B1 (ko) 2020-06-18 2026-06-26 엑스더블유파마 리미티드 수용성 원료의약품의 약학적 과립화제
AU2021292406B2 (en) * 2020-06-18 2024-03-14 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
WO2022020621A1 (en) 2020-07-24 2022-01-27 XWPharma Ltd. Pharmaceutical compositions and pharmacokinetics of a gamma-hydroxybutyric acid derivative
AU2021357705B2 (en) 2020-10-05 2024-09-26 XWPharma Ltd. Modified release compositions of a gamma-hydroxybutyric acid derivative
US12582622B2 (en) 2020-10-08 2026-03-24 Jazz Pharmaceuticals Ireland Limited Sodium oxybate to treat idiopathic hypersomnia
DK4308086T3 (da) 2021-03-19 2025-11-17 Xwpharma Ltd Farmakokinetik af formuleringer med kombineret frigivelse af et gamma-hydroxysmørsyrederivat
CN117157060A (zh) 2021-04-16 2023-12-01 南京纽邦生物科技有限公司 包衣β-羟基丁酸晶体及其制备方法
EP4415701A1 (en) * 2021-10-11 2024-08-21 Jazz Pharmaceuticals Ireland Limited Method of administering oxybate
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
CN122075721A (zh) * 2022-12-07 2026-05-26 南京纽邦生物科技有限公司 一种β-羟基丁酸或其盐的缓释制剂

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US20060210630A1 (en) 2004-09-30 2006-09-21 Likan Liang Controlled release compositions of gamma-hydroxybutyrate
JP2006524207A (ja) 2003-04-23 2006-10-26 フェリング ベスローテン フェンノートシャップ 薬効を有する医薬の含有割合が高いメサラジンサッシェ
JP2012507532A (ja) 2008-11-04 2012-03-29 ジャズ ファーマスーティカルス インコーポレイテッド ナトリウムオキシベートの即時放出投薬形態
JP2012508784A (ja) 2008-11-14 2012-04-12 デブルジャ・ゼ・タソシエ・ファルマ γ−ヒドロキシ酪酸に基づく新規の組成物
JP2013522373A (ja) 2010-03-24 2013-06-13 ジャズ、ファーマシューティカルズ、インコーポレイテッド 高用量、水溶性及び吸湿性薬剤基質用の制御放出性剤形
JP2014505094A (ja) 2011-02-11 2014-02-27 デブルジャ エ アソシエ ファルマ γ−ヒドロキシ酪酸の発泡性顆粒
JP6683886B2 (ja) 2016-07-22 2020-04-22 フラメル アイルランド リミテッド 薬物動態が改善された放出調節ガンマ−ヒドロキシ酪酸塩製剤

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FR2891459B1 (fr) * 2005-09-30 2007-12-28 Flamel Technologies Sa Microparticules a liberation modifiee d'au moins un principe actif et forme galenique orale en comprenant
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ITMI20111718A1 (it) * 2011-09-23 2013-03-24 Probiotical Spa Un materiale impermeabile alla umidita e allo ossigeno per confezionare prodotti dietetici, cosmetici e specialita medicinali.

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JP2006524207A (ja) 2003-04-23 2006-10-26 フェリング ベスローテン フェンノートシャップ 薬効を有する医薬の含有割合が高いメサラジンサッシェ
US20060210630A1 (en) 2004-09-30 2006-09-21 Likan Liang Controlled release compositions of gamma-hydroxybutyrate
JP2012507532A (ja) 2008-11-04 2012-03-29 ジャズ ファーマスーティカルス インコーポレイテッド ナトリウムオキシベートの即時放出投薬形態
JP2012508784A (ja) 2008-11-14 2012-04-12 デブルジャ・ゼ・タソシエ・ファルマ γ−ヒドロキシ酪酸に基づく新規の組成物
JP2013522373A (ja) 2010-03-24 2013-06-13 ジャズ、ファーマシューティカルズ、インコーポレイテッド 高用量、水溶性及び吸湿性薬剤基質用の制御放出性剤形
JP2014505094A (ja) 2011-02-11 2014-02-27 デブルジャ エ アソシエ ファルマ γ−ヒドロキシ酪酸の発泡性顆粒
JP6683886B2 (ja) 2016-07-22 2020-04-22 フラメル アイルランド リミテッド 薬物動態が改善された放出調節ガンマ−ヒドロキシ酪酸塩製剤

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Publication number Publication date
AU2024205227B2 (en) 2026-07-30
JP2023126652A (ja) 2023-09-07
JP7603091B2 (ja) 2024-12-19
US20210137843A1 (en) 2021-05-13
AU2018389797A1 (en) 2020-06-11
US20200360293A1 (en) 2020-11-19
AU2024205227A1 (en) 2024-08-15
CA3200357A1 (en) 2019-06-27
JP2023038309A (ja) 2023-03-16
WO2019123269A1 (en) 2019-06-27
EP3727348A1 (en) 2020-10-28
AU2018389797B2 (en) 2024-05-02
CA3084120C (en) 2023-09-05
CN111511355A (zh) 2020-08-07
US20190183806A1 (en) 2019-06-20
JP2021506752A (ja) 2021-02-22
CA3084120A1 (en) 2019-06-27
BR112020012417A2 (pt) 2020-11-24

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