CA3084120C - Packaged modified release gamma-hydroxybutyrate formulations having improved stability - Google Patents

Packaged modified release gamma-hydroxybutyrate formulations having improved stability Download PDF

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Publication number
CA3084120C
CA3084120C CA3084120A CA3084120A CA3084120C CA 3084120 C CA3084120 C CA 3084120C CA 3084120 A CA3084120 A CA 3084120A CA 3084120 A CA3084120 A CA 3084120A CA 3084120 C CA3084120 C CA 3084120C
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CA
Canada
Prior art keywords
gamma
hydroxybutyrate
pharmaceutical composition
dissolution
formulation
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.)
Active
Application number
CA3084120A
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English (en)
French (fr)
Other versions
CA3084120A1 (en
Inventor
Herve Guillard
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.)
Flamel Ireland Ltd
Original Assignee
Flamel Ireland Ltd
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 Flamel Ireland Ltd filed Critical Flamel Ireland Ltd
Priority to CA3200357A priority Critical patent/CA3200357A1/en
Publication of CA3084120A1 publication Critical patent/CA3084120A1/en
Application granted granted Critical
Publication of CA3084120C publication Critical patent/CA3084120C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/48—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

Landscapes

  • 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)
CA3084120A 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability Active CA3084120C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3200357A CA3200357A1 (en) 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability

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 (1)

Application Number Title Priority Date Filing Date
CA3200357A Division CA3200357A1 (en) 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability

Publications (2)

Publication Number Publication Date
CA3084120A1 CA3084120A1 (en) 2019-06-27
CA3084120C true CA3084120C (en) 2023-09-05

Family

ID=65269000

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3084120A Active CA3084120C (en) 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability
CA3200357A Pending CA3200357A1 (en) 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3200357A Pending CA3200357A1 (en) 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability

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)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1316309A1 (en) * 1998-12-23 2003-06-04 Orphan Medical Inc. Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
WO2004093883A2 (en) 2003-04-23 2004-11-04 Ferring B.V. Sachet for a pharmaceutical composition
US8193211B2 (en) * 2004-09-30 2012-06-05 Supernus Pharmaceuticals, Inc. Controlled release compositions of gamma-hydroxybutyrate
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
US8771735B2 (en) 2008-11-04 2014-07-08 Jazz Pharmaceuticals, Inc. Immediate release dosage forms of sodium oxybate
FR2938431B1 (fr) 2008-11-14 2013-12-20 Debregeas Et Associes Pharma Nouvelle composition a base d'acide gamma-hydroxybutyrique
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
EP2566462B1 (en) * 2010-05-04 2020-07-08 Jazz Pharmaceuticals Inc. Immediate release formulations and dosage forms of gamma-hydroxybutyrate
FR2971422B1 (fr) 2011-02-11 2016-05-20 Debregeas Et Associes Pharma Granules d'acide gamma-hydroxybutyrique
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.
UY37341A (es) 2016-07-22 2017-11-30 Flamel Ireland Ltd Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada

Also Published As

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
JP7349428B2 (ja) 2023-09-22
AU2018389797B2 (en) 2024-05-02
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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