AU2018389797B2 - Packaged modified release gamma-hydroxybutyrate formulations having improved stability - Google Patents

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

Info

Publication number
AU2018389797B2
AU2018389797B2 AU2018389797A AU2018389797A AU2018389797B2 AU 2018389797 B2 AU2018389797 B2 AU 2018389797B2 AU 2018389797 A AU2018389797 A AU 2018389797A AU 2018389797 A AU2018389797 A AU 2018389797A AU 2018389797 B2 AU2018389797 B2 AU 2018389797B2
Authority
AU
Australia
Prior art keywords
gamma
hydroxybutyrate
pharmaceutical composition
months
dissolution
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
AU2018389797A
Other languages
English (en)
Other versions
AU2018389797A1 (en
Inventor
Hervé 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
Publication of AU2018389797A1 publication Critical patent/AU2018389797A1/en
Application granted granted Critical
Publication of AU2018389797B2 publication Critical patent/AU2018389797B2/en
Priority to AU2024205227A priority Critical patent/AU2024205227B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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)
AU2018389797A 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability Active AU2018389797B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024205227A AU2024205227B2 (en) 2017-12-20 2024-07-30 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
AU2024205227A Division AU2024205227B2 (en) 2017-12-20 2024-07-30 Packaged modified release gamma-hydroxybutyrate formulations having improved stability

Publications (2)

Publication Number Publication Date
AU2018389797A1 AU2018389797A1 (en) 2020-06-11
AU2018389797B2 true AU2018389797B2 (en) 2024-05-02

Family

ID=65269000

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2018389797A Active AU2018389797B2 (en) 2017-12-20 2018-12-18 Packaged modified release gamma-hydroxybutyrate formulations having improved stability
AU2024205227A Active AU2024205227B2 (en) 2017-12-20 2024-07-30 Packaged modified release gamma-hydroxybutyrate formulations having improved stability

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024205227A Active AU2024205227B2 (en) 2017-12-20 2024-07-30 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

Citations (3)

* 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
US20060210630A1 (en) * 2004-09-30 2006-09-21 Likan Liang Controlled release compositions of gamma-hydroxybutyrate
US20120076865A1 (en) * 2010-03-24 2012-03-29 Jazz Pharmaceuticals, Inc. Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004093883A2 (en) 2003-04-23 2004-11-04 Ferring B.V. Sachet for a pharmaceutical composition
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
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

Patent Citations (3)

* 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
US20060210630A1 (en) * 2004-09-30 2006-09-21 Likan Liang Controlled release compositions of gamma-hydroxybutyrate
US20120076865A1 (en) * 2010-03-24 2012-03-29 Jazz Pharmaceuticals, Inc. Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances

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
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

Similar Documents

Publication Publication Date Title
CA3084120C (en) Packaged modified release gamma-hydroxybutyrate formulations having improved stability
US12097175B2 (en) Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
BR112021013766A2 (pt) Composições de gama-hidroxibutirato com farmacocinética melhorada no estado alimentado
AU2010308016A1 (en) Anti-misuse solid oral dosage form provided having a modified specific release profile
EP2726064B1 (en) Controlled release oral dosage form comprising oxycodone
CA2977168C (en) Enteric-coated pellets containing a proton pump inhibitor
CA3173256A1 (en) Methods of administering gamma-hydroxybutyrate compositions with divalproex sodium
AU702934B2 (en) Modified release oral pharmaceutical composition containing 5-asa and method for the treatment of bowel diseases
US20240216283A1 (en) Gamma-hydroxybutyrate formulations having improved stability after storage
BR112019000848B1 (pt) Formulações de gama-hidroxibutirato únicas noturnas

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)