AU2009315441B2 - Novel composition based on gamma-hydroxybutyric acid - Google Patents

Novel composition based on gamma-hydroxybutyric acid Download PDF

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Publication number
AU2009315441B2
AU2009315441B2 AU2009315441A AU2009315441A AU2009315441B2 AU 2009315441 B2 AU2009315441 B2 AU 2009315441B2 AU 2009315441 A AU2009315441 A AU 2009315441A AU 2009315441 A AU2009315441 A AU 2009315441A AU 2009315441 B2 AU2009315441 B2 AU 2009315441B2
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AU
Australia
Prior art keywords
granulate
gamma
hydroxybutyric acid
granulates
salts
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.)
Ceased
Application number
AU2009315441A
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English (en)
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AU2009315441A1 (en
Inventor
Christophe Lebon
Pascal Suplie
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.)
Debregeas Et Associes Pharma SAS
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Debregeas Et Associes Pharma SAS
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Application filed by Debregeas Et Associes Pharma SAS filed Critical Debregeas Et Associes Pharma SAS
Publication of AU2009315441A1 publication Critical patent/AU2009315441A1/en
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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • 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
    • 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
    • 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
    • A61K9/5078—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 with drug-free core
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2009315441A 2008-11-14 2009-11-10 Novel composition based on gamma-hydroxybutyric acid Ceased AU2009315441B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0857763 2008-11-14
FR0857763A FR2938431B1 (fr) 2008-11-14 2008-11-14 Nouvelle composition a base d'acide gamma-hydroxybutyrique
PCT/FR2009/052169 WO2010055260A1 (fr) 2008-11-14 2009-11-10 Nouvelle composition à base d'acide gamma-hydroxybutyrique

Publications (2)

Publication Number Publication Date
AU2009315441A1 AU2009315441A1 (en) 2010-05-20
AU2009315441B2 true AU2009315441B2 (en) 2015-02-26

Family

ID=40674006

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2009315441A Ceased AU2009315441B2 (en) 2008-11-14 2009-11-10 Novel composition based on gamma-hydroxybutyric acid

Country Status (34)

Country Link
US (1) US8529954B2 (enExample)
EP (1) EP2349217B1 (enExample)
JP (1) JP2012508784A (enExample)
KR (1) KR101563390B1 (enExample)
CN (2) CN104688691A (enExample)
AR (1) AR074351A1 (enExample)
AU (1) AU2009315441B2 (enExample)
BR (1) BRPI0916021B8 (enExample)
CA (1) CA2743767C (enExample)
CL (1) CL2011001114A1 (enExample)
CO (1) CO6382106A2 (enExample)
CU (1) CU20110109A7 (enExample)
CY (1) CY1122209T1 (enExample)
DK (1) DK2349217T3 (enExample)
EA (1) EA023305B1 (enExample)
ES (1) ES2749803T3 (enExample)
FR (1) FR2938431B1 (enExample)
HR (1) HRP20191911T1 (enExample)
HU (1) HUE046321T2 (enExample)
IL (1) IL212847A (enExample)
LT (1) LT2349217T (enExample)
MA (1) MA32790B1 (enExample)
MX (1) MX2011005073A (enExample)
NZ (1) NZ592850A (enExample)
PE (1) PE20120028A1 (enExample)
PL (1) PL2349217T3 (enExample)
PT (1) PT2349217T (enExample)
SI (1) SI2349217T1 (enExample)
SM (1) SMT201900721T1 (enExample)
TN (1) TN2011000231A1 (enExample)
TW (1) TWI446906B (enExample)
UA (1) UA103057C2 (enExample)
WO (1) WO2010055260A1 (enExample)
ZA (1) ZA201103542B (enExample)

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US12478604B1 (en) 2016-07-22 2025-11-25 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
US11000498B2 (en) 2016-07-22 2021-05-11 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 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
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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EP3727348A1 (en) * 2017-12-20 2020-10-28 Flamel Ireland Limited Packaged modified release gamma-hydroxybutyrate formulations having improved stability
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AU2020231916B2 (en) * 2019-03-01 2025-08-28 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
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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
AU2021292406B2 (en) * 2020-06-18 2024-03-14 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
AU2021293941B2 (en) * 2020-06-18 2024-03-28 XWPharma Ltd. Pharmaceutical granulations of water-soluble active pharmaceutical ingredients
CN116261451A (zh) 2020-07-24 2023-06-13 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的药物组合物和药物动力学
CN115666527B (zh) 2020-10-05 2025-03-07 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的修饰释放组合物
CN112868909A (zh) * 2021-01-22 2021-06-01 湖北神舟化工有限公司 一种无臭型丁酸钠及其生产方法
TW202300139A (zh) 2021-03-19 2023-01-01 凱瑞康寧生技股份有限公司 γ-羟基丁酸衍生物的聯合釋放製劑的藥代動力學
WO2022218364A1 (en) * 2021-04-16 2022-10-20 Nanjing Nutrabuilding Bio-Tech Co., Ltd. Coated beta hydroxybutyric acid crystal and methods for producing the same
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
CN117413958A (zh) * 2023-12-04 2024-01-19 湖北中烟工业有限责任公司 一种加热不燃烧烟草制品发烟段物料及其制作工艺和加热不燃烧烟草制品

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WO1993000083A1 (en) * 1991-06-28 1993-01-07 Gaetano Crepaldi Pharmaceutical composition containing gamma-hydroxybutyric acid or its lactone in the treatment of drug dependence and nutritional disorders
EP0635265A1 (en) * 1993-07-22 1995-01-25 LABORATORIO FARMACEUTICO C.T. S.r.l. Controlled release pharmaceutical compositions based on one or more pharmaceutically acceptable salts of gamma hydroxy-butyric acid
US20060210630A1 (en) * 2004-09-30 2006-09-21 Likan Liang Controlled release compositions of gamma-hydroxybutyrate
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Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0344704A1 (en) * 1988-06-03 1989-12-06 LABORATORIO FARMACEUTICO C.T. S.r.l. Use of gamma-hydroxybutyric acid salts for preparing pharmaceutical compositions for use in the treatment of alcoholism, and the compositions obtained
WO1993000083A1 (en) * 1991-06-28 1993-01-07 Gaetano Crepaldi Pharmaceutical composition containing gamma-hydroxybutyric acid or its lactone in the treatment of drug dependence and nutritional disorders
EP0635265A1 (en) * 1993-07-22 1995-01-25 LABORATORIO FARMACEUTICO C.T. S.r.l. Controlled release pharmaceutical compositions based on one or more pharmaceutically acceptable salts of gamma hydroxy-butyric acid
US20070270491A1 (en) * 1998-12-23 2007-11-22 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

Also Published As

Publication number Publication date
NZ592850A (en) 2012-11-30
IL212847A0 (en) 2011-07-31
BRPI0916021B8 (pt) 2021-05-25
AR074351A1 (es) 2011-01-12
PL2349217T3 (pl) 2020-03-31
DK2349217T3 (da) 2019-11-04
KR101563390B1 (ko) 2015-11-06
MA32790B1 (fr) 2011-11-01
SI2349217T1 (sl) 2020-01-31
CY1122209T1 (el) 2020-11-25
CL2011001114A1 (es) 2011-09-02
MX2011005073A (es) 2011-10-12
TWI446906B (zh) 2014-08-01
SMT201900721T1 (it) 2020-01-14
AU2009315441A1 (en) 2010-05-20
EP2349217B1 (fr) 2019-07-31
EA201100758A1 (ru) 2011-12-30
TW201031401A (en) 2010-09-01
CO6382106A2 (es) 2012-02-15
HRP20191911T1 (hr) 2020-01-10
BRPI0916021B1 (pt) 2020-01-14
HUE046321T2 (hu) 2020-02-28
FR2938431B1 (fr) 2013-12-20
PE20120028A1 (es) 2012-02-25
EP2349217A1 (fr) 2011-08-03
WO2010055260A1 (fr) 2010-05-20
BRPI0916021A2 (pt) 2015-11-10
US8529954B2 (en) 2013-09-10
IL212847A (en) 2015-02-26
ZA201103542B (en) 2012-01-25
UA103057C2 (ru) 2013-09-10
CA2743767C (fr) 2019-06-25
TN2011000231A1 (fr) 2012-12-17
PT2349217T (pt) 2019-11-04
FR2938431A1 (fr) 2010-05-21
CA2743767A1 (fr) 2010-05-20
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CN104688691A (zh) 2015-06-10
EA023305B1 (ru) 2016-05-31
ES2749803T3 (es) 2020-03-23
CN102215822A (zh) 2011-10-12
JP2012508784A (ja) 2012-04-12
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US20110293729A1 (en) 2011-12-01

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