DK2672961T3 - Brusende gamma-hydroxybutansyre-granulat - Google Patents

Brusende gamma-hydroxybutansyre-granulat Download PDF

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Publication number
DK2672961T3
DK2672961T3 DK12708564.5T DK12708564T DK2672961T3 DK 2672961 T3 DK2672961 T3 DK 2672961T3 DK 12708564 T DK12708564 T DK 12708564T DK 2672961 T3 DK2672961 T3 DK 2672961T3
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Denmark
Prior art keywords
granules
granule
active ingredient
gamma
absorption
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DK12708564.5T
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English (en)
Inventor
Pascal Suplie
Sylvie Lecoustey
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Debregeas Et Associes Pharma
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Publication of DK2672961T3 publication Critical patent/DK2672961T3/da

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    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007Effervescent
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/501Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/26Psychostimulants, e.g. nicotine, cocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Psychiatry (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Addiction (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (11)

1. Granulat der omfatter en fast kerne, på hvilken en aktiv ingrediens bæres, hvilken aktive bestanddel er valgt blandt gamma-hydroxybutansyre eller et af dens farmaceutisk acceptable salte, hvilket granulat er kendetegnet ved, at det består af: - 15-25 % fast kerne, - 50-60 % aktiv bestanddel; - 5-15 % natriumbicarbonat, gasgenerator - 2-18 % magnesiumaluminometasilikat, fortyndingsmiddel - 3-10 % shellak, bindemiddel - 3-6 % overtrækningsmembran.
2. Granulatet ifølge krav 1, kendetegnet ved, at den faste kerne er valgt fra gruppen, som består af polyoler, gummier, siliciumderivater, calcium- eller kaliumderivater, mineralske forbindelser, såsom dicalciumphosphater, tricalci-umphosphater og calciumcarbonater, saccharose, cellulosederivater, især mi-krokrystallinsk cellulose, ethylcellulose og hydroxypropylmethylcellulose, stivelse og blandinger deraf.
3. Granulat ifølge et hvilket som helst af kravene 1 eller 2, kendetegnet ved, at membranen er sammensat af overtræknings-excipienser til øjeblikkelig frigivelse.
4. Granulat ifølge et hvilket som helst af kravene 1 eller 2, kendetegnet ved, at membranen er sammensat af overtræknings-excipienser til vedvarende frigivelse.
5. Granulat ifølge et hvilket som helst af kravene 1 til 4, kendetegnet ved, at det endvidere omfatter et farvestof.
6. Granulat ifølge et hvilket som helst af kravene 1 til 5, kendetegnet ved, at det endvidere omfatter et sødemiddel.
7. Granulat ifølge et hvilket som helst af kravene 1 til 6, kendetegnet ved, at det endvidere omfatter et smagsstof.
8. Farmaceutisk sammensætning, der omfatter en blanding af granuler ifølge et hvilket som helst af kravene 1 til 7, hvilken blanding består af to grupper af granuler (A) og (B), hvilke granuler (A) og granuler (B) omfatter forskellige frigivelseskinetikker af aktiv bestanddel.
9. Granulat ifølge et hvilket som helst af kravene 1 til 7 til anvendelse ved behandling af patologier, der kræver mindst meget hurtig in v/vo-tilgængelighed af GHB.
10. Granulat ifølge et hvilket som helst af kravene 1 til 7 til anvendelse ved behandlingen ifølge krav 9, kendetegnet ved, at patologien er narkolepsi.
11. Granulat ifølge et hvilket som helst af kravene 1 til 7 til anvendelse ved behandlingen ifølge krav 9, kendetegnet ved, at patologien er tilbagetrækning af alkohol.
DK12708564.5T 2011-02-11 2012-02-03 Brusende gamma-hydroxybutansyre-granulat DK2672961T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1100433A FR2971422B1 (fr) 2011-02-11 2011-02-11 Granules d'acide gamma-hydroxybutyrique
PCT/FR2012/000046 WO2012107652A1 (fr) 2011-02-11 2012-02-03 Granules effervescents d'acide gamma - hydroxybutyrique

Publications (1)

Publication Number Publication Date
DK2672961T3 true DK2672961T3 (da) 2018-09-17

Family

ID=45819229

Family Applications (1)

Application Number Title Priority Date Filing Date
DK12708564.5T DK2672961T3 (da) 2011-02-11 2012-02-03 Brusende gamma-hydroxybutansyre-granulat

Country Status (30)

Country Link
US (2) US9943488B2 (da)
EP (1) EP2672961B1 (da)
JP (1) JP5869004B2 (da)
KR (1) KR101799620B1 (da)
CN (1) CN103347503B (da)
AR (1) AR085360A1 (da)
AU (1) AU2012215252C1 (da)
BR (1) BR112013020412B1 (da)
CA (1) CA2825053C (da)
CL (1) CL2013002243A1 (da)
CY (1) CY1120655T1 (da)
DK (1) DK2672961T3 (da)
EA (1) EA026403B1 (da)
ES (1) ES2680638T3 (da)
FR (1) FR2971422B1 (da)
HK (1) HK1185007A1 (da)
HR (1) HRP20181338T1 (da)
HU (1) HUE039484T2 (da)
IL (1) IL227631A (da)
LT (1) LT2672961T (da)
MA (1) MA34886B1 (da)
MX (1) MX362613B (da)
PL (1) PL2672961T3 (da)
PT (1) PT2672961T (da)
RS (1) RS57615B1 (da)
SI (1) SI2672961T1 (da)
TR (1) TR201811120T4 (da)
TW (1) TWI533865B (da)
UA (1) UA113506C2 (da)
WO (1) WO2012107652A1 (da)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011232408B2 (en) 2010-03-24 2015-07-30 Jazz Pharmaceuticals, Inc. Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances
US10398662B1 (en) 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
FR3049463B1 (fr) 2016-04-01 2019-07-05 Debregeas Et Associes Pharma Doses unitaires a liberation immediate de ghb ou de l'un de ses sels therapeutiquement acceptables administrees par voie orale et leur utilisation pour maintenir l'abstinence alcoolique
US11986451B1 (en) 2016-07-22 2024-05-21 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
US11602512B1 (en) 2016-07-22 2023-03-14 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
US11000498B2 (en) 2016-07-22 2021-05-11 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
US20180263936A1 (en) 2017-03-17 2018-09-20 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
RU2663466C1 (ru) * 2017-03-20 2018-08-06 Общество с ограниченной ответственностью "МБА-групп" Композиция для профилактики и/или лечения вич-инфекции
EA202091127A1 (ru) * 2017-11-02 2020-09-22 Замбон С.П.А. Фармацевтические композиции, включающие сафинамид
US11337920B2 (en) 2017-12-18 2022-05-24 Tris Pharma, Inc. Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release
WO2019126215A1 (en) * 2017-12-18 2019-06-27 Tris Pharma, Inc. Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
WO2019126218A1 (en) 2017-12-18 2019-06-27 Tris Pharma, Inc. Modified release drug powder composition comprising gastro-retentive raft forming systems having trigger pulse drug release
AU2018389797B2 (en) * 2017-12-20 2024-05-02 Flamel Ireland Limited Packaged modified release gamma-hydroxybutyrate formulations having improved stability
CA3115122A1 (en) 2018-11-19 2020-05-28 Jazz Pharmaceuticals Ireland Limited Alcohol-resistant drug formulations
AU2020231916A1 (en) * 2019-03-01 2021-08-05 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
JP2023537192A (ja) 2020-06-18 2023-08-31 エックスダブリューファーマ リミテッド 水溶性医薬品有効成分の医薬造粒物
US11896573B2 (en) 2020-07-24 2024-02-13 XWPharma Ltd. Pharmaceutical compositions and pharmacokinetics of a gamma-hydroxybutyric acid derivative
WO2022076466A1 (en) * 2020-10-05 2022-04-14 XWPharma Ltd. Modified release compositions of a gamma-hydroxybutyric acid derivative
US11510892B2 (en) 2021-03-19 2022-11-29 XWPharma Ltd. Pharmacokinetics of combined release formulations of a γ-hydroxybutyric acid derivative
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
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

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IT1266565B1 (it) 1993-07-22 1997-01-09 Ct Lab Farm Srl Composizioni farmaceutiche a rilascio controllato a base di uno o piu' sali farmaceuticamente accettabili dell'acido gamma-idrossi-butirrico.
ITMI20011446A1 (it) * 2001-07-06 2003-01-06 Altergon Sa Composizioni farmaceutiche di principi attivi suscettibili di somministrazione illecita
US8193211B2 (en) * 2004-09-30 2012-06-05 Supernus Pharmaceuticals, Inc. Controlled release compositions of gamma-hydroxybutyrate
FR2938431B1 (fr) * 2008-11-14 2013-12-20 Debregeas Et Associes Pharma Nouvelle composition a base d'acide gamma-hydroxybutyrique
FR2938432B1 (fr) * 2008-11-14 2011-05-20 Debregeas Et Associes Pharma Nouveau procede de preparation de granules de principes actifs, et granules tels qu'obtenus
FR2949062B1 (fr) * 2009-08-12 2011-09-02 Debregeas Et Associes Pharma Nouvelles formulations pharmaceutiques contre le mesusage des medicaments

Also Published As

Publication number Publication date
AU2012215252B2 (en) 2017-01-19
US9943488B2 (en) 2018-04-17
SI2672961T1 (sl) 2018-10-30
US20140004202A1 (en) 2014-01-02
HUE039484T2 (hu) 2019-01-28
BR112013020412B1 (pt) 2021-12-07
BR112013020412A2 (pt) 2016-10-25
ES2680638T3 (es) 2018-09-10
FR2971422B1 (fr) 2016-05-20
MX2013008299A (es) 2013-12-16
CA2825053A1 (fr) 2012-08-16
KR101799620B1 (ko) 2017-11-20
HRP20181338T1 (hr) 2018-10-19
HK1185007A1 (zh) 2014-02-07
LT2672961T (lt) 2018-09-10
MA34886B1 (fr) 2014-02-01
EA026403B1 (ru) 2017-04-28
IL227631A0 (en) 2013-09-30
RS57615B1 (sr) 2018-11-30
AU2012215252A1 (en) 2013-08-15
CA2825053C (fr) 2019-04-02
JP2014505094A (ja) 2014-02-27
PT2672961T (pt) 2018-10-19
CN103347503B (zh) 2016-06-01
AR085360A1 (es) 2013-09-25
TW201309285A (zh) 2013-03-01
NZ613206A (en) 2015-07-31
TR201811120T4 (tr) 2018-08-27
UA113506C2 (uk) 2017-02-10
CL2013002243A1 (es) 2014-01-31
FR2971422A1 (fr) 2012-08-17
JP5869004B2 (ja) 2016-02-24
MX362613B (es) 2019-01-28
IL227631A (en) 2017-08-31
AU2012215252C1 (en) 2017-05-25
PL2672961T3 (pl) 2018-11-30
CN103347503A (zh) 2013-10-09
TWI533865B (zh) 2016-05-21
WO2012107652A1 (fr) 2012-08-16
US20180193277A1 (en) 2018-07-12
CY1120655T1 (el) 2019-12-11
EP2672961B1 (fr) 2018-06-06
EA201300902A1 (ru) 2014-01-30
KR20140051118A (ko) 2014-04-30
EP2672961A1 (fr) 2013-12-18

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