BRPI0916021A2 - "granulado de ácido gama-hidroxibutírico, composição farmacêutica e processo de preparação de um granulado" - Google Patents

"granulado de ácido gama-hidroxibutírico, composição farmacêutica e processo de preparação de um granulado"

Info

Publication number
BRPI0916021A2
BRPI0916021A2 BRPI0916021A BRPI0916021A BRPI0916021A2 BR PI0916021 A2 BRPI0916021 A2 BR PI0916021A2 BR PI0916021 A BRPI0916021 A BR PI0916021A BR PI0916021 A BRPI0916021 A BR PI0916021A BR PI0916021 A2 BRPI0916021 A2 BR PI0916021A2
Authority
BR
Brazil
Prior art keywords
granulate
gamma
preparing
pharmaceutical composition
hydroxybutyric acid
Prior art date
Application number
BRPI0916021A
Other languages
English (en)
Inventor
Christophe Lebon
Pascal Suplie
Original Assignee
Debregeas Et Associes Pharma
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40674006&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0916021(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Debregeas Et Associes Pharma filed Critical Debregeas Et Associes Pharma
Publication of BRPI0916021A2 publication Critical patent/BRPI0916021A2/pt
Publication of BRPI0916021B1 publication Critical patent/BRPI0916021B1/pt
Publication of BRPI0916021B8 publication Critical patent/BRPI0916021B8/pt

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
    • A61K9/14—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

Landscapes

  • 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)
BRPI0916021A 2008-11-14 2009-11-10 grânulo de ácido gama-hidroxibutírico, composição farmacêutica e processo de preparação de um grânulo BRPI0916021B8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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 (3)

Publication Number Publication Date
BRPI0916021A2 true BRPI0916021A2 (pt) 2015-11-10
BRPI0916021B1 BRPI0916021B1 (pt) 2020-01-14
BRPI0916021B8 BRPI0916021B8 (pt) 2021-05-25

Family

ID=40674006

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0916021A BRPI0916021B8 (pt) 2008-11-14 2009-11-10 grânulo de ácido gama-hidroxibutírico, composição farmacêutica e processo de preparação de um grânulo

Country Status (33)

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

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FR2949062B1 (fr) 2009-08-12 2011-09-02 Debregeas Et Associes Pharma Nouvelles formulations pharmaceutiques contre le mesusage des medicaments
FR2949061B1 (fr) * 2009-08-12 2013-04-19 Debregeas Et Associes Pharma Microgranules flottants
AU2011232408B2 (en) 2010-03-24 2015-07-30 Jazz Pharmaceuticals, Inc. Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances
FR2971422B1 (fr) * 2011-02-11 2016-05-20 Debregeas Et Associes Pharma Granules d'acide gamma-hydroxybutyrique
US9050302B2 (en) * 2013-03-01 2015-06-09 Jazz Pharmaceuticals Ireland Limited Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
US10398662B1 (en) 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
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
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
CA3162919A1 (en) 2019-12-20 2021-06-24 XWPharma Ltd. Methods of synthesizing 4-valyloxybutyric acid
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
CN115038432B (zh) * 2020-06-18 2023-12-26 凯瑞康宁生物工程（武汉）有限公司 水溶性活性药物成分的控制释放制粒
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
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
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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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
FR2938431B1 (fr) 2013-12-20
TN2011000231A1 (fr) 2012-12-17
TWI446906B (zh) 2014-08-01
CA2743767C (fr) 2019-06-25
TW201031401A (en) 2010-09-01
AU2009315441A1 (en) 2010-05-20
LT2349217T (lt) 2019-11-11
AU2009315441B2 (en) 2015-02-26
ES2749803T3 (es) 2020-03-23
EA023305B1 (ru) 2016-05-31
PT2349217T (pt) 2019-11-04
KR20110099011A (ko) 2011-09-05
CN102215822A (zh) 2011-10-12
HRP20191911T1 (hr) 2020-01-10
IL212847A (en) 2015-02-26
CU20110109A7 (es) 2012-01-31
PE20120028A1 (es) 2012-02-25
WO2010055260A1 (fr) 2010-05-20
AR074351A1 (es) 2011-01-12
ZA201103542B (en) 2012-01-25
CL2011001114A1 (es) 2011-09-02
CO6382106A2 (es) 2012-02-15
PL2349217T3 (pl) 2020-03-31
HUE046321T2 (hu) 2020-02-28
KR101563390B1 (ko) 2015-11-06
UA103057C2 (ru) 2013-09-10
US20110293729A1 (en) 2011-12-01
CA2743767A1 (fr) 2010-05-20
IL212847A0 (en) 2011-07-31
US8529954B2 (en) 2013-09-10
NZ592850A (en) 2012-11-30
CN104688691A (zh) 2015-06-10
DK2349217T3 (da) 2019-11-04
MA32790B1 (fr) 2011-11-01
BRPI0916021B8 (pt) 2021-05-25
CY1122209T1 (el) 2020-11-25
SI2349217T1 (sl) 2020-01-31
EP2349217A1 (fr) 2011-08-03
MX2011005073A (es) 2011-10-12
FR2938431A1 (fr) 2010-05-21
EP2349217B1 (fr) 2019-07-31
BRPI0916021B1 (pt) 2020-01-14
JP2012508784A (ja) 2012-04-12
EA201100758A1 (ru) 2011-12-30

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