HRP20191911T1 - Granule gama-hidroksibutirične kiseline - Google Patents
Granule gama-hidroksibutirične kiseline Download PDFInfo
- Publication number
- HRP20191911T1 HRP20191911T1 HRP20191911TT HRP20191911T HRP20191911T1 HR P20191911 T1 HRP20191911 T1 HR P20191911T1 HR P20191911T T HRP20191911T T HR P20191911TT HR P20191911 T HRP20191911 T HR P20191911T HR P20191911 T1 HRP20191911 T1 HR P20191911T1
- Authority
- HR
- Croatia
- Prior art keywords
- granule
- gamma
- hydroxybutyric acid
- sucrose
- pharmaceutically acceptable
- Prior art date
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- 239000008187 granular material Substances 0.000 title claims 11
- SJZRECIVHVDYJC-UHFFFAOYSA-N 4-hydroxybutyric acid Chemical compound OCCCC(O)=O SJZRECIVHVDYJC-UHFFFAOYSA-N 0.000 title claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 3
- 229930006000 Sucrose Natural products 0.000 claims 3
- 239000011230 binding agent Substances 0.000 claims 3
- 239000011248 coating agent Substances 0.000 claims 3
- 239000000843 powder Substances 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 2
- 229920001800 Shellac Polymers 0.000 claims 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- 229920002472 Starch Polymers 0.000 claims 2
- 230000001476 alcoholic effect Effects 0.000 claims 2
- 235000010443 alginic acid Nutrition 0.000 claims 2
- 229920000615 alginic acid Polymers 0.000 claims 2
- HZVVJJIYJKGMFL-UHFFFAOYSA-N almasilate Chemical compound O.[Mg+2].[Al+3].[Al+3].O[Si](O)=O.O[Si](O)=O HZVVJJIYJKGMFL-UHFFFAOYSA-N 0.000 claims 2
- 235000003599 food sweetener Nutrition 0.000 claims 2
- 125000005456 glyceride group Chemical group 0.000 claims 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 229920005862 polyol Polymers 0.000 claims 2
- 150000003077 polyols Chemical class 0.000 claims 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Chemical compound [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 claims 2
- 239000004208 shellac Substances 0.000 claims 2
- 235000013874 shellac Nutrition 0.000 claims 2
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 claims 2
- 229940113147 shellac Drugs 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 239000008107 starch Substances 0.000 claims 2
- 235000019698 starch Nutrition 0.000 claims 2
- 239000003765 sweetening agent Substances 0.000 claims 2
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims 1
- 208000007848 Alcoholism Diseases 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 208000009132 Catalepsy Diseases 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- RGHNJXZEOKUKBD-SQOUGZDYSA-M D-gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O RGHNJXZEOKUKBD-SQOUGZDYSA-M 0.000 claims 1
- 235000019739 Dicalciumphosphate Nutrition 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- 229920000084 Gum arabic Polymers 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 241000978776 Senegalia senegal Species 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 206010047853 Waxy flexibility Diseases 0.000 claims 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- 239000000205 acacia gum Substances 0.000 claims 1
- 235000010489 acacia gum Nutrition 0.000 claims 1
- 201000007930 alcohol dependence Diseases 0.000 claims 1
- 229940072056 alginate Drugs 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 239000001506 calcium phosphate Substances 0.000 claims 1
- 150000004649 carbonic acid derivatives Chemical class 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 235000010980 cellulose Nutrition 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- 239000013078 crystal Substances 0.000 claims 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 claims 1
- 229940038472 dicalcium phosphate Drugs 0.000 claims 1
- 229910000390 dicalcium phosphate Inorganic materials 0.000 claims 1
- 235000014113 dietary fatty acids Nutrition 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 239000000194 fatty acid Substances 0.000 claims 1
- 229930195729 fatty acid Natural products 0.000 claims 1
- 150000004665 fatty acids Chemical class 0.000 claims 1
- 239000007888 film coating Substances 0.000 claims 1
- 238000009501 film coating Methods 0.000 claims 1
- 229940050410 gluconate Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims 1
- 239000001095 magnesium carbonate Substances 0.000 claims 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
- 239000000845 maltitol Substances 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- 229940035436 maltitol Drugs 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 229960001855 mannitol Drugs 0.000 claims 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 1
- 125000005395 methacrylic acid group Chemical group 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 229910000027 potassium carbonate Inorganic materials 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 235000010356 sorbitol Nutrition 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 229960002920 sorbitol Drugs 0.000 claims 1
- 238000005507 spraying Methods 0.000 claims 1
- 125000003696 stearoyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
- 229960002675 xylitol Drugs 0.000 claims 1
Classifications
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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
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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
- A61K9/48—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
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- 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
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- 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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Addiction (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (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)
Claims (7)
1. Granula gama-hidroksibutirične kiseline ili njezine farmaceutski prihvatljive soli, naznačena time, da se sastoji od čvrste jezgre i ljuske koja je postavljena oko jezgre, pri čemu se gama-hidroksibutirična kiselina ili jedna od njezinih farmaceutski prihvatljivih soli nalazi u sadržaju ljuske u prisutnosti veziva, te time, da:
- jezgra je odabrana iz skupine koja se sastoji od poliola kao što su manitol, sorbitol, maltitol ili ksilitol, laktoze, dikalcijevog fosfata, karbonata kao što su kalcijev karbonat, kalijev karbonat, magnezijev karbonat ili natrijev karbonat, glukonata, silikata, šećernih kristala, saharoze, škroba, koloidnog silicijevog dioksida i magnezijevog aluminosilikata;
- vezivo je odabrano iz skupine koja se sastoji od sljedećih: škrob, saharoza, guma arabika, polivinilpirolidon, hidroksipropilmetilceluloza, šelak, hidroksipropilceluloza, celuloza, polioli, alginati, magnezijev aluminosilikat, poliglikolizirani gliceridi ili makrogolgliceridi, posebice stearoil-makrogolgliceridi;
- gama-hidroksibutirična kiselina ili njezina farmaceutski prihvatljiva sol je predstavljena s najmanje 35% udjela u masi u odnosu na ukupnu masu granule.
2. Granula prema patentnom zahtjevu 1, naznačena time, da je ona obložena sa sredstvom za oblaganje koje je odabrano iz skupine koja se sastoji od sljedećih: šelak, polivinilpirolidon, polietilenglikol, hidroksipropilmetilceluloza, hidroksipropilceluloza, etilceluloza, saharoza, alginat, gliceridi masnih kiselina i metakrilni polimeri.
3. Granula prema patentnom zahtjevu 2, naznačena time, da ona nadalje obuhvaća mazivo i/ili aromu i/ili zaslađivač i/ili boju.
4. Farmaceutski pripravak, naznačen time, da obuhvaća granule u skladu s bilo kojim od patentnih zahtjeva 1 do 3.
5. Granula prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da se ona upotrebljava u liječenju katalepsije kod narkoleptičkih pacijenata, ili se upotrebljava za uzdržavanje od alkoholizma.
6. Postupak za proizvodnju granule prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da obuhvaća korak nanošenja praška s gama-hidroksibutiričnom kiselinom ili njezinom soli na čvrstu podlogu čestice, pri čemu korak nanošenja praška obuhvaća raspršivanje vodene, alkoholne ili vodeno-alkoholne otopine jednog veziva.
7. Postupak za proizvodnju granule prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da nakon koraka nanošenja praška, obuhvaća korak oblaganja granule, prvenstveno pomoću stavljanja sredstva za oblaganje u obliku obloge filmom na granulu, nakon čega, ako je prikladno, slijedi korak miješanja s mazivom i/ili s aromom i/ili sa zaslađivačem i/ili s bojom.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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| EP09768176.1A EP2349217B1 (fr) | 2008-11-14 | 2009-11-10 | Granulé d'acide gamma-hydroxybutyrique |
| PCT/FR2009/052169 WO2010055260A1 (fr) | 2008-11-14 | 2009-11-10 | Nouvelle composition à base d'acide gamma-hydroxybutyrique |
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| CN (2) | CN102215822A (hr) |
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| AU (1) | AU2009315441B2 (hr) |
| BR (1) | BRPI0916021B8 (hr) |
| CA (1) | CA2743767C (hr) |
| CL (1) | CL2011001114A1 (hr) |
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| FR (1) | FR2938431B1 (hr) |
| HR (1) | HRP20191911T1 (hr) |
| HU (1) | HUE046321T2 (hr) |
| IL (1) | IL212847A (hr) |
| LT (1) | LT2349217T (hr) |
| MA (1) | MA32790B1 (hr) |
| MX (1) | MX2011005073A (hr) |
| NZ (1) | NZ592850A (hr) |
| PE (1) | PE20120028A1 (hr) |
| PL (1) | PL2349217T3 (hr) |
| PT (1) | PT2349217T (hr) |
| SI (1) | SI2349217T1 (hr) |
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| UA (1) | UA103057C2 (hr) |
| WO (1) | WO2010055260A1 (hr) |
| ZA (1) | ZA201103542B (hr) |
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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 |
| US20120076865A1 (en) | 2010-03-24 | 2012-03-29 | 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 |
| US11504347B1 (en) | 2016-07-22 | 2022-11-22 | 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 |
| US11000498B2 (en) | 2016-07-22 | 2021-05-11 | 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 |
| US11986451B1 (en) | 2016-07-22 | 2024-05-21 | 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 |
| CN111511355A (zh) * | 2017-12-20 | 2020-08-07 | 弗拉梅爱尔兰有限公司 | 具有改善稳定性的γ-羟基丁酸盐的包装改性释放制剂 |
| JP7472116B2 (ja) * | 2018-11-19 | 2024-04-22 | ジャズ ファーマシューティカルズ アイルランド リミテッド | 耐アルコール性製剤 |
| JP7553453B2 (ja) * | 2019-03-01 | 2024-09-18 | フラメル アイルランド リミテッド | 食事摂取状態における改善された薬物動態を有するガンマ－ヒドロキシ酪酸塩組成物 |
| CA3162919A1 (en) | 2019-12-20 | 2021-06-24 | XWPharma Ltd. | Methods of synthesizing 4-valyloxybutyric acid |
| CA3183185A1 (en) * | 2020-06-18 | 2021-12-23 | Jia-Ning Xiang | Pharmaceutical granulations of water-soluble active pharmaceutical ingredients |
| 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 |
| 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 |
| CA3194665A1 (en) | 2020-10-05 | 2022-04-14 | Jia-Ning Xiang | 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 |
| 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 |
| 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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-
2008
- 2008-11-14 FR FR0857763A patent/FR2938431B1/fr active Active
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2009
- 2009-11-10 CN CN2009801457609A patent/CN102215822A/zh active Pending
- 2009-11-10 NZ NZ592850A patent/NZ592850A/xx unknown
- 2009-11-10 US US13/129,130 patent/US8529954B2/en active Active
- 2009-11-10 SI SI200932005T patent/SI2349217T1/sl unknown
- 2009-11-10 UA UAA201105987A patent/UA103057C2/ru unknown
- 2009-11-10 PT PT97681761T patent/PT2349217T/pt unknown
- 2009-11-10 EA EA201100758A patent/EA023305B1/ru not_active IP Right Cessation
- 2009-11-10 ES ES09768176T patent/ES2749803T3/es active Active
- 2009-11-10 HU HUE09768176A patent/HUE046321T2/hu unknown
- 2009-11-10 WO PCT/FR2009/052169 patent/WO2010055260A1/fr active Application Filing
- 2009-11-10 CA CA2743767A patent/CA2743767C/fr active Active
- 2009-11-10 CN CN201510047649.3A patent/CN104688691A/zh active Pending
- 2009-11-10 EP EP09768176.1A patent/EP2349217B1/fr active Active
- 2009-11-10 JP JP2011543797A patent/JP2012508784A/ja active Pending
- 2009-11-10 DK DK09768176T patent/DK2349217T3/da active
- 2009-11-10 AU AU2009315441A patent/AU2009315441B2/en active Active
- 2009-11-10 KR KR1020117013587A patent/KR101563390B1/ko active IP Right Grant
- 2009-11-10 PE PE2011001031A patent/PE20120028A1/es not_active Application Discontinuation
- 2009-11-10 BR BRPI0916021A patent/BRPI0916021B8/pt active IP Right Grant
- 2009-11-10 LT LT09768176T patent/LT2349217T/lt unknown
- 2009-11-10 PL PL09768176T patent/PL2349217T3/pl unknown
- 2009-11-10 MX MX2011005073A patent/MX2011005073A/es active IP Right Grant
- 2009-11-13 TW TW098138675A patent/TWI446906B/zh active
- 2009-11-16 AR ARP090104424A patent/AR074351A1/es unknown
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2011
- 2011-05-11 TN TN2011000231A patent/TN2011000231A1/fr unknown
- 2011-05-12 IL IL212847A patent/IL212847A/en active IP Right Grant
- 2011-05-13 ZA ZA2011/03542A patent/ZA201103542B/en unknown
- 2011-05-13 CU CU20110109A patent/CU20110109A7/es unknown
- 2011-05-13 CL CL2011001114A patent/CL2011001114A1/es unknown
- 2011-05-13 MA MA33838A patent/MA32790B1/fr unknown
- 2011-05-13 CO CO11059012A patent/CO6382106A2/es not_active Application Discontinuation
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