HRP20140390T1 - Novi oblik doziranja - Google Patents
Novi oblik doziranja Download PDFInfo
- Publication number
- HRP20140390T1 HRP20140390T1 HRP20140390AT HRP20140390T HRP20140390T1 HR P20140390 T1 HRP20140390 T1 HR P20140390T1 HR P20140390A T HRP20140390A T HR P20140390AT HR P20140390 T HRP20140390 T HR P20140390T HR P20140390 T1 HRP20140390 T1 HR P20140390T1
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- oral administration
- pyrrolidinone
- pyridinyl
- cyclobutyl
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title claims 24
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid group Chemical group C(CC(O)(C(=O)O)CC(=O)O)(=O)O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 15
- YFRBKEVUUCQYOW-UHFFFAOYSA-N 1-[6-[(3-cyclobutyl-1,2,4,5-tetrahydro-3-benzazepin-7-yl)oxy]pyridin-3-yl]pyrrolidin-2-one Chemical compound O=C1CCCN1C(C=N1)=CC=C1OC1=CC=C(CCN(CC2)C3CCC3)C2=C1 YFRBKEVUUCQYOW-UHFFFAOYSA-N 0.000 claims 10
- 238000000034 method Methods 0.000 claims 9
- 239000003381 stabilizer Substances 0.000 claims 9
- 150000003839 salts Chemical class 0.000 claims 8
- 239000000725 suspension Substances 0.000 claims 6
- 235000015165 citric acid Nutrition 0.000 claims 5
- 208000012902 Nervous system disease Diseases 0.000 claims 4
- 208000025966 Neurological disease Diseases 0.000 claims 4
- 239000012458 free base Substances 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 3
- 239000000126 substance Substances 0.000 claims 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 2
- 229920003084 Avicel® PH-102 Polymers 0.000 claims 2
- 239000004255 Butylated hydroxyanisole Substances 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- 229920000881 Modified starch Polymers 0.000 claims 2
- 229920002472 Starch Polymers 0.000 claims 2
- 235000019282 butylated hydroxyanisole Nutrition 0.000 claims 2
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims 2
- 229940043253 butylated hydroxyanisole Drugs 0.000 claims 2
- 238000007373 indentation Methods 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 201000006417 multiple sclerosis Diseases 0.000 claims 2
- 239000008107 starch Substances 0.000 claims 2
- 235000019698 starch Nutrition 0.000 claims 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims 1
- -1 3-benzazepin-7-yl Chemical group 0.000 claims 1
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims 1
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims 1
- 235000010323 ascorbic acid Nutrition 0.000 claims 1
- 239000011668 ascorbic acid Substances 0.000 claims 1
- 229960005070 ascorbic acid Drugs 0.000 claims 1
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims 1
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 238000000354 decomposition reaction Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000001630 malic acid Substances 0.000 claims 1
- 235000011090 malic acid Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000003960 organic solvent Substances 0.000 claims 1
- 235000002639 sodium chloride Nutrition 0.000 claims 1
Classifications
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- 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
- A61P25/06—Antimigraine agents
-
- 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
- A61P25/08—Antiepileptics; Anticonvulsants
-
- 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
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
-
- 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
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- 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
- A61P25/20—Hypnotics; Sedatives
-
- 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
- A61P25/22—Anxiolytics
-
- 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
- A61P25/24—Antidepressants
-
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Molecular Biology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Biophysics (AREA)
- Rheumatology (AREA)
- Zoology (AREA)
- Heart & Thoracic Surgery (AREA)
- Diabetes (AREA)
- Psychology (AREA)
- Immunology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Anesthesiology (AREA)
- Cardiology (AREA)
- Hospice & Palliative Care (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Medicinal Preparation (AREA)
Claims (26)
1. Oblik doziranja namijenjen oralnoj primjeni, naznačen time što sadrži noseću tabletu, gdje je navedena noseća tableta u najmanju ruku djelomično pokrivena filmom koji sadrži:
a) 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinon, ili njegovu farmaceutski prihvatljivu sol, i
b) stabilizator koji smanjuje razgradnju 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona u obliku doziranja, u usporedbi s oblikom doziranja koji ne sadrži navedeni stabilizator;
gdje se navedeni stabilizator bira iz skupine koju čine limunska kiselina, jabučna kiselina, askorbinska kiselina i njene soli, natrijev bikarbonat, butilirani hidroksianisol i butilirani hidroksitoluen.
2. Oblik doziranja namijenjen oralnoj primjeni u skladu s patentnim zahtjevom 1, naznačen time što film dodatno sadrži tvar koja pravi film.
3. Oblik doziranja namijenjen oralnoj primjeni u skladu s patentnim zahtjevom 2, naznačen time što je tvar koja pravi film hidroksipropilceluloza.
4. Oblik doziranja namijenjen oralnoj primjeni u skladu s patentnim zahtjevom 1, 2 ili 3, naznačen time što navedena noseća tableta ima u najmanju ruku jedno ulegnuće.
5. Oblik doziranja namijenjen oralnoj primjeni u skladu s patentnim zahtjevom 4, naznačen time što se navedeni film nalazi u ulegnuću na navedenoj nosećoj tableti.
6. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što noseća tableta uglavnom ne apsorbira 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinon, ili njegovu farmaceutski prihvatljivu sol.
7. Oblik doziranja namijenjen oralnoj primjeni u skladu s patentnim zahtjevom 6, naznačen time što je navedena noseća tableta obložena.
8. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što sadrži između 1 µg i 1 mg 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona, kada se mjeri kao količina prisutne slobodne baze.
9. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što sadrži 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinon u obliku slobodne baze.
10. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni stabilizator limunska kiselina i izborno butilirani hidroksianisol.
11. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je navedeni stabilizator limunska kiselina, te što je molarni omjer između slobodne baze 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona i limunske kiseline u rasponu od 1,5:1 do 1:500.
12. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što oblik doziranja i/ili film sadrži između 2 µg i 100 µg 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona, kada se mjeri kao količina prisutne slobodne baze.
13. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni oblik doziranja dodatno obložen.
14. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je noseća tableta tableta koja sadrži mikrokristalnu celulozu (primjerice Avicel PH-102), preželatinirani škrob (primjerice škrob 1500) i magnezijev stearat.
15. Oblik doziranja namijenjen oralnoj primjeni u skladu s patentnim zahtjevom 14, naznačen time što noseća tableta sadrži 90% mikrokristalne celuloze (primjerice Avicel PH-102), 9% preželatiniranog škroba (primjerice škroba 1500) i 1% magnezijevog stearata.
16. Postupak proizvodnje oblika doziranja namijenjenog oralnoj primjeni u skladu s patentnim zahtjevom 1, naznačen time što se sastoji u primjeni otopine ili suspenzije 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona, ili njegove farmaceutski prihvatljive soli, i stabilizatora na noseću tabletu.
17. Postupak u skladu s patentnim zahtjevom 16, naznačen time što se otopinu ili suspenziju 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona, ili njegove farmaceutski prihvatljive soli, i stabilizatora pripravlja uz upotrebu organskog otapala, koje je metanol, etanol, aceton, octena kiselina ili metilen-klorid.
18. Postupak u skladu s patentnim zahtjevom 16 ili 17, naznačen time što je stabilizator limunska kiselina i nalazi se u otopini ili suspenziji u količini između 2-3% tež./vol..
19. Postupak u skladu s patentnim zahtjevom 16, 17 ili 18, naznačen time što je, u obliku doziranja, noseća tableta najmanje djelomično pokrivena filmom u skladu s patentnim zahtjevom 1, što film dodatno sadrži tvar koja pravi film, koja je hidroksipropilceluloza, te što se, u postupku, hidroksipropilceluloza nalazi u otopini ili suspenziji u količini između 4-6% tež./vol..
20. Postupak u skladu s patentnim zahtjevom 16, 17, 18 ili 19, naznačen time što se noseća tableta i primijenjena otopina, odnosno suspenzija, grije kako bi se suvišna tekućina pretvorila u paru, te kako bi došlo do nastanka filma na najmanje jednom dijelu površine noseće tablete.
21. Postupak u skladu s bilo kojim od patentnih zahtjeva 16 do 20, naznačen time što noseća tableta koja se upotrebljava u postupku ima ulegnuće ili udubljenje koje je posudica u koju se nakuplja otopina ili suspenzija 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona, ili njegove farmaceutski prihvatljive soli, i stabilizatora nakon primjene.
22. Postupak u skladu s patentnim zahtjevom 21, naznačen time što se tu upotrebljavaju bikonkavne tablete koje imaju ulegnuće na dvije strane tablete.
23. Upotreba 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona, ili njegove farmaceutski prihvatljive soli, naznačena time što je navedeni spoj namijenjen proizvodnji oblika doziranja namijenjenog oralnoj primjeni u skladu s bilo kojim od patentnih zahtjeva 1 do 15 u liječenju neuroloških bolesti.
24. Upotreba 1-{6-[(3-ciklobutil-2,3,4,5-tetrahidro-1H-3-benzazepin-7-il)oksi]-3-piridinil}-2-pirolidinona, ili njegove farmaceutski prihvatljive soli, u skladu s patentnim zahtjevom 23, naznačena time što je neurološka bolest multipla skleroza.
25. Oblik doziranja namijenjen oralnoj primjeni u skladu s bilo kojim od patentnih zahtjeva 1 do 15, naznačen time što je namijenjen upotrebi u liječenju neuroloških bolesti.
26. Oblik doziranja u skladu s patentnim zahtjevom 25, naznačen time što je neurološka bolest multipla skleroza.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US89226707P | 2007-03-01 | 2007-03-01 | |
| PCT/EP2008/052430 WO2008104590A2 (en) | 2007-03-01 | 2008-02-28 | Novel dosage form |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20140390T1 true HRP20140390T1 (hr) | 2014-06-06 |
Family
ID=39248198
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20140390AT HRP20140390T1 (hr) | 2007-03-01 | 2014-04-29 | Novi oblik doziranja |
Country Status (30)
| Country | Link |
|---|---|
| US (1) | US20110014283A1 (hr) |
| EP (1) | EP2131818B1 (hr) |
| JP (2) | JP5743177B2 (hr) |
| KR (1) | KR101504371B1 (hr) |
| CN (1) | CN101674806B (hr) |
| AR (1) | AR065529A1 (hr) |
| AU (1) | AU2008220795B2 (hr) |
| BR (1) | BRPI0807882A2 (hr) |
| CA (1) | CA2679529A1 (hr) |
| CL (1) | CL2008000596A1 (hr) |
| CO (1) | CO6220900A2 (hr) |
| CR (1) | CR11013A (hr) |
| DK (1) | DK2131818T3 (hr) |
| DO (1) | DOP2009000207A (hr) |
| EA (1) | EA019865B1 (hr) |
| ES (1) | ES2463468T3 (hr) |
| HK (1) | HK1137363A1 (hr) |
| HR (1) | HRP20140390T1 (hr) |
| IL (1) | IL200619A (hr) |
| MA (1) | MA31198B1 (hr) |
| MX (1) | MX2009009362A (hr) |
| NZ (1) | NZ579374A (hr) |
| PE (1) | PE20090114A1 (hr) |
| PL (1) | PL2131818T3 (hr) |
| PT (1) | PT2131818E (hr) |
| SI (1) | SI2131818T1 (hr) |
| TW (1) | TWI424856B (hr) |
| UA (1) | UA102515C2 (hr) |
| WO (1) | WO2008104590A2 (hr) |
| ZA (1) | ZA200905866B (hr) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2049472B1 (en) | 2006-06-23 | 2015-01-21 | AbbVie Bahamas Ltd. | Cyclopropyl amine derivatives as histamin h3 receptor modulators |
| US9108948B2 (en) | 2006-06-23 | 2015-08-18 | Abbvie Inc. | Cyclopropyl amine derivatives |
| WO2010023170A1 (en) * | 2008-08-29 | 2010-03-04 | Glaxo Group Limited | Dosage form comprising 1-isopropyl-4-{[4-(tetrahydro-2H-pyran- 4-yloxy)phenyl]carbonyl}hexahydro-1H-1,4-diazepine or a salt thereof |
| US9186353B2 (en) * | 2009-04-27 | 2015-11-17 | Abbvie Inc. | Treatment of osteoarthritis pain |
| WO2011051423A1 (en) | 2009-11-02 | 2011-05-05 | Glaxo Group Limited | Treatment or prophylaxis of dementia, neurodegenerative disorders, schizophrenia, adhd, somnolence or epilepsy |
| US8853390B2 (en) | 2010-09-16 | 2014-10-07 | Abbvie Inc. | Processes for preparing 1,2-substituted cyclopropyl derivatives |
| US20130244943A1 (en) | 2011-09-06 | 2013-09-19 | Allergan, Inc. | Hyaluronic acid-collagen matrices for dermal filling and volumizing applications |
| JP6612874B2 (ja) | 2014-12-16 | 2019-11-27 | アクソファント サイエンシーズ ゲーエムベーハー | α７−ニコチン性アセチルコリン受容体のアゴニストとしてのジェミナル置換キヌクリジンアミド化合物 |
| MX2017016231A (es) | 2015-06-10 | 2018-11-29 | Axovant Sciences Gmbh | Compuestos de aminobencisoxazol como agonistas de receptores a7-nicotínicos de acetilcolina. |
| US10428062B2 (en) | 2015-08-12 | 2019-10-01 | Axovant Sciences Gmbh | Geminal substituted aminobenzisoxazole compounds as agonists of α7-nicotinic acetylcholine receptors |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1995006461A1 (en) * | 1993-09-03 | 1995-03-09 | Smithkline Beecham Corporation | Stabilized tablet formulation |
| ES2257886T3 (es) * | 1998-12-01 | 2006-08-01 | Dr. Reddy's Research Foundation | Nueva composicion farmaceutica y el proceso para su preparacion. |
| US20040037869A1 (en) * | 2002-08-16 | 2004-02-26 | Douglas Cleverly | Non-animal product containing veterinary formulations |
| CA2509413C (en) * | 2002-12-20 | 2012-05-01 | Glaxo Group Limited | Benzazepine derivatives for the treatment of neurological disorders |
| WO2005003096A1 (en) * | 2003-06-17 | 2005-01-13 | Arena Pharmaceuticals, Inc. | Benzazepine derivatives useful for the treatment of 5ht2c receptor associated diseases |
| US20070021391A1 (en) * | 2003-06-30 | 2007-01-25 | Takayuki Doi | Preventive/remedy for urinary disturbance |
| US20080009478A1 (en) * | 2003-10-22 | 2008-01-10 | Arena Pharmaceuticals, Inc. | Benzazepine Derivatives and Methods of Prophylaxis or Treatment of 5Ht2c Receptor Associated Diseases |
| US20060002986A1 (en) * | 2004-06-09 | 2006-01-05 | Smithkline Beecham Corporation | Pharmaceutical product |
| WO2005123723A1 (en) | 2004-06-18 | 2005-12-29 | Glaxo Group Limited | 3-cycloalkylbenzazepines as histamine h3 antagonists |
| JP2006022039A (ja) * | 2004-07-08 | 2006-01-26 | Towa Yakuhin Kk | 高い安定性を有するシンバスタチン固形製剤 |
| GB0418267D0 (en) * | 2004-08-16 | 2004-09-15 | Glaxo Group Ltd | Novel compounds |
-
2008
- 2008-02-27 CL CL200800596A patent/CL2008000596A1/es unknown
- 2008-02-28 WO PCT/EP2008/052430 patent/WO2008104590A2/en active Application Filing
- 2008-02-28 PT PT87172219T patent/PT2131818E/pt unknown
- 2008-02-28 SI SI200831205T patent/SI2131818T1/sl unknown
- 2008-02-28 AU AU2008220795A patent/AU2008220795B2/en not_active Ceased
- 2008-02-28 BR BRPI0807882-3A2A patent/BRPI0807882A2/pt not_active IP Right Cessation
- 2008-02-28 JP JP2009551216A patent/JP5743177B2/ja not_active Expired - Fee Related
- 2008-02-28 CA CA002679529A patent/CA2679529A1/en not_active Abandoned
- 2008-02-28 PE PE2008000398A patent/PE20090114A1/es not_active Application Discontinuation
- 2008-02-28 US US12/528,492 patent/US20110014283A1/en not_active Abandoned
- 2008-02-28 EA EA200970817A patent/EA019865B1/ru not_active IP Right Cessation
- 2008-02-28 AR ARP080100842A patent/AR065529A1/es unknown
- 2008-02-28 UA UAA200909976A patent/UA102515C2/ru unknown
- 2008-02-28 KR KR1020097020444A patent/KR101504371B1/ko not_active IP Right Cessation
- 2008-02-28 PL PL08717221T patent/PL2131818T3/pl unknown
- 2008-02-28 CN CN2008800144640A patent/CN101674806B/zh not_active Expired - Fee Related
- 2008-02-28 DK DK08717221.9T patent/DK2131818T3/da active
- 2008-02-28 MX MX2009009362A patent/MX2009009362A/es active IP Right Grant
- 2008-02-28 NZ NZ579374A patent/NZ579374A/en not_active IP Right Cessation
- 2008-02-28 ES ES08717221.9T patent/ES2463468T3/es active Active
- 2008-02-28 EP EP08717221.9A patent/EP2131818B1/en not_active Not-in-force
- 2008-02-29 TW TW097106936A patent/TWI424856B/zh not_active IP Right Cessation
-
2009
- 2009-08-24 ZA ZA200905866A patent/ZA200905866B/xx unknown
- 2009-08-27 IL IL200619A patent/IL200619A/en not_active IP Right Cessation
- 2009-08-28 DO DO2009000207A patent/DOP2009000207A/es unknown
- 2009-08-31 MA MA32184A patent/MA31198B1/fr unknown
- 2009-09-02 CR CR11013A patent/CR11013A/es unknown
- 2009-09-10 CO CO09097361A patent/CO6220900A2/es not_active Application Discontinuation
-
2010
- 2010-05-20 HK HK10104983.9A patent/HK1137363A1/xx not_active IP Right Cessation
-
2014
- 2014-04-29 HR HRP20140390AT patent/HRP20140390T1/hr unknown
- 2014-09-19 JP JP2014191832A patent/JP2015038098A/ja not_active Withdrawn
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| HRP20140390T1 (hr) | Novi oblik doziranja | |
| JP2010520174A5 (hr) | ||
| JP6084161B2 (ja) | ７−［４−（４−ベンゾ［ｂ］チオフェン−４−イル−ピペラジン−１−イル）ブトキシ］−１Ｈ−キノリン−２−オン又はその塩を含む錠剤 | |
| JP2009545560A5 (hr) | ||
| MX2015011896A (es) | Formulacion de liberacion sostenida de mosapride que proporciona efectos farmacologicos y clinicos con administracion una vez al dia. | |
| JP2020525436A5 (hr) | ||
| CN104257622B (zh) | 一种帕利哌酮控释片及其制备方法 | |
| KR20140131205A (ko) | 수용성 활성성분을 함유하는 서방형 약제학적 조성물 | |
| SK1752001A3 (en) | Pharmaceutical compositions comprising ibuprofen and domperidone | |
| JP2010189443A (ja) | 揮散防止型固形製剤およびその製造方法 | |
| KR101497354B1 (ko) | 활성 성분으로 에페리손을 함유하는 서방성 제제 조성물 | |
| CN106265583A (zh) | 一种帕利哌酮释放速率递增制剂及其制备方法 | |
| JP2020029441A (ja) | ダビガトランエテキシラートを含む製剤 | |
| KR20150079449A (ko) | 클로미프라민 함유 약학 조성물 및 이의 제조 방법 | |
| CN103040761B (zh) | 一种盐酸二甲双胍缓释小丸制剂及其制备方法 | |
| JP6396220B2 (ja) | フィルムコーティング液並びに経口固形製剤及びその製造方法 | |
| US9694007B2 (en) | Oral complex composition comprising pseudoephedrine and levocetirizine | |
| JP6181044B2 (ja) | カプセル剤 | |
| MX2011011937A (es) | Desfesoterodina en la forma de una sal del acido tartarico. | |
| BRPI0612990A2 (pt) | formulação de liberação prolongada de princìpios ativos de medicamentos | |
| JPS62240618A (ja) | 持続性製剤 | |
| JP2019034929A (ja) | エソメプラゾールマグネシウム水和物を含有する腸溶性コーティング製剤、およびその製造方法 | |
| CN104739775A (zh) | 一种新的盐酸文拉法辛缓释小丸及其制备方法 | |
| WO2013069897A1 (ko) | 사포그릴레이트의 안정화된 지속 방출 제제 | |
| JP6336651B1 (ja) | 化学的安定性が改善されたエソメプラゾール塩を含有する錠剤 |