DK1925308T3 - Farmaceutisk fast oralt aripiprazolpræparat og fremgangsmåder til fremstilling deraf - Google Patents
Farmaceutisk fast oralt aripiprazolpræparat og fremgangsmåder til fremstilling deraf Download PDFInfo
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- DK1925308T3 DK1925308T3 DK08000358.5T DK08000358T DK1925308T3 DK 1925308 T3 DK1925308 T3 DK 1925308T3 DK 08000358 T DK08000358 T DK 08000358T DK 1925308 T3 DK1925308 T3 DK 1925308T3
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- Prior art keywords
- aripiprazole
- crystals
- tablets
- granules
- minutes
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Classifications
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- C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
- C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
- C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
- C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D215/20—Oxygen atoms
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- A61P25/32—Alcohol-abuse
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- A—HUMAN NECESSITIES
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-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
- C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
- C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D215/20—Oxygen atoms
- C07D215/22—Oxygen atoms attached in position 2 or 4
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Psychiatry (AREA)
- Addiction (AREA)
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- Pain & Pain Management (AREA)
- Endocrinology (AREA)
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- Reproductive Health (AREA)
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- Child & Adolescent Psychology (AREA)
- Gynecology & Obstetrics (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (5)
1. Farmaceutisk fast oralt aripiprazolpræparat med a) mindst en opløsningshastighed målt efter opbevaring i det fri ved 25 °C/60 % RH i seks måneder udvalgt fra gruppen bestående af 70 % eller mere ved pH-værdi 4,5 efter 60 minutter, og 55 % eller mere ved pH-værdi 5,0 efter 60 minutter; eller b) mindst en opløsningshastighed målt efter opbevaring i det fri ved 40 °C/75 % RH i 1 uge udvalgt fra gruppen bestående af 70 % eller mere ved pH-værdi 4,5 efter 60 minutter, og 55 % eller mere ved pH 5,0 efter 60 minutter, som kan opnås ved at vådgranulere traditionelle vandfrie aripiprazolkrystaller eller traditionelle aripiprazolhydratkrystaller, at tørre de tilvejebragte granulater ved 70 til 100 °C, at størrelsesinddele dem, eventuelt at forme dem i form af tabletter, og derefter at tørre de størrelsesinddelte granulater eller tabletterne ved 70 til 100 °C igen.
2. Fremgangsmåde til fremstilling af et farmaceutisk fast oralt præparat ifølge krav 1, som er kendetegnet ved vådgranulering af traditionelle vandfrie aripiprazolkrystaller, tørring af de tilvejebragte granulater ved 70 til 100 °C og størrelsesinddeling af dem, derefter tørring af de størrelsesinddelte granulater ved 70 til 100 °C igen.
3. Fremgangsmåde til fremstilling af et farmaceutisk fast oralt præparat ifølge krav 1, som er kendetegnet ved vådgranulering af traditionelle vandfrie aripiprazolkrystaller, tørring af de tilvejebragte granulater ved 70 til 100 °C og størrelsesinddeling af dem og formning af dem i form af tabletter, og derefter tørring af tabletterne ved 70 til 100 °C.
4. Fremgangsmåde til fremstilling af et farmaceutisk fast oralt præparat ifølge krav 1, som er kendetegnet ved vådgranulering af traditionelle aripiprazolhydratkrystaller, tørring af de tilvejebragte granulater ved 70 til 100 °C og størrelsesinddeling af dem, derefter tørring af de størrelsesinddelte granula- ter ved 70 til 100 °C igen.
5. Fremgangsmåde til fremstilling af et farmaceutisk fast oralt præparat ifølge krav 1, som er kendetegnet ved vådgranulering af traditionelle aripiprazol-hydratkrystaller, tørring af de tilvejebragte granulater ved 70 til 100 °C og størrelsesinddeling af dem og formning af dem i form af tabletter, og derefter tørring af tabletterne ved 70 til 100 °C.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001290645 | 2001-09-25 | ||
| JP2001348276 | 2001-11-14 | ||
| CA 2379005 CA2379005A1 (en) | 2001-09-25 | 2002-03-27 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
| EP04002427.5A EP1419776B2 (en) | 2001-09-25 | 2002-09-25 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1925308T3 true DK1925308T3 (da) | 2016-12-12 |
Family
ID=36049773
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08000358.5T DK1925308T3 (da) | 2001-09-25 | 2002-09-25 | Farmaceutisk fast oralt aripiprazolpræparat og fremgangsmåder til fremstilling deraf |
Country Status (21)
| Country | Link |
|---|---|
| EP (1) | EP3081216A1 (da) |
| KR (2) | KR100490222B1 (da) |
| CN (12) | CN103755632B (da) |
| AR (3) | AR073111A2 (da) |
| CA (1) | CA2713466C (da) |
| CL (1) | CL2010000405A1 (da) |
| CY (4) | CY1110208T1 (da) |
| DK (1) | DK1925308T3 (da) |
| ES (1) | ES2596354T3 (da) |
| HK (14) | HK1203059A1 (da) |
| IL (3) | IL204707A (da) |
| LT (1) | LT1925308T (da) |
| MY (1) | MY138669A (da) |
| NO (1) | NO337844B1 (da) |
| PE (1) | PE20030445A1 (da) |
| PH (1) | PH12014500782A1 (da) |
| PL (7) | PL221521B1 (da) |
| PT (1) | PT1925308T (da) |
| RU (1) | RU2279429C2 (da) |
| SI (1) | SI1927357T1 (da) |
| TW (2) | TWI332839B (da) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ZA200602347B (en) * | 2003-10-23 | 2007-09-26 | Otsuka Pharma Co Ltd | Controlled release sterile injectable aripiprazole formulation and method |
| JOP20200109A1 (ar) * | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
| KR102128883B1 (ko) * | 2019-10-02 | 2020-07-01 | (주)삼화바이오팜 | 고순도 아리피프라졸의 신규 결정형 및 이의 제조방법 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS54130587A (en) | 1978-03-30 | 1979-10-09 | Otsuka Pharmaceut Co Ltd | Carbostyryl derivative |
| US5006528A (en) * | 1988-10-31 | 1991-04-09 | Otsuka Pharmaceutical Co., Ltd. | Carbostyril derivatives |
| JP2608788B2 (ja) | 1988-10-31 | 1997-05-14 | 大塚製薬 株式会社 | 精神分裂病治療剤 |
| JP3638447B2 (ja) * | 1998-09-10 | 2005-04-13 | 積水ハウス株式会社 | 笠木取付金具および笠木取付構造 |
| GB9930061D0 (en) * | 1999-12-20 | 2000-02-09 | Glaxo Group Ltd | Quinolone compounds for use in treating viral infections |
| NZ519981A (en) * | 2000-01-20 | 2005-02-25 | Eisai Co Ltd | Nitrogenous cyclic compounds and pharmaceutical compositions containing the same |
| CA2311734C (en) * | 2000-04-12 | 2011-03-08 | Bristol-Myers Squibb Company | Flash-melt oral dosage formulation |
| WO2003030868A1 (en) * | 2001-10-09 | 2003-04-17 | Bristol-Myers Squibb Company | Flashmelt oral dosage formulation |
| JP4197088B2 (ja) | 2000-06-05 | 2008-12-17 | 電気化学工業株式会社 | 低密度かつ低ガス透過性六方晶窒化硼素焼結体及びその製造方法 |
| JP2002193915A (ja) * | 2000-12-28 | 2002-07-10 | Otsuka Pharmaceut Co Ltd | ベンゼンスルフォナート化合物 |
-
2002
- 2002-09-20 MY MYPI20023512A patent/MY138669A/en unknown
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2004
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