PL1675573T5 - Sterylny preparat do wstrzykiwań arypiprazolu o kontrolowanym uwalnianiu i sposób - Google Patents
Sterylny preparat do wstrzykiwań arypiprazolu o kontrolowanym uwalnianiu i sposóbInfo
- Publication number
- PL1675573T5 PL1675573T5 PL04795514T PL04795514T PL1675573T5 PL 1675573 T5 PL1675573 T5 PL 1675573T5 PL 04795514 T PL04795514 T PL 04795514T PL 04795514 T PL04795514 T PL 04795514T PL 1675573 T5 PL1675573 T5 PL 1675573T5
- Authority
- PL
- Poland
- Prior art keywords
- controlled release
- sterile injectable
- aripiprazole formulation
- release sterile
- injectable aripiprazole
- Prior art date
Links
- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 title 1
- 229960004372 aripiprazole Drugs 0.000 title 1
- 238000013270 controlled release Methods 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
Classifications
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- 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
- A61K31/495—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
-
- 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
- A61K31/495—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
- A61K31/4965—Non-condensed pyrazines
- A61K31/497—Non-condensed pyrazines containing further heterocyclic rings
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US51361803P | 2003-10-23 | 2003-10-23 | |
PCT/US2004/034367 WO2005041937A2 (en) | 2003-10-23 | 2004-10-18 | Controlled release sterile injectable aripiprazole formulation and method |
EP04795514A EP1675573B2 (en) | 2003-10-23 | 2004-10-18 | Controlled release sterile injectable aripiprazole formulation and method |
Publications (3)
Publication Number | Publication Date |
---|---|
PL1675573T3 PL1675573T3 (pl) | 2009-04-30 |
PL1675573T5 true PL1675573T5 (pl) | 2012-10-31 |
PL1675573T4 PL1675573T4 (pl) | 2016-04-29 |
Family
ID=34549292
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PL04795514T PL1675573T4 (pl) | 2003-10-23 | 2004-10-18 | Sterylny preparat do wstrzykiwań arypiprazolu o kontrolowanym uwalnianiu i sposób |
Country Status (33)
Country | Link |
---|---|
US (12) | US7807680B2 (pl) |
EP (1) | EP1675573B2 (pl) |
JP (2) | JP4836797B2 (pl) |
KR (1) | KR100931784B1 (pl) |
CN (1) | CN1870980B (pl) |
AR (2) | AR046141A1 (pl) |
AT (1) | ATE411797T2 (pl) |
AU (1) | AU2004285448C1 (pl) |
BR (1) | BRPI0415531B8 (pl) |
CA (1) | CA2543242C (pl) |
CO (1) | CO5690539A2 (pl) |
CY (2) | CY1109040T1 (pl) |
DE (1) | DE602004017342D1 (pl) |
DK (1) | DK1675573T4 (pl) |
EC (2) | ECSP066512A (pl) |
ES (1) | ES2315721T5 (pl) |
FR (1) | FR14C0039I1 (pl) |
GE (1) | GEP20115205B (pl) |
HK (1) | HK1095266A1 (pl) |
IL (1) | IL175072A (pl) |
LU (1) | LU92427I2 (pl) |
MX (1) | MXPA06004489A (pl) |
MY (1) | MY146093A (pl) |
NO (2) | NO334919B1 (pl) |
NZ (1) | NZ546063A (pl) |
PE (1) | PE20050811A1 (pl) |
PL (1) | PL1675573T4 (pl) |
PT (1) | PT1675573E (pl) |
SI (1) | SI1675573T2 (pl) |
TW (2) | TWI383810B (pl) |
UA (1) | UA82561C2 (pl) |
WO (1) | WO2005041937A2 (pl) |
ZA (1) | ZA200602347B (pl) |
Families Citing this family (69)
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AR033485A1 (es) | 2001-09-25 | 2003-12-26 | Otsuka Pharma Co Ltd | Sustancia medicinal de aripiprazol de baja higroscopicidad y proceso para la preparacion de la misma |
US20050032811A1 (en) * | 2003-08-06 | 2005-02-10 | Josiah Brown | Methods for administering aripiprazole |
ZA200602347B (en) | 2003-10-23 | 2007-09-26 | Otsuka Pharma Co Ltd | Controlled release sterile injectable aripiprazole formulation and method |
WO2006053781A1 (en) * | 2004-11-18 | 2006-05-26 | Synthon B.V. | Process of making crystalline aripiprazole |
EP2279727A3 (en) * | 2005-09-15 | 2011-10-05 | Elan Pharma International Limited | Nanoparticulate aripiprazole formulations |
US8158152B2 (en) * | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
CN101351192A (zh) | 2006-01-05 | 2009-01-21 | 特瓦制药工业有限公司 | 阿立哌唑的湿法制粒的药用组合物 |
CA2627695A1 (en) * | 2006-01-05 | 2007-07-19 | Teva Pharmaceutical Industries Ltd. | Dry formulations of aripiprazole |
TR200604349A2 (tr) * | 2006-08-15 | 2008-03-21 | NOBEL İLAÇ SANAYii VE TiCARET A.Ş. | Aripiprazol içeren farmasötik bileşimler |
GB0618879D0 (en) * | 2006-09-26 | 2006-11-01 | Zysis Ltd | Pharmaceutical compositions |
SG182232A1 (en) * | 2007-06-25 | 2012-07-30 | Otsuka Pharma Co Ltd | Microspheres having core/shell structure |
UA97286C2 (ru) * | 2007-07-31 | 2012-01-25 | Оцука Фармасьютикал Ко., Лтд. | Способ изготовления суспензии арипипразола и лиофилизированного состава |
US20100316725A1 (en) | 2009-05-27 | 2010-12-16 | Elan Pharma International Ltd. | Reduction of flake-like aggregation in nanoparticulate active agent compositions |
KR101125210B1 (ko) * | 2009-09-11 | 2012-03-19 | 주식회사 대웅제약 | 아리피프라졸-벤토나이트-aea 혼성체, 이를 함유하는 약학 조성물 및 그 제조방법 |
CN103284968B (zh) * | 2010-04-13 | 2015-11-18 | 齐鲁制药有限公司 | 一种阿立哌唑组合物微晶的口腔崩解片及其制备方法 |
IL206739A (en) * | 2010-06-30 | 2016-06-30 | David Segal | An injectable drug containing silitol as an active substance |
MY174552A (en) | 2010-08-24 | 2020-04-24 | Otsuka Pharma Co Ltd | Suspension and cake composition containing carbostyryl derivative and silicone oil and/or silicone oil derivative |
US9469630B2 (en) | 2010-10-18 | 2016-10-18 | Sumitomo Dainippon Pharma Co., Ltd. | Sustained-release formulation for injection |
AU2011320758B2 (en) * | 2010-10-28 | 2015-09-24 | Alpha To Omega Pharmaceutical Consultants, Inc. | Aripiprazole compositions and methods for its transdermal delivery |
US9757374B2 (en) * | 2010-10-28 | 2017-09-12 | Aequus Pharmaceuticals Inc. | Aripiprazole compositions and methods for its transdermal delivery |
AR083884A1 (es) * | 2010-11-16 | 2013-03-27 | Otsuka Pharma Co Ltd | Jeringa prellenable de doble camara y relleno de aripiprazol en la jeringa |
CN102525915B (zh) * | 2010-12-14 | 2016-09-28 | 江苏豪森药业集团有限公司 | 一种持续释放的注射制剂及其制备方法和用途 |
SG191892A1 (en) * | 2011-01-24 | 2013-08-30 | Otsuka Pharma Co Ltd | Medical device containing a cake composition comprising aripiprazole as an active ingredient, and a cake composition comprising aripiprazole as an active ingredient |
RU2627469C2 (ru) | 2011-03-18 | 2017-08-08 | Алкермес Фарма Айэленд Лимитед | Фармацевтические композиции, содержащие водонерастворимое антипсихотическое средство и сложные эфиры сорбита |
JO3410B1 (ar) * | 2011-06-07 | 2019-10-20 | Otsuka Pharma Co Ltd | تركيبة أريبيبرازول مجفف بالتبريد |
CN102850268B (zh) * | 2011-06-27 | 2015-07-15 | 上海中西制药有限公司 | 阿立哌唑ⅰ型微晶、阿立哌唑固体制剂及制备方法 |
CN102846543B (zh) * | 2011-06-27 | 2014-11-19 | 上海中西制药有限公司 | 一种阿立哌唑药物制剂及其制备方法 |
US10004807B2 (en) | 2012-03-19 | 2018-06-26 | Alkermes Pharma Ireland Limited | Pharmaceutical compositions comprising fatty acid esters |
NZ630428A (en) | 2012-03-19 | 2017-02-24 | Alkermes Pharma Ireland Ltd | Pharmaceutical compositions comprising benzyl alcohol |
AU2013235523B9 (en) | 2012-03-19 | 2018-01-04 | Alkermes Pharma Ireland Limited | Pharmaceutical compositions comprising glycerol esters |
JOP20200109A1 (ar) | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
AR090775A1 (es) * | 2012-04-23 | 2014-12-03 | Otsuka Pharma Co Ltd | Preparado inyectable |
TWI562991B (en) | 2012-04-23 | 2016-12-21 | Otsuka Pharma Co Ltd | Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same |
CN104736561B (zh) * | 2012-08-21 | 2018-06-12 | 詹森药业有限公司 | 帕潘立酮的抗体及其用途 |
JP6339569B2 (ja) | 2012-08-21 | 2018-06-06 | ヤンセン ファーマシューティカ エヌ.ベー. | リスペリドンへの抗体及びその使用 |
EP2888287A4 (en) | 2012-08-21 | 2016-04-20 | Ortho Clinical Diagnostics Inc | ANTIBODIES AGAINST PALIPERIDONE HAPTENES AND THEIR USE |
AU2013305907B2 (en) | 2012-08-21 | 2018-01-18 | Saladax Biomedical Inc. | Antibodies to quetiapine and use thereof |
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CN108517014A (zh) | 2012-08-21 | 2018-09-11 | 詹森药业有限公司 | 利培酮半抗原的抗体及其用途 |
NZ748572A (en) | 2012-09-19 | 2020-07-31 | Alkermes Pharma Ireland Ltd | Pharmaceutical compositions having improved storage stability |
AR096131A1 (es) | 2013-04-30 | 2015-12-09 | Otsuka Pharma Co Ltd | Preparado oral sólido que comprende aripiprazol y un método para producir un preparado oral sólido que comprende aripiprazol |
CN105246461B (zh) * | 2013-04-30 | 2018-03-30 | 大塚制药株式会社 | 包含阿立哌唑的口服固体制剂以及用于产生包含阿立哌唑的口服固体制剂的方法 |
US10525057B2 (en) | 2013-09-24 | 2020-01-07 | Otsuka Pharmaceutical Co., Ltd. | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
AU2015231278B2 (en) | 2014-03-20 | 2020-01-23 | Alkermes Pharma Ireland Limited | Aripiprazole formulations having increased injection speeds |
US10016415B2 (en) | 2014-08-18 | 2018-07-10 | Alkermes Pharma Ireland Limited | Aripiprazole prodrug compositions |
SI3508196T1 (sl) | 2014-08-18 | 2021-12-31 | Alkermes Pharma Ireland Limited, | Sestavki aripiprazolnega predzdravila |
EP3185867B1 (en) * | 2014-08-25 | 2021-01-13 | Alkermes Pharma Ireland Limited | Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia |
WO2016189504A1 (en) * | 2015-05-28 | 2016-12-01 | Leiutis Pharmaceuticals Pvt Ltd | Non-lyophilized compositions of aripiprazole and methods of preparation thereof |
CN106474058B (zh) | 2015-08-31 | 2020-01-07 | 南京诺瑞特医药科技有限公司 | 具有延长的保质期的阿立哌唑可注射悬浮液制剂 |
TWI584823B (zh) * | 2015-08-31 | 2017-06-01 | 諾瑞特國際藥業股份有限公司 | 具有延長的保存期限的阿立哌唑可注射懸浮液製劑 |
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US10444250B2 (en) | 2015-12-17 | 2019-10-15 | Janssen Pharmaceutica Nv | Antibodies to risperidone and use thereof |
CN105663057A (zh) * | 2015-12-30 | 2016-06-15 | 中国药科大学 | 阿立哌唑长效混悬剂及其制备方法 |
AU2017303975A1 (en) * | 2016-07-28 | 2019-03-21 | Mylan Laboratories Ltd, | Process for preparing sterile aripiprazole formulation |
AU2019230014A1 (en) | 2018-03-05 | 2020-09-17 | Alkermes Pharma Ireland Limited | Aripiprazole dosing strategy |
CN108498456B (zh) | 2018-05-16 | 2021-01-01 | 丽珠医药集团股份有限公司 | 一种阿立哌唑缓释微球及其制备方法 |
CN110327296B (zh) * | 2019-08-06 | 2021-10-22 | 深圳市泛谷药业股份有限公司 | 一种阿立哌唑长效注射制剂及其制备方法 |
KR102486564B1 (ko) * | 2019-08-23 | 2023-01-19 | 주식회사 대웅테라퓨틱스 | 니클로사마이드 지연방출 조성물 및 이의 항바이러스 용도 |
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AU2021245713A1 (en) * | 2020-04-01 | 2022-12-01 | Otsuka Pharmaceutical Co., Ltd. | Methods for dose initiation of aripiprazole treatments |
KR102606504B1 (ko) * | 2020-04-10 | 2023-11-29 | 주식회사 대웅테라퓨틱스 | 니클로사마이드를 포함하는 폐고혈압의 예방 및 치료용 조성물 |
WO2021233402A1 (zh) * | 2020-05-21 | 2021-11-25 | 江苏先声药业有限公司 | 一种含依匹哌唑药物组合物及其制备方法 |
CN112656761B (zh) * | 2020-12-30 | 2023-09-08 | 河南合智医药科技有限公司 | 一种低刺激性阿立哌唑前药的油溶缓释注射制剂及其制备方法 |
EP4043008A1 (en) | 2021-02-15 | 2022-08-17 | Warszawskie Zaklady Farmaceutyczne Polfa S.A. | Method for the preparation of a pharmaceutical composition comprising aripiprazole |
HUP2100259A1 (hu) | 2021-07-07 | 2023-01-28 | Richter Gedeon Nyrt | Cariprazine tartalmú szabályozott hatóanyag-leadású injekciós készítmények |
CN115554253B (zh) * | 2022-10-14 | 2024-03-29 | 浙江圣兆药物科技股份有限公司 | 一种平稳释药的注射用阿立哌唑冻干制剂及其制备方法 |
GR1010656B (el) * | 2023-03-23 | 2024-03-21 | Φαρματεν Α.Β.Ε.Ε., | Φαρμακευτικο σκευασμα που περιλαμβανει εναν ατυπο αντιψυχωσικο παραγοντα και μεθοδος για την παρασκευη αυτου |
GR1010624B (el) * | 2023-03-23 | 2024-01-30 | Φαρματεν Α.Β.Ε.Ε., | Φαρμακευτικο σκευασμα που περιλαμβανει αριπιπραζολη και μεθοδος για την παρασκευη αυτου |
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