AR106449A2 - Formulación inyectable de aripiprazol estéril de liberación controlada la cual, después de la inyección, libera aripiprazol, una formulación de aripiprazol estéril de liberación controlada secada por congelamiento, y un método para su preparación - Google Patents
Formulación inyectable de aripiprazol estéril de liberación controlada la cual, después de la inyección, libera aripiprazol, una formulación de aripiprazol estéril de liberación controlada secada por congelamiento, y un método para su preparaciónInfo
- Publication number
- AR106449A2 AR106449A2 ARP160103230A ARP160103230A AR106449A2 AR 106449 A2 AR106449 A2 AR 106449A2 AR P160103230 A ARP160103230 A AR P160103230A AR P160103230 A ARP160103230 A AR P160103230A AR 106449 A2 AR106449 A2 AR 106449A2
- Authority
- AR
- Argentina
- Prior art keywords
- sterile
- formulation
- aripiprazol
- aripiprazole
- injection
- 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 abstract 12
- 238000009472 formulation Methods 0.000 title abstract 6
- 239000000203 mixture Substances 0.000 title abstract 6
- 239000007972 injectable composition Substances 0.000 title abstract 3
- 238000002347 injection Methods 0.000 title abstract 3
- 239000007924 injection Substances 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 3
- 238000002360 preparation method Methods 0.000 title abstract 2
- 238000001035 drying Methods 0.000 title 1
- 229960004372 aripiprazole Drugs 0.000 abstract 9
- 239000000725 suspension Substances 0.000 abstract 6
- 239000002245 particle Substances 0.000 abstract 4
- 238000013270 controlled release Methods 0.000 abstract 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 2
- 239000008215 water for injection Substances 0.000 abstract 2
- 238000004108 freeze drying Methods 0.000 abstract 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)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Una formulación inyectable estéril de aripiprazol, de liberación controlada la cual, después de la inyección, libera aripiprazol, que comprende: (a) aripipriopazol con un tamaño de partícula medio de 1 a 10 mm, (b) un vehículo para este, y (c) agua para inyección, en donde la formulación está en la forma de una suspensión estéril homogénea. Una formulación de aripiprazol estéril de liberación controlada secada por congelamiento, y un método para su preparación. Reivindicación 1: Una formulación inyectable estéril de aripiprazol, de liberación controlada la cual, después de la inyección, libera aripiprazol, caracterizada porque comprende: (a) aripipriopazol con un tamaño de partícula medio de 1 a 10 mm, (b) un vehículo para este, y (c) agua para inyección, en donde la formulación esté en la forma de una suspensión estéril homogénea. Reivindicación 22: Un método para preparar la formulación secada por congelamiento estéril de conformidad con la reivindicación 16, caracterizado porque comprende los pasos de: (a) preparar aripiprazol en volumen estéril, que tiene una distribución de tamaño de partícula deseada, (b) preparar un vehículo estéril para el aripiprazol en volumen estéril, (c) combinar dicho aripiprazol estéril y dicho vehículo estéril para formar una suspensión primaria estéril, (d) reducir el tamaño de partícula promedio de aripiprazol en dicha suspensión primaria estéril dentro del rango de 1 a 10 mm para formar una suspensión estéril final, y (e) secar por congelamiento dicha suspensión final estéril para formar la formulación secado por congelamiento.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US51361803P | 2003-10-23 | 2003-10-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR106449A2 true AR106449A2 (es) | 2018-01-17 |
Family
ID=34549292
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP040103849A AR046141A1 (es) | 2003-10-23 | 2004-10-22 | Formulacion de aripripazol inyectable, esteril, de liberacion controlada y metodo |
| ARP160103230A AR106449A2 (es) | 2003-10-23 | 2016-10-21 | Formulación inyectable de aripiprazol estéril de liberación controlada la cual, después de la inyección, libera aripiprazol, una formulación de aripiprazol estéril de liberación controlada secada por congelamiento, y un método para su preparación |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP040103849A AR046141A1 (es) | 2003-10-23 | 2004-10-22 | Formulacion de aripripazol inyectable, esteril, de liberacion controlada y metodo |
Country Status (32)
| Country | Link |
|---|---|
| US (12) | US7807680B2 (es) |
| EP (1) | EP1675573B2 (es) |
| JP (2) | JP4836797B2 (es) |
| KR (1) | KR100931784B1 (es) |
| CN (1) | CN1870980B (es) |
| AR (2) | AR046141A1 (es) |
| AT (1) | ATE411797T2 (es) |
| AU (1) | AU2004285448C1 (es) |
| BR (1) | BRPI0415531B8 (es) |
| CA (1) | CA2543242C (es) |
| CO (1) | CO5690539A2 (es) |
| CY (2) | CY1109040T1 (es) |
| DE (1) | DE602004017342D1 (es) |
| DK (1) | DK1675573T4 (es) |
| EC (2) | ECSP066512A (es) |
| ES (1) | ES2315721T5 (es) |
| FR (1) | FR14C0039I1 (es) |
| GE (1) | GEP20115205B (es) |
| IL (1) | IL175072A (es) |
| LU (1) | LU92427I2 (es) |
| MX (1) | MXPA06004489A (es) |
| MY (1) | MY146093A (es) |
| NO (2) | NO334919B1 (es) |
| NZ (1) | NZ546063A (es) |
| PE (1) | PE20050811A1 (es) |
| PL (1) | PL1675573T4 (es) |
| PT (1) | PT1675573E (es) |
| SI (1) | SI1675573T2 (es) |
| TW (2) | TWI383810B (es) |
| UA (1) | UA82561C2 (es) |
| WO (1) | WO2005041937A2 (es) |
| ZA (1) | ZA200602347B (es) |
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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 |
| CA2543242C (en) | 2003-10-23 | 2015-04-14 | Otsuka Pharmaceutical Co., Ltd. | Controlled release sterile freeze-dried aripiprazole formulation and injectable formulation thereof |
| EP1812397A1 (en) * | 2004-11-18 | 2007-08-01 | Synthon B.V. | Process of making crystalline aripiprazole |
| EP1933814A2 (en) * | 2005-09-15 | 2008-06-25 | Elan Pharma International Limited | Nanoparticulate aripiprazole formulations |
| US8158152B2 (en) * | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
| EP1808164B2 (en) | 2006-01-05 | 2018-07-04 | Teva Pharmaceutical Industries Ltd | Wet granulation method for preparing pharmaceutical compositions of aripiprazole |
| WO2007081367A1 (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 |
| ES2529746T3 (es) * | 2007-06-25 | 2015-02-25 | Otsuka Pharmaceutical Co., Ltd. | Microesferas con una estructura de núcleo/cáscara |
| PT2170279T (pt) * | 2007-07-31 | 2018-04-06 | Otsuka Pharma Co Ltd | Métodos para produção de suspensão de aripiprazole e formulação liofilizada |
| CA2763456C (en) | 2009-05-27 | 2017-10-24 | Alkermes Pharma Ireland Limited | 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 |
| PH12012502076A1 (en) | 2010-08-24 | 2013-02-04 | 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 |
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| PL2888593T3 (pl) * | 2012-08-21 | 2019-02-28 | Janssen Pharmaceutica Nv | Przeciwciała przeciwko rysperydonowi i ich zastosowanie |
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