AR037138A1 - Formulacion farmaceutica, uso de fulvestrant en la preparacion de la misma y jeringa o vial esteriles que comprenden dicha formulacion - Google Patents
Formulacion farmaceutica, uso de fulvestrant en la preparacion de la misma y jeringa o vial esteriles que comprenden dicha formulacionInfo
- Publication number
- AR037138A1 AR037138A1 ARP020102523A ARP020102523A AR037138A1 AR 037138 A1 AR037138 A1 AR 037138A1 AR P020102523 A ARP020102523 A AR P020102523A AR P020102523 A ARP020102523 A AR P020102523A AR 037138 A1 AR037138 A1 AR 037138A1
- Authority
- AR
- Argentina
- Prior art keywords
- pharmaceutical formulation
- formulation
- weight
- fulvestrant
- vehicle
- Prior art date
Links
Classifications
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- 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
- A61K47/06—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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Abstract
Formulación farmacéutica de liberación sostenida adaptada para administrar por inyección que contiene el compuesto 7-alfa-[9-(4,4,5,5,5-pentafluoropentilsulfinil)nonil]estra-1, 3, 5(10)-trieno-3,17-beta-diol, Fulvestrant, que contiene una alta concentración de dicho compuesto, más en particular a una formulación adaptada para administrar por inyección que contiene el compuesto 7-alfa-[9-(4,4,5,5,5-pentafluoropentilsulfinil)nonil]estra-1, 3, 5(10)-trieno-3,17-beta-diol (por lo menos 100mg/ml) en solución en un vehículo de ricinoleato que comprende adicionalmente por lo menos un alcohol y un solvente éster no acuoso miscible en el vehículo de ricinoleato. Dicha formulación farmacéutica adaptada para inyección intramuscular comprende 100mg/ml o más de fulvestrant, 10% en peso o más de un alcohol farmacéuticamente aceptable por volumen de formulación farmacéutica, 5% en peso o más de un solvente éster no acuoso farmacéuticamente aceptable por volumen de formulación farmacéutica y 5% en peso o más de excipiente ricinoleato por volumen de formulación farmacéutica siempre y cuando: a) la formulación farmacéutica comprenda por lo menos un 5% en peso etanol por volumen de formulación farmacéutica; b) si el alcohol farmacéuticamente aceptable es menor o igual que un 13% entonces la formulación farmacéutica debe comprender por lo menos un 50% de solvente éster no acuoso; y c) si el alcohol farmacéuticamente aceptable es más de un 20% pero menor o igual que 25%, entonces la formulación farmacéutica debe comprender por lo menos un 30% de solvente éster no acuoso; y también siempre y cuando se excluya la siguiente formulación farmacéutica: fulvestrant hasta 102mg/ml, 15% en peso de etanol por volumen de vehículo de formulación, 15% en peso de alcohol bencílico por volumen de vehículo de formulación, 15% en peso de benzoato de bencilo por volumen de vehículo de formulación y 30% en peso más de excipiente ricinoleato por volumen de vehículo de formulación. El fulvestrant se usa en la preparación de estas formulaciones farmacéuticas que se utilizan en el tratamiento de una enfermedad benigna o maligna de las mamas o del tracto reproductor en un humano.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0116619.8A GB0116619D0 (en) | 2001-07-07 | 2001-07-07 | Formulation |
| US31571101P | 2001-08-30 | 2001-08-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR037138A1 true AR037138A1 (es) | 2004-10-27 |
Family
ID=26246290
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP020102523A AR037138A1 (es) | 2001-07-07 | 2002-07-05 | Formulacion farmaceutica, uso de fulvestrant en la preparacion de la misma y jeringa o vial esteriles que comprenden dicha formulacion |
Country Status (15)
| Country | Link |
|---|---|
| EP (1) | EP1406662A1 (es) |
| JP (1) | JP2004534093A (es) |
| CN (1) | CN1553815A (es) |
| AR (1) | AR037138A1 (es) |
| BR (1) | BR0210898A (es) |
| CA (1) | CA2453111A1 (es) |
| CO (1) | CO5560585A2 (es) |
| HU (1) | HUP0400115A3 (es) |
| IL (1) | IL159576A0 (es) |
| IS (1) | IS7097A (es) |
| MX (1) | MXPA04000028A (es) |
| NO (1) | NO20040047L (es) |
| PL (1) | PL367624A1 (es) |
| RU (1) | RU2004102393A (es) |
| WO (1) | WO2003006064A1 (es) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0000313D0 (en) | 2000-01-10 | 2000-03-01 | Astrazeneca Uk Ltd | Formulation |
| JP5809624B2 (ja) | 2009-08-31 | 2015-11-11 | シーアン リーバン ファーマシューティカル テクノロジー シーオー．， エルティーディー．Ｘｉ’Ａｎ Ｌｉｂａｎｇ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｔｅｃｈｎｏｌｏｇｙ Ｃｏ．， Ｌｔｄ． | フルベストラントナノスフェア／ミクロスフェア並びにその調製方法及び使用 |
| CN102600065B (zh) * | 2012-03-31 | 2014-08-13 | 莱普德制药有限公司 | 一种氟维司群或其衍生物油性制剂及其制备方法 |
| CN102600073B (zh) | 2012-03-31 | 2014-01-01 | 莱普德制药有限公司 | 以乳酸酯为基础的氟维司群或其衍生物油性制剂及其制备方法 |
| CN102600064A (zh) * | 2012-03-31 | 2012-07-25 | 西安力邦制药有限公司 | 氟维司群或其衍生物缓释制剂及其制备方法 |
| US9271990B2 (en) | 2014-02-14 | 2016-03-01 | Fresenius Kabi Usa, Llc | Fulvestrant formulations |
| CN108883118B (zh) | 2016-04-06 | 2021-06-15 | 富士胶片株式会社 | 医药组合物 |
| IL285928B1 (en) * | 2016-05-06 | 2025-02-01 | Eagle Pharmaceuticals Inc | Fulvestrant formulations and methods of using them |
| US11590077B2 (en) | 2016-05-06 | 2023-02-28 | Eagle Pharmaceuticals, Inc. | Fulvestrant formulations and methods of their use |
| CN109152785B (zh) | 2016-05-31 | 2021-02-09 | 富士胶片株式会社 | 医药组合物 |
| IL274433B2 (en) | 2017-11-08 | 2024-07-01 | Eagle Pharmaceuticals Inc | Fulvestrant formulations and methods of their use |
| US20210169897A1 (en) * | 2017-12-07 | 2021-06-10 | Nevakar Inc. | Concentrated Fulvestrant Compositions |
| CN111465398A (zh) * | 2018-01-31 | 2020-07-28 | 富士胶片株式会社 | 注射用制剂的制造方法 |
| CN111481559B (zh) * | 2019-01-25 | 2021-10-08 | 江苏恒瑞医药股份有限公司 | 一种高浓度的氟维司群组合物及其制备方法 |
| CN113260353B (zh) * | 2019-12-11 | 2024-11-29 | 上海云晟研新生物科技有限公司 | 氟维司群药物组合物、其制备方法及应用 |
| CN118717660B (zh) * | 2024-06-12 | 2025-02-28 | 湖州亚瑟制药有限公司 | 一种注射用氟维司群药物组合物及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8813353D0 (en) * | 1988-06-06 | 1988-07-13 | Ici Plc | Therapeutic product |
| GB9525194D0 (en) * | 1995-12-12 | 1996-02-07 | Zeneca Ltd | Pharmaceutical composition |
| GB0000313D0 (en) * | 2000-01-10 | 2000-03-01 | Astrazeneca Uk Ltd | Formulation |
| GB0008172D0 (en) * | 2000-04-05 | 2000-05-24 | Astrazeneca Ab | Therapy |
-
2002
- 2002-07-03 EP EP02740940A patent/EP1406662A1/en not_active Withdrawn
- 2002-07-03 BR BR0210898-4A patent/BR0210898A/pt not_active IP Right Cessation
- 2002-07-03 CN CNA028171888A patent/CN1553815A/zh active Pending
- 2002-07-03 JP JP2003511869A patent/JP2004534093A/ja active Pending
- 2002-07-03 IL IL15957602A patent/IL159576A0/xx unknown
- 2002-07-03 HU HU0400115A patent/HUP0400115A3/hu unknown
- 2002-07-03 PL PL02367624A patent/PL367624A1/xx not_active Application Discontinuation
- 2002-07-03 RU RU2004102393/15A patent/RU2004102393A/ru not_active Application Discontinuation
- 2002-07-03 WO PCT/GB2002/003092 patent/WO2003006064A1/en not_active Application Discontinuation
- 2002-07-03 CA CA002453111A patent/CA2453111A1/en not_active Abandoned
- 2002-07-05 AR ARP020102523A patent/AR037138A1/es not_active Application Discontinuation
-
2004
- 2004-01-05 IS IS7097A patent/IS7097A/is unknown
- 2004-01-06 NO NO20040047A patent/NO20040047L/no not_active Application Discontinuation
- 2004-01-07 MX MXPA04000028A patent/MXPA04000028A/es unknown
- 2004-01-07 CO CO04000761A patent/CO5560585A2/es not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CN1553815A (zh) | 2004-12-08 |
| HUP0400115A3 (en) | 2005-11-28 |
| CA2453111A1 (en) | 2003-01-23 |
| WO2003006064A1 (en) | 2003-01-23 |
| PL367624A1 (en) | 2005-03-07 |
| JP2004534093A (ja) | 2004-11-11 |
| IS7097A (is) | 2004-01-05 |
| BR0210898A (pt) | 2004-06-22 |
| NO20040047L (no) | 2004-02-23 |
| RU2004102393A (ru) | 2005-03-27 |
| EP1406662A1 (en) | 2004-04-14 |
| CO5560585A2 (es) | 2005-09-30 |
| IL159576A0 (en) | 2004-06-01 |
| HUP0400115A2 (hu) | 2004-06-28 |
| MXPA04000028A (es) | 2004-05-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA | Abandonment or withdrawal |