BR0210898A - Pharmaceutical formulation, unit dose thereof, use of powder in the preparation of a pharmaceutical formulation, and sterile syringe or vial - Google Patents

Pharmaceutical formulation, unit dose thereof, use of powder in the preparation of a pharmaceutical formulation, and sterile syringe or vial

Info

Publication number
BR0210898A
BR0210898A BR0210898-4A BR0210898A BR0210898A BR 0210898 A BR0210898 A BR 0210898A BR 0210898 A BR0210898 A BR 0210898A BR 0210898 A BR0210898 A BR 0210898A
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
preparation
unit dose
vial
powder
Prior art date
Application number
BR0210898-4A
Other languages
Portuguese (pt)
Inventor
Julie Kay Cahill
Paul Richard Gellert
Alan Marshall Irving
Original Assignee
Astrazeneca Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB0116619.8A external-priority patent/GB0116619D0/en
Application filed by Astrazeneca Ab filed Critical Astrazeneca Ab
Publication of BR0210898A publication Critical patent/BR0210898A/en

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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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

"FORMULAçãO FARMACêUTICA, DOSE UNITáRIA DA MESMA, USO DE FULVESTRANTE NA PREPARAçãO DE UMA FORMULAçãO FARMACêUTICA, E, SERINGA OU FRASCO ESTéRIL". A invenção refere-se a uma formulação farmacêutica de liberação sustentada, adaptada para administração por injeção contendo o composto fulvestrante, 7 <244>-[9-(4,4,5,5,5-pentafluoropentilsulfinil)nonil] estra-1,3,5-(10)-trieno-3,17 <225>-diol, na concentração de pelo menos 100 mg/ml em solução em um veículo de ricinoleato que, adicionalmente, compreende pelo menos um álcool e um solvente de éster não-aquoso, que é miscível no veículo de ricinoleato."PHARMACEUTICAL FORMULATION, UNIT DOSE OF THE SAME, USE OF FULVESTRANT IN THE PREPARATION OF A PHARMACEUTICAL FORMULATION, AND SYRINGE OR STERILE BOTTLE". The invention relates to a sustained release pharmaceutical formulation adapted for injection administration containing the fulvestrant compound, 7? - [9- (4,4,5,5,5-pentafluoropentylsulfinyl) nonyl] estra-1, 3,5- (10) -trieno-3,17? -Diol, at a concentration of at least 100 mg / ml in solution in a ricinoleate carrier which additionally comprises at least one alcohol and one non-ester ester solvent - aqueous, which is miscible in the ricinoleate vehicle.

BR0210898-4A 2001-07-07 2002-07-03 Pharmaceutical formulation, unit dose thereof, use of powder in the preparation of a pharmaceutical formulation, and sterile syringe or vial BR0210898A (en)

Applications Claiming Priority (3)

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
PCT/GB2002/003092 WO2003006064A1 (en) 2001-07-07 2002-07-03 Pharmaceutical formulation for the intramuscular administration of fulvestrant

Publications (1)

Publication Number Publication Date
BR0210898A true BR0210898A (en) 2004-06-22

Family

ID=26246290

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0210898-4A BR0210898A (en) 2001-07-07 2002-07-03 Pharmaceutical formulation, unit dose thereof, use of powder in the preparation of a pharmaceutical formulation, and sterile syringe or vial

Country Status (15)

Country Link
EP (1) EP1406662A1 (en)
JP (1) JP2004534093A (en)
CN (1) CN1553815A (en)
AR (1) AR037138A1 (en)
BR (1) BR0210898A (en)
CA (1) CA2453111A1 (en)
CO (1) CO5560585A2 (en)
HU (1) HUP0400115A3 (en)
IL (1) IL159576A0 (en)
IS (1) IS7097A (en)
MX (1) MXPA04000028A (en)
NO (1) NO20040047L (en)
PL (1) PL367624A1 (en)
RU (1) RU2004102393A (en)
WO (1) WO2003006064A1 (en)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0000313D0 (en) 2000-01-10 2000-03-01 Astrazeneca Uk Ltd Formulation
CN102264372B (en) 2009-08-31 2012-07-11 西安力邦医药科技有限责任公司 Fulvestrant nanosphere/microsphere and preparative method and use thereof
CN102600064A (en) * 2012-03-31 2012-07-25 西安力邦制药有限公司 Fulvestrant or fulvestrant derivative sustained release preparation and preparation method thereof
CN102600073B (en) * 2012-03-31 2014-01-01 莱普德制药有限公司 Lactate-based fulvestrant or fulvestrant derivative oily preparation and preparation method of oily preparation
CN102600065B (en) * 2012-03-31 2014-08-13 莱普德制药有限公司 Fulvestrant or fulvestrant derivative oily preparation and preparation method thereof
US9271990B2 (en) 2014-02-14 2016-03-01 Fresenius Kabi Usa, Llc Fulvestrant formulations
WO2017175810A1 (en) * 2016-04-06 2017-10-12 富士フイルム株式会社 Medicinal composition
US11590077B2 (en) 2016-05-06 2023-02-28 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use
JP2019516789A (en) * 2016-05-06 2019-06-20 イーグル ファーマスーティカルズ、インク． Fulvestrant formulation and method of use thereof
WO2019094650A1 (en) * 2017-11-08 2019-05-16 Eagle Pharmaceuticals, Inc Fulvestrant formulations and methods of their use
WO2017208847A1 (en) 2016-05-31 2017-12-07 富士フイルム株式会社 Pharmaceutical composition
WO2019113361A1 (en) * 2017-12-07 2019-06-13 Nevakar Inc. Concentrated fulvestrant compositions
EP3747442B1 (en) * 2018-01-31 2024-07-10 FUJIFILM Corporation Method for producing preparation for injection
CN111481559B (en) * 2019-01-25 2021-10-08 江苏恒瑞医药股份有限公司 High-concentration fulvestrant composition and preparation method thereof
US20220370359A1 (en) * 2019-12-11 2022-11-24 Shanghai Bocimed Pharmaceutical Co., Ltd. Fulvestrant pharmaceutical composition, preparation method therefor, and application thereof

Family Cites Families (4)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
NO20040047L (en) 2004-02-23
CN1553815A (en) 2004-12-08
EP1406662A1 (en) 2004-04-14
JP2004534093A (en) 2004-11-11
AR037138A1 (en) 2004-10-27
CO5560585A2 (en) 2005-09-30
IS7097A (en) 2004-01-05
IL159576A0 (en) 2004-06-01
HUP0400115A2 (en) 2004-06-28
RU2004102393A (en) 2005-03-27
HUP0400115A3 (en) 2005-11-28
MXPA04000028A (en) 2004-05-21
WO2003006064A1 (en) 2003-01-23
PL367624A1 (en) 2005-03-07
CA2453111A1 (en) 2003-01-23

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 4A,5A,6A E 7A ANUIDADES.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 DA RPI 2029 DE 24/11/2009.