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1. WO2017208847 - PHARMACEUTICAL COMPOSITION

Publication Number WO/2017/208847
Publication Date 07.12.2017
International Application No. PCT/JP2017/018739
International Filing Date 18.05.2017
IPC
A61K 31/565 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopentahydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
A61K 47/10 2017.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols ; Poloxamers; PEG/POE alkyl ethers
A61K 47/14 2017.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen
14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 9/08 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
A61P 35/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
A61P 5/32 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
5Drugs for disorders of the endocrine system
24of the sex hormones
32Antioestrogens
CPC
A61K 31/565
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
565not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
A61K 47/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
A61K 47/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/44
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
44Oils, 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
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
A61K 9/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
Applicants
  • 富士フイルム株式会社 FUJIFILM CORPORATION [JP]/[JP]
Inventors
  • 谷坂 浩輝 TANISAKA, Hiroki
  • 千賀 京子 SENGA, Kyoko
Agents
  • 特許業務法人太陽国際特許事務所 TAIYO, NAKAJIMA & KATO
Priority Data
2016-10926831.05.2016JP
Publication Language Japanese (ja)
Filing Language Japanese (JA)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITION
(FR) PRÉPARATION PHARMACEUTIQUE
(JA) 医薬組成物
Abstract
(EN) A pharmaceutical composition including 4.5-10.0 mass% of fulvestrant relative to the total mass of the pharmaceutical composition, 8-23 mass% of at least one polyhydric alcohol selected from propylene glycol and 1,3-butylene glycol relative to the total mass of the pharmaceutical composition, 5-24 mass% of benzyl alcohol relative to the total mass of the pharmaceutical composition, 8-19 mass% of benzyl benzoate relative to the total mass of the pharmaceutical composition, and castor oil. The content of ethanol is less than 1 mass% relative to the total mass of the pharmaceutical composition, and the content of benzoic acid is less than 1 mass% relative to the total mass of the pharmaceutical composition.
(FR) L'invention porte sur une formule pharmaceutique composée de 4,5 à 10,0 % de fulvestrant, de 8 à 23 % d'au moins un alcool polyhydrique, soit le propylène glycol, ou le 1,3-butylène glycol; de 5 à 24 % d'alcool benzylique; de 8 à 19 % de benzoate de benzyle et de l'huile de ricin. Les teneurs en éthanol et en acide benzoïque sont inférieurs à 1 %.
(JA) 医薬組成物の全質量に対して4.5質量%以上10.0質量%以下のフルベストラントと、医薬組成物の全質量に対して8質量%以上23質量%以下の、プロピレングリコール及び1,3-ブチレングリコールから選ばれる少なくとも1種の多価アルコールと、医薬組成物の全質量に対して5質量%以上24質量%以下のベンジルアルコールと、医薬組成物の全質量に対して8質量%以上19質量%以下の安息香酸ベンジルと、ヒマシ油と、を含み、エタノールの含有率が医薬組成物の全質量に対して1質量%未満であり、安息香酸の含有率が医薬組成物の全質量に対して1質量%未満である医薬組成物。
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