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1. JP2009539856 - インシュリン組成物

Office Japan
Application Number 2009514394
Application Date 08.06.2007
Publication Number 2009539856
Publication Date 19.11.2009
Publication Kind A5
IPC
A61K 38/28
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
28Insulins
A61K 9/107
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
107Emulsions
A61K 9/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
12Aerosols; Foams
A61K 47/04
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
02Inorganic compounds
04Non-metals; Compounds thereof
A61K 47/08
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
A61K 47/12
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
12Carboxylic acids; Salts or anhydrides thereof
CPC
A61K 9/0043
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
0043Nose
A61K 9/107
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
107Emulsions ; ; Emulsion preconcentrates; Micelles
A61K 9/1075
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
107Emulsions ; ; Emulsion preconcentrates; Micelles
1075Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
A61K 38/28
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
28Insulins
A61K 47/02
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
02Inorganic compounds
A61K 47/08
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
Applicants シーペックス ファーマシューティカルズ インコーポレイテッド
Inventors ギュリック ロバート ジェイ
レピュッチ カール
リー ゼンマオ
Agents 熊倉 禎男
小川 信夫
箱田 篤
浅井 賢治
平山 孝二
Priority Data 60/811,913 08.06.2006 US
Title
(JA) インシュリン組成物
Abstract
(JA)

インシュリンで患者を治療するための組成物及び方法を開示し、ここで、患者に経鼻放出するのに適した形状にある組成物は、治療的に有効な量のインシュリンと、透過性増強剤と、液状担体と、酸性pHであるが、4.5以下のpHを与えるのに十分な量で前記組成物中に存在する酸とを含み、該酸は、一価の無機酸、硫酸、及び酢酸からなる群から選択される。好ましくは、該組成物は本質的にシトレートを含まず、かつ本質的にホスフェートを含まない。即ち、該組成物は、本質的にフィブリル型(又はβ-シート状)インシュリン多形体を含まない組成物を与えるように設計されている。また、ヒト又は温血動物に経鼻投与するための薬理組成物をも提供し、該薬理組成物は、(A) 治療的に有効な量のインシュリン、(B) 透過性増強剤、及び(C) 液状担体を含み、更に該組成物は以下の各々又は何れかを含み、あるいは特徴として含む:(D) ノニオン性界面活性剤の組合せ、ここで該ノニオン性界面活性剤の組合せは、(i) 少なくとも1種の、糖又は糖アルコールの脂肪酸エステル及び(ii) 少なくとも1種の、糖又は糖アルコールの、ペジレート化脂肪酸エステルを含む;(E) 該組成物は、酸性pHであるが、4.5以下のpHを持つ;及び(F) 該組成物の浸透性は、<200 mOsmol/Kg H2Oである。