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長時間作用型コロイド状インスリン製剤及びその調製
专利权人:
フラメル・テクノロジー
发明人:
コンスタンス アラン,ニコラス フロランス,ムイリュー レミ,スーラ オリヴィエ
申请号:
JP2007521993
公开号:
JP4961343B2
申请日:
2005.06.09
申请国别(地区):
JP
年份:
2012
代理人:
摘要:
The invention relates to injectable long-acting insulin formulations for the treatment of types I and II diabetes in humans and animals. The essential object of the invention is to provide an injectable long-acting insulin formulation in the form of a colloidal suspension which is stable, which has a good local tolerance and toxicity compatible with the chronic treatment of diabetics, and which maintains a substantial hypoglycemic effect extending over at least 24 hours after a single administration, e.g. by the subcutaneous route. To achieve this object, the invention relates to a stable aqueous colloidal formulation of insulin-laden nanoparticles of at least one poly(Leu-block-Glu) in which the pH is between 5.8 and 7.0, the osmolarity O (in mOsmol) . . . : 270&nlEO&nlE800, and the viscosity v (in mPa·s) is low, namely v&nlE40. The nanoparticles of poly(Leu-block-Glu) have a mean hydrodynamic diameter Dh such that: 15&nlEDh&nlE40. The invention relates to an antidiabetic drug based on this long-acting insulin formulation and injectable using needles of gauge 29 G, 30 G or 31 G.
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中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/
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