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专利概况
专利名称 Insulin analogs and insulin inhalation particles of high purity, as well as the production of high efficiency
申请号 JP2018535397 申请日
公开(公告)号 JP2019505519A 公开(公告)日 2016-01-08
申请(专利权)人 发明人 ジェフリー ティン; アイリー ボー; マリー ツーピン ルオ; ジャック ヨンフォン チャン
专利来源 国家知识产权局 转化方式
摘要

A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics : (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 μm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.

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