DING, JEFFREY,BO, AILI,LUO, MARY ZIPING,ZHANG, JACK YONGFENG
申请号：
CA3010211
公开号：
CA3010211A1
申请日:
2016.01.08
申请国别(地区):
CA
年份:
2017
代理人:
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.
