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HIGH-PURITY INHALABLE PARTICLES OF INSULIN AND INSULIN ANALOGUES, AND HIGH-EFFICIENCY METHODS OF MANUFACTURING THE SAME
专利权人:
发明人:
申请号:
EP16711707.6
公开号:
EP3399961A1
申请日:
2016.01.08
申请国别(地区):
EP
年份:
2018
代理人:
摘要:
A kind of high-purity may be inhaled the material of insulin, and preparation is used for lungs drug, including insulin granule in micron and has following features with partial size. The purity of (I) is not less than 96% basal insulin It is no more than 2% in the total amount of (II) of abstinence from alcohol disease impurity related with insulin The total amount of (III) solvent impurity does not have lungs product of cosolvent formulation components, is no more than 0.03% The total amount of (IV) non-solvent impurities is no more than 0.3%. The partial size of the inhalable insulin of the insulin granule of most 99% volume % is less than 5 μm, the insulin granule based on total amount. A kind of efficient method, which prepares high-purity, may be inhaled insulin material. The efficient method of yield is 75 to 85% or more.
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