http://rdf.ncbi.nlm.nih.gov/pubchem/patent/AU-2020201000-A1

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filingDate 2020-02-12-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_25673ea06003d5941ccf16ad265ba4b6
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publicationDate 2020-02-27-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AU-2020201000-A1
titleOfInvention High-purity inhalable particles of insulin and insulin analogues, and high-efficiency methods of manufacturing the same
abstract HIGH-PURITY INHALABLE PARTICLES OF INSULIN AND INSULIN ANALOGUES, AND HIGH-EFFICIENCY METHODS OF MANUFACTURING THE SAME 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) 10 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 pm, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable 15 insulin material. The yield rate for the high-efficiency method is 75 to 85% or more. -44-
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