Improved process for preparing micronized polypeptide drugs

Details Improved process for preparing micronized polypeptide drugs Improved process for preparing micronized polypeptide drugs

A - Human Necessities

61

K

A61K 9/14 (2006.01) A61K 38/19 (2006.01) A61K 38/21 (2006.01) A61K 38/27 (2006.01)

Patent

CA 2127877

2127877 9313752 PCTABS00024 Solid particle aerosol formulations of polypeptide drugs are made by lyophilizing solutions of the drugs which contain milling stabilizers that inhibit degradation of the drug during subsequent milling. The lyophilized drug is milled in fluid energy mills that have been fitted with abrasion-resistant materials and which use pure nitrogen that has been filtered to eliminate particles of greater than 0.1 µm to transport the drug. The use of (a) milling stabilizers in the solution and (b) abrasion-resistant fluid energy mills that use pure filtered nitrogen in the milling step reduce insoluble contaminants and inactive fractions in the milled product.

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