Process for preparing micronized polypeptide drugs

Details Process for preparing micronized polypeptide drugs Process for preparing micronized polypeptide drugs

1993-02-16

1994-10-11

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424 46, A61K 914

Patent

active

053545621

ABSTRACT:
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 .mu.m 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.

REFERENCES:
patent: 4783484 (1988-11-01), Violante
patent: 4900734 (1990-02-01), Maxson
patent: 4940588 (1990-07-01), Sparks
patent: 5011678 (1991-04-01), Wang
patent: 5057321 (1991-10-01), Edgren
Pikal, M. J., "Freeze-Drying of Proteins, Part 1: Process Design", BioPharm (Sep. 1990) pp. 18-27.
Franks, F., "Freeze-Drying: From Empiricism to Predictability", Cryoletters (1990) 11:93-110.

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