Formulation processes for lipophilic proteins

Details Formulation processes for lipophilic proteins Formulation processes for lipophilic proteins

1995-06-07

1997-07-01

Ulm, John

Drug, bio-affecting and body treating compositions

Lymphokine

Interferon

424 856, 424 852, 530351, A61K 3820, A61K 3821

Patent

active

056435665

ABSTRACT:
Highly stable, pharmaceutical compositions comprising a therapeutically effective amount of a biologically active recombinant lipophilic protein such as human .beta.-interferon and interleukin-2 dissolved in a non-toxic, inert, therapeutically compatible aqueous-based carrier at pH ranges of from about 6.8 to 7.8 and about 8.5 to 10, which formulations contain a stabilizer for the protein selected from the group comprising human serum album, human serum albumin and dextrose or human plasma protein fraction, and at a pH range of from about 2 to 4, which latter formulations optionally contain a carbohydrate and/or protein stabilizer, are disclosed. Further, preferred formulation processes to prepare said compositions are described which avoid highly alkaline conditions.

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