LYOPHILIZED SOMATOTROPIN FORMULATIONS - Patent Pending

ABSTRACT:
Somatotropin solutions which remain clear for extended periods
and which remain clear when subjected to mechanical agitation are
prepared by mixing a lyophilized somatotropin composition
containing about 1 part somatotropin per 2 to 8 parts arginine HC1 on a
weight basis, wherein the pH of the composition prior to
lyophilization was about 7.2 to about 8.5, and a biocompatible diluent
which comprises EDTA and a nonionic surfactant. If the pH of the
somatotropin composition prior to lyophilization was between 7.2 and
7.8, the diluent further comprises a buffer; otherwise the
diluent optionally further can comprise a buffer or nonbuffering
agent.
(72) Inventors (Country): SEELY, JAMES E. (United States)
HULBERT, MATTHEW H. (United States)
RICHEY, CARL W., JR. (United States)
AUER, HENRY E. (United States)
(73) Owners (Country): MALLINCKRODT VETERINARY, INC. (United States)
(71) Applicants (Country):
(74) Agent: OSLER, HOSKIN & HARCOURT LLP
(45) Issued:
(86) PCT Filing Date: Apr. 5 , 1993
(87) PCT Publication Date: Oct. 14, 1993
Examination requested: Oct. 5 , 1994
(51) International Class (IPC): A61K 9/08
A61K 9/14
A61K 47/26
A61K 38/27
Patent Cooperation Treaty (PCT): Yes (85) National Entry: Oct. 5 , 1994
(86) PCT Filing number: PCT/US1993/003182
(87) International publication number: WO1993/019773